WorldWideScience

Sample records for oncology drugs advisory

  1. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2010-12-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee...

  2. 75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-11-23

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee....

  3. 77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-06-25

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Oncologic Drugs Advisory Committee. This meeting...

  4. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... committee have been resolved. FOR FURTHER INFORMATION CONTACT: Caleb Briggs, Center for Drug Evaluation...

  5. 76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  6. 76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  7. 76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-02

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  8. 75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-02

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  9. 75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-06

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  10. 77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-06

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  11. 76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-26

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  12. 76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-24

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  13. 78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  14. 78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-09

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  15. 77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-24

    ...] [FR Doc No: 2012-12588] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of...

  16. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Science.gov (United States)

    2013-02-25

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Medical Imaging Drugs Advisory...: Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee. General Function of... Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. BILLING CODE 4160-01-P ...

  17. Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews.

    Science.gov (United States)

    Chan, John K; Kiet, Tuyen K; Monk, Bradley J; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S; Amanam, Idoroenyi

    2014-03-01

    Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. All applications referred to the ODAC from 2001 to 2012 were reviewed. Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001-2004, 2005-2008, 2009-2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs.

  18. Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

    Science.gov (United States)

    Kiet, Tuyen K.; Monk, Bradley J.; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S.; Amanam, Idoroenyi

    2014-01-01

    Background Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. Methods All applications referred to the ODAC from 2001 to 2012 were reviewed. Results Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001–2004, 2005–2008, 2009–2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Conclusion. Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs. PMID:24599479

  19. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... plans for four products that are in development for an adult oncology indication. The subcommittee...

  20. 75 FR 66773 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-29

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... were either recently approved by FDA or, are in late stage development for an adult oncology...

  1. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... ] (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... relevance and potential use of such measures in the pediatric development plans of oncology products....

  2. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... late stage development for various adult oncology indications. The subcommittee will consider...

  3. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-05

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of..., are in late stage development for an adult oncology indication, or in late stage development...

  4. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee...

  5. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

    Science.gov (United States)

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

    Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years.

  6. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Science.gov (United States)

    2011-07-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Medical Imaging Drugs.... SUMMARY: The Food and Drug Administration (FDA) is announcing the re- establishment of the Medical Imaging... language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory...

  7. 76 FR 25357 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment

    Science.gov (United States)

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee; Medical Imaging Drugs Advisory Committee... Administration (FDA) is announcing the ] reestablishment of the Medical Imaging Drugs Advisory Committee in the.... 101-635); and 21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical Imaging Drugs...

  8. Quantitative Information on Oncology Prescription Drug Websites.

    Science.gov (United States)

    Sullivan, Helen W; Aikin, Kathryn J; Squiers, Linda B

    2016-09-02

    Our objective was to determine whether and how quantitative information about drug benefits and risks is presented to consumers and healthcare professionals on cancer-related prescription drug websites. We analyzed the content of 65 active cancer-related prescription drug websites. We assessed the inclusion and presentation of quantitative information for two audiences (consumers and healthcare professionals) and two types of information (drug benefits and risks). Websites were equally likely to present quantitative information for benefits (96.9 %) and risks (95.4 %). However, the amount of the information differed significantly: Both consumer-directed and healthcare-professional-directed webpages were more likely to have quantitative information for every benefit (consumer 38.5 %; healthcare professional 86.1 %) compared with every risk (consumer 3.1 %; healthcare professional 6.2 %). The numeric and graphic presentations also differed by audience and information type. Consumers have access to quantitative information about oncology drugs and, in particular, about the benefits of these drugs. Research has shown that using quantitative information to communicate treatment benefits and risks can increase patients' and physicians' understanding and can aid in treatment decision-making, although some numeric and graphic formats are more useful than others.

  9. 75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-31

    ... HUMAN SERVICES Food and Drug Administration Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  10. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-26

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  11. 78 FR 37820 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-24

    ... HUMAN SERVICES Food and Drug Administration Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  12. 77 FR 7587 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of...

  13. 78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-09-17

    ... HUMAN SERVICES Food and Drug Administration Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  14. 76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-07

    ... HUMAN SERVICES Food and Drug Administration Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  15. Drug interactions in female oncologic inpatients: differences among databases

    OpenAIRE

    Patricia Moriel; Jorge Augusto Siqueira; Renata Cavalcanti Carnevale; Caroline de Godoi Rezende Costa; Aline Aparecida da Cruz; Nice Maria Oliveira da Silva; Adélia Corina Bernardes; Roberta Paro Carvalho; Priscila Gava Mazzola

    2013-01-01

    The aim of the present study was to quantify drug interactions in prescriptions for women undergoing supportive therapy in an oncology setting at a women’s hospital in Brazil and compare the information provided by different databases regarding these drug interactions. A convenience sample was selected of prescriptions for patients diagnosed with breast or gynecological tumors hospitalized in the clinical oncology and surgery wards from April to June 2009. DRUGDEX/M...

  16. 75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2010-06-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee... Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This meeting...

  17. 78 FR 13349 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the...

  18. 75 FR 47309 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the...

  19. 76 FR 65736 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the...

  20. Drug repurposing in pediatrics and pediatric hematology oncology.

    Science.gov (United States)

    Blatt, Julie; Corey, Seth J

    2013-01-01

    Drug 'repurposing', that is, using old drugs for new indications, has been proposed as a more efficient strategy for drug development than the current standard of beginning with novel agents. In this review, we explore the scope of drug repurposing in pediatric hematology oncology and in pediatrics in general. Drugs commonly used in children were identified using the Harriet Lane Handbook (HLH) and searched in PubMed for different uses. Additional drugs were identified by searching PubMed and Google.com for 'drug repurposing' or 'drug repositioning'. Almost 10% of drugs with primary uses in pediatrics have been repurposed in pediatric hematology oncology or pediatrics. The observant clinician, pharmacologist and translational bioinformatician, as well as structural targeting, will have a role in discovering new repurposing opportunities.

  1. Precision medicine in oncology drug development: a pharma perspective.

    Science.gov (United States)

    Hollingsworth, Simon J

    2015-12-01

    A rapid expansion in precision medicine founded on the potential for durable clinical benefit through matching a drug to a predictive marker used to select patients has driven the development of targeted drugs with accompanied companion diagnostics for patient selection. Oncology has been at the forefront, with the improvements in patient survival notable. Increasing numbers of molecular subgroups require an equally increasing number (and new generation) of highly selective agents targeting inevitably lower incidence molecular segments, posing significant challenges for drug development. Innovative trial designs (umbrella or basket studies) are emerging as patient-centric approaches and public-private partnerships, cross-industry, government and non-profit sector collaborations are enabling implementation. Success will require continued innovation, new paradigms in oncology drug development and market approval and continued collaboration. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Drug interactions in female oncologic inpatients: differences among databases

    Directory of Open Access Journals (Sweden)

    Patricia Moriel

    2013-08-01

    Full Text Available The aim of the present study was to quantify drug interactions in prescriptions for women undergoing supportive therapy in an oncology setting at a women’s hospital in Brazil and compare the information provided by different databases regarding these drug interactions. A convenience sample was selected of prescriptions for patients diagnosed with breast or gynecological tumors hospitalized in the clinical oncology and surgery wards from April to June 2009. DRUGDEX/Micromedex (Thomson Micromedex was the main database used for the identification of drug interactions and was compared with two other databases: Drugs.com and Lexicomp. The search was performed by inputting all drug combinations found in the prescriptions in Micromedex and Drugs.com. All interactions identified and classified by Micromedex and/or Drugs.com as of major severity were then checked in Lexicomp. A total of 152 interactions were identified by Micromedex (61 major, 69 moderate and 22 minor. In Drugs.com, 614 interactions were identified (85 major, 464 moderate and 65 minor. Forty-four were classified as major drug interactions in at least one of the databases: 30 in Micromedex, 26 in Drugs. com and 14 in Lexicomp. The present findings reveal discrepancies among the three databases analyzed. Thus, standardization should be proposed. Moreover, both the pharmacist and multidisciplinary team should perform a critical analysis of prescriptions to promote safe practices in the use of medications and minimize potential complications caused by drug interactions.

  3. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. ] Name of Committee: Cardiovascular and Renal Drugs Advisory Committee....

  4. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-06

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... application (NDA) 202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research...

  5. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Science.gov (United States)

    2011-07-29

    ... Committee; Medical Imaging Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION... on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research. FDA... requesting nominations for voting members on the Medical Imaging Drugs Advisory Committee (the Committee...

  6. 76 FR 12972 - Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory...

    Science.gov (United States)

    2011-03-09

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Nonprescription Drugs Advisory...., Silver Spring, MD. The hotel telephone number is 301- 589-5200. Contact Person: Diem-Kieu Ngo, Center for... that administration by caregivers can be improved so that medication errors can be minimized. FDA...

  7. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-03-21

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of..., Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of the Committee: To provide...

  8. 75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-29

    ... [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of the Committee:...

  9. Non interventional drug studies in oncology: Why we need them?

    Science.gov (United States)

    Mishra, Divya; Vora, Jesal

    2010-10-01

    Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs). While the randomized nature of the RCT ensures its high internal validity by removing bias, their 'controlled' nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct.

  10. Non interventional drug studies in oncology: Why we need them?

    Directory of Open Access Journals (Sweden)

    Divya Mishra

    2010-01-01

    Full Text Available Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs. While the randomized nature of the RCT ensures its high internal validity by removing bias, their ′controlled′ nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct.

  11. Spontaneous adverse drug reaction monitoring in oncology: Our experience

    Directory of Open Access Journals (Sweden)

    K Kaur

    2015-01-01

    Full Text Available Background: Adverse drug reaction (ADR monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. Materials And Methods: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted: demographics, premedication (if any, diagnosis, chemotherapy (regimen, cycles, medication history, and alteration in the treatment or co morbidities, ADRs (severity and management. Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. Results: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52% followed by pyrimidine antagonists (19.88%. The most common malignancy reported in our hospital was Carcinoma breast (20% followed by leukemia (12% and Ca ovary (12%. Alopecia (27.76% was the most common ADR followed by anemia (7.48%, thrombocytopenia (6.96% and constipation (6.16%. Conclusion: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.

  12. Phase 0 clinical trials in oncology new drug development.

    Science.gov (United States)

    Gupta, Umesh Chandra; Bhatia, Sandeep; Garg, Amit; Sharma, Amit; Choudhary, Vaibhav

    2011-01-01

    Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.

  13. Phase 0 clinical trials in oncology new drug development

    Directory of Open Access Journals (Sweden)

    Umesh Chandra Gupta

    2011-01-01

    Full Text Available Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.

  14. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-20

    ... is for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes (beta-thalassemia intermedia, HbE beta-thalassemia, and alpha-thalassemia) aged 10 years and older...

  15. 76 FR 1181 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-07

    ... treatment of epidermal growth factor receptor (EGFR)-expressing colorectal cancer that has metastasized (spread beyond the colon or rectum) in patients for whom chemotherapy using irinotecan alone is... patients following complete gross resection (removal) of a form of cancer known as Kit (CD117)...

  16. 77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-31

    ... cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s). During the... person and submit a brief statement of the general nature of the evidence or arguments they wish...

  17. 77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-27

    ... receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced...) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor... statement of the general nature of the evidence or arguments they wish to present, the names and...

  18. 75 FR 64314 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-19

    ... advanced melanoma in patients who have received prior therapy. During the afternoon session, the committee... unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer. FDA intends to make... presentations should notify the contact person and submit a brief statement of the general nature of...

  19. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-02-24

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Amendment of... Administration (FDA) is announcing an amendment to the notice of a meeting of the Pulmonary-Allergy Drugs... meeting of the Pulmonary-Allergy Drugs Advisory Committee would be held on March 10 and 11, 2010. On...

  20. The Challenges of Precision Oncology Drug Development and Implementation.

    Science.gov (United States)

    Hollingsworth, Simon J; Biankin, Andrew V

    2015-01-01

    The drivers of precision medicine are clear: for patients (and physicians)--more options, durable clinical benefit, reduced exposure to non-effective drugs and potential to leverage current scientific and technological advances; for the pharmaceutical industry--the potential to tackle core challenges in discovering and developing better and more efficacious medicines, to reduce rates of attrition in drug development and to reduce development costs; for healthcare systems and payers--improved efficiency through the provision of effective care and avoiding ineffective treatments. Oncology has been at the vanguard, the improvements gained in patient survival notable. However, the increasing number of molecular subgroups requires an equally increasing number (and new generation) of highly selective agents targeting inevitably lower incidence molecular segments. Innovative trial designs (umbrella/basket studies) are emerging as a patient-centric approach to drug development, and the rise in public-private partnerships, cross-industry, government and non-profit sector collaborations is enabling implementation of complex clinical trial designs. This poses significant challenges for healthcare systems and regulatory approval. Further substantial evolution of policy and processes, particularly regulatory requirements for approval for new therapeutics, are required.

  1. Development of biosimilars in an era of oncologic drug shortages

    Directory of Open Access Journals (Sweden)

    Li E

    2015-06-01

    Full Text Available Edward Li,1 Janakiraman Subramanian,2 Scott Anderson,3 Dolca Thomas,4 Jason McKinley,5 Ira A Jacobs4 1University of New England College of Pharmacy, Portland, ME, USA; 2Hanna Cancer Associates, Knoxville, TN, USA; 3Pfizer Inc, La Jolla, CA, USA; 4Pfizer Inc, New York, NY, USA; 5Pfizer Inc, Groton, CT, USA Abstract: Acute and chronic shortages of various pharmaceuticals and particularly of sterile injectable products are being reported on a global scale, prompting evaluation of more effective strategies to manage current shortages and development of new, high-quality pharmaceutical products to mitigate the risk of potential future shortages. Oncology drugs such as liposomal doxorubicin and 5-fluorouracil represent examples of first-choice drugs critically affected by shortages. Survey results indicate that the majority of hospitals and practicing oncologists have experienced drug shortages, which may have compromised patient safety and clinical outcomes, and increased health care costs, due to delays or changes in treatment regimens. Clinical trials evaluating novel agents in combination with standard-of-care drugs are also being affected by drug shortages. Clinical and ethical considerations on treatment objectives, drug indication, and availability of alternative options may help in prioritizing cancer patients involved in active drug shortages. The United States Food and Drug Administration and the European Medicines Agency have identified manufacturing problems, delays in supply, and lack of available active ingredients as the most frequent causes of recent or ongoing drug shortages, and have released specific guidance to monitor, manage, and reduce the risk of shortages. The upcoming loss of exclusivity for a number of anticancer biologics, together with the introduction of an abbreviated approval pathway for biosimilars, raises the question of whether these products will be vulnerable to shortages. Future supply by reliable

  2. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  3. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Science.gov (United States)

    2011-10-14

    ... Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY... public. Name of Committees: Drug Safety and Risk Management Advisory Committee and Dermatologic and... Management Advisory Committee (DSaRM). On December 1, 2011, the DSaRM and the Dermatologic and Ophthalmic...

  4. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food... in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can...

  5. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-04

    ... HUMAN SERVICES Food and Drug Administration Medical Imaging Drugs Advisory Committee; Notice of Meeting... the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the... resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients...

  6. 78 FR 50423 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-19

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee... be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee...) or a CHD risk equivalent. FDA intends to make background material available to the public no...

  7. 77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-12

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... patients with acute coronary syndrome (ACS) [ST elevation myocardial infarction (STEMI), non-ST...

  8. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... atherothrombotic events in patients with a history of myocardial infarction (MI). The applicant also proposes...

  9. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... coronary syndrome [ST elevation myocardial infarction, non-ST elevation myocardial infarction, or...

  10. 75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  11. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  12. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  13. 77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  14. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  15. 77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  16. 78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  17. 77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  18. 75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  19. 78 FR 27405 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory...

  20. 76 FR 78283 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory...

  1. 78 FR 29142 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory...

  2. 77 FR 67380 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory...

  3. 77 FR 8262 - Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-02-14

    ... HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee... Administration (FDA) is announcing an amendment to the notice of the meeting of the Dermatologic and Ophthalmic... that a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee would be held on February 27...

  4. 76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-11-17

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  5. 75 FR 26264 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-05-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  6. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  7. 77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-25

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... West- Ward Pharmaceutical Corp., to increase blood pressure in acute hypotensive states, such as...

  8. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-19

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of...

  9. Off-label use of oncology drugs: national survey results

    Directory of Open Access Journals (Sweden)

    Eva González-Haba Peña

    2015-09-01

    Full Text Available Purpose: identify by means of a survey the off-label treatments more often used in the oncohaematology area, as well as to know the established procedures and criteria used to authorise those treatments. Methods: a four-section survey was designed: 1 demographic data and hospital activity, 2 Off-label treatments protocol, 3 Approval criteria and 4 Off-label oncology treatments conducted during the last year. Results: in 42.1% of the hospitals it’s needed an authorisation before dispensing in more tan 80% of the treatments. The most influential factor in the approval-dispensation system is the available evidence. The consent of the hospital management with previous Pharmacy department’s report was the most common authorisation procedure. 55.3% of the hospitals settled specific patient criteria to help the decision-making altogether with the available safety and efficacy data of the drug for the requested indication. In most centers a lower level of evidence is accepted if there are no therapeutic alternatives as well as in tumors of low prevalence. Most of the centers have not clearly established a criterion of effectiveness to consider a benefit as clinically relevant, nor the cost-effectiveness threshold for approving a FFT. Conclusions: there is a great variability in the off-label treatments use and also in the criteria used for its approval.

  10. Outlook of the process of storage of oncology drugs from the logistic operator in Colombia

    Directory of Open Access Journals (Sweden)

    Pedro Vicente Sánchez-Calvera

    2014-05-01

    Full Text Available This article mainly on the problem of  storage of oncology drugs, which is an important element in the supply chain, applied in the context of warehouse management of oncology drugs, in the logistics operator and providers of health services institutions (IPS for its acronym in Spanish of Bogotá DC and in the contex of a macro project "Methodological proposal for the definition of policies , rules of negotation and coordination in supply management of oncology drugs in Colombia," funded by Colciencias and the Universidad Nacional of Colombia. This article presents the current situation of oncology drugs, marking a characterization, diagnosis and identification and startegies evaluated under different scenarios. Finally, it is presented a proposal of improvement applied tranversely to storage processes including labels such as just in Time and the application of information and communication technologies (ICT.

  11. Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

    Science.gov (United States)

    Hayakawa, Yoshihiro; Kawada, Manabu; Nishikawa, Hiroyoshi; Ochiya, Takahiro; Saya, Hideyuki; Seimiya, Hiroyuki; Yao, Ryoji; Hayashi, Masahiro; Kai, Chieko; Matsuda, Akira; Naoe, Tomoki; Ohtsu, Atsushi; Okazaki, Taku; Saji, Hideo; Sata, Masataka; Sugimura, Haruhiko; Sugiyama, Yuichi; Toi, Masakazu; Irimura, Tatsuro

    2016-02-01

    Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.

  12. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

    Science.gov (United States)

    Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

    2014-10-01

    Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

  13. Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs.

    Science.gov (United States)

    Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven

    2016-01-01

    Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs- Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers- A well-considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in assessment and appraisal at national and European level in order to coordinate the views of different stakeholders and allow efficient resource allocation This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on PRO and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.

  14. 75 FR 2875 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-19

    ... another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee... in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in...

  15. PET and SPECT Imaging of Tumor Biology: New Approaches towards Oncology Drug Discovery and Development.

    Science.gov (United States)

    Van Dort, Marcian E; Rehemtulla, Alnawaz; Ross, Brian D

    2008-01-01

    Spiraling drug developmental costs and lengthy time-to-market introduction are two critical challenges facing the pharmaceutical industry. The clinical trials success rate for oncology drugs is reported to be 5% as compared to other therapeutic categories (11%) with most failures often encountered late in the clinical development process. PET and SPECT nuclear imaging technologies could play an important role in facilitating the drug development process improving the speed, efficiency and cost of drug development. This review will focus on recent studies of PET and SPECT radioligands in oncology and their application in the investigation of tumor biology. The use of clinically-validated radioligands as imaging-based biomarkers in oncology could significantly impact new cancer therapeutic development.

  16. 75 FR 36427 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Arthritis Advisory Committee and the...: Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ] General...

  17. Lessons Learned: Dose Selection of Small Molecule-Targeted Oncology Drugs.

    Science.gov (United States)

    Bullock, Julie M; Rahman, Atiqur; Liu, Qi

    2016-06-01

    Evaluation of dose plays a critical role in a successful oncology development program. Typically for oncology agents, the first-in-man phase I dose-escalation trials are conducted to determine a maximum tolerated dose (MTD). This MTD is taken forward into subsequent trials to establish the safety and efficacy of the drug product. Although this approach was appropriate historically for cytotoxics, the application of MTD as the recommend phase II dose has been problematic for the newer small molecule-targeted oncology agents. Promising alternative approaches using dose and exposure exploration, including lessons learned from recent targeted oncology agent development and approvals, are summarized and discussed. Clin Cancer Res; 22(11); 2630-8. ©2016 AACR SEE ALL ARTICLES IN THIS CCR FOCUS SECTION, "NEW APPROACHES FOR OPTIMIZING DOSING OF ANTICANCER AGENTS".

  18. The oncologic radiotherapy experience for patients: a poison-drug

    OpenAIRE

    Rosani Manfrin Muniz; Marcia Maria Fontão Zago

    2008-01-01

    The study aimed at understanding the patients' experience with oncologic radiotherapy. The anthropological interpretative approach and the ethnographic method guided the investigation. Ten patients took part in the study. They were of both genders, within the age range from 34 to 80 years old and monitored during radiotherapy treatment. Data were collected through semi-structured interviews, participative observation and medical records. The analysis of the respondents' statements allowed for...

  19. Crowdfunding drug development: the state of play in oncology and rare diseases.

    Science.gov (United States)

    Dragojlovic, Nick; Lynd, Larry D

    2014-11-01

    In this article, we present descriptive data on 125 crowdfunding campaigns aimed at financing research in oncology (including basic research, drug discovery, and clinical trials). We also describe five campaigns that have succeeded in raising substantial funds to support the development of treatments for ultrarare diseases. The data suggest that crowdfunding is a viable approach to supporting early proof-of-concept research that could allow researchers in oncology and rare diseases to succeed in traditional grant competitions or to attract private investment. The data also suggest that such an approach could become a valuable additional source of funding for early-stage innovators in the drug development arena.

  20. PET and SPECT Imaging of Tumor Biology: New Approaches towards Oncology Drug Discovery and Development

    OpenAIRE

    Van Dort, Marcian E.; Rehemtulla, Alnawaz; Brian D. Ross

    2008-01-01

    Spiraling drug developmental costs and lengthy time-to-market introduction are two critical challenges facing the pharmaceutical industry. The clinical trials success rate for oncology drugs is reported to be 5% as compared to other therapeutic categories (11%) with most failures often encountered late in the clinical development process. PET and SPECT nuclear imaging technologies could play an important role in facilitating the drug development process improving the speed, efficiency and cos...

  1. Individualized network-based drug repositioning infrastructure for precision oncology in the panomics era.

    Science.gov (United States)

    Cheng, Feixiong; Hong, Huixiao; Yang, Shengyong; Wei, Yuquan

    2016-06-12

    Advances in next-generation sequencing technologies have generated the data supporting a large volume of somatic alterations in several national and international cancer genome projects, such as The Cancer Genome Atlas and the International Cancer Genome Consortium. These cancer genomics data have facilitated the revolution of a novel oncology drug discovery paradigm from candidate target or gene studies toward targeting clinically relevant driver mutations or molecular features for precision cancer therapy. This focuses on identifying the most appropriately targeted therapy to an individual patient harboring a particularly genetic profile or molecular feature. However, traditional experimental approaches that are used to develop new chemical entities for targeting the clinically relevant driver mutations are costly and high-risk. Drug repositioning, also known as drug repurposing, re-tasking or re-profiling, has been demonstrated as a promising strategy for drug discovery and development. Recently, computational techniques and methods have been proposed for oncology drug repositioning and identifying pharmacogenomics biomarkers, but overall progress remains to be seen. In this review, we focus on introducing new developments and advances of the individualized network-based drug repositioning approaches by targeting the clinically relevant driver events or molecular features derived from cancer panomics data for the development of precision oncology drug therapies (e.g. one-person trials) to fully realize the promise of precision medicine. We discuss several potential challenges (e.g. tumor heterogeneity and cancer subclones) for precision oncology. Finally, we highlight several new directions for the precision oncology drug discovery via biotherapies (e.g. gene therapy and immunotherapy) that target the 'undruggable' cancer genome in the functional genomics era.

  2. Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs

    Directory of Open Access Journals (Sweden)

    Arora A

    2017-09-01

    Full Text Available Ankur Arora,1,2 Rajinder K Jalali,1,2 Divya Vohora1 1School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India; 2Medical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Gurgaon, Haryana, India Background: Numerous reporting biases have been known to affect spontaneous reporting databases. The Weber effect, which constitutes a peak in adverse event (AE reporting of a drug at the end of second year after regulatory approval followed by a continuous decline thereafter, has been considered an important bias for a long time. The existence of this bias in AE reporting of oncology drugs remains an underevaluated area, prompting a targeted examination.Methods: The US Food and Drug Administration (USFDA Adverse Event Reporting System (FAERS was studied for AE reporting patterns of 5 years of 15 new molecular entities (NMEs and biologics used in oncology. This 5-year period started from the USFDA date of approval for the NMEs and biologics. The number of AEs reported for each of the drugs was plotted against time (years. The AE reporting patterns were specifically examined for the existence of the Weber effect. In addition, AE reporting rate patterns of 5 years of seven NMEs and biologics used in oncology were examined.Results: A total of 50,630 AE reports were logged in to the FAERS for all 15 drugs examined for AE reporting patterns. We observed five distinct AE reporting patterns for 15 drugs; however, none of the AE patterns were identical to the Weber effect. We did not observe a consistent AE reporting rate pattern for the seven drugs examined for AE reporting rates. With the exception of one drug (cetuximab, none of the drugs exhibited a second-year peak in AE reporting rates. This peak was not followed by continuous decline in AE reporting rate thereafter.Conclusion: This study does not support the existence of the Weber effect in AE reporting of oncology drugs. The contemporary AE reporting of oncology

  3. Polymer-Drug Conjugates: Recent Development in Clinical Oncology

    OpenAIRE

    Li, Chun; Wallace, Sidney

    2008-01-01

    Targeted drug delivery aims to increase the therapeutic index by making more drug molecules available at the diseased sites while reducing systemic drug exposure. In this update, we provide an overview of polymer-drug conjugates that have advanced into the clinical trials. These systems use synthetic water-soluble polymers as the drug carriers. The preclinical pharmacology and recent data in clinical trials with poly(L-glutamic acid)-paclitaxel (PG-TXL) are discussed first. This is followed b...

  4. Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.

    Science.gov (United States)

    Tampal, Nilufer; Mandula, Haritha; Zhang, Hongling; Li, Bing V; Nguyen, Hoainhon; Conner, Dale P

    2015-02-01

    Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) introduced by Amidon (1) and adopted by the FDA, presents opportunities to avoid conducting the bioequivalence studies in humans. This paper analyzes the application of the BCS approach by the generic pharmaceutical industry and the FDA to oncology drug products. To date, the FDA has granted BCS-based biowaivers for several drug products involving at least four different drug substances, used to treat cancer. Compared to in vivo BE studies, development of data to justify BCS waivers is considered somewhat easier, faster, and more cost effective. However, the FDA experience shows that the approval times for applications containing in vitro studies to support the BCS-based biowaivers are often as long as the applications containing in vivo BE studies, primarily because of inadequate information in the submissions. This paper deliberates some common causes for the delays in the approval of applications requesting BCS-based biowaivers for oncology drug products. Scientific considerations of conducting a non-BCS-based in vivo BE study for generic oncology drug products are also discussed. It is hoped that the information provided in our study would help the applicants to improve the quality of ANDA submissions in the future.

  5. [New targets and new drugs in thoracic oncology].

    Science.gov (United States)

    Rouviere, D; Bousquet, E; Pons, E; Milia, J-D; Guibert, N; Mazieres, J

    2015-10-01

    A number of mechanisms that drive oncogenesis have been deciphered over the last 20 years. The main oncogenic factors in the field of thoracic oncology are mutations of EGFR, KRAS, and EML4-ALK translocation, which are most often reported in adenocarcinomas. However, new molecular targets have been highlighted recently including BRAF mutations, HER2 or PI3K, new translocations such as ROS1 or KIF5B-RET. Molecular abnormalities have also been identified in tumors other than adenocarcinoma (squamous and small cell carcinoma). Therapeutic strategies have been designed to inhibit these signaling pathways including monoclonal antibodies and tyrosine kinase inhibitors. Some of these molecules are now approved as therapies, others are currently undergoing testing in clinical trials. We here present a review of novel targeted agents for lung cancer.

  6. 75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  7. 78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  8. 78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  9. 78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  10. 75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  11. 75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  12. 77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  13. 75 FR 75681 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-06

    ... HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs... and circulation) of the central nervous system. The BBB is an area consisting of specialized cells...

  14. 76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  15. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration Advisory... Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and... that a meeting of the Science Board to the Food and Drug Administration would be held on February...

  16. [HTA-Perspective: Challenges in the early assessment of new oncological drugs].

    Science.gov (United States)

    Wild, Claudia; Nachtnebel, Anna

    2013-01-01

    Oncologic drug therapies have gained wide attention in the context of health policy priority setting for serious and socially significant diseases with high human and monetary costs. Due to uncertainties and scepticism about the actual therapeutic importance of newly approved oncology products, an early assessment programme was already established in Austria in 2007. The assessment of new oncology products is thereby faced with special challenges, since study populations are frequently not representative or the study design is laid out in such a manner that a definitive assessment of patient-relevant endpoints is not possible (cross-overs after interim assessments, surrogate parameters as primary endpoints, uncontrolled studies or those with unrealistic comparators, invalidated post-hoc identified biomarkers). On account of these major uncertainties, even the European Medicines Agency (EMA) is already contemplating multi-stage, "adaptive" approvals, and national reimbursement institutions are increasingly working with outcome-oriented, conditional reimbursement. (As supplied by publisher).

  17. 75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

    Science.gov (United States)

    2010-09-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Peripheral and Central Nervous System... the public. Name of Committees: Peripheral and Central Nervous System Drugs Advisory Committee and the...

  18. Applications of Carbon-Based Nanomaterials for Drug Delivery in Oncology

    Science.gov (United States)

    Levi-Polyachenko, Nicole H.; Carroll, David L.; Stewart, John H.

    The goal of this chapter is to introduce carbon nanomaterials and highlight research focused on their use as cancer therapeutics. The physical properties of fullerenes and carbon nanotubes, including their spectral characteristics are described. Current oncology treatment regimes are described to provide an overview of where carbon nanomaterials may have significant value in further development of the established standards of care procedures. Photodynamic therapy and drug delivery using fullerene C60 is explored. Thermal ablation techniques using carbon nanotubes are explained and alternate hyperthermic methods using carbon nanotubes are described. Specifically, carbon nanotubes are examined for their potential contribution to the currently practiced clinical therapy intraperitoneal hyperthermic chemoperfusion. Nanotubes and nanohorns filled with chemotherapeutic agents are examined as are different methods for filling and containment of drug moieties. The attachment of active molecules to fullerenes is described with examples for use in oncology. Toxicity issues are explored and the future directions and potential for carbon nanomaterial types concludes the chapter.

  19. 76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System...

  20. 75 FR 13559 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-22

    ... analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory...

  1. Phase 0 clinical trials in oncology new drug development

    OpenAIRE

    Umesh Chandra Gupta; Sandeep Bhatia; Amit Garg; Amit Sharma; Vaibhav Choudhary

    2011-01-01

    Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a visi...

  2. Robotized compounding of oncology drugs in a hospital pharmacy.

    Science.gov (United States)

    Palma, Elisabetta; Bufarini, Celestino

    2014-01-01

    In 2005, the Pharmacy Department of the University Hospital of Ancona began collaboration with the engineers of the Loccioni group in order to realize a fully automated system for the preparation of cytostatic drugs, which could be safe for both healthcare workers and patients. At present, the cytotoxic laboratory of Ancona is equipped with two robots and one Class II biological-safety cabinet. The introduction of the robots in the cytotoxic laboratory has increased both efficiency and safety of the working process. The drug-preparation process begins when the pharmacist confirms the medical prescription (exact posology, modalities of reconstitution), and starts the preparation cycle. The sterility of the preparations is monthly tested in collaboration to the local microbiology laboratory. All preparations' results were germ-free even after storage at room temperature for two weeks. The dose accuracy is verified by visual and gravimetric independent systems. Drug concentration errors exceeding the limit of 10% fixed by the Italian Pharmacopeia were found only in 1.1% of the preparations. The average dose error was 0.8% (standard deviation 1.7%).

  3. Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review

    Directory of Open Access Journals (Sweden)

    Rocchi A

    2015-06-01

    Full Text Available Angela Rocchi,1 Isabelle Chabot,2 Judith Glennie3 1Athena Research Inc., Burlington, ON, 2EvAccess Inc., Vaudreuil-Dorion, QC, 3JL Glennie Consulting Inc., Aurora, ON, Canada Background: In 2007, Canada chose to develop a separate and distinct path for oncology drug health technology assessment (HTA. In 2013, the decision was made to transfer the pan-Canadian Oncology Drug Review (pCODR to the Canadian Agency for Drugs and Technologies in Health (CADTH, to align the pCODR and CADTH Common Drug Review processes while building on the best practices of both. The objective of this research was to conduct an examination of the best practices established by the pCODR. Methods: A qualitative research approach was taken to assess the policies, processes, and practices of the pCODR, based on internationally accepted best practice “principles” in HTA, with a particular focus on stakeholder engagement. Publicly available information regarding the approach of the pCODR was used to gauge the agency's performance against these principles. In addition, stakeholder observations and real-world experiences were gathered through key informant interviews to be inclusive of perspectives from patient advocacy groups, provincial and/or cancer agency decision-makers, community and academic oncologists, industry, expert committee members, and health economists. Results: This analysis indicated that, through the pCODR, oncology stakeholders have had a voice in and have come to trust the quality and relevance of oncology HTA as a vital tool to ensure the best decisions for Canadians with cancer and their health care system. It could be expected that adoption of the principles and processes of the pCODR would bring a similar level of engagement and trust to other HTA organizations in Canada and elsewhere. Conclusion: The results of this research led to recommendations for improvement and potential extrapolation of these best practices to other HTA organizations

  4. Creating a unique, multi-stakeholder Paediatric Oncology Platform to improve drug development for children and adolescents with cancer.

    Science.gov (United States)

    Vassal, Gilles; Rousseau, Raphaël; Blanc, Patricia; Moreno, Lucas; Bode, Gerlind; Schwoch, Stefan; Schrappe, Martin; Skolnik, Jeffrey; Bergman, Lothar; Bradley-Garelik, Mary Brigid; Saha, Vaskar; Pearson, Andy; Zwierzina, Heinz

    2015-01-01

    Seven years after the launch of the European Paediatric Medicine Regulation, limited progress in paediatric oncology drug development remains a major concern amongst stakeholders - academics, industry, regulatory authorities, parents, patients and caregivers. Restricted increases in early phase paediatric oncology trials, legal requirements and regulatory pressure to propose early Paediatric Investigation Plans (PIPs), missed opportunities to explore new drugs potentially relevant for paediatric malignancies, lack of innovative trial designs and no new incentives to develop drugs against specific paediatric targets are some unmet needs. Better access to new anti-cancer drugs for paediatric clinical studies and improved collaboration between stakeholders are essential. The Cancer Drug Development Forum (CDDF), previously Biotherapy Development Association (BDA), with Innovative Therapy for Children with Cancer Consortium (ITCC), European Society for Paediatric Oncology (SIOPE) and European Network for Cancer Research in Children and Adolescents (ENCCA) has created a unique Paediatric Oncology Platform, involving multiple stakeholders and the European Union (EU) Commission, with an urgent remit to improve paediatric oncology drug development. The Paediatric Oncology Platform proposes to recommend immediate changes in the implementation of the Regulation and set the framework for its 2017 revision; initiatives to incentivise drug development against specific paediatric oncology targets, and repositioning of drugs not developed in adults. Underpinning these changes is a strategy for mechanism of action and biology driven selection and prioritisation of potential paediatric indications rather than the current process based on adult cancer indications. Pre-competitive research and drug prioritisation, early portfolio evaluation, cross-industry cooperation and multi-compound/sponsor trials are being explored, from which guidance for innovative trial designs will be

  5. Development of immuno-oncology drugs - from CTLA4 to PD1 to the next generations.

    Science.gov (United States)

    Hoos, Axel

    2016-04-01

    Since the regulatory approval of ipilimumab in 2011, the field of cancer immunotherapy has been experiencing a renaissance. This success is based on progress in both preclinical and clinical science, including the development of new methods of investigation. Immuno-oncology has become a sub-specialty within oncology owing to its unique science and its potential for substantial and long-term clinical benefit. Immunotherapy agents do not directly attack the tumour but instead mobilize the immune system - this can be achieved through various approaches that utilize adaptive or innate immunity. Therefore, immuno-oncology drug development encompasses a broad range of agents, including antibodies, peptides, proteins, small molecules, adjuvants, cytokines, oncolytic viruses, bi-specific molecules and cellular therapies. This Perspective summarizes the recent history of cancer immunotherapy, including the factors that led to its success, provides an overview of novel drug-development considerations, summarizes three generations of immunotherapies that have been developed since 2011 and, thus, illustrates the breadth of opportunities these new generations of immunotherapies represent.

  6. Evaluation of the effect on cardiac repolarization (QTc interval) of oncologic drugs.

    Science.gov (United States)

    Morganroth, J

    2007-01-01

    The 12-lead electrocardiograph (ECG) is the standard safety measurement used in clinical trials to identify drug-induced cardiac adverse effects. Drug-induced prolongation of the QTc interval (the measure of cardiac repolarization change), when excessive and in conjunction with the right risk factors, can degenerate into a polymorphic ventricular tachycardia called torsades de pointes and has become a new focus for new drug development. The assessment of an ECG in clinical practice using machine-defined QTc duration is intrinsically unreliable. Current regulatory concepts have focused on the need for measuring ECG intervals using manual techniques using digital processing in a central ECG laboratory. The QT interval is subject to a large degree of spontaneous variability requiring attention to basic clinical trial design issues such as sample size (use as large a cohort as possible), frequency of measurements taken (at least three to six ECGs at baseline and at many time points on therapy with pharmacokinetic samples if possible), and their accuracy. Since most oncologic products are cytotoxic, a Thorough or Dedicated ECG Trial cannot be conducted and in the usual trail, especially in phase I, all changes seen on the ECG will be attributed to the new oncology drug. For most nononcologic drugs, there is regulatory guidance on how much an effect on QTc duration might be related to the risk of cardiac toxicity. For oncology products, the central tendency magnitude and proportion of outliers needs to be well defined to construct a label if the risk-benefit analysis leads to marketing approval. Clinical cardiac findings such as syncope, ventricular tachyarrhythmias, and other cardiac effects will be important in this analysis.

  7. Patient adherence to oral anticancer drugs: an emerging issue in modern oncology.

    Science.gov (United States)

    Foulon, V; Schöffski, P; Wolter, P

    2011-01-01

    The steady increase in the use of oral anticancer drugs in modern oncology has created a paradigm shift, challenging traditional attitudes towards cancer care and requiring new concepts of organization of oncology services. Important issues are the prolonged treatment period, management of toxicity, treatment adherence, reimbursement conditions and patient and family education. Although most patients generally prefer oral therapy over intravenous treatment for reasons of convenience, the daily use of oral anticancer drugs can be a challenging commitment for many patients. Reports on adherence and persistence among patients with cancer show that adherence ranges from 16% to 100%, depending on the type of therapy and the measurement/definition of adherence. Apart from demographic, disease and therapy related factors, the determinants that mostly influence (non-)adherence are the satisfaction with care activities performed at the initiation of the drug treatment, and the perceived necessity of treatment. Therefore, patient education addressing these issues is considered the cornerstone of successful oral anticancer treatment. Studies examining the role of different health care providers in the pharmacotherapeutic care of patients with cancer, treated with oral anti-cancer drugs, support the need for a multidisciplinary approach to achieve a maximum benefit for the individual patient and consequently for the whole health system. Limiting adverse events and developing appropriate supportive care are only some aspects that need to be considered in this.

  8. 78 FR 48690 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-09

    ... the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the... (involving internal organs), mucosal (involving areas such as inside the mouth and nose), and cutaneous... limited. If the number of registrants requesting to speak is greater than can be reasonably...

  9. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-06-08

    ... this meeting. Submit electronic comments to http://www.regulations.gov . Submit written comments to the... accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm ; under the heading ``Resources for You... potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an...

  10. Drug induced interstitial lung disease in oncology phase I trials.

    Science.gov (United States)

    Yonemori, Kan; Hirakawa, Akihiro; Kawachi, Asuka; Kinoshita, Fumie; Okuma, Hitomi; Nishikawa, Tadaaki; Tamura, Kenji; Fujiwara, Yasuhiro; Takebe, Naoko

    2016-12-01

    Interstitial lung disease is a serious drug-related condition that can cause life threatening organ failure. The incidence and risk factors of drug-induced interstitial lung disease (DILD) are unknown in oncology phase I trials. This study analyzed clinical information from 8906 patients with malignancies who were enrolled in 470 phase I trials sponsored by the Cancer Therapy Evaluation Program, National Cancer Institute, from 1988 to 2014. Logistic and Cox statistical analyses were utilized to determine clinical differences between patients who developed DILD and patients who did not. In this study, the overall incidence rate of patients with pulmonary toxicity was 2.7%. The overall incidence rate for DILD was 0.77%, whereas for grade 3 or 4 DILD it was 0.31%. Median time to occurrence of DILD was 1.4 months. The Cox hazard analysis indicated smaller body surface area and a combination of thoracic radiation with investigational drug regimens were significant risk factors for time to occurrence of interstitial lung disease. Investigators should carefully monitor for DILD in oncology patients enrolled in phase I trials with identified risk factors. A 6-month observation period would be sufficient to detect the onset of most DILD in such patients.

  11. On the possibility of low cost, adherent therapeutic drug monitoring in oncology

    Science.gov (United States)

    Dalla Marta, Silvia; Fornasaro, Stefano; Jaworska, Aleksandra; Toffoli, Giuseppe; Bonifacio, Alois; Sergo, Valter

    2016-05-01

    A frequent quantification of drugs concentrations in plasma of patients subject to chemotherapy is seldom performed, mostly because the standard methods (Gas or Liquid Chromatography coupled with Mass Spectroscopy) are expensive and time consuming. In this paper we report the approach pursued in one of the research units of the EU project RAMAN4CLINICS to tackle the problem of a low cost, time adherent quantification of drugs used for oncological patients using a Surface Enhanced Raman Scattering (SERS) spectroscopy. More specifically, the issues concerning the repeatability of the nanostructured substrates will be presented and some promising results to increase the selectivity of the measures toward specific drugs will be discussed, with examples concerning one cytotoxic agent, Irinotecan and one kinase inhibitor, Sunitinib.

  12. Nonclinical Evaluations of Small-Molecule Oncology Drugs: Integration into Clinical Dose Optimization and Toxicity Management.

    Science.gov (United States)

    Dambach, Donna M; Simpson, Natalie E; Jones, Thomas W; Brennan, Richard J; Pazdur, Richard; Palmby, Todd R

    2016-06-01

    Multidisciplinary approaches that incorporate nonclinical pharmacologic and toxicologic characterization of small-molecule oncology drugs into clinical development programs may facilitate improved benefit-risk profiles and clinical toxicity management in patients. The performance of the current nonclinical safety-testing scheme was discussed, highlighting current strengths and areas for improvement. While current nonclinical testing appears to predict the clinical outcome where the prevalence of specific adverse effects are high, nonclinical testing becomes less reliable for predicting clinical adverse effects that occur infrequently, as with some kinase inhibitors. Although adverse effects associated with kinase inhibitors can often be predicted on the basis of target biology, drugs can be promiscuous and inhibit targets with poorly defined function and associated risks. Improvements in adverse effect databases and better characterization of the biologic activities of drug targets may enable better use of computational modeling approaches in predicting adverse effects with kinase inhibitors. Assessing safety of a lead candidate in parallel with other drug properties enables incorporation of a molecule's best features during chemical design, eliminates the worst molecules early, and permits timely investigation/characterization of toxicity mechanisms for identified liabilities. A safety lead optimization and candidate identification strategy that reduces intrinsic toxicity and metabolic risk and enhances selectivity can deliver selective kinase inhibitors that demonstrate on-target adverse effects identified nonclinically. Integrating clinical and nonclinical data during drug development can facilitate better identification and management of oncology drugs. Follow-up nonclinical studies may be used to better understand the risks in a given patient population and minimize or manage these risks more appropriately. Clin Cancer Res; 22(11); 2618-22. ©2016 AACR SEE ALL

  13. Admission of new oncological drugs to the Slovenian health care system and their accessibility to the patients

    Directory of Open Access Journals (Sweden)

    Mitja Kos

    2007-09-01

    Full Text Available Background: The aim of the present study is to analyze the admission of anticancer drugs to the Slovenian healthcare system, and to evaluate patients’ accessibility to these medications.Methods: Admission and accessibility to anticancer drugs was evaluated by analysing: differences in registration time among USA, selected member states of EU, and Slovenia; time from the registration to the first use in Slovenia; differences between the first use in Slovenia and the first use in selected member states of EU and by analysing the market of oncology drugs. The study included drugs of the ATC groups such as Antitumor medications (cytostatics (ATC = L01 and Endocrine treatment (ATC = L02 that were used in Slovenia for the first time between 1999 to 2005. Registration data for Slovenia and EU was obtained from the registration documention of selected drugs at the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, and the European Agency for the Evaluation of Medicinal Products (EMEA. Registration data for USA was obtained from the registration documention of selected drugs at the Food and Drug Administration (FDA. The information upon the first use of drugs in Slovenia was acquired from the PharMIS system, and the information upon the first use of drugs in selected member states of EU was obtained from the study on patients’ access to oncology drugs by Nils Wilking and Bengt Jönsson, performed from 2005. Data for the market analysis of oncology drugs was obtained from the PharMIS system.Results: In previous years a delay in registration time between Slovenia and compared states was present for some oncology drugs. Along with the acceptance of Slovenia as a new member state of EU, on 1st May 2004, registration process in Slovenia became a part of the registration system of the European Agency for the Evaluation of Medicinal Products (EMEA. Majority of drugs had a time difference between the registration and the first use

  14. Robot-assisted preparation of oncology drugs: the role of nurses.

    Science.gov (United States)

    Palma, Elisabetta; Bufarini, Celestino

    2012-12-15

    Since 2007, the preparation of cancer drugs at the Pharmacy of the University Hospital of Ancona has been progressively robotized. Currently, the process of preparation of intravenous cancer drugs is almost totally automated (95%). At present, the Cytotoxic laboratory of Ancona is the sole, in Europe, that can count on two robots. The robots handle 56 oncology molecules, which correspond to more than 160 different vials. The production rate in 2011 exceeded 19,000 preparations. The quality of compounding and the sterility controls are satisfactory, every step of the process is traceable. The nursing staff played a fundamental role in the robot development process. The nursing staff and the pharmacists are still collaborating with the robotic engineers in order to increase efficiency, ergonomics and user-friendliness of the robots.

  15. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public...) (added by the Food and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and...

  16. Evaluation of working practices and surface contamination with antineoplastic drugs in outpatient oncology health care settings.

    Science.gov (United States)

    Kopp, Bettina; Schierl, Rudolf; Nowak, Dennis

    2013-01-01

    Many antineoplastic drugs are classified as carcinogenic, mutagenic and teratogenic for humans. Therefore, minimization of exposure is required to reduce health risks to employees. The aim of this study was to evaluate working practices and safety measures during drug administration and to assess workplace contamination in outpatient oncology health care settings. Questionnaires about working procedures were sent to 137 day hospitals and private practices. Workplace contamination with 5-fluorouracil, platinum, gemcitabine, cyclophosphamide, ifosfamide, methotrexate, docetaxel and paclitaxel was assessed using wipe samples. Forty institutions participated in the study, and in 28 departments, wipe samples were taken. Depending on the kind of activity, working procedures often (5-80%) were not confirmed with recommendations for safe handling of antineoplastic drugs. Altogether, 60.9% of the sampling results were above the limit of detection (LOD). Most frequent loads were detected with 5-FU (93.5%) and platinum (88.4%). Contamination was detected on all surfaces and the results ranged between drugs handled and the extent of surface contamination. However, specific working practices resulting in a lower number of positive wipe samples could be identified (e.g., use of closed infusion systems). Workplace contamination with antineoplastic drugs is still present. As patients have to be considered as a potential source of contamination, surface contamination is difficult to avoid. However, our study revealed that it is possible to administer a large number of preparations without causing high workplace contamination.

  17. Evaluation of genotoxicity induced by exposure to antineoplastic drugs in lymphocytes of oncology nurses and pharmacists.

    Science.gov (United States)

    El-Ebiary, Ahmad A; Abuelfadl, Arwa A; Sarhan, Naglaa I

    2013-03-01

    The hazards of handling antineoplastic drugs have been raised and discussed in several studies. Introduction of new antineoplastics together with abuse of safety standards have contributed to the exposure risk for personnel who handle these substances. Interactions of antineoplastic drugs with biological structures vary according to the drug(s) and the individual's genetic susceptibility. This study was carried out to evaluate the genome damage induced by exposure to antineoplastic drugs in nurses (n = 20) and pharmacists (n = 18) working in the Oncology Department of Tanta Cancer Center. Thirty subjects matched in age, gender and smoking habit were selected as controls. Both chromosomal aberration analysis and micronucleus assay were used to evaluate genome damage in peripheral blood lymphocytes of the study subjects. The numbers of aberrant lymphocytes, as well as chromosomal aberration and micronuclei frequencies, were significantly increased in exposed personnel in comparison to matched controls. Compared with pharmacists, nurses showed notably higher level of chromosome damage. On the other hand, no significant difference in micronuclei frequency was observed between nurses and pharmacists. Correlation analyses pointed to the influence of age and duration of occupational exposure on the level of chromosome damage among exposed subjects. The results of this study confirmed that handling antineoplastic drugs without appropriate precautions imposed a genotoxic risk for exposed healthcare workers. These results address the need for regular biomonitoring of exposed personnel. In addition, they call attention to the need for proper implementation of intervention measures aiming to eliminate or significantly reduce worker exposure and prevent untoward biological effects. Copyright © 2011 John Wiley & Sons, Ltd.

  18. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    Directory of Open Access Journals (Sweden)

    Deepti Chopra

    2016-01-01

    Full Text Available Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs. The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013 were studied. These reports were analyzed for various carcinomas under treatment, medications used, types of ADRs, organ system involvement, severity, causality assessment, and preventability. Results: Over a period of 2 years, a total 591 cases were received with an incidence of 58.6%. The prevalence of ADRs was more in female patients (73.6% as compared to men. ADRs mostly occurred in the age group of 41-50 years (27.4%. Patients treated for breast carcinoma (39.1% reported the highest incidence of ADRs. Cisplatin (19.6% was found to be the most common offending drug. The most common ADR reported was nausea and vomiting (23%. Gastroenterology (40.1% was the most affected system. About 50.2% of the ADRs required treatment and 12.9% ADRs were considered serious. Causality assessment revealed that 80% of the ADRs were possible. About 86.97% cases were found to be mild, and 51% were not preventable. Conclusion: The success of chemotherapy comes with the word of caution regarding toxicities of antineoplastic drugs. Pharmacovigilance of these drugs needs to be explored, and use of preventative measures needs to be enhanced in order to reduce the incidence and severity of ADRs.

  19. European Union centralised procedure for marketing authorisation of oncology drugs: an in-depth review of its efficiency.

    Science.gov (United States)

    Netzer, Tilo

    2006-03-01

    In the European Union (EU) 20 anticancer agents have been successfully authorised via the Centralised Procedure since its implementation in 1995. Public information on these 20 agents has been reviewed in order to evaluate the effectiveness of the available regulatory mechanisms to facilitate the marketing authorisation of such drugs in the EU. These mechanisms include orphan drug legislation, exceptional circumstances provision and the accelerated evaluation procedure. Based on the fact that the EU orphan drug legislation was not implemented before the year 2000 no conclusions on its effectiveness to facilitate oncology drug development can be drawn today. Much more data are available on the effects of the exceptional circumstances provision, which was used in 6 out of 10 cases over the past four years. An analysis of the clinical data packages indicates that this provision allows authorisation of innovative oncology drugs based on smaller clinical data sets than required for full approval. The accelerated evaluation procedure was used in only one case and significantly reduced the scientific review time at the EU agencies. However, this mechanism does not influence the administrative time at the authorities, which accounted for almost one-third of the overall duration of the EU marketing authorisation procedures for oncology drugs. Revision of the EU drug legislation brings about some changes to the above-described provisions, with the potential for an improvement in the current situation. Thus, its implementation offers the chance to reduce the time that innovative oncology agents take to reach the market, although -- based on experience with the current procedures -- more effort is likely to be required to achieve this goal.

  20. Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.

    Science.gov (United States)

    Kogure, Seiji; Koyama, Nobuyuki; Hidaka, Shinji

    2017-06-19

    Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies. © 2017, The American College of Clinical Pharmacology.

  1. Optimising translational oncology in clinical practice: strategies to accelerate progress in drug development.

    Science.gov (United States)

    Stahel, R; Bogaerts, J; Ciardiello, F; de Ruysscher, D; Dubsky, P; Ducreux, M; Finn, S; Laurent-Puig, P; Peters, S; Piccart, M; Smit, E; Sotiriou, C; Tejpar, S; Van Cutsem, E; Tabernero, J

    2015-02-01

    Despite intense efforts, the socioeconomic burden of cancer remains unacceptably high and treatment advances for many common cancers have been limited, suggesting a need for a new approach to drug development. One issue central to this lack of progress is the heterogeneity and genetic complexity of many tumours. This results in considerable variability in therapeutic response and requires knowledge of the molecular profile of the tumour to guide appropriate treatment selection for individual patients. While recent advances in the molecular characterisation of different cancer types have the potential to transform cancer treatment through precision medicine, such an approach presents a major economic challenge for drug development, since novel targeted agents may only be suitable for a small cohort of patients. Identifying the patients who would benefit from individual therapies and recruiting sufficient numbers of patients with particular cancer subtypes into clinical trials is challenging, and will require collaborative efforts from research groups and industry in order to accelerate progress. A number of molecular screening platforms have already been initiated across Europe, and it is hoped that these networks, along with future collaborations, will benefit not only patients but also society through cost reductions as a result of more efficient use of resources. This review discusses how current developments in translational oncology may be applied in clinical practice in the future, assesses current programmes for the molecular characterisation of cancer and describes possible collaborative approaches designed to maximise the benefits of translational science for patients with cancer.

  2. Multidrug resistance in oncology and beyond : from imaging of drug efflux pumps to cellular drug targets

    NARCIS (Netherlands)

    Nagengast, Wouter B; Oude Munnink, Thijs H; Dijkers, Eli; Hospers, Geesiena; Brouwers, Adrienne H; Schröder, Carolien P; Lub-de Hooge, Marjolijn; de Vries, Elisabeth G E

    2010-01-01

    Resistance of tumor cells to several structurally unrelated classes of natural products, including anthracyclines, taxanes, and epipodophyllotoxines, is often referred as multidrug resistance (MDR). This is associated with ATP-binding cassette transporters, which function as drug efflux pumps such a

  3. Protection behaviors for cytotoxic drugs in oncology nurses of chemotherapy centers in Shiraz hospitals, South of Iran.

    Science.gov (United States)

    Abbasi, Khadijeh; Hazrati, Maryam; Mohammadbeigi, Abolfazl; Ansari, Jasem; Sajadi, Mahboubeh; Hosseinnazzhad, Azam; Moshiri, Esmail

    2016-01-01

    The use of antineoplastic agents for the treatment of cancer is an increasingly common practice in hospitals. As a result, workers involved with handling antineoplastic drugs may be accidentally exposed to these agents, placing them at potential risk for long-term adverse effects. This study aimed to determine the occupational protection status of clinical nursing staff exposed to cytotoxic drugs. The study was designed as an analytic descriptive survey. The research settings took place in six centers of chemotherapy in Shiraz, Iran. The participants were 86 nurses who worked in oncology units and administered cytotoxic drugs. Data were collected using a questionnaire and a checklist which was developed by the investigators to determine occupational protection status of clinical nursing staff exposed to cytotoxic drugs. Percentage calculations and the independent samples t-test were used to see the general distribution and analysis of data. To statistically analyze of the data, SPSS software (version 16) was applied. The mean age of participants was 30.52 ± 6.50 years and 66.27% of the nurses worked on inpatient oncology wards. The mean practice score was 21.1 ± 3.76 that ranged from 12.5 to 31. The independent samples t-test showed the outpatient nurses were weaker in practice (17.2 ± 2.52) in comparison with university hospitals (23.35 ± 3.02, P < 0.001). Occupational protection status of clinical nursing staff exposed to cytotoxic drugs especially during administration and disposal of medicines was poor and rarely trained with this subject and was observed under the standard conditions. There is deficiency in the understanding and related protection practices of clinical nursing staff vocationally exposed to cytotoxic drugs. It is recommended that all clinical nursing staff should receive full occupational protection training about these matters and the authorities provide standard conditions of oncology wards.

  4. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

    OpenAIRE

    Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

    2011-01-01

    A review of the issues involved in medical device regulation in radiation oncology, including a general review of federal medical device regulation and explanations of the legal and regulatory framework.

  5. The Metaboloepigenetic Dimension of Cancer Stem Cells: Evaluating the Market Potential for New Metabostemness-Targeting Oncology Drugs.

    Science.gov (United States)

    Menendez, Javier A

    2015-01-01

    The current global portfolio of oncology drugs is unlikely to produce durable disease remission for millions of cancer patients worldwide. This is due, in part, to the existence of so-called cancer stem cells (CSCs), a particularly aggressive type of malignant cell that is capable of indefinite self-replication, is refractory to conventional treatments, and is skilled at spreading and colonizing distant organs. To date, no drugs from big-league Pharma companies are capable of killing CSCs. Why? Quite simply, a classic drug development approach based on mutated genes and pathological protein products cannot efficiently target the plastic, epigenetic proclivity of cancer tissues to generate CSCs. Recent studies have proposed that certain elite metabolites (oncometabolites) and other common metabolites can significantly influence the establishment and maintenance of epigenetic signatures of stemness and cancer. Consequently, cellular metabolism and the core epigenetic codes, DNA methylation and histone modification, can be better viewed as an integrated metaboloepigenetic dimension of CSCs, which we have recently termed cancer metabostemness. By targeting weaknesses in the bridge connecting metabolism and epigenetics, a new generation of metabostemnessspecific drugs can be generated for potent and long-lasting elimination of life-threatening CSCs. Here I evaluate the market potential of re-modeling the oncology drug pipeline by discovering and developing new metabolic approaches able to target the apparently undruggable epigenetic programs that dynamically regulate the plasticity of non-CSC and CSC cellular states.

  6. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-04-06

    ... Management Advisory Committee. This meeting was announced in the Federal Register of March 8, 2010 (75 FR... meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of March 8, 2010, FDA announced that a joint... drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis....

  7. Drug waste minimisation and cost-containment in Medical Oncology: Two-year results of a feasibility study

    Directory of Open Access Journals (Sweden)

    Mansutti Mauro

    2008-04-01

    Full Text Available Abstract Background Cost-containment strategies are required to face the challenge of rising drug expenditures in Oncology. Drug wastage leads to economic loss, but little is known about the size of the problem in this field. Methods Starting January 2005 we introduced a day-to-day monitoring of drug wastage and an accurate assessment of its costs. An internal protocol for waste minimisation was developed, consisting of four corrective measures: 1. A rational, per pathology distribution of chemotherapy sessions over the week. 2. The use of multi-dose vials. 3. A reasonable rounding of drug dosages. 4. The selection of the most convenient vial size, depending on drug unit pricing. Results Baseline analysis focused on 29 drugs over one year. Considering their unit price and waste amount, a major impact on expense was found to be attributable to six drugs: cetuximab, docetaxel, gemcitabine, oxaliplatin, pemetrexed and trastuzumab. The economic loss due to their waste equaled 4.8% of the annual drug expenditure. After the study protocol was started, the expense due to unused drugs showed a meaningful 45% reduction throughout 2006. Conclusion Our experience confirms the economic relevance of waste minimisation and may represent a feasible model in addressing this issue. A centralised unit of drug processing, the availability of a computerised physician order entry system and an active involvement of the staff play a key role in allowing waste reduction and a consequent, substantial cost-saving.

  8. Drug interactions between antineoplastic and antidepressant agents: analysis of patients seen at an oncology clinic at a general hospital

    Directory of Open Access Journals (Sweden)

    Camila de Araújo Reinert

    2015-06-01

    Full Text Available Objectives: To determine the prevalence of depressive symptoms among oncology patients and identify simultaneous use of antineoplastic and antidepressant agents.Methods: This was a cross-sectional study that interviewed 56 oncology patients using two data collection instruments: a questionnaire covering clinical and sociodemographic data and the Beck Depression Inventory-II (BDI-II, for assessment of depressive symptoms. For data analysis, descriptive statistics were used to determine the prevalence of depressive symptoms and the chi-square test was used to evaluate associations between sociodemographic and clinical variables and depressive symptoms.Results: A 26.7% (15 patients prevalence of depression was detected. Just eight of these 15 patients (53.3% were receiving treatment for depression. In the sample as a whole, 13 of the patients interviewed (23.2% were taking antidepressants and 11 of these 13 patients (19.6% were taking antidepressive and antineoplastic agents simultaneously. A total of five (8.9% of the sample contraindicated drug interactions were detected.Conclusions:Depressive symptoms are more prevalent among cancer patients than in the general population, but they are generally under-diagnosed and under-treated. Simultaneous use of antidepressant and antineoplastic agents is common and so, in order to reduce the number of harmful adverse effects, possible drug interactions must be identified before antidepressants are prescribed to cancer patients.

  9. Pharmacogenomics in Pediatric Oncology: Review of Gene—Drug Associations for Clinical Use †

    Science.gov (United States)

    Mlakar, Vid; Huezo-Diaz Curtis, Patricia; Satyanarayana Uppugunduri, Chakradhara Rao; Krajinovic, Maja; Ansari, Marc

    2016-01-01

    During the 3rd congress of the European Society of Pharmacogenomics and Personalised Therapy (ESPT) in Budapest in 2015, a preliminary meeting was held aimed at establishing a pediatric individualized treatment in oncology and hematology committees. The main purpose was to facilitate the transfer and harmonization of pharmacogenetic testing from research into clinics, to bring together basic and translational research and to educate health professionals throughout Europe. The objective of this review was to provide the attendees of the meeting as well as the larger scientific community an insight into the compiled evidence regarding current pharmacogenomics knowledge in pediatric oncology. This preliminary evaluation will help steer the committee’s work and should give the reader an idea at which stage researchers and clinicians are, in terms of personalizing medicine for children with cancer. From the evidence presented here, future recommendations to achieve this goal will also be suggested. PMID:27618021

  10. Pharmacogenomics in Pediatric Oncology: Review of Gene—Drug Associations for Clinical Use

    Directory of Open Access Journals (Sweden)

    Vid Mlakar

    2016-09-01

    Full Text Available During the 3rd congress of the European Society of Pharmacogenomics and Personalised Therapy (ESPT in Budapest in 2015, a preliminary meeting was held aimed at establishing a pediatric individualized treatment in oncology and hematology committees. The main purpose was to facilitate the transfer and harmonization of pharmacogenetic testing from research into clinics, to bring together basic and translational research and to educate health professionals throughout Europe. The objective of this review was to provide the attendees of the meeting as well as the larger scientific community an insight into the compiled evidence regarding current pharmacogenomics knowledge in pediatric oncology. This preliminary evaluation will help steer the committee’s work and should give the reader an idea at which stage researchers and clinicians are, in terms of personalizing medicine for children with cancer. From the evidence presented here, future recommendations to achieve this goal will also be suggested.

  11. Trends in Bone Morphogenetic Protein Usage since the U.S. Food and Drug Administration Advisory in 2008: What Happens to Physician Practices When the Food and Drug Administration Issues an Advisory?

    Science.gov (United States)

    Mckie, Janay; Qureshi, Sheeraz; Iatridis, James; Egorova, Natalia; Cho, Samuel; Hecht, Andrew

    2014-06-01

    Study Design Retrospective cross-sectional study of spinal procedures from 2002 to 2010 using the Nationwide Inpatient Sample database. Objective To determine the patterns of bone morphogenetic protein (BMP) usage in fusion surgery before and after the U.S. Food and Drug Administration (FDA) 2008 advisory for the anterior cervical spine to understand how advisories affect U.S. physician practices. Methods Procedures were identified through International Classification of Diseases, Ninth Revision procedure codes and were plotted over time based on fusion procedure type, site, and area of fusion. U.S. national trends were approximated by polynomial regression analysis. Results The majority of the data trends of BMP usage reflect a second-order polynomial model. BMP usage in anterior cervical spine fusion procedures plateaued during the fourth quarter of 2007. The most apparent change in trend was noted in BMP usage pre- and postadvisory in the analysis of anterior cervical spine fusions. BMP percentage of use decreased in this area by 5% from the time of the FDA advisory to the fourth quarter of 2010. Conclusions The decrease in BMP usage in anterior cervical spinal fusion procedures coincided with the timing of the FDA advisory. The fact that BMP continued to be used in cervical spine fusion procedures, even at lower rates, despite the advisory, may reflect the availability of new clinical information that could lessen complications (i.e., lower BMP dose, perioperative steroids, BMP containment). Furthermore, factors like the natural ceiling effect of use or demand for new technology, complications, prohibitive institutional costs, access to information, and insurance compensation may have all contributed to the BMP usage trends observed.

  12. Optimal Dosing for Targeted Therapies in Oncology: Drug Development Cases Leading by Example.

    Science.gov (United States)

    Sachs, Jeffrey R; Mayawala, Kapil; Gadamsetty, Satvik; Kang, Soonmo Peter; de Alwis, Dinesh P

    2016-03-15

    One of the key objectives of oncology first-in-human trials has often been to establish the maximum tolerated dose (MTD). However, targeted therapies might not exhibit dose-limiting toxicities (DLT) at doses significantly higher than sufficiently active doses, and there is frequently a limited ability to objectively quantify adverse events. Thus, while MTD-based determination of recommended phase II dose may have yielded appropriate dosing for some cytotoxics, targeted therapeutics (including monoclonal antibodies and/or immunotherapies) sometimes need alternative or complementary strategies to help identify dose ranges for a randomized dose-ranging study. One complementary strategy is to define a biologically efficacious dose (BED) using an "effect marker." An effect marker could be a target engagement, pharmacodynamic, or disease progression marker (change in tumor size for solid tumors or bone marrow blast count for some hematologic tumors). Although the concept of BED has been discussed extensively, we review specific examples in which the approach influenced oncology clinical development. Data extracted from the literature and the examples support improving dose selection strategies to benefit patients, providers, and the biopharmaceutical industry. Although the examples illustrate key contributions of effect markers in dose selection, no one-size-fits-all approach to dosing can be justified. Higher-than-optimal dosing can increase toxicity in later trials (and in clinical use), which can have a negative impact on efficacy (via lower adherence or direct sequelae of toxicities). Proper dose selection in oncology should follow a multifactorial decision process leading to a randomized, dose-ranging study instead of a single phase II dose. ©2015 American Association for Cancer Research.

  13. Measuring extent of surface contamination produced by the handling of antineoplastic drugs in low- to middle-income country oncology health care settings.

    Science.gov (United States)

    Müller-Ramírez, Claudio; Squibb, Katherine; McDiarmid, Melissa

    2017-09-03

    Antineoplastic drugs are known to cause detrimental effects to health care workers who are exposed through work tasks. Environmental monitoring studies are an excellent approach to measure the extent of surface contamination produced by the handling of antineoplastic drugs in the workplace and to assess the potential for occupational exposures in oncology health care settings. The main aim of the study was to establish the extent of surface contamination produced by the handling of antineoplastic drugs in a limited-resource oncology health care facility in Colombia by conducting an environmental monitoring study using affordable analytical instrumentation. Contamination with antineoplastic drugs was widespread in the health care facility under evaluation, which could result in health care worker exposure to antineoplastic drugs. A comprehensive review of current safety guidelines and protocols including assessment of adherence in the health care facility should be done.

  14. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Science.gov (United States)

    2013-11-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Veterinary Medicine... Food and Drug Administration (FDA) is announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of...

  15. Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects.

    Science.gov (United States)

    Nagai, Sumimasa; Ozawa, Keiya

    2016-12-01

    To reduce the delay in marketing authorization of drugs in Japan, four Japanese national projects were instituted. We examined all oncologic drugs for adult patients approved or discussed through these schemes, for the first time. All the data are publicly available. In total, 197 applications/demands (181 indications and 16 dosages/uses) were collected. As of December 31, 2015, 64 indications and 10 dosages/uses were approved as off-label drugs through these schemes without conducting additional registration trials in Japan. Furthermore, 46 indications and two dosages/uses were approved after registration trials in Japan requested by the national scheme councils. Regarding the following 23 indications of the 197 applications/demands, registration trials in Japan were commenced after the national scheme council's request: 17 hematological malignancies and six orphan solid tumors. Moreover, 54 indications and three dosages/uses, for which demands were submitted, were regarded as not a high medical priority by the national scheme council. Regarding two hematological malignancy indications, the dosage approved in foreign countries was intolerable for the Japanese patients in Japanese registration trials and this stopped the clinical development in Japan. Our analysis showed that 110 indications and 12 dosages/uses were approved in Japan through these schemes. These national projects have provided numerous therapeutic options for Japanese patients and may be meaningful for promoting clinical development and regulatory approval especially in orphan diseases in countries other than Japan.

  16. Measuring the Value of New Drugs: Validity and Reliability of 4 Value Assessment Frameworks in the Oncology Setting.

    Science.gov (United States)

    Bentley, Tanya G K; Cohen, Joshua T; Elkin, Elena B; Huynh, Julie; Mukherjea, Arnab; Neville, Thanh H; Mei, Matthew; Copher, Ronda; Knoth, Russell; Popescu, Ioana; Lee, Jackie; Zambrano, Jenelle M; Broder, Michael S

    2017-06-01

    Several organizations have developed frameworks to systematically assess the value of new drugs. To evaluate the convergent validity and interrater reliability of 4 value frameworks to understand the extent to which these tools can facilitate value-based treatment decisions in oncology. Eight panelists used the American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), Institute for Clinical and Economic Review (ICER), and National Comprehensive Cancer Network (NCCN) frameworks to conduct value assessments of 15 drugs for advanced lung and breast cancers and castration-refractory prostate cancer. Panelists received instructions and published clinical data required to complete the assessments, assigning each drug a numeric or letter score. Kendall's Coefficient of Concordance for Ranks (Kendall's W) was used to measure convergent validity by cancer type among the 4 frameworks. Intraclass correlation coefficients (ICCs) were used to measure interrater reliability for each framework across cancers. Panelists were surveyed on their experiences. Kendall's W across all 4 frameworks for breast, lung, and prostate cancer drugs was 0.560 (P= 0.010), 0.562 (P = 0.010), and 0.920 (P fair to excellent, increasing with clinical benefit subdomain concordance and simplicity of drug trial data. Interrater reliability, highest for ASCO and ESMO, improved with clarity of instructions and specificity of score definitions. Continued use, analyses, and refinements of these frameworks will bring us closer to the ultimate goal of using value-based treatment decisions to improve patient care and outcomes. This work was funded by Eisai Inc. Copher and Knoth are employees of Eisai Inc. Bentley, Lee, Zambrano, and Broder are employees of Partnership for Health Analytic Research, a health services research company paid by Eisai Inc. to conduct this research. For this study, Cohen, Huynh, and Neville report fees from Partnership for Health Analytic Research

  17. Phase 0 clinical trials: Theoretical and practical implications in oncologic drug development

    NARCIS (Netherlands)

    P.M. Coloma (Preciosa)

    2012-01-01

    textabstractDrug discovery and development has become a risky, expensive, and protracted process, with the cost of introducing a new drug to the market going as high as US$2 billion and the entire process taking at least 10-15 years. Great advances in biomedical research in recent years have not res

  18. [Review process of new oncology drug application in Japan--role of MD reviewer].

    Science.gov (United States)

    Fujiwara, Y

    1999-01-01

    On the basis of discussion by the Committee for Drug Safety Ensuring Measures, the Japanese Ministry of Health and Welfare (MHW) has amended the Pharmaceutical Affairs Law and related laws, and is reforming its review system for approving new drugs. One of the most important changes in the review system is the establishment of Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) in July, 1997 under the National Institute of Health Sciences, a research institute under MHW. PMDEC, the Evaluation and Licensing Division at MHW and the Organization for Drug ADR Relief, R&D Promotion and Product Review (the Drug Organization) are in charge of drug approval, and reexamination and reevaluation applications. Before the reform new drug application reviews had been conducted mainly by the Central Pharmaceutical Affairs Council (CPAC). After the reform PMDEC, employing technical officials who have expertise in pharmacology, toxicology, biostatistics, clinical medicine, or other scientific fields, jointly review the applications with CPAC. The Evaluation and Licensing Division takes charge of administrative matters, such as final decisions on approvals, developing guidelines concerning the review process, international affairs, and regulatory instructions. During the early part of review the Drug Organization conducts a compliance review on the documents, which a sponsor submits with the approval application, and GCP inspection.

  19. Multiparametric Analysis of Oncology Drug Screening with Aqueous Two-Phase Tumor Spheroids.

    Science.gov (United States)

    Shahi Thakuri, Pradip; Ham, Stephanie L; Luker, Gary D; Tavana, Hossein

    2016-11-07

    Spheroids present a biologically relevant three-dimensional model of avascular tumors and a unique tool for discovery of anticancer drugs. Despite being used in research laboratories for several decades, spheroids are not routinely used in the mainstream drug discovery pipeline primarily due to the difficulty of mass-producing uniformly sized spheroids and intense labor involved in handling, drug treatment, and analyzing spheroids. We overcome this barrier using a polymeric aqueous two-phase microtechnology to robotically microprint spheroids of well-defined size in standard 384-microwell plates. We use different cancer cells and show that resulting spheroids grow over time and display characteristic features of solid tumors. We demonstrate the feasibility of robotic, high-throughput screening of 25 standard chemotherapeutics and molecular inhibitors against tumor spheroids of three different cancer cell lines. This screening uses over 7000 spheroids to elicit high quality dose-dependent drug responses from spheroids. To quantitatively compare performance of different drugs, we employ a multiparametric scoring system using half-maximum inhibitory concentration (IC50), maximum inhibition (Emax), and area under the dose-response curve (AUC) to take into account both potency and efficacy parameters. This approach allows us to identify several compounds that effectively inhibit growth of spheroids and compromise cellular viability, and distinguish them from moderately effective and ineffective drugs. Using protein expression analysis, we demonstrate that spheroids generated with the aqueous two-phase microtechnology reliably resolve molecular targets of drug compounds. Incorporating this low-cost and convenient-to-use tumor spheroid technology in preclinical drug discovery will make compound screening with realistic tumor models a routine laboratory technique prior to expensive and tedious animal tests to dramatically improve testing throughput and efficiency and

  20. Phase 0 clinical trials: theoretical and practical implications in oncologic drug development

    OpenAIRE

    Coloma PM

    2013-01-01

    Preciosa M ColomaDepartment of Medical Informatics, Erasmus MC University Medical Center, Rotterdam, The NetherlandsAbstract: Drug discovery and development has become a risky, expensive, and protracted process, with the cost of introducing a new drug to the market going as high as US$2 billion and the entire process taking at least 10–15 years. Great advances in biomedical research in recent years have not resulted in translation into medical product development, and there has been...

  1. Novel and Expanded Oncology Drug Approvals of 2016-PART 1: New Options in Solid Tumor Management.

    Science.gov (United States)

    Knepper, Todd C; Saller, James; Walko, Christine M

    2017-02-15

    The nonradiologic medical management of solid tumors has evolved from the use of traditional cytotoxic agents to modern targeted therapies, monoclonal antibodies, and immunotherapies. Advances in the understanding of cancer biology and therapeutic strategies have resulted in increasing numbers of new drug applications and approvals. Consequently, practicing oncologists need to learn how the newly available agents function and what toxicities to watch for, as well as ways to optimize the use of both new drugs and previously approved drugs with new indications. In 2016, the US Food and Drug Administration approved three novel drugs for the treatment of solid malignancies-olaratumab in selected patients with soft-tissue sarcoma, atezolizumab for the treatment of bladder cancer, and rucaparib for the treatment of ovarian cancer; also in 2016, the use of previously approved anticancer agents (including atezolizumab) was expanded into 11 new patient populations. The diversity of options for patients is evident in the broad range of the 2016 approvals, which include immune checkpoint inhibitors, targeted therapies, monoclonal antibodies, and traditional cytotoxic agents. This article focuses on the new agents and indications that emerged in 2016 for solid tumor treatment. We review the drug indications, mechanisms of action, pivotal trial data, pertinent toxicities, use in special populations, and the appropriate clinical contexts for treatment planning.

  2. Mechanisms of drug resistance in veterinary oncology – A review with an emphasis on canine lymphoma

    NARCIS (Netherlands)

    Zandvliet, M.M.J.M.; Teske, E.

    2015-01-01

    Drug resistance (DR) is the major limiting factor in the successful treatment of systemic neoplasia with cytotoxic chemotherapy. DR can be either intrinsic or acquired, and although the development and clinical implications are different, the underlying mechanisms are likely to be similar. Most caus

  3. 75 FR 32188 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Science.gov (United States)

    2010-06-07

    ... before July 8, 2010. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 9:15 a.m. on July 23, 2010. Those desiring to make formal oral presentations should notify the... will solicit feedback from the advisory committees and public on the components of that proposal....

  4. The effect of learning via module versus lecture teaching methods on the knowledge and practice of oncology nurses about safety standards with cytotoxic drugs in Shiraz University of Medical Sciences

    National Research Council Canada - National Science Library

    Abbasi, Khadijeh; Hazrati, Maryam; Mohamadi, Nasrin Pourali; Rajaeefard, Abdolreza

    2013-01-01

    .... In this study, the effect of teacher-centered (lecture) and student-centered (module) teaching methods in relation to safety standards with cytotoxic drugs on the knowledge and practice of oncology nurses was compared...

  5. Study on Chromosome Damage Among Nurses Occupationally Exposed to Antineoplastic Drugs in an Oncology Department

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    @@ INTRODUCTION Many antineoplastic agents have been shown to be mutagenic, teratogenic and carcinogenic in experimental animals and in vitro test systems. Epidemiological data on the association of secondary neoplasms with a specific chemotherapeutic treatment are available on some 30 agents. Several previous studies concerning hospital personnel have indicated that occupational exposure to cytostatic drugs may be detected by genotoxicological biomonitoring methods, e.g., comet assay, SCEs, chromosomal aberration and micronucleus test.

  6. Designs of drug-combination phase I trials in oncology: a systematic review of the literature

    OpenAIRE

    Riviere, Marie-karelle; Le Tourneau, C.; Paoletti, X.; Dubois, F.; Zohar, Sarah

    2015-01-01

    International audience; Background Combining several anticancer agents can increase the overall antitumor action, but at the same time, it can also increase the overall observed toxicity. Adaptive dose-escalation designs for drug combinations have recently emerged as an attractive alternative to algorithm-based designs, and they seem more effective in combination recommendations. These methods are not used in practice currently. Our aim is to describe international scientific practices in the...

  7. Phase I/II adaptive design for drug combination oncology trials

    OpenAIRE

    Wages, Nolan A.; Conaway, Mark R.

    2014-01-01

    Existing statistical methodology on dose finding for combination chemotherapies has focused on toxicity considerations alone in finding a maximum tolerated dose combination to recommend for further testing of efficacy in a phase II setting. Recently, there has been increasing interest in integrating phase I and phase II trials in order to facilitate drug development. In this article, we propose a new adaptive phase I/II method for dual-agent combinations that takes into account both toxicity ...

  8. Nanomedicine: towards development of patient-friendly drug-delivery systems for oncological applications

    Directory of Open Access Journals (Sweden)

    Ranganathan R

    2012-02-01

    Full Text Available Ramya Ranganathan1,*, Shruthilaya Madanmohan1,*, Akila Kesavan1, Ganga Baskar1, Yoganathan Ramia Krishnamoorthy2, Roy Santosham3, D Ponraju4, Suresh Kumar Rayala2, Ganesh Venkatraman1 1Department of Human Genetics, Sri Ramachandra University, Porur, 2Department of Biotechnology, Indian Institute of Technology, Madras, 3Department of Radiology and Imaging Sciences, Sri Ramachandra University, Porur, Chennai, 4Safety Engineering Division, Nuclear and Engineering Safety Group, Indira Gandhi Center for Atomic Research, Kalpakkam, India*Authors contributed equally to this workAbstract: The focus on nanotechnology in cancer treatment and diagnosis has intensified due to the serious side effects caused by anticancer agents as a result of their cytotoxic actions on normal cells. This nonspecific action of chemotherapy has awakened a need for formulations capable of definitive targeting with enhanced tumor-killing. Nanooncology, the application of nanobiotechnology to the management of cancer, is currently the most important area of nanomedicine. Currently several nanomaterial-based drug-delivery systems are in vogue and several others are in various stages of development. Tumor-targeted drug-delivery systems are envisioned as magic bullets for cancer therapy and several groups are working globally for development of robust systems.Keywords: patient-friendly, drug-delivery systems, cancer, nanomedicine

  9. Synthesis of silica nanoparticles for encapsulation of oncology drugs with low water solubility: effect of processing parameters on structural evolution

    Science.gov (United States)

    Bürglová, Kristýna; Hlaváč, Jan; Bartlett, John R.

    2015-12-01

    Silica nanoparticles with tailored properties have been developed for a variety of biomedical applications, with particular emphasis on their use as carriers for the encapsulation and controlled release of bioactive species. Among the various strategies described, silica nanoparticles with uniform mesoporosity (MSN) prepared in aqueous solution at elevated temperatures using cetyltrimethylammonium bromide as a template have a range of desirable properties. However, the processing windows available to control the dimensions and other key properties of such nanoparticles prepared using fluoride salts as catalysts have not been elucidated, with mixed products containing gel fragments and non-uniform products obtained under many conditions. Here, we present a parametric study of the synthesis of MSN under fluoride-catalysed conditions using tetraethylorthosilicate as silica precursor. The processing conditions required to produce uniform nanoparticles with controlled dimensions are elucidated, together with the conditions under which dried powders can be re-dispersed in aqueous solution after long-term storage to regenerate unaggregated nanospheres with dimensions (as measured by dynamic light scattering) comparable to those measured via scanning electron microscopy analysis of the dried material. The ability to dry and store such powders for extended periods of time is an important requirement for the use of such materials in drug delivery applications. Preliminary results demonstrating the use of such MSNs as hosts for oncology drugs [substituted 3-hydroxyquinolinones ( 3-HQ)] with low water solubility (≪1 µg/g H2O) are presented, with loadings of several wt% demonstrated. The ability of the silica host to protect the 3-HQ from oxidative degradation during impregnation and release is discussed.

  10. Synthesis of silica nanoparticles for encapsulation of oncology drugs with low water solubility: effect of processing parameters on structural evolution

    Energy Technology Data Exchange (ETDEWEB)

    Bürglová, Kristýna; Hlaváč, Jan [Institute of Molecular and Translational Medicine, Palacký University Olomouc, Faculty of Medicine and Dentistry (Czech Republic); Bartlett, John R., E-mail: JBartlett@usc.edu.au [University of the Sunshine Coast, Faculty of Science, Health, Education and Engineering (Australia)

    2015-12-15

    Silica nanoparticles with tailored properties have been developed for a variety of biomedical applications, with particular emphasis on their use as carriers for the encapsulation and controlled release of bioactive species. Among the various strategies described, silica nanoparticles with uniform mesoporosity (MSN) prepared in aqueous solution at elevated temperatures using cetyltrimethylammonium bromide as a template have a range of desirable properties. However, the processing windows available to control the dimensions and other key properties of such nanoparticles prepared using fluoride salts as catalysts have not been elucidated, with mixed products containing gel fragments and non-uniform products obtained under many conditions. Here, we present a parametric study of the synthesis of MSN under fluoride-catalysed conditions using tetraethylorthosilicate as silica precursor. The processing conditions required to produce uniform nanoparticles with controlled dimensions are elucidated, together with the conditions under which dried powders can be re-dispersed in aqueous solution after long-term storage to regenerate unaggregated nanospheres with dimensions (as measured by dynamic light scattering) comparable to those measured via scanning electron microscopy analysis of the dried material. The ability to dry and store such powders for extended periods of time is an important requirement for the use of such materials in drug delivery applications. Preliminary results demonstrating the use of such MSNs as hosts for oncology drugs [substituted 3-hydroxyquinolinones (3-HQ)] with low water solubility (≪1 µg/g H{sub 2}O) are presented, with loadings of several wt% demonstrated. The ability of the silica host to protect the 3-HQ from oxidative degradation during impregnation and release is discussed.

  11. 77 FR 36548 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-06-19

    ... disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees... neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion... make every effort to accommodate persons with physical disabilities or special needs. If you...

  12. Drug Interactions In Female Oncologic Inpatients: Differences Among Databases [interações Medicamentosas Em Mulheres Internadas Com Câncer: Diferenças Entre Bases De Dados

    OpenAIRE

    Moriel P.; Siqueira J.A.; Carnevale R.C.; Rezende Costa C.G.; da Cruz A.A.; da Silva N.M.O.; Bernardes A.C.; Carvalho R.P.; Mazzola P.G.

    2013-01-01

    The aim of the present study was to quantify drug interactions in prescriptions for women undergoing supportive therapy in an oncology setting at a women's hospital in Brazil and compare the information provided by different databases regarding these drug interactions. A convenience sample was selected of prescriptions for patients diagnosed with breast or gynecological tumors hospitalized in the clinical oncology and surgery wards from April to June 2009. DRUGDEX/Micromedex (Thomson Micromed...

  13. Recent developments in the chromatographic bioanalysis of approved kinase inhibitor drugs in oncology.

    Science.gov (United States)

    Rood, Johannes J M; Schellens, Jan H M; Beijnen, Jos H; Sparidans, Rolf W

    2016-10-25

    In recent years (2010-present) there has been an increase in the number of publications reporting the development, validation and use of bioanalytical methods in the rapidly expanding drug class of small molecule protein kinase inhibitors. Most reports describe the technological set-up of the methods that have allowed for drug concentration measurements from various sample types. This includes plasma, dried blood-spot, and tissue-analysis. Also method development, exploration of various techniques, as well as measurement and identification of metabolites were addressed. For the bioanalysis, a variety of sample-pretreatment methods like protein-precipitation, liquid-liquid extraction, and solid-phase extraction have been employed, all varying in complexity, cleanliness and time-consumption. Chromatographic separation, nowadays, is more focused on separating components from ion-suppressive effects, since for MS/MS detection, various components do not have to be baseline separated. For detection multiple types of detectors were used, ranging from state-of-the-art high resolution, and tandem mass spectrometry with low picogram per milliliter detection limits to the classical UV-detector with several nanograms per milliliter limits. As new bioanalytical methods have arisen that do rely on chromatographic separation, for example for high-throughput analysis, these are addressed in this review as well.

  14. 77 FR 67013 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-08

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... links: December 4, 2012: Blood Products Advisory Committee Day 1:...

  15. Computational oncology.

    Science.gov (United States)

    Lefor, Alan T

    2011-08-01

    Oncology research has traditionally been conducted using techniques from the biological sciences. The new field of computational oncology has forged a new relationship between the physical sciences and oncology to further advance research. By applying physics and mathematics to oncologic problems, new insights will emerge into the pathogenesis and treatment of malignancies. One major area of investigation in computational oncology centers around the acquisition and analysis of data, using improved computing hardware and software. Large databases of cellular pathways are being analyzed to understand the interrelationship among complex biological processes. Computer-aided detection is being applied to the analysis of routine imaging data including mammography and chest imaging to improve the accuracy and detection rate for population screening. The second major area of investigation uses computers to construct sophisticated mathematical models of individual cancer cells as well as larger systems using partial differential equations. These models are further refined with clinically available information to more accurately reflect living systems. One of the major obstacles in the partnership between physical scientists and the oncology community is communications. Standard ways to convey information must be developed. Future progress in computational oncology will depend on close collaboration between clinicians and investigators to further the understanding of cancer using these new approaches.

  16. Comparative oncology today.

    Science.gov (United States)

    Paoloni, Melissa C; Khanna, Chand

    2007-11-01

    The value of comparative oncology has been increasingly recognized in the field of cancer research, including the identification of cancer-associated genes; the study of environmental risk factors, tumor biology, and progression; and, perhaps most importantly, the evaluation of novel cancer therapeutics. The fruits of this effort are expected to be the creation of better and more specific drugs to benefit veterinary and human patients who have cancer. The state of the comparative oncology field is outlined in this article, with an emphasis on cancer in dogs.

  17. Sistema integrado de prevención de errores en el proceso de utilización de medicamentos en oncología Integrated system for error prevention in process of drugs used in Oncology

    Directory of Open Access Journals (Sweden)

    Jorge L. Soriano García

    2007-08-01

    indirectos. Conclusiones: Constituye el primer reporte de un sistema integrado de prevención de errores en los antineoplásicos en países con recursos limitados y puede, por su sencillez y factibilidad, ser aplicado en cualquiera de estos países.Justification: Medication mistakes in case of chemotherapy or adjuvant treatment used in any stage of drug application process: prescription, transcription, preparation, dispense or administration, are a frequent cause of side effects of antineoplastic drugs. Methods: Main sourses of information were meetings to analyze application of quality guarantee program in Oncology in services and the revision of medical literature published in from 1995 to January 2006, appeared in MEDLINE. Searching strategy was performed under headings “mediction errors” and “chemotherapy”. Additional searches were performed under headings “safety patient”, “antineoplastic drugs”, “preventing medications errors”, and were combined each other. Results: Experience of Oncology Service from “Hermanos Ameijeiras” Clinical Surgical Hospital was exposed as for application of work strategy related to error prevention in administration of drugs in above service from year 2000. To date, some novel features has been applied: forms for chemotherapeutic treatment, standardized suggestions in pre-printed sheets, drugs dilution tables, new organizing nursing systems, and report sheets in case of patient toxicity. Application of above strategy involves antineoplastic chemotherapy, and global survival of patients. It contributes to reduct direct health expenses (decrease in complications and treatment derived from it, real time of staff in different phases of drug use process, and consumption of cytostatic sera and indirect charges. Conclusions: This is the first report from aa integrated system of error prevention in antineoplastic drugs in countries with limites resources, and by its simplicity and feasibility, may be applied in any of these

  18. Systematic in-vitro evaluation of the NCI/NIH Developmental Therapeutics Program Approved Oncology Drug Set for the identification of a candidate drug repertoire for MLL-rearranged leukemia

    Directory of Open Access Journals (Sweden)

    Hoeksema KA

    2011-09-01

    Full Text Available Kimberley A Hoeksema1, Aarthi Jayanthan1, Todd Cooper2, Lia Gore3, Tanya Trippett4, Jessica Boklan6, Robert J Arceci5, Aru Narendran11Division of Pediatric Oncology, Alberta Children's Hospital, Calgary, AB, Canada; 2Aflac Cancer Center and Blood Disorders Service, Children's Healthcare of Atlanta, Emory University, Atlanta, GA, USA; 3Center for Cancer and Blood Disorders, Children's Hospital, University of Colorado Denver, Aurora, CO, USA; 4Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 5Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA; 6Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, AZ, USAAbstract: Despite significant progress made in the overall cure rate, the prognosis for relapsed and refractory malignancies in children remains extremely poor. Hence, there is an urgent need for studies that enable the timely selection of appropriate agents for Phase I clinical studies. The Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC is systematically evaluating libraries of known and novel compounds for activity against subsets of high-risk pediatric malignancies with defined molecular aberrations for future clinical development. In this report, we describe the in-vitro activity of a diverse panel of approved oncology drugs against MLL-rearranged pediatric leukemia cell lines. Agents in the Approved Oncology Drug Set II (National Cancer Institute/National Institutes of Health Developmental Therapeutics Program were evaluated by in-vitro cytotoxicity assays in pediatric acute lymphoblastic leukemia and acute myeloid leukemia cell lines with MLL gene rearrangements. Validation studies were carried out with patient leukemia cells in culture. Comparative analysis for toxicity against nonmalignant cells was evaluated in normal bone marrow stromal cells and normal human lymphocytes. Results from this study show that 42 of the 89 agents tested have

  19. Geriatric Oncology

    National Research Council Canada - National Science Library

    Helen Hughes; Vikram Swaminathan; Alice Pellegrini; Riccardo Audisio

    2014-01-01

    .... In this article, we review the current field of geriatric oncology. We highlight that age is not a contradiction to cancer treatment but geriatric assessment is needed to identify which treatment a patient may tolerate and benefit from.

  20. [Clinical evaluation of new drugs against orphan diseases in oncology - the current situation in Europe and in our country].

    Science.gov (United States)

    Stěrba, Jaroslav; Stěrbová, Sylva; Kodytková, Daniela; Valík, Dalibor; Demlová, Regina

    2014-01-01

    Cancer represents one of the main causes of death among diseases across the age spectrum. Tumors in children, however, represent less than 1% of the total number of cancers in the population and in terms of the definition of orphan diseases in Europe are all children's cancers considered as orphan diseases. This is the reason why the research and development of new agents against cancer in childhood stands outside of the main interest. Every year around 30,000 new cases of cancer in children and adolescents are diagnosed in the European Unioun (EU) and approximately 80% of them achieve long-term remission using mainly conventional methods of treatment. However, almost 6,000 children and adolescents die every year of malignant tumors therefore cancer remains a major cause of morbidity and mortality. Consequently, there is a demand for new and safe drugs for children suffering from cancer which would lead to improved survival and to risk reduction of late adverse effects of cancer treatment. In the past 10 years in the EU, more in the EU-15 than in our country, 20 performed oncology trials in phase I involving adults account for only one trial in pediatric patients. The issue of new drugs clinical testing in rare cancers is very complex, complicated and for current unsatisfactory situation might be responsible various aspects. These aspects contain the legislative field, the problem of determining the correct dose of testing drug as a single agent or in combination therapy, the use of testing drug in advanced disease or already in de novo diagnosed patients, as well as equity (equal) access to new drugs being tested, the goal set for each molecule/drug in clinical trials, the conflict of interest balanced with sufficient professionalism and last but not least, the need for new methodologies and statistical approaches. The aim of this article is to describe the issue complexity of incorporation of new, modern drug for cancer patients with orphan diseases, including

  1. The economic evaluation of personalised oncology medicines: ethical challenges.

    Science.gov (United States)

    Lewis, Jan R R; Lipworth, Wendy L; Kerridge, Ian H; Day, Richard O

    2013-10-01

    Insights into the molecular drivers of cancer are providing opportunities for the development of new targeted treatments and more personalised approaches to cancer management. Drugs targeting mutant epidermal growth factor receptors, such as erlotinib and gefitinib, may provide more effective, safer and better tolerated treatment options compared with chemotherapy among appropriately selected patients with advanced non-small cell lung cancer (NSCLC). First-line access to these newer treatments remains unfunded after several considerations by the Pharmaceutical Benefits Advisory Committee and their assessment that these are not cost-effective treatments. We suggest that there may be evidentiary and ethical challenges associated with the assessment of the cost-effectiveness of personalised oncology medicines in Australia, and that a new approach is needed to determine the value and cost-effectiveness of personalised medicine.

  2. 76 FR 59405 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-26

    ...-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia, and the draft document entitled ``Guidance for Industry: Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment,'' published November 2010 (see FDA Web site at...

  3. 78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-04-04

    ... indication of replacement ] therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil microembolism in the lungs and... committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED...

  4. Nanomedicine in veterinary oncology.

    Science.gov (United States)

    Lin, Tzu-Yin; Rodriguez, Carlos O; Li, Yuanpei

    2015-08-01

    Nanomedicine is an interdisciplinary field that combines medicine, engineering, chemistry, biology and material sciences to improve disease management and can be especially valuable in oncology. Nanoparticle-based agents that possess functions such as tumor targeting, imaging and therapy are currently under intensive investigation. This review introduces the basic concept of nanomedicine and the classification of nanoparticles. Because of their favorable pharmacokinetics, tumor targeting properties, and resulting superior efficacy and toxicity profiles, nanoparticle-based agents can overcome several limitations associated with conventional diagnostic and therapeutic protocols in veterinary oncology. The two most important tumor targeting mechanisms (passive and active tumor targeting) and their dominating factors (i.e. shape, charge, size and nanoparticle surface display) are discussed. The review summarizes published clinical and preclinical studies that utilize different nanoformulations in veterinary oncology, as well as the application of nanoparticles for cancer diagnosis and imaging. The toxicology of various nanoformulations is also considered. Given the benefits of nanoformulations demonstrated in human medicine, nanoformulated drugs are likely to gain more traction in veterinary oncology.

  5. 77 FR 6567 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-08

    ... the heading ``Resources for You,'' click on ``Public Meetings at the FDA White Oak Campus.'' Please... enough to provide timely notice. Therefore, you should always check the Agency's Web site and call the... preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity....

  6. 78 FR 48174 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-07

    ..., 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, Building 31, the Great Room, White Oak... discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing... susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product...

  7. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).

    Science.gov (United States)

    Fujiwara, Yasuhiro; Kobayashi, Ken

    2002-05-01

    In 1996 the Japanese Diet amended the Pharmaceutical Affairs Law (PAL) and its related laws based on 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. Between 1996 and 2000, the drug approval system in Japan underwent a series of radical reforms. We describe in this paper the current system for drug approval, discuss the post-approval reexamination and reevaluation system, conditions under which development and review may be expedited, and mechanisms for approval of off-label usage. Finally, we discuss the impact of the International Conference on Harmonization (ICH) agreement on drug development and review in Japan.

  8. Antineoplastic drugs in veterinary oncology: excretion in dogs, contamination of the environment and exposure assessment of people at risk

    NARCIS (Netherlands)

    Janssens, T.|info:eu-repo/dai/nl/345809386

    2012-01-01

    Anticancer drugs themselves can cause adverse health effects when administered to human patients. In addition, it has become apparent that personnel in human medicine, occupationally exposed to these anticancer drugs, may also be at risk. The past decades, the use of chemotherapy in veterinary

  9. 75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-26

    ... HUMAN SERVICES Food and Drug Administration Veterinary Medicine Advisory Committee; Notice of Meeting... the public. Name of Committee: Veterinary Medicine Advisory Committee. General Function of the...-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and...

  10. Therapeutic drug monitoring of monoclonal antibodies in inflammatory and malignant disease: translating TNF-ɑ experience to oncology

    NARCIS (Netherlands)

    Oude Munnink, T.H.; Henstra, M.J.; Segerink, L.I.; Movig, K.L.L.; Brummelhuis-Visser, P.

    2016-01-01

    Lack of response to monoclonal antibodies (mAbs) has been associated with inadequate mAb serum concentrations. Therapeutic drug monitoring (TDM) of mAbs has the potential to guide to more effective dosing in individual patients. This review discusses the mechanisms responsible for interpatient varia

  11. Medicinal cannabis in oncology.

    Science.gov (United States)

    Engels, Frederike K; de Jong, Floris A; Mathijssen, Ron H J; Erkens, Joëlle A; Herings, Ron M; Verweij, Jaap

    2007-12-01

    In The Netherlands, since September 2003, a legal medicinal cannabis product, constituting the whole range of cannabinoids, is available for clinical research, drug development strategies, and on prescription for patients. To date, this policy, initiated by the Dutch Government, has not yet led to the desired outcome; the amount of initiated clinical research is less than expected and only a minority of patients resorts to the legal product. This review aims to discuss the background for the introduction of legal medicinal cannabis in The Netherlands, the past years of Dutch clinical experience in oncology practice, possible reasons underlying the current outcome, and future perspectives.

  12. 75 FR 9416 - Advisory Committee Information Hotline

    Science.gov (United States)

    2010-03-02

    ... Panel 3014510232 Microbiology Devices Panel 3014512517 Molecular and Clinical Genetics Panel 3014510231... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee Information Hotline AGENCY: Food and Drug...

  13. The oncology drug elesclomol selectively transports copper to the mitochondria to induce oxidative stress in cancer cells.

    Science.gov (United States)

    Nagai, Masazumi; Vo, Nha H; Shin Ogawa, Luisa; Chimmanamada, Dinesh; Inoue, Takayo; Chu, John; Beaudette-Zlatanova, Britte C; Lu, Rongzhen; Blackman, Ronald K; Barsoum, James; Koya, Keizo; Wada, Yumiko

    2012-05-15

    Elesclomol is an investigational drug that exerts potent anticancer activity through the elevation of reactive oxygen species (ROS) levels and is currently under clinical evaluation as a novel anticancer therapeutic. Here we report the first description of selective mitochondrial ROS induction by elesclomol in cancer cells based on the unique physicochemical properties of the compound. Elesclomol preferentially chelates copper (Cu) outside of cells and enters as elesclomol-Cu(II). The elesclomol-Cu(II) complex then rapidly and selectively transports the copper to mitochondria. In this organelle Cu(II) is reduced to Cu(I), followed by subsequent ROS generation. Upon dissociation from the complex, elesclomol is effluxed from cells and repeats shuttling elesclomol-Cu complexes from the extracellular to the intracellular compartments, leading to continued copper accumulation within mitochondria. An optimal range of redox potentials exhibited by copper chelates of elesclomol and its analogs correlated with the elevation of mitochondrial Cu(I) levels and cytotoxic activity, suggesting that redox reduction of the copper triggers mitochondrial ROS induction. Importantly the mitochondrial selectivity exhibited by elesclomol is a distinct characteristic of the compound that is not shared by other chelators, including disulfiram. Together these findings highlight a unique mechanism of action with important implications for cancer therapy.

  14. 77 FR 4567 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-30

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To..., the meeting will also be Web cast. The Blood Products Advisory Committee Web cast will be available...

  15. The effect of learning via module versus lecture teaching methods on the knowledge and practice of oncology nurses about safety standards with cytotoxic drugs in Shiraz University of Medical Sciences.

    Science.gov (United States)

    Abbasi, Khadijeh; Hazrati, Maryam; Mohamadi, Nasrin Pourali; Rajaeefard, Abdolreza

    2013-11-01

    Several studies have established that all nurses need continuing education, especially those who are working in oncology wards. In the current programs, there are just two general patterns for teaching: Teacher-centered and student-centered patterns. In this study, the effect of teacher-centered (lecture) and student-centered (module) teaching methods in relation to safety standards with cytotoxic drugs on the knowledge and practice of oncology nurses was compared. This research was a quasi-experimental study with two intervention groups (module and lecture) and a control group. In this study, 86 nurses in Shiraz, Fars province in 2011, who participated in the prescription of cytotoxic drugs to patients were selected and randomly divided into three groups. The module group used a self-directed module, the lecture group was taught by an experienced lecturer in the classroom and the control group did not receive any intervention. Data in relation to knowledge and practice of oncology nurses in the three groups were collected before and 8 weeks after the intervention by using a questionnaire and checklist. To analyze the data paired-samples t-test and one way ANOVA analysis were used. Knowledge and practice scores increased significantly from baseline in both intervention groups, but there was no significant difference between the scores of the two groups. No considerable changes were observed in the control group. Both module and lecture methods have similar effects on improving the knowledge and practice of nurses in oncology wards. Therefore, considering the advantages of student-centered educational methods, the work load of nurses and the sensitivity of their jobs, we suggest using module.

  16. The effect of learning via module versus lecture teaching methods on the knowledge and practice of oncology nurses about safety standards with cytotoxic drugs in Shiraz University of Medical Sciences

    Science.gov (United States)

    Abbasi, Khadijeh; Hazrati, Maryam; Mohamadi, Nasrin Pourali; Rajaeefard, Abdolreza

    2013-01-01

    Background: Several studies have established that all nurses need continuing education, especially those who are working in oncology wards. In the current programs, there are just two general patterns for teaching: Teacher-centered and student-centered patterns. In this study, the effect of teacher-centered (lecture) and student-centered (module) teaching methods in relation to safety standards with cytotoxic drugs on the knowledge and practice of oncology nurses was compared. Materials and Methods: This research was a quasi-experimental study with two intervention groups (module and lecture) and a control group. In this study, 86 nurses in Shiraz, Fars province in 2011, who participated in the prescription of cytotoxic drugs to patients were selected and randomly divided into three groups. The module group used a self-directed module, the lecture group was taught by an experienced lecturer in the classroom and the control group did not receive any intervention. Data in relation to knowledge and practice of oncology nurses in the three groups were collected before and 8 weeks after the intervention by using a questionnaire and checklist. To analyze the data paired-samples t-test and one way ANOVA analysis were used. Results: Knowledge and practice scores increased significantly from baseline in both intervention groups, but there was no significant difference between the scores of the two groups. No considerable changes were observed in the control group. Conclusions: Both module and lecture methods have similar effects on improving the knowledge and practice of nurses in oncology wards. Therefore, considering the advantages of student-centered educational methods, the work load of nurses and the sensitivity of their jobs, we suggest using module. PMID:24554947

  17. Nanotechnology in radiation oncology.

    Science.gov (United States)

    Wang, Andrew Z; Tepper, Joel E

    2014-09-10

    Nanotechnology, the manipulation of matter on atomic and molecular scales, is a relatively new branch of science. It has already made a significant impact on clinical medicine, especially in oncology. Nanomaterial has several characteristics that are ideal for oncology applications, including preferential accumulation in tumors, low distribution in normal tissues, biodistribution, pharmacokinetics, and clearance, that differ from those of small molecules. Because these properties are also well suited for applications in radiation oncology, nanomaterials have been used in many different areas of radiation oncology for imaging and treatment planning, as well as for radiosensitization to improve the therapeutic ratio. In this article, we review the unique properties of nanomaterials that are favorable for oncology applications and examine the various applications of nanotechnology in radiation oncology. We also discuss the future directions of nanotechnology within the context of radiation oncology. © 2014 by American Society of Clinical Oncology.

  18. Personalized oncology

    DEFF Research Database (Denmark)

    Tuxen, Ida Viller; Jønson, Lars; Santoni-Rugiu, Eric;

    2014-01-01

    accelerated drug development. The overall advantage is to determine which mutation profiles correlate with sensitivity or lack of resistance to specific targeted therapies. The utility and current limitations of genomic screening to guide selection to Phase 1 clinical trial will be discussed....

  19. Medical oncology future plan of the Spanish Society of Medical Oncology: challenges and future needs of the Spanish oncologists.

    Science.gov (United States)

    Rivera, F; Andres, R; Felip, E; Garcia-Campelo, R; Lianes, P; Llombart, A; Piera, J M; Puente, J; Rodriguez, C A; Vera, R; Virizuela, J A; Martin, M; Garrido, P

    2017-04-01

    The SEOM Future Plan is aimed at identifying the main challenges, trends and needs of the medical oncology speciality over the next years, including potential oncologist workforce shortages, and proposing recommendations to overcome them. The estimations of the required medical oncologists workforce are based on an updated Medical Oncologist Register in Spain, Medical Oncology Departments activity data, dedication times and projected cancer incidence. Challenges, needs and future recommendations were drawn from an opinion survey and an advisory board. A shortage of 211 FTE medical oncologist specialists has been established. To maintain an optimal ratio of 158 new cases/FTE, medical oncology workforce should reach 1881 FTE by 2035. Main recommendations to face the growing demand and complexity of oncology services include a yearly growth of 2.5% of medical oncologist's workforce until 2035, and development and application of more accurate quality indicators for cancer care and health outcomes measure.

  20. 77 FR 10755 - Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication...

    Science.gov (United States)

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION... the Risk Communication Advisory Committee, Office of Planning, Office of Policy and Planning,...

  1. 75 FR 65640 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and... Tumor Vaccines and Biotechnology Branch, Office of Cellular, Tissue and Gene Therapies, Center...

  2. 77 FR 73472 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice...

  3. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Device Good Manufacturing Practice Advisory Committee... meeting will be open to the public. Name of Committee: Device Good Manufacturing Practice Advisory... effects of extreme weather and natural disasters on medical device manufacturing chain processes...

  4. 76 FR 60848 - National Mammography Quality Assurance Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-30

    ... HUMAN SERVICES Food and Drug Administration National Mammography Quality Assurance Advisory Committee... be open to the public. Name of Committee: National Mammography Quality Assurance Advisory Committee...) Proposed changes to the Mammography Quality Standard Act (MQSA) policies and inspection procedures;...

  5. Acute oncological emergencies.

    LENUS (Irish Health Repository)

    Gabriel, J

    2012-01-01

    The number of people receiving systemic anti-cancer treatment and presenting at emergency departments with treatment-related problems is rising. Nurses will be the first point of contact for most patients and need to be able to recognise oncological emergencies to initiate urgent assessment of patients and referral to the acute oncology team so that the most appropriate care can be delivered promptly. This article discusses the role of acute oncology services, and provides an overview of the most common acute oncological emergencies.

  6. POSSIBILITY OF PLANTS ACTIVE PARTS USAGE FOR ONCOLOGICAL DISEASES TREATMENT

    Directory of Open Access Journals (Sweden)

    T. S. Goncharova

    2015-01-01

    Full Text Available The article describes an implementation of plant drugs for oncological diseases treatment. It focuses on multicomponent combination herbal medicinal preparation, its therapeutic action, and supposed efficiency during its implementation with basic therapy for oncological disease.

  7. 75 FR 74735 - Food Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-01

    ...'s consumption of synthetic color additives in food and adverse effects on behavior. FDA intends to... HUMAN SERVICES Food and Drug Administration Food Advisory Committee; Notice of Meeting AGENCY: Food and... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public....

  8. Electrical potential difference across the stomach wall and gastric morphology in anaesthetized pigs after intravenous administration of cytotoxic drugs

    DEFF Research Database (Denmark)

    Fabrin, B.; Højgaard, L.; Olesen, H.P.;

    1991-01-01

    Oncologi, cytotoxic drugs, electrical potential difference, medicin, cander, gastric, side effects, chemotherapy......Oncologi, cytotoxic drugs, electrical potential difference, medicin, cander, gastric, side effects, chemotherapy...

  9. 77 FR 7588 - Blood Products Advisory Committee; Cancellation

    Science.gov (United States)

    2012-02-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Blood Products...

  10. Precision oncology: origins, optimism, and potential.

    Science.gov (United States)

    Prasad, Vinay; Fojo, Tito; Brada, Michael

    2016-02-01

    Imatinib, the first and arguably the best targeted therapy, became the springboard for developing drugs aimed at molecular targets deemed crucial to tumours. As this development unfolded, a revolution in the speed and cost of genetic sequencing occurred. The result--an armamentarium of drugs and an array of molecular targets--set the stage for precision oncology, a hypothesis that cancer treatment could be markedly improved if therapies were guided by a tumour's genomic alterations. Drawing lessons from the biological basis of cancer and recent empirical investigations, we take a more measured view of precision oncology's promise. Ultimately, the promise is not our concern, but the threshold at which we declare success. We review reports of precision oncology alongside those of precision diagnostics and novel radiotherapy approaches. Although confirmatory evidence is scarce, these interventions have been widely endorsed. We conclude that the current path will probably not be successful or, at a minimum, will have to undergo substantive adjustments before it can be successful. For the sake of patients with cancer, we hope one form of precision oncology will deliver on its promise. However, until confirmatory studies are completed, precision oncology remains unproven, and as such, a hypothesis in need of rigorous testing.

  11. Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

    Science.gov (United States)

    Ivanova, Anastasia; Paul, Barry; Marchenko, Olga; Song, Guochen; Patel, Neerali; Moschos, Stergios J

    2016-01-01

    We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.

  12. Breakthrough cancer medicine and its impact on novel drug development in China:report of the US Chinese Anti-Cancer Association (USCACA) and Chinese Society of Clinical Oncology (CSCO) Joint Session at the 17th CSCO Annual Meeting

    Institute of Scientific and Technical Information of China (English)

    Feng Roger Luo; Ge Zhang; Li Xu; Pascal Qian; Li Yan; Jian Ding; Helen X. Chen; Hao Liu; Man-Cheong Fung; Maria Koehler; Jean Pierre Armand; Lei Jiang; Xiao Xu

    2014-01-01

    The US Chinese Anti-Cancer Association (USCACA) teamed up with Chinese Society of Clinical Oncology (CSCO) to host a joint session at the17th CSCO Annual Meeting on September 20th, 2014 in Xiamen, China. With a focus on breakthrough cancer medicines, the session featured innovative approaches to evaluate breakthrough agents and established a platform to interactively share successful experiences from case studies of 6 novel agents from both the United States and China. The goal of the session is to inspire scientific and practical considerations for clinical trial design and strategy to expedite cancer drug development in China. A panel discussion further provided in-depth advice on advancing both early and ful development of novel cancer medicines in China.

  13. Oncology Advanced Practitioners Bring Advanced Community Oncology Care.

    Science.gov (United States)

    Vogel, Wendy H

    2016-01-01

    Oncology care is becoming increasingly complex. The interprofessional team concept of care is necessary to meet projected oncology professional shortages, as well as to provide superior oncology care. The oncology advanced practitioner (AP) is a licensed health care professional who has completed advanced training in nursing or pharmacy or has completed training as a physician assistant. Oncology APs increase practice productivity and efficiency. Proven to be cost effective, APs may perform varied roles in an oncology practice. Integrating an AP into an oncology practice requires forethought given to the type of collaborative model desired, role expectations, scheduling, training, and mentoring.

  14. Identifying oncological emergencies.

    Science.gov (United States)

    Guddati, Achuta K; Kumar, Nilay; Segon, Ankur; Joy, Parijat S; Marak, Creticus P; Kumar, Gagan

    2013-01-01

    Prompt identification and treatment of life-threatening oncological conditions is of utmost importance and should always be included in the differential diagnosis. Oncological emergencies can have a myriad of presentations ranging from mechanical obstruction due to tumor growth to metabolic conditions due to abnormal secretions from the tumor. Notably, hematologic and infectious conditions may complicate the presentation of oncological emergencies. Advanced testing and imaging is generally required to recognize these serious presentations of common malignancies. Early diagnosis and treatment of these conditions can significantly affect the patient's clinical outcome.

  15. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-30

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... meeting. Agenda: On July 22, 2013, the committee will discuss the Assessment of SpondyloArthritis...

  16. 76 FR 42715 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  17. 77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  18. 75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  19. 78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  20. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-12

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease...

  1. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency...

  2. 77 FR 64524 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  3. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-28

    ... HUMAN SERVICES Food and Drug Administration Veterinary Medicine Advisory Committee; Notice of Meeting... the public. Name of Committee: Veterinary Medicine Advisory Committee. General Function of the... Rockville Pike, Rockville MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for...

  4. 77 FR 29667 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-18

    ... No. FDA-2012-N-0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To..., Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends...

  5. 78 FR 56899 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-09-16

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors. In the...

  6. 78 FR 38351 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of..., Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends...

  7. 78 FR 2677 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee:...

  8. 77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice...

  9. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-10-26

    ... Initiative, foodborne outbreaks and related recall communications, and the challenges of effectively... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the Risk Communication Advisory Committee. This meeting...

  10. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the Brain ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA ...

  11. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Menu Home Drugs of Abuse Commonly Abused Drugs Charts Emerging Trends and Alerts Alcohol Club Drugs Cocaine ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA ...

  12. [Quality assurance in head and neck medical oncology].

    Science.gov (United States)

    Digue, Laurence; Pedeboscq, Stéphane

    2014-05-01

    In medical oncology, how can we be sure that the right drug is being administered to the right patient at the right time? The implementation of quality assurance criteria is important in medical oncology, in order to ensure that the patient receives the best treatment safely. There is very little literature about quality assurance in medical oncology, as opposed to radiotherapy or cancer surgery. Quality assurance must cover the entire patient care process, from the diagnosis, to the therapeutic decision and drug distribution, including its selection, its preparation and its delivery to the patient (administration and dosage), and finally the potential side effects and their management. The dose-intensity respect is crucial, and its reduction can negatively affect overall survival rates, as shown in breast and testis cancers for example. In head and neck medical oncology, it is essential to respect the few well-standardized recommendations and the dose-intensity, in a population with numerous comorbidities. We will first review quality assurance criteria for the general medical oncology organization and then focus on head and neck medical oncology. We will then describe administration specificities of head and neck treatments (chemoradiation, radiation plus cetuximab, postoperative chemoradiation, induction and palliative chemotherapy) as well as their follow-up. Lastly, we will offer some recommendations to improve quality assurance in head and neck medical oncology.

  13. American Society for Radiation Oncology

    Science.gov (United States)

    ... for other cancer types View videos on radiation oncology Please Select an Action Read a news release ... This online career board is the premier radiation oncology recruitment tool, offering employers and job seekers an ...

  14. Female Representation in the Academic Oncology Physician Workforce: Radiation Oncology Losing Ground to Hematology Oncology.

    Science.gov (United States)

    Ahmed, Awad A; Hwang, Wei-Ting; Holliday, Emma B; Chapman, Christina H; Jagsi, Reshma; Thomas, Charles R; Deville, Curtiland

    2017-05-01

    Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Quality Assessment in Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2012-07-01

    The movement to improve healthcare quality has led to a need for carefully designed quality indicators that accurately reflect the quality of care. Many different measures have been proposed and continue to be developed by governmental agencies and accrediting bodies. However, given the inherent differences in the delivery of care among medical specialties, the same indicators will not be valid across all of them. Specifically, oncology is a field in which it can be difficult to develop quality indicators, because the effectiveness of an oncologic intervention is often not immediately apparent, and the multidisciplinary nature of the field necessarily involves many different specialties. Existing and emerging comparative effectiveness data are helping to guide evidence-based practice, and the increasing availability of these data provides the opportunity to identify key structure and process measures that predict for quality outcomes. The increasing emphasis on quality and efficiency will continue to compel the medical profession to identify appropriate quality measures to facilitate quality improvement efforts and to guide accreditation, credentialing, and reimbursement. Given the wide-reaching implications of quality metrics, it is essential that they be developed and implemented with scientific rigor. The aims of the present report were to review the current state of quality assessment in oncology, identify existing indicators with the best evidence to support their implementation, and propose a framework for identifying and refining measures most indicative of true quality in oncologic care.

  16. Active surveillance: Oncologic outcome

    NARCIS (Netherlands)

    L.D.F. Venderbos (Lionne); L.P. Bokhorst (Leonard); C.H. Bangma (Chris); M.J. Roobol-Bouts (Monique)

    2013-01-01

    textabstractPURPOSE OF REVIEW: To give insight into recent literature (during the past 12-18 months) reporting on oncologic outcomes of men on active surveillance. RECENT FINDINGS: From recent published trials comparing radical prostatectomy vs. watchful waiting, we learn that radical treatment only

  17. Molecular imaging in oncology

    Energy Technology Data Exchange (ETDEWEB)

    Schober, Otmar; Riemann, Burkhard (eds.) [Universitaetsklinikum Muenster (Germany). Klinik fuer Nuklearmedizin

    2013-02-01

    Considers in detail all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. Examines technological issues and probe design. Discusses preclinical studies in detail, with particular attention to multimodality imaging. Presents current clinical use of PET/CT, SPECT/CT, and optical imagingWritten by acknowledged experts. The impact of molecular imaging on diagnostics, therapy, and follow-up in oncology is increasing significantly. The process of molecular imaging includes key biotarget identification, design of specific molecular imaging probes, and their preclinical evaluation, e.g., in vivo using small animal studies. A multitude of such innovative molecular imaging probes have already entered clinical diagnostics in oncology. There is no doubt that in future the emphasis will be on multimodality imaging in which morphological, functional, and molecular imaging techniques are combined in a single clinical investigation that will optimize diagnostic processes. This handbook addresses all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. The first section is devoted to technology and probe design, and examines a variety of PET and SPECT tracers as well as multimodality probes. Preclinical studies are then discussed in detail, with particular attention to multimodality imaging. In the third section, diverse clinical applications are presented, and the book closes by looking at future challenges. This handbook will be of value to all who are interested in the revolution in diagnostic oncology that is being brought about by molecular imaging.

  18. Pharmacy cytotoxic drug reconstitution services and role of oncology pharmacists in Hong Kong%香港医院药剂部化疗药物配置服务以及肿瘤学药剂师的作用

    Institute of Scientific and Technical Information of China (English)

    吴剑华; 苏国基

    2007-01-01

    In Hong Kong, health care services are provided by the Hospital Authority through 44 public hospitals. Among them six have oncology center. At present four centers provide 100% cytotoxic drug reconstitution service by the pharmacy and only one employs nurses for the service. Among the six centers, staff number varies and is not commensurate with its workload. Oncology pharmacists in Hong Kong are still heavily engaged in production. They are usually involved in daily reconstitution routine and can take up minimal clinical activities. None of them does ward rounds regularly. Usually they work on rotational roster which hinders professional development and specialization. The Queen Elizabeth Hospital (QEH) started to free up pharmacists to improve system of work, assure quality of work, liaise with doctors and train staff. Total parenteral nutrition (TPN) production automation allows redeployment of staff for the reconstituti service. Standardized regimens were developed to streamline productions and "dose banding" scheme boosts up production efficiency. The pharmacist is also freed up to participate in hospital safety committee, bringing awareness of occupational risks. Despite these breakthroughs in the QEH Pharmacy, the road towards clinical and ward-based oncology pharmacy is still long and winding.%香港医院管理局通过44家公立医院,向全港市民提供医疗保健服务,其中6家医院有肿瘤学中心.目前已有4家肿瘤学中心由药剂部提供100%的化疗药物配置服务,仅一家中心雇用护士提供该服务.6家肿瘤学中心的工作人员数量不等,而且有些员工人数与工作量不相称.香港的肿瘤学药剂师仍处于机械式工作状态,他们只有足够时间从事日常的药品调剂工作,没有时间深入临床药剂的研究,更加没有机会参与日常病房的巡查工作.通常他们根据轮转式值勤表上班,该模式妨碍了药剂师提高专业水平和技能.伊利沙伯医院(QEH)创新地

  19. Do all patients in the phase I oncology trials need to be hospitalized? Domestic but outstanding issues for globalization of drug development in Japan.

    Science.gov (United States)

    Shimomura, Akihiko; Kondo, Shunsuke; Kobayashi, Noriko; Iwasa, Satoru; Kitano, Shigehisa; Tamura, Kenji; Fujiwara, Yutaka; Yamamoto, Noboru

    2017-08-01

    Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment. Study designs were classified into three types: first-in-human (FIH) study, dose-escalation study (conventional dose-escalation study to determine maximum tolerated dose (MTD) in Japanese patients), and dose-finding study (to assess safety and pharmacokinetic profiles up to the MTD previously determined in the West). A total of 945 patients who participated in a variety of single-agent phase I clinical trials between December 1996 and August 2014 were included in this study. Patients participated in one of three study types: dose-escalation (n = 582, 62%), first-in-human (n = 129, 14%), or dose-finding (n = 234, 25%). A total of 76 study drugs were evaluated as part of this pool of phase I studies. Subdivided by mechanism of action, 20 (26%) were cytotoxic, 50 (66%) were molecularly targeted, and 6 (8%) were immune checkpoint inhibitor. Thirty-six patients (3.8%) had severe toxicities requiring hospitalization during the first cycle. The overall number of toxicities requiring hospitalization and/or grade 4 toxicities during any cycle was 5.0%. The frequency of severe toxicity that needs to be hospitalized was unexpectedly low. The data did not demonstrate the need for hospitalization in the phase I trials, suggesting that phase I trials in Japan could be conducted in outpatient settings.

  20. 76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-29

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  1. 75 FR 57967 - Science Advisory Board to the National Center for Toxicological Research Notice of Meeting

    Science.gov (United States)

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory Board...

  2. 77 FR 57569 - Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

    Science.gov (United States)

    2012-09-18

    ... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory Board...

  3. Integrative oncology: an overview.

    Science.gov (United States)

    Deng, Gary; Cassileth, Barrie

    2014-01-01

    Integrative oncology, the diagnosis-specific field of integrative medicine, addresses symptom control with nonpharmacologic therapies. Known commonly as "complementary therapies" these are evidence-based adjuncts to mainstream care that effectively control physical and emotional symptoms, enhance physical and emotional strength, and provide patients with skills enabling them to help themselves throughout and following mainstream cancer treatment. Integrative or complementary therapies are rational and noninvasive. They have been subjected to study to determine their value, to document the problems they ameliorate, and to define the circumstances under which such therapies are beneficial. Conversely, "alternative" therapies typically are promoted literally as such; as actual antitumor treatments. They lack biologic plausibility and scientific evidence of safety and efficacy. Many are outright fraudulent. Conflating these two very different categories by use of the convenient acronym "CAM," for "complementary and alternative therapies," confuses the issue and does a substantial disservice to patients and medical professionals. Complementary and integrative modalities have demonstrated safety value and benefits. If the same were true for "alternatives," they would not be "alternatives." Rather, they would become part of mainstream cancer care. This manuscript explores the medical and sociocultural context of interest in integrative oncology as well as in "alternative" therapies, reviews commonly-asked patient questions, summarizes research results in both categories, and offers recommendations to help guide patients and family members through what is often a difficult maze. Combining complementary therapies with mainstream oncology care to address patients' physical, psychologic and spiritual needs constitutes the practice of integrative oncology. By recommending nonpharmacologic modalities that reduce symptom burden and improve quality of life, physicians also enable

  4. Neurologic complications in oncology

    Directory of Open Access Journals (Sweden)

    Andrea Pace

    2010-06-01

    Full Text Available Neurologic side effects related to cancer therapy are a common problem in oncology practice. These complications can negatively affect the management of the patient, because they can inhibit treatment and diminish quality of life. Therefore specific skills are required to recognise symptoms and clinical manifestations. This review focuses on the most common neurologic complications to improve physician’s familiarity in determining the aetiology of these symptoms.

  5. Quality Indicators in Radiation Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2013-03-15

    Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts.

  6. 76 FR 18757 - Monthly Public Meetings of the Local Government Advisory Committee's Small Community Advisory...

    Science.gov (United States)

    2011-04-05

    ... AGENCY Monthly Public Meetings of the Local Government Advisory Committee's Small Community Advisory... Advisory Committee Act, the U.S. Environmental Protection Agency's Local Government Advisory Committee's... the Local Government Advisory Committee. BILLING CODE 6560-50-P...

  7. 77 FR 71591 - Meetings of the Local Government Advisory Committee and the Small Communities Advisory Subcommittee

    Science.gov (United States)

    2012-12-03

    ... AGENCY Meetings of the Local Government Advisory Committee and the Small Communities Advisory... environmental issues affecting small communities. The Local Government Advisory Committee (LGAC) will meet in... INFORMATION CONTACT: Local Government Advisory Committee (LGAC) and Small Communities Advisory...

  8. Citizens Advisory Committees.

    Science.gov (United States)

    Stemnock, Suzanne K.

    1968-01-01

    This document contains the results of a national survey designed to determine the composition and location of permanent citizens advisory committees operating within the nation's school districts. The 52 district-wide, continuing citizens advisory bodies identified by 290 responding school systems are listed alphabetically by State. The following…

  9. Oncology in Cambodia.

    Science.gov (United States)

    Eav, S; Schraub, S; Dufour, P; Taisant, D; Ra, C; Bunda, P

    2012-01-01

    Cambodia, a country of 14 million inhabitants, was devastated during the Khmer Rouge period and thereafter. The resources of treatment are rare: only one radiotherapy department, renovated in 2003, with an old cobalt machine; few surgeons trained to operate on cancer patients; no hematology; no facilities to use intensive chemotherapy; no nuclear medicine department and no palliative care unit. Cervical cancer incidence is one of the highest in the world, while in men liver cancer ranks first (20% of all male cancers). Cancers are seen at stage 3 or 4 for 70% of patients. There is no prevention program - only a vaccination program against hepatitis B for newborns - and no screening program for cervical cancer or breast cancer. In 2010, oncology, recognized as a full specialty, was created to train the future oncologists on site at the University of Phnom Penh. A new National Cancer Center will be built in 2013 with modern facilities for radiotherapy, medical oncology, hematology and nuclear medicine. Cooperation with foreign countries, especially France, and international organizations has been established and is ongoing. Progress is occurring slowly due to the shortage of money for Cambodian institutions and the lay public.

  10. Molecular radio-oncology

    Energy Technology Data Exchange (ETDEWEB)

    Baumann, Michael; Krause, Mechthild; Cordes, Nils (eds.) [Technische Univ. Dresden (Germany). Faculty of Medicine and University Hospital

    2016-07-01

    This book concisely reviews our current understanding of hypoxia, molecular targeting, DNA repair, cancer stem cells, and tumor pathophysiology, while also discussing novel strategies for putting these findings into practice in daily clinical routine. Radiotherapy is an important part of modern multimodal cancer treatment, and the past several years have witnessed not only substantial improvements in radiation techniques and the use of new beam qualities, but also major strides in our understanding of molecular tumor biology and tumor radiation response. Against this backdrop, the book highlights recent efforts to identify reasonable and clinically applicable biomarkers using broad-spectrum tissue microarrays and high-throughput systems biology approaches like genomics and epigenomics. In particular, it describes in detail how such molecular information is now being exploited for diagnostic imaging and imaging throughout treatment using the example of positron emission tomography. By discussing all these issues in the context of modern radiation oncology, the book provides a broad, up-to-date overview of the molecular aspects of radiation oncology that will hopefully foster its further optimization.

  11. Applied Nanotechnology and Nanoscience in Orthopedic Oncology.

    Science.gov (United States)

    Savvidou, Olga D; Bolia, Ioanna K; Chloros, George D; Goumenos, Stavros D; Sakellariou, Vasileios I; Galanis, Evanthia C; Papagelopoulos, Panayiotis J

    2016-09-01

    Nanomedicine is based on the fact that biological molecules behave similarly to nanomolecules, which have a size of less than 100 nm, and is now affecting most areas of orthopedics. In orthopedic oncology, most of the in vitro and in vivo studies have used osteosarcoma or Ewing sarcoma cell lineages. In this article, tumor imaging and treatment nanotechnology applications, including nanostructure delivery of chemotherapeutic agents, gene therapy, and the role of nano-selenium-coated implants, are outlined. Finally, the potential role of nanotechnology in addressing the challenges of drug and radiotherapy resistance is discussed. [Orthopedics. 2016; 39(5):280-286.].

  12. Oncology Nurses' Use of the Internet for Continuing Education: A Survey of Oncology Nursing Society Congress Attendees.

    Science.gov (United States)

    Cobb, Susan C.; Baird, Susan B.

    1999-01-01

    A survey to determine whether oncology nurses (n=670) use the Internet and for what purpose revealed that they use it for drug information, literature searches, academic information, patient education, and continuing education. Results suggest that continuing-education providers should pursue the Internet as a means of meeting the need for quick,…

  13. Perceived roles of oncology nursing.

    Science.gov (United States)

    Lemonde, Manon; Payman, Naghmeh

    2015-01-01

    The Canadian Association of Nurses in Oncology (CANO) Standards of Care (2001) provides a framework that delineates oncology nursing roles and responsibilities. The purpose of this study was to explore how oncology nurses perceive their roles and responsibilities compared to the CANO Standards of Care. Six focus groups were conducted and 21 registered nurses (RNs) from a community-based hospital participated in this study. Transcripts were analyzed using qualitative inductive content analysis. Three themes were identified: (1) Oncology nurses perceive a gap between their defined roles and the reality of daily practice, as cancer care becomes more complex and as they provide advanced oncology care to more patients while there is no parallel adaptation to the health care system to support them, such as safe staffing; (2) Oncology nursing, as a specialty, requires sustained professional development and leadership roles; and (3) Oncology nurses are committed to providing continuous care as a reference point in the health care team by fostering interdisciplinary collaboration andfacilitating patient's navigation through the system. Organizational support through commitment to appropriate staffing and matching scope ofpractice to patient needs may lead to maximize the health and well-being of nurses, quality of patient care and organizational performance.

  14. Mathematical oncology 2013

    CERN Document Server

    Gandolfi, Alberto

    2014-01-01

    With chapters on free boundaries, constitutive equations, stochastic dynamics, nonlinear diffusion–consumption, structured populations, and applications of optimal control theory, this volume presents the most significant recent results in the field of mathematical oncology. It highlights the work of world-class research teams, and explores how different researchers approach the same problem in various ways. Tumors are complex entities that present numerous challenges to the mathematical modeler. First and foremost, they grow. Thus their spatial mean field description involves a free boundary problem. Second, their interiors should be modeled as nontrivial porous media using constitutive equations. Third, at the end of anti-cancer therapy, a small number of malignant cells remain, making the post-treatment dynamics inherently stochastic. Fourth, the growth parameters of macroscopic tumors are non-constant, as are the parameters of anti-tumor therapies. Changes in these parameters may induce phenomena that a...

  15. [Dermato-oncological rehabilitation].

    Science.gov (United States)

    Buhles, N; Sander, C

    2005-07-01

    National insurance companies in Germany support health cures for patients with malignant tumors (malignant melanoma, squamous cell carcinoma, Merkel cell tumor, malignant cutaneous lymphoma). The clinical requirements are an invasively growing tumor, problems of self-assurance, and dis-integration of the patient regarding his social and/or professional environment. The decision for a health cure is made by the treating dermatologist in the hospital. In this context, the following sociomedical criteria should be applied: impairment, disability, and handicap. Usually, rehabilitation starts after the patient is discharged from the hospital. The inpatient rehabilitation program should be performed at an institution capable of providing dermatological and psychological treatment. The dermatologist acts as a manager for the members of the rehabilitation team (psychologists, physiotherapists, social workers, and ergo-therapists). In conclusion, dermato-oncologic rehabilitation plays an important role in re-integrating the patient into his professional life to avoid retirement.

  16. 77 FR 20643 - Blood Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-05

    ... needs to advance risk assessment for emerging infectious diseases for blood and blood products. FDA... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  17. Big Data and Pharmacovigilance: The Role of Oncology Nurses.

    Science.gov (United States)

    Glenn, David G

    2016-10-01

    When new anticancer medications are approved, their safety profiles are often not fully understood. Oncology nurses have a responsibility to file reports of adverse drug events with safety registries such as MedWatch. If these registries receive prompt, complete, and accurate data from clinicians, agencies such as the U.S. Food and Drug Administration will have a stronger ability to detect hazards and to issue safety recommendations.
.

  18. Tendencia del perfil de sensibilidad antimicrobiana de los aislamientos de sangre en un hospital oncológico (1998-2003 Trend of antimicrobial drug-susceptibility of blood isolates at an oncological center (1998-2003

    Directory of Open Access Journals (Sweden)

    Patricia Cornejo-Juárez

    2005-07-01

    oncological hospital. MATERIAL AND METHODS: All strains obtained from blood cultures from 1998 to 2003 were included and processed using the Bactec and Microscan system to determinate isolates and susceptibility to antimicrobials. The percent difference (increase or decrease was obtained by comparing the frequency of resistance at baseline and at the end of the study. RESULTS: A total of 2 071 positive blood cultures were obtained; 59.7% of isolates were Gram negative bacteria, 35.7% Gram-positive bacteria and 4.6% were yeasts. E.coli was the most frequent isolated (18.6%, followed by Staphylococcus. epidermidis (12.7% and Klebsiella spp (9%. Throughout the study the susceptibility of Gram negative bacteria was stable and over 88% for most of the antimicrobials tested (except for Pseudomonas aeruginosa. Ciprofloxacin susceptibility for Escherichia coli stayed around 50%. Susceptibility to amikacin was higher than that to gentamicin. Staphylococcus aureus susceptibility for oxacillin was 96% and that for vancomycin 100%. S. epidermidis susceptibility for oxacillin was 14% and for vancomycin was 98.6%. No strains of vancomycin-resistant enterococci were found. All Streptococcus pneumoniae strains were penicillin susceptible. CONCLUSIONS: The drug-resistance found in this hospital is the result of the control in the use of antimicrobials, the hospital nosocomial infection program and the use of drug combination in all patients with bacteremia.

  19. 78 FR 11655 - Neonatal Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-19

    ... HUMAN SERVICES Food and Drug Administration Neonatal Subcommittee of the Pediatric Advisory Committee... be open to the public. Name of Committee: Neonatal Subcommittee of the Pediatric Advisory Committee... science to include the neonatal population. On March 15, 2013, FDA's Neonatal Subcommittee of...

  20. 76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

    Science.gov (United States)

    2011-08-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Postponement of... Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011...

  1. 77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-18

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... lines derived from human tumors for vaccine manufacture. FDA intends to make background material...

  2. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends to...

  3. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2011-08-23

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological... announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on...

  4. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-08

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated...

  5. 76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-20

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The...

  6. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-19

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season. FDA...

  7. 77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15...

  8. 75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-28

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... Lentiviral Vector Based Gene Therapy Products. FDA intends to make background material available to...

  9. 78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-03-12

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  10. 77 FR 63840 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee..., Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and..., Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and...

  11. 76 FR 18768 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-05

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  12. 76 FR 22405 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-21

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... gene therapy products for the treatment of retinal disorders. Topics to be considered include...

  13. 78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-07-23

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center...

  14. 76 FR 81513 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee..., Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and... Gene Therapies, Center for Biologics Evaluation and Research, FDA. FDA intends to make...

  15. 76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory...

  16. 78 FR 36309 - Research Advisory Committee on Gulf War Veterans' Illnesses, Notice of Meeting

    Science.gov (United States)

    2013-06-17

    ... diagnosing and treating Gulf War Veterans, and a drug treatment trial which is underway. On June 18, the... AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses, Notice of Meeting The Department of... Research Advisory Committee on Gulf War Veterans' Illnesses will meet on June 17 and 18, 2013, in room...

  17. 78 FR 9060 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

    Science.gov (United States)

    2013-02-07

    ... failure. Dental Products Panel of the 3 November 1, 2013. Medical Devices Advisory Committee--Dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials... Radiological Health, Food and Drug Assurance Advisory Committee. Administration, 10903 New Hampshire...

  18. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-04-01

    ... HUMAN SERVICES Food and Drug Administration Molecular and Clinical Genetics Panel of the Medical Devices... Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published... meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, and the...

  19. 78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-08

    ... HUMAN SERVICES Food and Drug Administration Pediatric Ethics Subcommittee of the Pediatric Advisory... Administration (FDA). The meeting will be open to the public. Name of Subcommittee: Pediatric Ethics Subcommittee... recommendations to the Pediatric Advisory Committee on pediatric ethical issues. Date and Time: The meeting...

  20. Payment Reform: Unprecedented and Evolving Impact on Gynecologic Oncology

    Directory of Open Access Journals (Sweden)

    Sachin eApte

    2016-04-01

    Full Text Available With the signing of the Medicare Access and CHIP Reauthorization Act (MACRA in April 2015, the Centers for Medicare and Medicaid Services (CMS is now positioned to drive the development and implementation of sweeping changes to how physicians and hospitals are paid for the provision of oncology related services. These changes will have a long-lasting impact on the sub-specialty of gynecologic oncology, regardless of practice structure, physician employment and compensation model, or local insurance market. Recently, commercial payers have piloted various models of payment reform via oncology specific clinical pathways, oncology medical homes, episode payment arrangements, and accountable care organizations. Despite the positive results of some pilot programs, adoption remains limited. The goals are to eliminate unnecessary variation in cancer treatment, provide coordinated patient-centered care, while controlling costs. Yet, meaningful payment reform in oncology remains elusive. As the largest payer for oncology services in the United States, CMS has the leverage to make cancer services more value-based. Thus far, the focus has been around pricing of physician-administered drugs with recent work in the area of the Oncology Medical Home. Gynecologic oncology is a unique sub-specialty which blends surgical and medical oncology, with treatment that often involves radiation therapy. This forward-thinking, multi-disciplinary model works to keep the patient at the center of the care continuum and emphasizes care coordination. Because of the breadth and depth of gynecologic oncology, this sub-specialty has both the potential to be disrupted by payment reform as well as potentially benefit from the aspects of reform which can align incentives appropriately to improve coordination. Although the precise future payment models are unknown at this time, focused engagement of gynecologic oncologists and the full care team is imperative to assure that the

  1. Payment Reform: Unprecedented and Evolving Impact on Gynecologic Oncology

    Science.gov (United States)

    Apte, Sachin M.; Patel, Kavita

    2016-01-01

    With the signing of the Medicare Access and CHIP Reauthorization Act in April 2015, the Centers for Medicare and Medicaid Services (CMS) is now positioned to drive the development and implementation of sweeping changes to how physicians and hospitals are paid for the provision of oncology-related services. These changes will have a long-lasting impact on the sub-specialty of gynecologic oncology, regardless of practice structure, physician employment and compensation model, or local insurance market. Recently, commercial payers have piloted various models of payment reform via oncology-specific clinical pathways, oncology medical homes, episode payment arrangements, and accountable care organizations. Despite the positive results of some pilot programs, adoption remains limited. The goals are to eliminate unnecessary variation in cancer treatment, provide coordinated patient-centered care, while controlling costs. Yet, meaningful payment reform in oncology remains elusive. As the largest payer for oncology services in the United States, CMS has the leverage to make cancer services more value based. Thus far, the focus has been around pricing of physician-administered drugs with recent work in the area of the Oncology Medical Home. Gynecologic oncology is a unique sub-specialty that blends surgical and medical oncology, with treatment that often involves radiation therapy. This forward-thinking, multidisciplinary model works to keep the patient at the center of the care continuum and emphasizes care coordination. Because of the breadth and depth of gynecologic oncology, this sub-specialty has both the potential to be disrupted by payment reform as well as potentially benefit from the aspects of reform that can align incentives appropriately to improve coordination. Although the precise future payment models are unknown at this time, focused engagement of gynecologic oncologists and the full care team is imperative to assure that the practice remains patient centered

  2. VSWI Wetlands Advisory Layer

    Data.gov (United States)

    Vermont Center for Geographic Information — This dataset represents the DEC Wetlands Program's Advisory layer. This layer makes the most up-to-date, non-jurisdictional, wetlands mapping avaiable to the public...

  3. [Oncologic gynecology and the Internet].

    Science.gov (United States)

    Gizler, Robert; Bielanów, Tomasz; Kulikiewicz, Krzysztof

    2002-11-01

    The strategy of World Wide Web searching for medical sites was presented in this article. The "deep web" and "surface web" resources were searched. The 10 best sites connected with the gynecological oncology, according to authors' opinion, were presented.

  4. American Society of Clinical Oncology

    Science.gov (United States)

    ... of Interest Mobile App Privacy Policy Privacy Policy Social Media Policy Sponsor Policy Terms of Use American Society of Clinical Oncology ASCO Annual Meeting Register and Reserve Your Hotel June 2-6, 2017 | Chicago, Illinois Hotel Reservation & ...

  5. Personalizing medicine in geriatric oncology

    National Research Council Canada - National Science Library

    Walko, Christine M; McLeod, Howard L

    2014-01-01

    Minimizing toxicity while maximizing efficacy is a common goal in the treatment of any condition but its importance is underscored in the discipline of oncology because of the serious nature of many...

  6. Restricted mouth opening and trismus in oral oncology.

    Science.gov (United States)

    Satheeshkumar, P S; Mohan, Minu P; Jacob, Jayan

    2014-06-01

    Restricted mouth opening (RMO) and trismus are terms commonly used in oral oncology in instances where there is difficulty in mouth opening. The term trismus in oral oncology is mainly used to indicate the radiation-induced fibrosis of the muscles of mastication. The treatment given for RMO as reported in the literature is given for muscular dysfunction trismus, whereas RMO in oral oncology can occur owing to various reasons other than muscular dysfunction. RMO occurs in various conditions of the oral cavity; in posterior pharyngeal infection, where it is termed reflectory trismus; in oral submucous fibrosis; in oral mucosal disorders; in the use of certain drugs; and in minor dental procedures of the posterior oral cavity. The usage of the term trismus in all RMO cases would complicate the treatment; thus, the word should not be used in all RMO cases.

  7. Side effects of chemotherapy in musculoskeletal oncology.

    Science.gov (United States)

    Mavrogenis, Andreas F; Papagelopoulos, Panayiotis J; Romantini, Matteo; Angelini, Andrea; Ruggieri, Pietro

    2010-01-01

    With recent advances in medical and orthopedic oncology, radiation therapy and single- or multiple-agent perioperative chemotherapy are currently applied as an essential part of the multidisciplinary treatment to improve disease-free and overall survival of patients with primary and metastatic bone and soft tissue tumors. However, these treatments have led to unwanted complications. A better understanding of the effects of various antineoplastic agents on bone, soft tissue, and organs may provide the basis for the more efficacious use of antiproliferative drugs when fracture healing or allograft incorporation is required. This knowledge may also provide a rationale for concurrent treatment with drugs that protect against or compensate for adverse effects in osseous repair resulting from chemotherapy.

  8. [Unproven methods in oncology].

    Science.gov (United States)

    Jallut, O; Guex, P; Barrelet, L

    1984-09-08

    As in some other chronic diseases (rheumatism, multiple sclerosis, etc.), unproven methods of diagnosis and treatment have long been current in cancer. Since 1960 the American Cancer Society has published an abundant literature on these "unproven methods", which serves as a basis for a historical review: some substances (Krebiozen, Laetrile) have enjoyed tremendous if shortlived success. The present trend is back to nature and "mild medicine". The proponents of this so-called natural medicine are often disciples of a pseudoscientific religion using irrational arguments. Direct attacks on these erroneous theories and their public refutation fail to convince the adepts, who trust in these methods and are not amenable to a scientific approach. Study of their psychological motivations reveals that in fact they seek something more reassuring than plain medical explanation which is aware of its limits. They feel reassured by theories which often bear some resemblance to the old popular medicine. To protect patients against these dangerous methods and all the disillusionment they entail, the Swiss Society of Oncology and the Swiss Cancer League have decided to gather information and draw up a descriptive list of the commonest unproven methods in Switzerland (our File No. 2, "Total anti-cancer cure", is given as an example). The files are published in French, German and English and are available to physicians, nursing teams, and also patients who wish to have more objective information on these methods.

  9. [Economic limits in oncology].

    Science.gov (United States)

    Hellriegel, K P

    2000-12-01

    Economic aspects require consideration even in oncology. However, they have to be seen in context with open questions concerning especially the evaluation of therapeutic effectiveness, of methodology, and particularly of ethics. Medical procedures and achievements should primarily be measured against objective results, against effectiveness and benefits. Consequently, the suitability of diagnostic and therapeutic strategies has to be evaluated. Overall objective of medical achievements should be their optimalization, not their maximization. For a physician being aware of his responsibility, the optimal care for his patients always has highest priority. Medical guidelines for diagnosis, treatment and follow-up are the basis for effective and economic patient care. They have to undergo economic evaluation and permanent updating. For systematic collection, documentation and evaluation, the clinical register is the appropriate instrument. For the assessment of medical care, a continuous monitoring of its processes has to be established. The documentation of medical care processes should lead to sustainable cost reductions together with an optimalization of the quality of care.

  10. Micronutrients in Oncological Intervention

    Directory of Open Access Journals (Sweden)

    Uwe Gröber

    2016-03-01

    Full Text Available Nutritional supplements are widely used among patients with cancer who perceive them to be anticancer and antitoxicity agents. Depending on the type of malignancy and the gender 30%–90% of the cancer patients supplement their diets with antioxidant and immuno-stabilizing micronutrients, such as selenium, vitamin C, and vitamin D, often without the knowledge of the treating physician. From the oncological viewpoint, there are justifiable concerns that dietary supplements decrease the effectiveness of chemotherapy and radiotherapy. Recent studies, however, have provided increasing evidence that treatment is tolerated better—with an increase in patient compliance and a lower rate of treatment discontinuations—when micronutrients, such as selenium, are added as appropriate to the patient’s medication. Nutritional supplementation tailored to an individual’s background diet, genetics, tumor histology, and treatments may yield benefits in subsets of patients. Clinicians should have an open dialogue with patients about nutritional supplements. Supplement advice needs to be individualized and come from a credible source, and it is best communicated by the physician.

  11. 75 FR 36346 - Olympic National Forest; Title II Resource Advisory Committee Meeting Advisory

    Science.gov (United States)

    2010-06-25

    ... Olympic National Forest; Title II Resource Advisory Committee Meeting Advisory AGENCY: Olympic National Forest, USDA Forest Service. ACTION: Notice of meeting. SUMMARY: The Olympic Peninsula Resource Advisory..., Forest Supervisor, the Designated Federal Official for the Olympic National Forest Resource Advisory...

  12. Determination of platinum surface contamination in veterinary and human oncology centres using inductively coupled plasma mass spectrometry

    NARCIS (Netherlands)

    Janssens, T.; Brouwers, E. E M; de Vos, J. P.; de Vries, N.; Schellens, J. H M; Beijnen, J. H.

    2015-01-01

    The objective of this study was to determine the surface contamination with platinum-containing antineoplastic drugs in veterinary and human oncology centres. Inductively coupled plasma mass spectrometry was used to measure platinum levels in surface samples. In veterinary and human oncology

  13. Report on the International Colloquium on Cardio-Oncology (Rome, 12–14 March 2014)

    Science.gov (United States)

    Ewer, Michael; Gianni, Luca; Pane, Fabrizio; Sandri, Maria Teresa; Steiner, Rudolf K; Wojnowski, Leszek; Yeh, Edward T; Carver, Joseph R; Lipshultz, Steven E; Minotti, Giorgio; Armstrong, Gregory T; Cardinale, Daniela; Colan, Steven D; Darby, Sarah C; Force, Thomas L; Kremer, Leontien CM; Lenihan, Daniel J; Sallan, Stephen E; Sawyer, Douglas B; Suter, Thomas M; Swain, Sandra M; van Leeuwen, Flora E

    2014-01-01

    Cardio-oncology is a relatively new discipline that focuses on the cardiovascular sequelae of anti-tumour drugs. As any other young adolescent discipline, cardio-oncology struggles to define its scientific boundaries and to identify best standards of care for cancer patients or survivors at risk of cardiovascular events. The International Colloquium on Cardio-Oncology was held in Rome, Italy, 12–14 March 2014, with the aim of illuminating controversial issues and unmet needs in modern cardio-oncology. This colloquium embraced contributions from different kind of disciplines (oncology and cardiology but also paediatrics, geriatrics, genetics, and translational research); in fact, cardio-oncology goes way beyond the merging of cardiology with oncology. Moreover, the colloquium programme did not review cardiovascular toxicity from one drug or the other, rather it looked at patients as we see them in their fight against cancer and eventually returning to everyday life. This represents the melting pot in which anti-cancer therapies, genetic backgrounds, and risk factors conspire in producing cardiovascular sequelae, and this calls for screening programmes and well-designed platforms of collaboration between one key professional figure and another. The International Colloquium on Cardio-Oncology was promoted by the Menarini International Foundation and co-chaired by Giorgio Minotti (Rome), Joseph R Carver (Philadelphia, Pennsylvania, United States), and Steven E Lipshultz (Detroit, Michigan, United States). The programme was split into five sessions of broad investigational and clinical relevance (what is cardiotoxicity?, cardiotoxicity in children, adolescents, and young adults, cardiotoxicity in adults, cardiotoxicity in special populations, and the future of cardio-oncology). Here, the colloquium chairs and all the session chairs briefly summarised what was said at the colloquium. Topics and controversies were reported on behalf of all members of the working group

  14. Reorganisation of Oncologic Care in Greece: A Proposal

    Directory of Open Access Journals (Sweden)

    Emmanouilides Christos

    2015-12-01

    Full Text Available Cancer is becoming a major public health issue as patients enjoy longer survivals than ever before due to the introduction innovative but expensive drugs in the clinic. In addition, the ageing of the population in Greece is expected to increase the absolute incidence of cancer. The National Health System should rapidly and efficiently adapt to the new challenges, including increased pharmaceutical costs. Resources ought to be allocated rationally and efficiently while maintaining adequate coverage for the insured population. Economising due to large-scale operations should be pursued by the governmental single payor (EOPYY, so that affordable coverage remains feasible. Establishment of mechanisms to deal with new and very costly drugs should be put in place. The major changes in anchor oncologic hospitals are needed in order to play a role as regional leaders in oncologic care, including merging of similar divisions, subspecialisation of services and promotion of clinical research. These major centres could coordinate a host of satellite oncology services in other urban hospitals and in the provinces. In addition, joint operations in training and patient care should be pursued with major private centres, without mutual mistrust or obsolete inflexibilities. The current financial crisis represents an excellent opportunity for revisioning and restructuring oncologic care in Greece, taking into account the societal needs and based on flexibility and efficiency.

  15. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA Donating to NIDA Frequently ... risk for getting HIV. Drug and alcohol intoxication affect judgment and can lead to unsafe sexual practices, ...

  16. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA Donating to ... 2005 –Ongoing Behaviors associated with drug abuse are among the main ...

  17. 16 CFR 1018.26 - Advisory functions.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Advisory functions. 1018.26 Section 1018.26... Advisory Committees § 1018.26 Advisory functions. (a) Unless otherwise specifically provided by statute, advisory committees shall be utilized solely for advisory functions. (b) The Commission shall ensure...

  18. Oocyte cryopreservation in oncological patients.

    Science.gov (United States)

    Porcu, Eleonora; Fabbri, Raffaella; Damiano, Giuseppe; Fratto, Rosita; Giunchi, Susanna; Venturoli, Stefano

    2004-04-05

    The use of chemotherapy and radiotherapy in oncological patients may reduce their reproductive potential. Sperm cryopreservation has been already used in men affected by neoplastic disease. Oocyte cryopreservation might be an important solution for these patients at risk of losing ovarian function. A program of oocyte cryopreservation for oncological patients is also present in our center. From June 1996 to January 2000, 18 patients awaiting chemotherapy and radiotherapy for neoplastic disease were included in our oocyte cryopreservation program. Our experience documents that oocyte storage may be a concrete and pragmatic alternative for oncological patients. The duration of oocyte storage does not seem to interfere with oocyte survival as pregnancies occurred even after several years of gamete cryopreservation in liquid nitrogen.

  19. Multidisciplinary care in pediatric oncology

    Directory of Open Access Journals (Sweden)

    Cantrell MA

    2011-05-01

    Full Text Available Mary Ann Cantrell1, Kathy Ruble21College of Nursing, Villanova University, Villanova, PA, USA; 2Department of Pediatric Oncology, Johns Hopkins University, School of Medicine, Baltimore, MD, USAAbstract: This paper describes the significant advances in the treatment of childhood cancer and supportive care that have occurred over the last several decades and details how these advances have led to improved survival and quality of life (QOL for children with cancer through a multidisciplinary approach to care. Advances in the basic sciences, general medicine, cooperative research protocols, and policy guidelines have influenced and guided the multidisciplinary approach in pediatric oncology care across the spectrum from diagnosis through long-term survival. Two case studies are provided to highlight the nature and scope of multidisciplinary care in pediatric oncology care.Keywords: childhood cancer, chemotherapy, leukemia

  20. Personality types of oncology nurses.

    Science.gov (United States)

    Bean, C A; Holcombe, J K

    1993-12-01

    Personality type influences the choice of occupation. The breadth of specialty areas within oncology nursing allows for divergent activities and relationships and, thus, the accommodation of different personality characteristics. This exploratory study examined personality types for a convenience sample of oncology nurses predominantly employed in hospitals. According to the personality typology defined by Carl Jung, a person demonstrates a preference among four dimensions, i.e., extraversion/introversion, sensory/intuition, thinking/feeling, and judging/perceiving. The type with the strongest self-selection for these oncology nurses was ISFJ, where feeling is introverted and perception is practical, so that helping others is both a responsibility and a pleasure. The discussion relates the personality types to Jung's theory and their impact in clinical practice. Strengths and weaknesses of each personality type are described.

  1. Palliative medicine and medical oncology.

    Science.gov (United States)

    Maltoni, M; Amadori, D

    2001-04-01

    Traditionally, medical oncology and palliative care have been considered two distinct and separate disciplines, both as regards treatment objectives and delivery times. Palliative care in terminal stages, aimed exclusively at evaluating and improving quality of life, followed antitumor therapies, which concentrated solely on quantitative results (cure, prolongation of life, tumoral mass shrinkage). Over the years, more modern concepts have developed on the subject. Medical oncology, dealing with the skills and strategic co-ordination of oncologic interventions from primary prevention to terminal phases, should also include assessment and treatment of patients' subjective needs. Anticancer therapies should be evaluated in terms of both the quantitative and qualititative impact on patients' lives. Hence, the traditional view of palliative care has to be modified: it constitutes a philosophical and methodological approach to be adopted from the early phases of illness. It is not the evident cultural necessity of integrating medical oncology with palliative medicine that may be a matter of argument, but rather the organizational models needed to put this combined care into practice: should continuous care be guaranteed by a single figure, the medical oncologist, or rather by an interdisciplinary providers' team, including full-time doctors well-equipped for palliative care? In this paper the needs of cancer patients and the part that a complete oncologist should play to deal with such difficult and far-reaching problems are firstly described. Then, as mild provocation, data and critical considerations on the ever increasing needs of palliative care, the present shortcomings in quality of life and pain assessment and management by medical oncologists, and the uncertain efficacy of interventional programmes to change clinical practice are described. Finally, a model of therapeutic continuity is presented. which in our view is realistic and feasible: an Oncologic

  2. Geriatric oncology in the Netherlands: a survey of medical oncology specialists and oncology nursing specialists.

    Science.gov (United States)

    Jonker, J M; Smorenburg, C H; Schiphorst, A H; van Rixtel, B; Portielje, J E A; Hamaker, M E

    2014-11-01

    To identify ways to improve cancer care for older patients, we set out to examine how older patients in the Netherlands are currently being evaluated prior to oncological treatment and to explore the potential obstacles in the incorporation of a geriatric evaluation, using a web-based survey sent to Dutch medical oncology specialists and oncology nursing specialists. The response rate was 34% (183 out of 544). Two-thirds of respondents reported that a geriatric evaluation was being used, although primarily on an ad hoc basis only. Most respondents expressed a desire for a routine evaluation or more intensive collaboration with the geriatrician and 86% of respondents who were not using a geriatric evaluation expressed their interest to do so. The most important obstacles were a lack of time or personnel and insufficient availability of a geriatrician to perform the assessment. Thus, over 30% of oncology professionals in the Netherlands express an interest in geriatric oncology. Important obstacles to a routine implementation of a geriatric evaluation are a lack of time, or insufficient availability of geriatricians; this could be overcome with policies that acknowledge that quality cancer care for older patients requires the investment of time and personnel.

  3. PET/MR in oncology

    DEFF Research Database (Denmark)

    Balyasnikova, Svetlana; Löfgren, Johan; de Nijs, Robin

    2012-01-01

    of the challenges inherent in this new technology, but focus on potential applications for simultaneous PET/MR in the field of oncology. Methods and tracers for use with the PET technology will be familiar to most readers of this journal; thus this paper aims to provide a short and basic introduction to a number...... be applied together with PET increasing the amount of information about the tissues of interest. The potential clinical benefit of applying PET/MR in staging, radiotherapy planning and treatment evaluation in oncology, as well as the research perspectives for the use of PET/MR in the development of new...

  4. Global Health in Radiation Oncology

    DEFF Research Database (Denmark)

    Rodin, Danielle; Yap, Mei Ling; Grover, Surbhi

    2017-01-01

    The massive global shortfall in radiotherapy equipment and human resources in developing countries is an enormous challenge for international efforts in cancer control. This lack of access to treatment has been long-standing, but there is now a growing consensus about the urgent need to prioritize...... programs. However, formalized training and career promotion tracks in global health within radiation oncology have been slow to emerge, thereby limiting the sustained involvement of students and faculty, and restricting opportunities for leadership in this space. We examine here potential structures...... and funding models might be used to further develop and expand radiation oncology services globally....

  5. PET/MR in oncology

    DEFF Research Database (Denmark)

    Balyasnikova, Svetlana; Löfgren, Johan; de Nijs, Robin

    2012-01-01

    of the challenges inherent in this new technology, but focus on potential applications for simultaneous PET/MR in the field of oncology. Methods and tracers for use with the PET technology will be familiar to most readers of this journal; thus this paper aims to provide a short and basic introduction to a number...... be applied together with PET increasing the amount of information about the tissues of interest. The potential clinical benefit of applying PET/MR in staging, radiotherapy planning and treatment evaluation in oncology, as well as the research perspectives for the use of PET/MR in the development of new...

  6. Predictive In Vivo Models for Oncology.

    Science.gov (United States)

    Behrens, Diana; Rolff, Jana; Hoffmann, Jens

    2016-01-01

    Experimental oncology research and preclinical drug development both substantially require specific, clinically relevant in vitro and in vivo tumor models. The increasing knowledge about the heterogeneity of cancer requested a substantial restructuring of the test systems for the different stages of development. To be able to cope with the complexity of the disease, larger panels of patient-derived tumor models have to be implemented and extensively characterized. Together with individual genetically engineered tumor models and supported by core functions for expression profiling and data analysis, an integrated discovery process has been generated for predictive and personalized drug development.Improved “humanized” mouse models should help to overcome current limitations given by xenogeneic barrier between humans and mice. Establishment of a functional human immune system and a corresponding human microenvironment in laboratory animals will strongly support further research.Drug discovery, systems biology, and translational research are moving closer together to address all the new hallmarks of cancer, increase the success rate of drug development, and increase the predictive value of preclinical models.

  7. 76 FR 14980 - National Institute on Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of...

    Science.gov (United States)

    2011-03-18

    ... HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism... Council on Alcohol Abuse and Alcoholism and the National Advisory Council on Drug Abuse. The meeting will...: National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse....

  8. Microfluidics for research and applications in oncology.

    Science.gov (United States)

    Chaudhuri, Parthiv Kant; Ebrahimi Warkiani, Majid; Jing, Tengyang; Kenry; Lim, Chwee Teck

    2016-01-21

    Cancer is currently one of the top non-communicable human diseases, and continual research and developmental efforts are being made to better understand and manage this disease. More recently, with the improved understanding in cancer biology as well as the advancements made in microtechnology and rapid prototyping, microfluidics is increasingly being explored and even validated for use in the detection, diagnosis and treatment of cancer. With inherent advantages such as small sample volume, high sensitivity and fast processing time, microfluidics is well-positioned to serve as a promising platform for applications in oncology. In this review, we look at the recent advances in the use of microfluidics, from basic research such as understanding cancer cell phenotypes as well as metastatic behaviors to applications such as the detection, diagnosis, prognosis and drug screening. We then conclude with a future outlook on this promising technology.

  9. [Adaptogens as agents for prophylactic oncology].

    Science.gov (United States)

    Bocharova, O A

    1999-01-01

    The paper considers whether it is advisable to use the new acting preparations adaptogens, including phytoadaptogens, in oncological care for prevention of cancer. The adaptogens are shown to have a regulating action, to be able to activate the protective properties of the body, to protect it from extreme exposures and to stimulate regenerative processes. The author associates the antitumor effect of adaptogens with the immunomodulating (they can activate macrophages, natural killer cells, antigen-dependent T lymphocytes) and interferonogenic actions and with the their ability to suppress experimental tumor growth, to enhance tissue differentiation, to improve intercellular adhesion, to reduce the likelihood of metastasis spreading. Furthermore, the use of adaptogens, and phytoadaptogens in particular, decreases the toxic effects of chemotherapy and improves drug tolerance.

  10. 76 FR 64111 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2011-10-17

    ... SPACE ADMINISTRATION NASA Advisory Council; Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, Public... Advisory Council Administrative Officer, National Aeronautics and Space Administration, Washington,...

  11. 75 FR 28542 - Superior Resource Advisory Committee

    Science.gov (United States)

    2010-05-21

    ... orient the new Superior Resource Advisory Committee members on their roles and responsibilities. DATES... of the roles and responsibilities of the Superior Resource Advisory Committee members; Election of... Forest Service Superior Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice...

  12. Analgesic stairway in the treatment of oncological pain

    Directory of Open Access Journals (Sweden)

    Sarah María Regueira Betancourt

    2015-10-01

    Full Text Available Pain represents the main symptom in an important group of patients who are in active treatment for cancer and in sick people in a very advanced stage. The objective of this article is to review the basic pharmacology of the nonsteroidal antiinflammatory drugs, weak opioids, bigger opioids, as well as the different special pharmacological and non- pharmacological techniques that constitute the analgesic stairway in the management of patients who are suffering from oncological pain.

  13. Oncology pharma costs to exceed $150 billion by 2020.

    Science.gov (United States)

    2016-10-01

    Worldwide costs of oncology drugs will rise above $150 billion by 2020, according to a report by the IMS Institute for Healthcare Informatics. Many factors are in play, according to IMS, including the new wave of expensive immunotherapies. Pembrolizumab (Keytruda), priced at $150,000 per year per patient, and nivolumab (Opdivo), priced at $165,000, may be harbingers of the market for cancer immunotherapies.

  14. Oncological emergencies for the internist

    Directory of Open Access Journals (Sweden)

    Umesh Das

    2015-01-01

    Full Text Available An oncologic emergency is defined as any acute, potentially life-threatening event, either directly or indirectly related to a patient′s cancer (ca or its treatment. It requires rapid intervention to avoid death or severe permanent damage. Most oncologic emergencies can be classified as metabolic, hematologic, structural, or side effects from chemotherapy agents. Tumor lysis syndrome is a metabolic emergency that presents as severe electrolyte abnormalities. The condition is treated with aggressive hydration, allopurinol or urate oxidase to lower uric acid levels. Hypercalcemia of malignancy is treated with aggressive rehydration, furosemide, and intravenous (IV bisphosphonates. Syndrome of inappropriate antidiuretic hormone should be suspected if a patient with ca presents with normovolemic hyponatremia. This metabolic condition usually is treated with fluid restriction and furosemide. Febrile neutropenia is a hematologic emergency that usually requires inpatient therapy with broad-spectrum antibiotics, although outpatient therapy may be appropriate for low-risk patients. Hyperviscosity syndrome usually is associated with Waldenstrφm′s macroglobulinemia, which is treated with plasmapheresis and chemotherapy. Structural oncologic emergencies are caused by direct compression of surrounding structures or by metastatic disease. Superior vena cava syndrome is the most common structural oncological emergency. Treatment options include chemotherapy, radiation, and IV stenting. Epidural spinal cord compression can be treated with dexamethasone, radiation, or surgery. Malignant pericardial effusion, which often is undiagnosed in ca patients, can be treated with pericardiocentesis or a pericardial window procedure.

  15. Exploring targeted therapies in oncology

    NARCIS (Netherlands)

    Mom, Constantijne Helene

    2007-01-01

    Targeted therapy in oncology is treatment directed at specific biological pathways and processes that play a critical role in carcinogenesis. Increased knowledge regarding the molecular changes underlying tumor progression and metastatis has resulted in the development of agents that are designed to

  16. [What's new in geriatric oncology?].

    Science.gov (United States)

    Terret, Catherine; Albrand, Gilles; Jeanton, Martine; Courpron, Philippe; Droz, Jean-Pierre

    2006-01-01

    Remarkably, although 60% of new cancer cases and over 70% of cancer deaths occur in patients aged 65 years and older in Europe, standard treatment strategies have been mostly validated in younger adults. This demographic trend has led to the emergence of a new medical discipline, geriatric oncology and the development worldwide of geriatric oncology programs for the individualized management of elderly cancer patients. Elderly cancer patients represent an increasing share of the population and strategies for treating cancer must evolve to face this ineluctable reality. Treatment should take into account the highly heterogeneous physiological age of the elderly, their individual life expectancy, functional reserves, social support and preferences. French geriatric oncology programs have been mostly based on the interdependence of geriatricians, oncologists and auxiliary nursing people. This approach represent the best way to offer patients optimal management; oncologists and geriatricians collaborate to assess both global health status by means of Comprehensive Geriatric Assessment (CGA) and tumor stage by means of Comprehensive Tumor Assessment (CTA) and to initiate individualized care plans, involving comprehensive management and follow-up of all identified problems. This paper focuses on progress observed in the field of geriatric oncology both in France and worldwide.

  17. [History of Oncology in Slovakia].

    Science.gov (United States)

    Ondruš, D; Kaušitz, J

    2016-01-01

    The history of oncology in Slovakia is closely linked to the history of St. Elizabeth Hospital, which was set up in the mid-18th century by nuns of the St. Elizabeth Order in Bratislava. In the first half of the 20th century, a unit was set up in the hospital dedicated to diagnosis and treatment of cancer. Shortly after World War II, the unit was turned into the Institute for Cancer Research and Treatment. In 1950, St. Elizabeth Hospital was nationalized, and the Cancer Research Institute of the Slovak Academy of Science and the Institute of Clinical Oncology were located there as centers for oncological diagnosis and treatment. After the restitution of church property in the early 1990s, the hospital was returned to the Order of St. Elizabeth, which set up the St. Elisabeth Cancer Institute in the hospital premises in January of 1996. This year marks the 20th anniversary of this institute in its new premises and the 85th anniversary of the Institute of Radiumtherapy founded in Bratislava, and thus the establishment of institutional healthcare for cancer patients in Slovakia is the reason for balancing. We present a view of the consecutive changes in the organization, space and staff of the Institute and evaluate the impact of celebrities on medicine who developed oncology as a clinical, scientific and educational discipline in Bratislava and in other cities and regions of Slovakia.

  18. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-07-19

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee would be...

  19. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... Surgery Devices Panel of the Medical Devices Advisory Committee would be held on November 18, 2010. On...

  20. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2013-04-04

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of...

  1. National trends in spending on and use of oral oncologics, first quarter 2006 through third quarter 2011.

    Science.gov (United States)

    Conti, Rena M; Fein, Adam J; Bhatta, Sumita S

    2014-10-01

    Oral prescription drugs are an increasingly important treatment option for cancer. Yet contemporaneous US trends in spending on anticancer drugs known as oral oncologics have not been described. Using nationally representative data, we describe trends in national spending on and use of forty-seven oral oncologics between the first quarter of 2006 and the third quarter of 2011. Average quarterly national spending on oral oncologics increased 37 percent, from $940.3 million to $1.4 billion in 2012 dollars, a significant change. Average quarterly use of oral oncologics in the same time period measured in extended units increased at a significant pace but more slowly than spending (10 percent). Within this broader trend, differences in spending among categories of oral oncologics were observed. High levels of and increases in both spending and use were concentrated among new brand-name and patent-protected oral oncologics, including second-generation tyrosine kinase inhibitors used to treat chronic myelogenous leukemia. Decreased spending but increased use was observed among oral oncologics that lost patent protection during the study period and were available in generic form, including hormonal therapies used to treat breast and prostate cancers. Spending on new and patent-protected oral oncologics and associated price increases are significant drivers of increased spending.

  2. The National Practice Benchmark for oncology, 2014 report on 2013 data.

    Science.gov (United States)

    Towle, Elaine L; Barr, Thomas R; Senese, James L

    2014-11-01

    The National Practice Benchmark (NPB) is a unique tool to measure oncology practices against others across the country in a way that allows meaningful comparisons despite differences in practice size or setting. In today's economic environment every oncology practice, regardless of business structure or affiliation, should be able to produce, monitor, and benchmark basic metrics to meet current business pressures for increased efficiency and efficacy of care. Although we recognize that the NPB survey results do not capture the experience of all oncology practices, practices that can and do participate demonstrate exceptional managerial capability, and this year those practices are recognized for their participation. In this report, we continue to emphasize the methodology introduced last year in which we reported medical revenue net of the cost of the drugs as net medical revenue for the hematology/oncology product line. The effect of this is to capture only the gross margin attributable to drugs as revenue. New this year, we introduce six measures of clinical data density and expand the radiation oncology benchmarks. Copyright © 2014 by American Society of Clinical Oncology.

  3. Raman Spectroscopy for Clinical Oncology

    Directory of Open Access Journals (Sweden)

    Michael B. Fenn

    2011-01-01

    Full Text Available Cancer is one of the leading causes of death throughout the world. Advancements in early and improved diagnosis could help prevent a significant number of these deaths. Raman spectroscopy is a vibrational spectroscopic technique which has received considerable attention recently with regards to applications in clinical oncology. Raman spectroscopy has the potential not only to improve diagnosis of cancer but also to advance the treatment of cancer. A number of studies have investigated Raman spectroscopy for its potential to improve diagnosis and treatment of a wide variety of cancers. In this paper the most recent advances in dispersive Raman spectroscopy, which have demonstrated promising leads to real world application for clinical oncology are reviewed. The application of Raman spectroscopy to breast, brain, skin, cervical, gastrointestinal, oral, and lung cancers is reviewed as well as a special focus on the data analysis techniques, which have been employed in the studies.

  4. 76 FR 14009 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2011-03-15

    ... Advisory Council will hold a meeting on Wednesday, March 30, 2011 in the Commission Meeting Room, from 1 p..., DC 20554. FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: Technical Advisory...

  5. 78 FR 55255 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2013-09-10

    ... INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: The FCC Technological Advisory Council will discuss progress... Advisory Council (TAC) will hold a meeting in the Commission Meeting Room to discuss progress on...

  6. 78 FR 33092 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2013-06-03

    ... Advisory Council will hold a meeting on Thursday, June 13, 2013 in the Commission Meeting Room, from 1 p.m.... FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: The FCC Technological Advisory...

  7. 76 FR 58513 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2011-09-21

    ... Advisory Council will hold a meeting on Tuesday, September 27th, 2011, in the Commission Meeting Room, from...., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: Technical Advisory...

  8. 77 FR 12839 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-03-02

    ... Advisory Council will hold a meeting on Wednesday, March 28, 2012 in the Commission Meeting Room, from 1 p... 20554. FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: Technical Advisory Council...

  9. 78 FR 67362 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2013-11-12

    ... Advisory Council will hold a meeting on Monday, December 9, 2013 in the Commission Meeting Room, from 1 p.m.... FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: The FCC Technological Advisory...

  10. 77 FR 30289 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-05-22

    ... Advisory Council will hold a meeting on Wednesday, June 27, 2012 in the Commission Meeting Room, from 1 p.m.... FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: The FCC Technological Advisory...

  11. Applications of coxsackievirus A21 in oncology

    Directory of Open Access Journals (Sweden)

    Bradley S

    2014-04-01

    Full Text Available Stephen Bradley,1 Adam D Jakes,1 Kevin Harrington,2 Hardev Pandha,3 Alan Melcher,1 Fiona Errington-Mais11Leeds Institute of Cancer and Pathology, Cancer Research UK and Experimental Cancer Medicine Centre, St James' University Hospital, Leeds, UK; 2Division of Cancer Biology, The Institute of Cancer Research, London, UK; 3Oncology Department, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UKAbstract: The clinical management of cancer continues to be dominated by macroscopic surgical resection, radiotherapy, and cytotoxic drugs. The major challenge facing oncology is to achieve more selective, less toxic and effective methods of targeting disseminated tumors, a challenge oncolytic virotherapy may be well-placed to meet. Characterization of coxsackievirus A21 (CVA21 receptor-based mechanism of virus internalization and lysis in the last decade has suggested promise for CVA21 as a virotherapy against malignancies which overexpress those receptors. Preclinical studies have demonstrated proof of principle, and with the results of early clinical trials awaited, CVA21 may be one of the few viruses to demonstrate benefit for patients. This review outlines the potential of CVA21 as an oncolytic agent, describing the therapeutic development of CVA21 in preclinical studies and early stage clinical trials. Preclinical evidence supports the potential use of CVA21 across a range of malignancies. Malignant melanoma is the most intensively studied cancer, and may represent a “test case” for future development of the virus. Although there are theoretical barriers to the clinical utility of oncolytic viruses like CVA21, whether these will block the efficacy of the virus in clinical practice remains to be established, and is a question which can only be answered by appropriate trials. As these data become available, the rapid journey of CVA21 from animal studies to clinical trials may offer a model for the translation of other

  12. Generalities of the oncological pain

    Directory of Open Access Journals (Sweden)

    Sarah María Regueira Betancourt

    2015-09-01

    Full Text Available Cancer pain can be caused by a malignant tumor, by the therapy used to treat it, or by both causes. It begins with an acute onset that goes towards healing or chronicity. Together with the manifestations of a chronic pain, acute episodes may appear. A bibliographic study was carried out on the oncological pain, using the resources available in the Infomed network, specifically Ebsco, The Cochrane Librery, PubMed, Hinari and SciELO, by means of which the following databases were accessed: MEDLINE, AcademicSearch Premier and MedicLatina. The presence of pain in an oncological process is variable and it depends on the type and extension of the disease, as well as on each person's own individual tolerance. The terminal intense oncological pain is a circumstance both foreseeable and necessarily avoidable. Its relief is a priority in the cancer program of the World Health Organization. To know the classification of pain, its causes, the assessment scales and the way in which it may be described provides a comprehensive treatment for cancer pain. It also helps to optimize the comprehensive care to the patients suffering from this condition and improve their quality of life.

  13. Orthodontic treatment in oncological patients.

    Science.gov (United States)

    Mituś-Kenig, Maria; Łoboda, Magdalena; Marcinkowska-Mituś, Agata; Durka-Zajac, Magdalena; Pawłowska, Elzbieta

    2015-01-01

    The progress in oncological treatment has led to the current increase of childhood cancer survival rate to 80%. That is why orthodontists more and more frequently consult patients who had completed a successful anti-cancer therapy in childhood. Oncological treatments such as chemotherapy, radiotherapy or supportive immunosuppressive therapy cause numerous side effects in growing patients, connected i.a. with growth, the development of teeth or the viscerocranium. This is a special group of patients that needs an optimised plan of orthodontic treatment and often has to accept a compromise result. The purpose of the current work is to discuss the results of orthodontic treatment in patients after an anti-cancer therapy. Time of treatment was 12,5 months. In 6 patients (from 40 undergoing orthodontic therapy) we haven't reached a normocclusion, in 9 patients we should have stopped the therapy because of the recurrence. In 11 patients we found mucosa inflammation and in 1 patient the therapy stopped before the end because of very low oral hygiene level. Bearing in mind the limited number of original works on the above topic in Polish medical literature, the study has been carried out in order to make Polish orthodontists more acquainted with the topic and the standards of dealing with an oncological patient.

  14. Ash cloud aviation advisories

    Energy Technology Data Exchange (ETDEWEB)

    Sullivan, T.J.; Ellis, J.S. [Lawrence Livermore National Lab., CA (United States); Schalk, W.W.; Nasstrom, J.S. [EG and G, Inc., Pleasanton, CA (United States)

    1992-06-25

    During the recent (12--22 June 1991) Mount Pinatubo volcano eruptions, the US Air Force Global Weather Central (AFGWC) requested assistance of the US Department of Energy`s Atmospheric Release Advisory Capability (ARAC) in creating volcanic ash cloud aviation advisories for the region of the Philippine Islands. Through application of its three-dimensional material transport and diffusion models using AFGWC meteorological analysis and forecast wind fields ARAC developed extensive analysis and 12-hourly forecast ash cloud position advisories extending to 48 hours for a period of five days. The advisories consisted of ``relative`` ash cloud concentrations in ten layers (surface-5,000 feet, 5,000--10,000 feet and every 10,000 feet to 90,000 feet). The ash was represented as a log-normal size distribution of 10--200 {mu}m diameter solid particles. Size-dependent ``ashfall`` was simulated over time as the eruption clouds dispersed. Except for an internal experimental attempt to model one of the Mount Redoubt, Alaska, eruptions (12/89), ARAC had no prior experience in modeling volcanic eruption ash hazards. For the cataclysmic eruption of 15--16 June, the complex three-dimensional atmospheric structure of the region produced dramatically divergent ash cloud patterns. The large eruptions (> 7--10 km) produced ash plume clouds with strong westward transport over the South China Sea, Southeast Asia, India and beyond. The low-level eruptions (< 7 km) and quasi-steady-state venting produced a plume which generally dispersed to the north and east throughout the support period. Modeling the sequence of eruptions presented a unique challenge. Although the initial approach proved viable, further refinement is necessary and possible. A distinct need exists to quantify eruptions consistently such that ``relative`` ash concentrations relate to specific aviation hazard categories.

  15. American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards.

    Science.gov (United States)

    Jacobson, Joseph O; Polovich, Martha; McNiff, Kristen K; LeFebvre, Kristine B; Cummings, Charmaine; Galioto, Michele; Bonelli, Katherine R; McCorkle, Michele R

    2009-11-01

    Standardization of care can reduce the risk of errors, increase efficiency, and provide a framework for best practice. In 2008, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) invited a broad range of stakeholders to create a set of standards for the administration of chemotherapy to adult patients in the outpatient setting. At the close of a full-day structured workshop, 64 draft standards were proposed. After a formal process of electronic voting and conference calls, 29 draft standards were eliminated, resulting in a final list of 35 draft measures. The proposed set of standards was posted for 6 weeks of open public comment. Three hundred twenty-two comments were reviewed by the Steering Group and used as the basis for final editing to a final set of standards. The final list includes 31 standards encompassing seven domains, which include the following: review of clinical information and selection of a treatment regimen; treatment planning and informed consent; ordering of treatment; drug preparation; assessment of treatment compliance; administration and monitoring; assessment of response and toxicity monitoring. Adherence to ASCO and ONS standards for safe chemotherapy administration should be a goal of all providers of adult cancer care.

  16. 78 FR 77443 - Electricity Advisory Committee

    Science.gov (United States)

    2013-12-23

    ... Electricity Advisory Committee AGENCY: Office of Electricity Delivery and Energy Reliability, Department of... Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770.../oe/services/electricity-advisory-committee-eac . FOR FURTHER INFORMATION CONTACT: Matthew Rosenbaum...

  17. OCLC and Its Advisory Committees.

    Science.gov (United States)

    Baker, Shirley K.

    1998-01-01

    Describes the Online Computer Library Center (OCLC) advisory committees in terms of research, public, college and university, and special libraries. All four of the type-of-library advisory groups work to shape OCLC policies and programs, according to the particular needs of each group. OCLC's financial and programmatic success depends upon…

  18. 76 FR 52016 - NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-08-19

    ... SPACE ADMINISTRATION NASA International Space Station Advisory Committee and the Aerospace Safety... International Space Station Advisory Committee and the Aerospace Safety Advisory Panel. The purpose of this... consideration by NASA for Commercial Resupply Services for the International Space Station (ISS),...

  19. 75 FR 20844 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-04-21

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  20. 77 FR 6113 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2012-02-07

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC's) Advisory Committee on Diversity for Communications in the Digital...

  1. 75 FR 70004 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-11-16

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  2. 77 FR 57085 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2012-09-17

    ... From the Federal Register Online via the Government Publishing Office ] FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  3. 78 FR 21354 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2013-04-10

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  4. 75 FR 6031 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-02-05

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  5. 76 FR 64348 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2011-10-18

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  6. 75 FR 60458 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-09-30

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  7. 78 FR 39289 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2013-07-01

    ... From the Federal Register Online via the Government Publishing Office ] FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital... Communications Commission's (FCC) Advisory Committee on Diversity for Communications in the Digital...

  8. Organisational design for an integrated oncological department

    Directory of Open Access Journals (Sweden)

    Ch.L. Meiss-de Haas

    2001-09-01

    Full Text Available Objective: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated Oncological Department in- and outside (i.e. home care the hospital. Research design: Comparative Qualitative Case Study. Methods: Auditing based on care-as-usual norms by an external, experienced auditing committee. Research setting: Integrated Oncological Departments of three hospitals. Results: Successful multidisciplinary care in an integrated, oncological department needs broad support inside the hospital and a well-defined organisational plan.

  9. 78 FR 25304 - Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), Including On...

    Science.gov (United States)

    2013-04-30

    ... Employment and Training Administration Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), Including On-Site Leased Workers From Source Right Solutions, Concord, California, Now Located... 5, 2012, applicable to workers of Siemens Medical Solutions, USA, Inc., Oncology Care...

  10. Cardiac management of oncology patients clinical handbook for cardio-oncology

    CERN Document Server

    Baron Esquivias, Gonzalo

    2015-01-01

    This book is designed for clinical cardiologists and other physicians working with cardiac patients, where specific specialized teams of cardio-oncologists are not available and who are called to perform a clinical consultation to evaluate both the cardiac condition and the eligibility for chemotherapy or radiotherapy treatment, and to evaluate if a cancer treatment produces toxic effects on a patient treated with chemo or radiotherapy and if appearance of new symptoms is due to this treatment. In recent years, progress in oncologic therapy has resulted in important developments and the prognostic improvement of patients with malignancy. The cornerstone of chemotherapy are the anthracyclines (and the analogue Mitoxantrone), that are direct cellular toxic agents and that are among the most powerful anti-neoplastic drugs, but their cardiac toxicity is well known. Significant breakthroughs in cancer therapy have also been achieved with the introduction of signalling inhibitors, such as VEGF inhibitors, HERB2 inh...

  11. 75 FR 42100 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2010-07-20

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  12. 76 FR 2697 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-01-14

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... ] hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  13. 76 FR 81952 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-12-29

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  14. 77 FR 52752 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-08-30

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  15. 77 FR 22581 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-04-16

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  16. 76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-08-18

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  17. 75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2010-03-24

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  18. 78 FR 45252 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2013-07-26

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  19. 77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-12-05

    ... HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting... hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the... unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse....

  20. 78 FR 28237 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2013-05-14

    ... SECURITY President's National Security Telecommunications Advisory Committee AGENCY: National Protection... Advisory Committee Meeting. SUMMARY: The President's National Security Telecommunications Advisory... Telecommunications Advisory Committee, National Protection and Programs Directorate, Department of Homeland...

  1. Introduction to veterinary clinical oncology

    Energy Technology Data Exchange (ETDEWEB)

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  2. Introduction to veterinary clinical oncology

    Energy Technology Data Exchange (ETDEWEB)

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  3. New Technologies in Radiation Oncology

    Science.gov (United States)

    Schlegel, Wolfgang; Bortfeld, Thomas; Grosu, Anca-Ligia

    This book provides an overview of recent advances in radiation oncology, many of which have originated from physics and engineering sciences. After an introductory section on basic aspects of 3D medical imaging, the role of 3D imaging in the context of radiotherapy is explored in a series of chapters on the various modern imaging techniques. A further major section addresses 3D treatment planning for conformal radiotherapy, with consideration of both external radiotherapy and brachytherapy. Subsequently the modern techniques of 3D conformal radiotherapy are described, including stereotactic radiotherapy, intensity-modulated radiation therapy, image-guided and adaptive radiotherapy, and radiotherapy with charged particles.

  4. Clinical oncology and chemical thermodynamics.

    Science.gov (United States)

    Seitz, D E; Pearce, H L

    1990-01-01

    The development of oncolytic agents for cancer chemotherapy is often based on chance discovery and intensive structure modification. A mechanistic understanding of the essential biochemistry of many anticancer drugs remains elusive because of the biological complexity of drug-drug and drug-target interactions. The potential of computational science to analyze and quantify these interactions may provide a rational basis for drug modification and clinical trial design.

  5. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel with regard to the decision not to award him a periodic one-step advancement for the 2006 reference year. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the notice of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main building (Bldg. 500) from 17 March to 30 March 2008. Human Resources Department Tel. 73911

  6. Joint Advisory Appeals Board

    CERN Document Server

    2013-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a former member of the personnel, a beneficiary of the CERN Pension Fund, against the calculation of his pension in the framework of the Progressive Retirement Programme.   The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the attention of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be available from 26 July to 11 August 2013 at the following link. HR Department Head Office

  7. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel against the decision to grant him only a periodic one-step advancement for the 2006 reference year. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the attention of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main Building (Bldg. 500) from 1 September to 14 September 2008. Human Resources Department (73911)

  8. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel with regard to the decision not to grant him an indefinite contract. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the notice of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main Building (Bldg. 500) from 26 May to 6 June 2008. Human Resources Department (73911)

  9. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2007-01-01

    The Joint Advisory Appeals Board was convened to examine an internal appeal lodged by a member of the personnel with regard to the decision not to grant him an indefinite contract. The person concerned has requested that the report of the Board and the final decision of the Director-General be brought to the notice of the members of the personnel, in accordance with Article R VI 1.18 of the Staff Regulations. The relevant documents will therefore be posted on the notice board of the Main building (Bldg. 60) from 24 September to 7 October 2007. Human Resources Department

  10. Joint Advisory Appeals Board

    CERN Document Server

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board was convened to examine an internal appeal lodged by a member of the personnel with regard to the decision not to grant him an indefinite contract. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the notice of the members of the personnel, in accordance with Article R VI 1.18 of the Staff Regulations. These documents will therefore be posted on the notice board of the Main Building (Bldg. 60) from 21 January to 3 February 2008. Human Resources Department (73911)

  11. Joint Advisory Appeals Board

    CERN Document Server

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel against the decision to grant him only a periodic one-step advancement for the 2006 reference year. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the attention of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main building (bldg. 500) from 1 September to 14 September 2008. Human Resources Department (73911)

  12. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2006-01-01

    The Joint Advisory Appeals Board was convened to examine an appeal lodged by a member of the personnel with regard to advancement. The person concerned has requested that the report of the Board and the final decision of the Director-General be brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (No. 60) from 24 March to 10 April 2006. Human Resources Department Tel. 74128

  13. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Serge Peraire with regard to exceptional advancement. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 17 to 31 May 2002. Human Resources Division Tel. 74128

  14. Joint Advisory Appeals Board

    CERN Multimedia

    2003-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mrs Judith Igo-Kemenes concerning the application of procedures foreseen by Administrative Circular N§ 26 (Rev. 3). As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 6 to 20 June 2003. Human Resources Division Tel. 74128

  15. Joint Advisory Appeals Board

    CERN Multimedia

    2004-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mrs Maria DIMOU with regard to a periodic one-step increase. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 30 April to 14 May 2004. Human Resources Department Tel. 74128

  16. Joint Advisory Appeals Board

    CERN Multimedia

    2003-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Aloïs Girardoz with regard to classification and advancement. As the appellant has not objected, the Board's report and the Director-General's decision will be brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 15 to 29 August 2003. Human Resources Division Tel. 74128

  17. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Bertrand Nicquevert with regard to the non-resident allowance. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 29 November to 13 December 2002. Human Resources Division Tel. 74128

  18. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Jack Blanchard with regard to 'non recognition of specific functions'. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 12th to 26th April 2002. Human Resources Division Tel. 74128

  19. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Antonio Millich with regard to advancement. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 27 September to 11 October 2002. Human Resources Division Tel. 74128

  20. Joint Advisory Appeals Board

    CERN Multimedia

    2003-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Poul Frandsen concerning his assimilation into the new career structure. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 13 to 24 January 2003. Human Resources Division Tel. 74128

  1. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Luc Vos with regard to advancement. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 14 to 28 June 2002. Human Resources Division Tel. 74128

  2. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Personnel Division

    1999-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Joào Bento with regard to residential category. As the appellant has not objected, the recommendations of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article RÊVIÊ1.20 of the Staff Regulations.The relevant documents will therefore be posted on the notice boards of the Administration Building (N¡ 60) from 29 October to 12 November 1999.Personnel DivisionTel. 74128

  3. AMCP Partnership Forum: Driving Value and Outcomes in Oncology.

    Science.gov (United States)

    2017-05-01

    Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself. The Academy of Managed Care Pharmacy (AMCP) convened a Partnership Forum to address how to improve value and outcomes in cancer care. In this multistakeholder forum, several areas were addressed: current methods for assessing the value of oncology products, the need for balancing population management with precision medicine, and the outlook for value-based contracting for oncology medications in managed care settings. Participants recommended ways in which stakeholders can work toward solutions in these areas. The forum brought together stakeholders from health plans, integrated delivery systems, pharmacy benefit managers, clinical practice, biopharmaceutical industry, and laboratory companies. Also participating were representatives from trade and professional associations. During this 1.5-day forum, participants identified current challenges, readiness, and ways to address value and improve outcomes in cancer therapy. Some of the challenges identified include choosing a viable (and practical) outcome target for value-based contracting in oncology, the development and use of value frameworks and clinical pathways, managing cancer diagnostics, utilization of alternative payment systems, moving from a large evidence base to a small clinical trial base in considering targeted treatments, and lack of best practices in value-based payment

  4. Report from the OECI Oncology Days 2014

    NARCIS (Netherlands)

    Harten, van W.H.; Stanta, G.; Bussolati, G.; Riegman, P.; Hoefler, G.; Becker, K.F.; Folprecht, G.; Truini, M.; Haybaeck, J.; Buiga, R.; Dono, M.; Bagg, A.; Lopez Guerrero, J.A.; Zupo, S.; Lemare, F.; Lorenzo, de F.; Goedbloed, N.; Razavi, D.; Lovey, J.; Cadariu, P.A.; Rollandi, G.A.; Paparo, F.; Pierotti, M.; Ciuleanu, T.; de Paoli, P.; Weiner, G.; Saghatchian, M.; Lombardo, Claudio

    2014-01-01

    The 2014 OECI Oncology Days was held at the ‘Prof. Dr. Ion Chiricuta’ Oncology Institute in Cluj, Romania, from 12 to 13 June. The focus of this year’s gathering was on developments in personalised medicine and other treatment advances which have made the cost of cancer care too high for many region

  5. Nursing 436A: Pediatric Oncology for Nurses.

    Science.gov (United States)

    Jackman, Cynthia L.

    A description is provided of "Pediatric Oncology for Nurses," the first in a series of three courses offered to fourth-year nursing students in pediatric oncology. The first section provides a course overview, discusses time assignments, and describes the target student population. Next, a glossary of terms, and lists of course goals, long-range…

  6. Perceptions of Oncology as a Medical Specialty.

    Science.gov (United States)

    Cassileth, Barrie R.; And Others

    1980-01-01

    The characteristics and prestige associated with oncology and assessed shifts in medical students' perceptions as a result of participation in an oncology course are explored. Respondents were asked to rate the prestige of eight specialities and asked to select characteristics "that best describe each type of specialist." (MLW)

  7. Art Therapy with an Oncology Care Team

    Science.gov (United States)

    Nainis, Nancy A.

    2005-01-01

    Oncology nurses are particularly vulnerable to "burnout" syndrome due to the intensity of their work and the ongoing losses they experience while providing oncology care to their patients. High levels of stress in the workplace left untended lead to high job turnover, poor productivity, and diminished quality of care for patients.…

  8. Clinical Oncology Assistantship Program for Medical Students.

    Science.gov (United States)

    Neilan, Barbara A.; And Others

    1985-01-01

    The Clinical Oncology Assistantship Program at the University of Arkansas for Medical Sciences is described, along with student reactions to the program. The summer elective program involves cancer lectures (one week) and clinical exposure (nine weeks) in medical, surgical, and pediatric oncology services, as well as self-directed learning…

  9. Organisational design for an integrated oncological department

    NARCIS (Netherlands)

    Meiss-de Haas, Ch.L.; Falkmann, H.; Douma, J.; Van Gassel, J.G.; Peters, W.G.; Van Mierlo, R.; Van Turnhout, J.M.; Verhagen, C.A.H.H.V.M.; Schrijvers, A.J.P.

    2001-01-01

    Objective: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT) analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated Oncolog

  10. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Science.gov (United States)

    2010-04-01

    ..., State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees. 20.84 Section 20.84 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C....

  11. Big data in oncologic imaging.

    Science.gov (United States)

    Regge, Daniele; Mazzetti, Simone; Giannini, Valentina; Bracco, Christian; Stasi, Michele

    2017-06-01

    Cancer is a complex disease and unfortunately understanding how the components of the cancer system work does not help understand the behavior of the system as a whole. In the words of the Greek philosopher Aristotle "the whole is greater than the sum of parts." To date, thanks to improved information technology infrastructures, it is possible to store data from each single cancer patient, including clinical data, medical images, laboratory tests, and pathological and genomic information. Indeed, medical archive storage constitutes approximately one-third of total global storage demand and a large part of the data are in the form of medical images. The opportunity is now to draw insight on the whole to the benefit of each individual patient. In the oncologic patient, big data analysis is at the beginning but several useful applications can be envisaged including development of imaging biomarkers to predict disease outcome, assessing the risk of X-ray dose exposure or of renal damage following the administration of contrast agents, and tracking and optimizing patient workflow. The aim of this review is to present current evidence of how big data derived from medical images may impact on the diagnostic pathway of the oncologic patient.

  12. [Therapeutic Aggressiveness and Liquid Oncology].

    Science.gov (United States)

    Barón Duarte, F J; Rodríguez Calvo, M S; Amor Pan, J R

    2017-01-01

    Aggressiveness criteria proposed in the scientific literature a decade ago provide a quality judgment and are a reference in the care of patients with advanced cancer, but their use is not generalized in the evaluation of Oncology Services. In this paper we analyze the therapeutic aggressiveness, according to standard criteria, in 1.001 patients with advanced cancer who died in our Institution between 2010 and 2013. The results seem to show that aggressiveness at the end of life is present more frequently than experts recommend. About 25% of patients fulfill at least one criterion of aggressiveness. This result could be explained by a liquid Oncology which does not prioritize the patient as a moral subject in the clinical appointment. Medical care is oriented to necessities and must be articulated in a model focused on dignity and communication. Its implementation through Advanced Care Planning, consideration of patient's values and preferences, and Limitation of therapeutic effort are ways to reduce aggressiveness and improve clinical practice at the end of life. We need to encourage synergic and proactive attitudes, adding the best of cancer research with the best clinical care for the benefit of human being, moral subject and main goal of Medicine.

  13. Decision making in surgical oncology.

    Science.gov (United States)

    Lamb, B; Green, J S A; Vincent, C; Sevdalis, N

    2011-09-01

    Decisions in surgical oncology are increasingly being made by multi-disciplinary teams (MDTs). Although MDTs have been widely accepted as the preferred model for cancer service delivery, the process of decision making has not been well described and there is little evidence pointing to the ideal structure of an MDT. Performance in surgery has been shown to depend on non-technical skills, such as decision making, as well as patient factors and the technical skills of the healthcare team. Application of this systems approach to MDT working allows the identification of factors that affect the quality of decision making for cancer patients. In this article we review the literature on decision making in surgical oncology and by drawing from the systems approach to surgical performance we provide a framework for understanding the process of decision making in MDTs. Technical factors that affect decision making include the information about patients, robust ICT and video-conferencing equipment, a minimum dataset with expert review of radiological and pathological information, implementation and recording of the MDTs decision. Non-technical factors with an impact on decision making include attendance of team members at meetings, leadership, teamwork, open discussion, consensus on decisions and communication with patients and primary care. Optimising these factors will strengthen the decision making process and raise the quality of care for cancer patients.

  14. Optical imaging probes in oncology.

    Science.gov (United States)

    Martelli, Cristina; Lo Dico, Alessia; Diceglie, Cecilia; Lucignani, Giovanni; Ottobrini, Luisa

    2016-07-26

    Cancer is a complex disease, characterized by alteration of different physiological molecular processes and cellular features. Keeping this in mind, the possibility of early identification and detection of specific tumor biomarkers by non-invasive approaches could improve early diagnosis and patient management.Different molecular imaging procedures provide powerful tools for detection and non-invasive characterization of oncological lesions. Clinical studies are mainly based on the use of computed tomography, nuclear-based imaging techniques and magnetic resonance imaging. Preclinical imaging in small animal models entails the use of dedicated instruments, and beyond the already cited imaging techniques, it includes also optical imaging studies. Optical imaging strategies are based on the use of luminescent or fluorescent reporter genes or injectable fluorescent or luminescent probes that provide the possibility to study tumor features even by means of fluorescence and luminescence imaging. Currently, most of these probes are used only in animal models, but the possibility of applying some of them also in the clinics is under evaluation.The importance of tumor imaging, the ease of use of optical imaging instruments, the commercial availability of a wide range of probes as well as the continuous description of newly developed probes, demonstrate the significance of these applications. The aim of this review is providing a complete description of the possible optical imaging procedures available for the non-invasive assessment of tumor features in oncological murine models. In particular, the characteristics of both commercially available and newly developed probes will be outlined and discussed.

  15. Chances, risks and limitations of neoadjuvant therapy in surgical oncology

    Directory of Open Access Journals (Sweden)

    Lordick Florian

    2016-09-01

    Full Text Available Over the last decades, neoadjuvant treatment has been established as a standard of care for a variety of tumor types in visceral oncology. Neoadjuvant treatment is recommended in locally advanced esophageal and gastric cancer as well as in rectal cancer. In borderline resectable pancreatic cancer, neoadjuvant therapy is an emerging treatment concept, whereas in resectable colorectal liver metastases, neoadjuvant treatment is often used, although the evidence for improvement of survival outcomes is rather weak. What makes neoadjuvant treatment attractive from a surgical oncology viewpoint is its ability to shrink tumors to a smaller size and to increase the chances for complete resection with clear surgical margins, which is a prerequisite for cure. Studies suggest that local tumor control is increased in some visceral tumor types, especially with neoadjuvant chemoradiotherapy. In some other studies, a better control of systemic disease has contributed to significantly improved survival rates. Additionally, delaying surgery offers the chance to bring the patient into a better general condition for major surgery, but it also confers the risk of progression. Although it is a relatively rare event, cancers may progress locally during neoadjuvant treatment or distant metastases may occur, jeopardizing a curative surgical treatment approach. Although this is seen as risk of neoadjuvant treatment, it can also be seen as a chance to select only those patients for surgery who have a better control of systemic disease. Some studies showed increased perioperative morbidity in patients who underwent neoadjuvant treatment, which is another potential disadvantage. Optimal multidisciplinary teamwork is key to controlling that risk. Meanwhile, the neoadjuvant treatment period is also used as a “window of opportunity” for studying the activity of novel drugs and for investigating predictive and prognostic biomarkers of chemoradiotherapy and radiochemotherapy

  16. Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

    Science.gov (United States)

    Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

    2015-01-01

    In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

  17. Lean oncology: a new model for oncologists.

    Science.gov (United States)

    Montesarchio, Vincenzo; Grimaldi, Antonio Maria; Fox, Bernard A; Rea, Antonio; Marincola, Francesco M; Ascierto, Paolo A

    2012-04-25

    The history of the term Lean is relatively recent and originates from the Toyota Production System (TPS). The term "Lean" means "thin", which refers to a mental process, operational, productive, no-frills, quick but not hasty, consequential to the previous event. The Lean process flows seamlessly into the result, eliminates unnecessary complications to the effect, prevents unnecessary equipment processes. The idea is to 'do more with less', like using the (few) available resources in the most productive way possible, through the elimination of all types of waste that inevitably accompanies every stage of a production process. Lean management is primarily a management philosophy, a system of values and behaviors that goes beyond the mere application of the instrument and that, once internalized, will form the nucleus of the corporate culture. "Lean Oncology" is a term coined to identify a methodology of care and treatment to cancer patients, consisting on process simplification, streamlining of the organizational and routes of drug treatment, detection and elimination of waste. Its main objective is the centrality of the patient.

  18. Lean oncology: a new model for oncologists

    Directory of Open Access Journals (Sweden)

    Montesarchio Vincenzo

    2012-04-01

    Full Text Available Abstract The history of the term Lean is relatively recent and originates from the Toyota Production System (TPS. The term "Lean" means "thin", which refers to a mental process, operational, productive, no-frills, quick but not hasty, consequential to the previous event. The Lean process flows seamlessly into the result, eliminates unnecessary complications to the effect, prevents unnecessary equipment processes. The idea is to 'do more with less', like using the (few available resources in the most productive way possible, through the elimination of all types of waste that inevitably accompanies every stage of a production process. Lean management is primarily a management philosophy, a system of values and behaviors that goes beyond the mere application of the instrument and that, once internalized, will form the nucleus of the corporate culture. "Lean Oncology" is a term coined to identify a methodology of care and treatment to cancer patients, consisting on process simplification, streamlining of the organizational and routes of drug treatment, detection and elimination of waste. Its main objective is the centrality of the patient.

  19. Oncological image analysis: medical and molecular image analysis

    Science.gov (United States)

    Brady, Michael

    2007-03-01

    This paper summarises the work we have been doing on joint projects with GE Healthcare on colorectal and liver cancer, and with Siemens Molecular Imaging on dynamic PET. First, we recall the salient facts about cancer and oncological image analysis. Then we introduce some of the work that we have done on analysing clinical MRI images of colorectal and liver cancer, specifically the detection of lymph nodes and segmentation of the circumferential resection margin. In the second part of the paper, we shift attention to the complementary aspect of molecular image analysis, illustrating our approach with some recent work on: tumour acidosis, tumour hypoxia, and multiply drug resistant tumours.

  20. Molecular targeted therapy in modern oncology: Imaging assessment of treatment response and toxicities

    Energy Technology Data Exchange (ETDEWEB)

    Krajewski, Katherine M.; Braschi-Amirfarzan, Marta; DiPiro, Pamela J.; Jagannathan, Jyothi P.; Shinagare, Atul B. [Dept. of of Imaging, Dana Farber Cancer Institute, Boston (United States)

    2017-01-15

    Oncology is a rapidly evolving field with a shift toward personalized cancer treatment. The use of therapies targeted to the molecular features of individual tumors and the tumor microenvironment has become much more common. In this review, anti-angiogenic and other molecular targeted therapies are discussed, with a focus on typical and atypical response patterns and imaging manifestations of drug toxicities.

  1. The integration of research and care in pediatric oncology: implications for review and consent

    NARCIS (Netherlands)

    Dekking, S.A.S.

    2016-01-01

    The large majority of children with cancer participate in medical research. This varies from observational studies, to laboratory research on different types of tissue, to drug research, to supportive care studies. As such, pediatric oncology is a field where treatments are often provided in the res

  2. Crash course in readers' advisory

    CERN Document Server

    Orr, Cynthia

    2014-01-01

    One of the key services librarians provide is helping readers find books they'll enjoy. This ""crash course"" will furnish you with the basic, practical information you need to excel at readers' advisory (RA) for adults and teens.

  3. KZBW Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  4. KZOA Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  5. KZSE Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  6. KZMA Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  7. KZLC Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  8. Design Challenges of an Episode-Based Payment Model in Oncology: The Centers for Medicare & Medicaid Services Oncology Care Model.

    Science.gov (United States)

    Kline, Ronald M; Muldoon, L Daniel; Schumacher, Heidi K; Strawbridge, Larisa M; York, Andrew W; Mortimer, Laura K; Falb, Alison F; Cox, Katherine J; Bazell, Carol; Lukens, Ellen W; Kapp, Mary C; Rajkumar, Rahul; Bassano, Amy; Conway, Patrick H

    2017-07-01

    The Centers for Medicare & Medicaid Services developed the Oncology Care Model as an episode-based payment model to encourage participating practitioners to provide higher-quality, better-coordinated care at a lower cost to the nearly three-quarter million fee-for-service Medicare beneficiaries with cancer who receive chemotherapy each year. Episode payment models can be complex. They combine into a single benchmark price all payments for services during an episode of illness, many of which may be delivered at different times by different providers in different locations. Policy and technical decisions include the definition of the episode, including its initiation, duration, and included services; the identification of beneficiaries included in the model; and beneficiary attribution to practitioners with overall responsibility for managing their care. In addition, the calculation and risk adjustment of benchmark episode prices for the bundle of services must reflect geographic cost variations and diverse patient populations, including varying disease subtypes, medical comorbidities, changes in standards of care over time, the adoption of expensive new drugs (especially in oncology), as well as diverse practice patterns. Other steps include timely monitoring and intervention as needed to avoid shifting the attribution of beneficiaries on the basis of their expected episode expenditures as well as to ensure the provision of necessary medical services and the development of a meaningful link to quality measurement and improvement through the episode-based payment methodology. The complex and diverse nature of oncology business relationships and the specific rules and requirements of Medicare payment systems for different types of providers intensify these issues. The Centers for Medicare & Medicaid Services believes that by sharing its approach to addressing these decisions and challenges, it may facilitate greater understanding of the model within the oncology

  9. Challenge of pediatric oncology in Africa.

    Science.gov (United States)

    Hadley, Larry G P; Rouma, Bankole S; Saad-Eldin, Yasser

    2012-05-01

    The care of children with malignant solid tumors in sub-Saharan Africa is compromised by resource deficiencies that range from inadequate healthcare budgets and a paucity of appropriately trained personnel, to scarce laboratory facilities and inconsistent drug supplies. Patients face difficulties accessing healthcare, affording investigational and treatment protocols, and attending follow-up. Children routinely present with advanced local and metastatic disease and many children cannot be offered any effective treatment. Additionally, multiple comorbidities, including malaria, tuberculosis, and HIV when added to acute on chronic malnutrition, compound treatment-related toxicities. Survival rates are poor. Pediatric surgical oncology is not yet regarded as a health care priority by governments struggling to achieve their millennium goals. The patterns of childhood solid malignant tumors in Africa are discussed, and the difficulties encountered in their management are highlighted. Three pediatric surgeons from different regions of Africa reflect on their experiences and review the available literature. The overall incidence of pediatric solid malignant tumor is difficult to estimate in Africa because of lack of vital hospital statistics and national cancer registries in most of countries. The reported incidences vary between 5% and 15.5% of all malignant tumors. Throughout the continent, patterns of malignant disease vary with an obvious increase in the prevalence of Burkitt lymphoma (BL) and Kaposi sarcoma in response-increased prevalence of HIV disease. In northern Africa, the most common malignant tumor is leukemia, followed by brain tumors and nephroblastoma or neuroblastoma. In sub-Saharan countries, BL is the commonest tumor followed by nephroblastoma, non-Hodgkin lymphoma, and rhabdomyosarcoma. The overall 5-years survival varied between 5% (in Côte d'Ivoire before 2001) to 34% in Egypt and up to 70% in South Africa. In many reports, the survival rate of

  10. Educating medical students about radiation oncology: initial results of the oncology education initiative.

    Science.gov (United States)

    Hirsch, Ariel E; Singh, Deeptej; Ozonoff, Al; Slanetz, Priscilla J

    2007-10-01

    Multidisciplinary cancer care requires the integration of teaching across established educational boundaries. Because exposure to oncology and radiation oncology is limited in the undergraduate medical curriculum, the authors introduced an oncology education initiative at their institution. They report on the addition of structured multidisciplinary oncology education to the required radiology core clerkship. An institutional-based cohort study of fourth-year medical students rotating through a required clerkship in radiology at Boston University School of Medicine was conducted, beginning with the class of 2007. An educational questionnaire measuring the perceived quality of oncology education before and after exposure to a structured didactic program was administered. Of the 149 fourth-year students, 121 (81%) have completed the didactics of the initiative. Although 68 of 121 (56%) students reported having limited exposure to cancer care in the clinical years, 107 of 121 (88%) were motivated to learn more about the subject, and 100 of 121 (83%) reported a better understanding of the multidisciplinary nature of cancer care after this oncology education initiative. One hundred ten of 121 (91%) felt that the radiology clerkship was an opportune time to receive oncology and radiation oncology teaching. As a result of the initiative, 32% of the students pursued advanced training in radiation oncology. Of students who before the initiative were not planning on taking oncology electives, 70 of 99 (71%) agreed or strongly agreed that the lecture motivated them to learn more about the subject, and 43 of 99 (43%) agreed or strongly agreed that the lecture motivated them to take oncology electives. Systematic exposure to multidisciplinary oncology education as part of a radiology core clerkship provides an excellent opportunity for the integrated teaching of oncologic principles and patient management. This type of experience addresses an important yet underrepresented

  11. 76 FR 64122 - NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter

    Science.gov (United States)

    2011-10-17

    ... SPACE ADMINISTRATION NASA Advisory Committee; Renewal of NASA's International Space Station Advisory... and amendment of the Charter of the International Space Station Advisory Committee. SUMMARY: Pursuant... Space Station Advisory Committee is in the public interest in connection with the performance of...

  12. 77 FR 15751 - Meetings of the Local Government Advisory Committee and the Small Communities Advisory Subcommittee

    Science.gov (United States)

    2012-03-16

    ... AGENCY Meetings of the Local Government Advisory Committee and the Small Communities Advisory... requests for appearances requires it. The Local Government Advisory Committee (LGAC) will meet at EPA's...: Local Government Advisory Committee (LGAC) contact Frances Eargle at (202) 564-3115 or email at...

  13. 77 FR 2539 - Meetings of the Small Communities Advisory Subcommittee and the Local Government Advisory Committee

    Science.gov (United States)

    2012-01-18

    ... AGENCY Meetings of the Small Communities Advisory Subcommittee and the Local Government Advisory... if the number of requests for appearances requires it. The Local Government Advisory Committee (LGAC... at davis.catherinem@epa.gov . For the Local Government Advisory Committee (LGAC) contact...

  14. 75 FR 22754 - Federal Advisory Committee; Chief of Engineers Environmental Advisory Board; Charter Renewal

    Science.gov (United States)

    2010-04-30

    ... of the Secretary Federal Advisory Committee; Chief of Engineers Environmental Advisory Board; Charter... that it is renewing the charter for the Chief of Engineers Environmental Advisory Board (hereafter referred to as the Board). FOR FURTHER INFORMATION CONTACT: Jim Freeman, Deputy Advisory...

  15. 75 FR 22560 - Federal Advisory Committee; U.S. Air Force Scientific Advisory Board; Charter Renewal

    Science.gov (United States)

    2010-04-29

    ... of the Secretary Federal Advisory Committee; U.S. Air Force Scientific Advisory Board; Charter... that it is renewing the charter for the U.S. Air Force Scientific Advisory Board (hereafter referred to as the Board). FOR FURTHER INFORMATION CONTACT: Jim Freeman, Deputy Advisory Committee...

  16. Nutrition support in surgical oncology.

    Science.gov (United States)

    Huhmann, Maureen B; August, David A

    2009-01-01

    This review article, the second in a series of articles to examine the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, evaluates the evidence related to the use of nutrition support in surgical oncology patients. Cancer patients develop complex nutrition issues. Nutrition support may be indicated in malnourished cancer patients undergoing surgery, depending on individual patient characteristics. As with the first article in this series, this article provides background concerning nutrition issues in cancer patients, as well as discusses the role of nutrition support in the care of surgical cancer patients. The goal of this review is to enrich the discussion contained in the clinical guidelines as they relate to recommendations made for surgical patients, cite the primary literature more completely, and suggest updates to the guideline statements in light of subsequently published studies.

  17. Companion diagnostics in oncology - current status and future aspects.

    Science.gov (United States)

    Jørgensen, Jan Trøst

    2013-01-01

    A large number of targeted anticancer drugs are currently under development and most of them will have a companion diagnostic linked to their use. If a diagnostic assay is developed in conjunction with a targeted anticancer drug, such an assay will later end up determining the conditions for the use of the drug after its approval. The assay then becomes a kind of 'gatekeeper' in relation to which patients should be treated with the drug in question. This 'gatekeeper' role implies that companion diagnostic assays must live up to the same regulatory standards and requirements known from drug development. The assays must have proven to be analytically robust and reliable and to have demonstrated clinical utility before they are routinely used in the clinic. In the drug-diagnostic codevelopment model, several 'traditional' study designs have been used to demonstrate clinical utility. However, if we are to benefit from the increasing knowledge provided by molecular oncology, new ways should be developed to demonstrate the clinical utility of drug-diagnostic combinations. The development of such an approach will require a rethinking at different levels and is likely to include a number of ethical, regulatory and practical challenges.

  18. Chemotherapy drugs for Oncology at the harm of Occupational Protection and Nurses%化疗药物对肿瘤科护士的危害和职业防护

    Institute of Scientific and Technical Information of China (English)

    李娜

    2014-01-01

    Facing the high incidence of tumor,chemotherapy as one of the means for comprehensive treatment of tumor,has been widely used.But the long-term contact chemotherapy drugs,their toxicity,teratogenecity,mutagenicity and carcinogenicity has brought serious harm to the nurse.In addition,due to the lack management of tumor chemotherapy drug,less protective equipments for preparation of chemotherapy,operators lack the necessary protective appliances,operation staff lack the protection consciousness and the mismanagement for antineoplastic drug waste and a series of problems become a great threat for nurse’s health.Therefore to strengthen nursing staff occupational safety education and its protection becomes very important.%面对肿瘤的高发病率,化疗作为肿瘤的综合治疗手段之一,目前已广泛应用,但是长期接触化疗药物,其毒性、致畸性、致突变性和致癌性给护士带来严重危害。此外,由于肿瘤化疗药物缺乏管理,配制化疗药的防护设备甚少、操作人员缺少必要的防护用具、操作人员防护意识淡薄以及抗肿瘤药物废弃物管理不善等一系列问题,对护士的健康构成了极大的威胁。因此加强护理人员的职业安全教育及其防护就变得尤为重要。

  19. The impact of genomics on oncology nursing.

    Science.gov (United States)

    Beamer, Laura Curr; Linder, Lauri; Wu, Bohua; Eggert, Julia

    2013-12-01

    Since 2003, genetics and genomics information has led to exciting new diagnostics, prognostics, and treatment options in oncology practice. Profiling of cancers offers providers insight into treatment and prognostic factors. Germline testing provides an individual with information for surveillance or therapy that may help them prevent cancer in their lifetime and options for family members as yet untouched by malignancy. This offers a challenge for oncology nurses and other oncology health care providers to become comfortable with incorporating education about genetics/genomics into their clinical practice and patient education.

  20. PET-Based Thoracic Radiation Oncology.

    Science.gov (United States)

    Simone, Charles B; Houshmand, Sina; Kalbasi, Anusha; Salavati, Ali; Alavi, Abass

    2016-07-01

    Fluorodeoxyglucose-PET is increasingly being integrated into multiple aspects of oncology. PET/computed tomography (PET/CT) has become especially important in radiation oncology. With the increasing use of advanced techniques like intensity-modulated radiation therapy and proton therapy, PET/CT scans have played critical roles in the target delineation of tumors for radiation oncologists delivering conformal treatment techniques. Use of PET/CT is well established in lung cancer and several other thoracic malignancies. This article details the current uses of PET/CT in thoracic radiation oncology with a focus on lung cancer and describes expected future roles of PET/CT for thoracic tumors.

  1. The Danish Neuro-Oncology Registry

    DEFF Research Database (Denmark)

    Hansen, Steinbjørn

    2016-01-01

    AIM OF DATABASE: The Danish Neuro-Oncology Registry (DNOR) was established by the Danish Neuro-Oncology Group as a national clinical database. It was established for the purpose of supporting research and development in adult patients with primary brain tumors in Denmark. STUDY POPULATION: DNOR has...... advantage of reporting indicators is the related multidisciplinary discussions giving a better understanding of what actually is going on, thereby facilitating the work on adjusting the national guidelines in the Danish Neuro-Oncology Group. CONCLUSION: The establishment of DNOR has optimized the quality...

  2. Optimizing oncology therapeutics through quantitative translational and clinical pharmacology: challenges and opportunities.

    Science.gov (United States)

    Venkatakrishnan, K; Friberg, L E; Ouellet, D; Mettetal, J T; Stein, A; Trocóniz, I F; Bruno, R; Mehrotra, N; Gobburu, J; Mould, D R

    2015-01-01

    Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure-response understanding to optimize the benefit-risk balance of novel therapies for cancer patients. This review article discusses the principles and applications of modeling and simulation approaches across the lifecycle of development of oncology therapeutics. Illustrative examples are used to convey the value gained from integration of quantitative clinical pharmacology strategies from the preclinical-translational phase through confirmatory clinical evaluation of efficacy and safety.

  3. 76 FR 34230 - Technological Advisory Council

    Science.gov (United States)

    2011-06-13

    ... persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a... Johnston, Chief, Electromagnetic Compatibility Division, Office of Engineering and Technology 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: Technical Advisory Council members have...

  4. 76 FR 3633 - Consumer Advisory Committee

    Science.gov (United States)

    2011-01-20

    ... COMMISSION Consumer Advisory Committee AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: This document announces the rechartering of the Consumer Advisory Committee (hereinafter ``the... ``Commission'') regarding consumer issues within the jurisdiction of the Commission and to facilitate...

  5. 78 FR 54629 - Consumer Advisory Board meeting

    Science.gov (United States)

    2013-09-05

    ... From the Federal Register Online via the Government Publishing Office CONSUMER FINANCIAL PROTECTION BUREAU Consumer Advisory Board meeting AGENCY: Bureau of Consumer Financial Protection. ACTION... Consumer Advisory Board (``CAB'' or ``Board'') of the Consumer Financial Protection Bureau (Bureau)....

  6. 76 FR 56454 - Consumer Advisory Committee Meeting

    Science.gov (United States)

    2011-09-13

    ... COMMISSION Consumer Advisory Committee Meeting AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: The Commission announces the next meeting date and agenda of its Consumer Advisory Committee (Committee). The purpose of the Committee is to make recommendations to the Commission regarding...

  7. 75 FR 9898 - Consumer Advisory Committee

    Science.gov (United States)

    2010-03-04

    ... COMMISSION Consumer Advisory Committee AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: The Commission announces the next meeting date and agenda of its Consumer Advisory Committee (``Committee''). The purpose of the ] Committee is to make recommendations to the Commission regarding...

  8. 75 FR 4819 - Consumer Advisory Committee

    Science.gov (United States)

    2010-01-29

    ... COMMISSION Consumer Advisory Committee AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: The Commission announces the next meeting date and agenda of its Consumer Advisory Committee (``Committee''). The purpose of the Committee is to make recommendations to the Commission regarding...

  9. 77 FR 57086 - Open Internet Advisory Committee

    Science.gov (United States)

    2012-09-17

    ... COMMISSION Open Internet Advisory Committee AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: The Commission announces the next meeting date, time, and agenda of the Open Internet Advisory... Open Internet rules, and to provide any recommendations it deems appropriate to the...

  10. 78 FR 16852 - Open Internet Advisory Committee

    Science.gov (United States)

    2013-03-19

    ... COMMISSION Open Internet Advisory Committee AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: The Commission announces the next meeting date, time, and agenda of the Open Internet Advisory... Open Internet rules, and to provide any recommendations it deems appropriate to the...

  11. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2001-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Neil Calder, Mrs Sudeshna Datta Cockerill, Mrs Andrée Fontbonne, Mrs Moniek Laurent and Mr Ulrich Liptow with regard to membership in the Pension Fund under the period with a Paid Associate contract, appeals dealt with on a collective basis. As the appellants have not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 10 to 31 August 2001.

  12. The correlation between HTA recommendations and reimbursement status of orphan drugs in Europe

    OpenAIRE

    Kawalec, Paweł; Sagan, Anna; Pilc, Andrzej

    2016-01-01

    Background The aim of this study was to review and compare types of reimbursement recommendations for orphan drugs issued by eight European health technology assessment (HTA) agencies and the reimbursement status of these drugs in the corresponding countries. Separate calculations were also performed for three sub-groups: ultra-orphan drugs, oncology orphan drugs and other (non-ultra, non-oncology) orphan drugs. Results We reviewed drugs authorized by the European Medicine Agency (EMA) betwee...

  13. Evidence-based practice in times of drug shortage.

    Science.gov (United States)

    de Lemos, Mário L; Waignein, Sally; de Haan, Marie

    2016-06-01

    Shortage of oncology drugs is a particularly complicated issue because there are usually limited therapeutic options. Moreover, oncology practice may employ medications for supportive indications which differ from their main usage. This means shortage of oncology drugs is not usually addressed by the major drug shortage guidelines. We have previously shown that, during a shortage crisis, it is possible to make a recommendation on the use of an expired drug supply based on a reasonable estimate of its safety and efficacy. Here, we would like to share further examples on how to deduce potential therapeutic alternatives based on pharmacokinetic and pharmacodynamic principles in the absence of direct clinical evidence in the literature.

  14. Cardio-Oncology: How New Targeted Cancer Therapies and Precision Medicine Can Inform Cardiovascular Discovery.

    Science.gov (United States)

    Bellinger, Andrew M; Arteaga, Carlos L; Force, Thomas; Humphreys, Benjamin D; Demetri, George D; Druker, Brian J; Moslehi, Javid J

    2015-12-01

    Cardio-oncology (the cardiovascular care of cancer patients) has developed as a new translational and clinical field based on the expanding repertoire of mechanism-based cancer therapies. Although these therapies have changed the natural course of many cancers, several may also lead to cardiovascular complications. Many new anticancer drugs approved over the past decade are "targeted" kinase inhibitors that interfere with intracellular signaling contributing to tumor progression. Unexpected cardiovascular and cardiometabolic effects of patient treatment with these inhibitors have provided unique insights into the role of kinases in human cardiovascular biology. Today, an ever-expanding number of cancer therapies targeting novel kinases and other specific cellular and metabolic pathways are being developed and tested in oncology clinical trials. Some of these drugs may affect the cardiovascular system in detrimental ways and others perhaps in beneficial ways. We propose that the numerous ongoing oncology clinical trials are an opportunity for closer collaboration between cardiologists and oncologists to study the cardiovascular and cardiometabolic changes caused by the modulation of these pathways in patients. In this regard, cardio-oncology represents an opportunity and a novel platform for basic and translational investigation and can serve as a potential avenue for optimization of anticancer therapies and for cardiovascular research and drug discovery.

  15. An interprofessionally developed geriatric oncology curriculum for hematology–oncology fellows

    Science.gov (United States)

    Eid, Ahmed; Hughes, Caren; Karuturi, Meghan; Reyes, Connie; Yorio, Jeffrey; Holmes, Holly

    2016-01-01

    Objective Because the cancer population is aging, interprofessional education incorporating geriatric principles is essential to providing adequate training for oncology fellows. We report the targeted needs assessment, content, and evaluation tools for our geriatric oncology curriculum at MD Anderson Cancer Center. Methods A team comprising a geriatrician, a medical oncologist, an oncology PharmD, an oncology advanced nurse practitioner, and two oncology chief fellows developed the geriatric oncology curriculum. First, a general needs assessment was conducted by reviewing the literature and medical societies’ publications and by consulting experts. A targeted needs assessment was then conducted by reviewing the fellows’ evaluations of the geriatric oncology rotation and by interviewing fellows and recently graduated oncology faculty. Results Geriatric assessment, pharmacology, and psychosocial knowledge skills were the three identified areas of educational need. Curriculum objectives and an evaluation checklist were developed to evaluate learners in the three identified areas. The checklist content was validated by consulting experts in the field. Online materials, including a curriculum, a geriatric pharmacology job aid, and pharmacology cases, were also developed and delivered as part of the curriculum. Conclusion An interprofessional team approach was a successful method for identifying areas of learners’ educational needs, which in turn helped us develop an integrated geriatric oncology curriculum. The curriculum is currently being piloted and evaluated. PMID:25487037

  16. 76 FR 63664 - Arts Advisory Panel

    Science.gov (United States)

    2011-10-13

    ... Doc No: 2011-26421] NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory Panel Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that thirteen meetings of the Arts Advisory Panel to the...

  17. 5 CFR 724.403 - Advisory guidelines.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines...

  18. 39 CFR 447.31 - Advisory service.

    Science.gov (United States)

    2010-07-01

    ... Advisory Services and Post-Employment Activities § 447.31 Advisory service. (a) The Ethical Conduct Officer is responsible for the administration of the ethics program of the Postal Service. In the exercise of that responsibility, the Ethical Conduct Officer shall coordinate the advisory service provided by...

  19. 78 FR 9038 - Electricity Advisory Committee Meeting

    Science.gov (United States)

    2013-02-07

    ... Electricity Advisory Committee Meeting AGENCY: Office of Electricity Delivery and Energy Reliability... Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770... FURTHER INFORMATION CONTACT: Matthew Rosenbaum, Office of Electricity Delivery and Energy Reliability, U.S...

  20. 76 FR 10577 - Electricity Advisory Committee Meeting

    Science.gov (United States)

    2011-02-25

    ... Electricity Advisory Committee Meeting AGENCY: Office of Electricity Delivery and Energy Reliability... reestablished Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat... of Electricity Delivery and Energy Reliability, U.S. Department of Energy, Forrestal Building, Room...

  1. 77 FR 10486 - Electricity Advisory Committee Meeting

    Science.gov (United States)

    2012-02-22

    ... Electricity Advisory Committee Meeting AGENCY: Office of Electricity Delivery and Energy Reliability... Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L. 92- 463, 86 Stat. 770... INFORMATION CONTACT: Matthew Rosenbaum, Office of Electricity Delivery and Energy Reliability, U.S. Department...

  2. 75 FR 61454 - Electricity Advisory Committee

    Science.gov (United States)

    2010-10-05

    ... Electricity Advisory Committee AGENCY: Department of Energy, Office of Electricity Delivery and Energy...-established DOE Electricity Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat...: David Meyer, Designated Federal Officer, Office of Electricity Delivery and Energy Reliability, U.S...

  3. 48 CFR 401.371 - AGAR Advisories.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false AGAR Advisories. 401.371... ACQUISITION REGULATION SYSTEM Agency Acquisition Regulations 401.371 AGAR Advisories. The SPE may issue AGAR Advisories, consistent with the policies of the FAR and the AGAR, for the following purposes: (a)...

  4. 75 FR 69698 - Invasive Species Advisory Committee

    Science.gov (United States)

    2010-11-15

    ... Doc No: 2010-28653] DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory..., notice is hereby given of meetings of the Invasive Species Advisory Committee (ISAC). Comprised of 30 nonfederal invasive species experts and stakeholders from across the nation, the purpose of the Advisory...

  5. 77 FR 23740 - Invasive Species Advisory Committee

    Science.gov (United States)

    2012-04-20

    ... Office of the Secretary Invasive Species Advisory Committee AGENCY: Office of the Secretary, Interior. ACTION: Notice of Public Meetings of the Invasive Species Advisory Committee. SUMMARY: Pursuant to the provisions of the Federal Advisory Committee Act, notice is hereby given of meetings of the Invasive Species...

  6. 76 FR 68776 - Invasive Species Advisory Committee

    Science.gov (United States)

    2011-11-07

    ...] [FR Doc No: 2011-28743] DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory..., notice is hereby given of meetings of the Invasive Species Advisory Committee (ISAC). Comprised of 29 nonfederal invasive species experts and stakeholders from across the nation, the purpose of the Advisory...

  7. [NON-ONCOLOGIC CHRONIC PAIN TREATMENT WITH OPIATES].

    Science.gov (United States)

    Molas Ferrer, Glòria; Castellà Kastner, Montse; Lombraña Mencia, María

    2014-09-01

    Non-oncologic chronic pain is a very common symptom. It causes great impact on daily activities of people who suffer it. The incidence of this type of pain is rising due to the increase in life expectancy. The most affected population is geriatric population. Back pain, osteoarthritic pain and neuropathic pain are the most prevalent types of non-oncologic chronic pain. Opiates, among other analgesic drugs, are used to alleviate this type of pain. Opiates are divided into minor opiates (tramadol, codeine) and major opiates (morphine, fentanyl, oxycodone, methadone). Opiates are very effective to treat pain, but they also have important adverse effects that we must know and try to prevent. One of these adverse effects is the opiates ability to cause dependence, tolerance, addiction and other aberrant behaviors. Terminology of these concepts is sometimes confusing. It is necessary to be careful and control the patient periodically in order to avoid these aberrant behaviors. However, if health professionals take precautions to prevent these behaviors, the risk is considerably reduced. Controlling patients on opiate treatment is essential to achieve a correct use if these drugs.

  8. Complementary and alternative medicine in oncology nursing.

    Science.gov (United States)

    Somani, Salima; Ali, Fauziya; Saeed Ali, Tazeen; Sulaiman Lalani, Nasreen

    Use of complementary and alternative medicine (CAM) has increased globally, particularly among oncology patients. This study investigated the knowledge, experience and attitudes of oncology nurses towards CAM. A quantitative study was conducted in tertiary care hospitals in Karachi, Pakistan, where 132 oncology nurses were surveyed. The survey revealed that more than 50% of nurses had never heard about many of the CAM therapies used in Pakistan. Approximately 65% of the nurses had knowledge about prayer and less than 30% had experience of CAM education or training. In addition, the majority of nurses had seen patients using CAM and felt that their health status could be enhanced with the use of CAM. This study showed that oncology nurses had a positive experience of and attitude towards CAM, although they needed to enhance their knowledge of it to maximise patient satisfaction and quality of care.

  9. Organisational design for an integrated oncological department

    NARCIS (Netherlands)

    Meiss-de Haas, Ch.L.; Falkmann, H.; Douma, J.; Van Gassel, J.G.; Peters, W.G.; Van Mierlo, R.; Van Turnhout, J.M.; Verhagen, C.A.H.H.V.M.; Schrijvers, A.J.P.

    2001-01-01

    Objective: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT) analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated

  10. Genetically Engineered Mouse Models of Pancreatic Cancer: The KPC Model (LSL-Kras(G12D/+) ;LSL-Trp53(R172H/+) ;Pdx-1-Cre), Its Variants, and Their Application in Immuno-oncology Drug Discovery.

    Science.gov (United States)

    Lee, Jae W; Komar, Chad A; Bengsch, Fee; Graham, Kathleen; Beatty, Gregory L

    2016-06-01

    Pancreatic ductal adenocarcinoma (PDAC) ranks fourth among cancer-related deaths in the United States. For patients with unresectable disease, treatment options are limited and lack curative potential. Preclinical mouse models of PDAC that recapitulate the biology of human pancreatic cancer offer an opportunity for the rational development of novel treatment approaches that may improve patient outcomes. With the recent success of immunotherapy for subsets of patients with solid malignancies, interest is mounting in the possible use of immunotherapy for the treatment of PDAC. Considered in this unit is the value of genetic mouse models for characterizing the immunobiology of PDAC and for investigating novel immunotherapeutics. Several variants of these models are described, all of which may be used in drug development and for providing information on unique aspects of disease biology and therapeutic responsiveness. © 2016 by John Wiley & Sons, Inc.

  11. [Interests of applied anthropology to oncology].

    Science.gov (United States)

    Soum-Pouyalet, Fanny; Hubert, Annie; Dilhuydy, Jean-Marie

    2008-01-01

    From now on the introduction of social and human sciences studies in the field of oncology has not always been conclusive. This article aims to analyze the bounds that border the meeting and the understanding between physicians, patients and anthropologists. It also treats the problems due to the introduction of applied anthropology in the field of oncology and points up the interests and practical contributions that this disciplinary bring and could bring.

  12. Exploring resilience in paediatric oncology nursing staff.

    Science.gov (United States)

    Zander, Melissa; Hutton, Alison; King, Lindy

    2013-01-01

    Resilience has been suggested as an important coping strategy for nurses working in demanding settings, such as paediatric oncology. This qualitative study explored paediatric oncology nurses' perceptions of their development of resilience and how this resilience underpinned their ability to deal with work-related stressors. Five paediatric oncology nurses were interviewed about their understanding of the concept of resilience, their preferred coping mechanisms, and their day-today work in paediatric oncology. Using thematic analysis, the interviews were subsequently grouped together into seventeen initial themes. These themes were then grouped into seven major aspects that described how the participants perceived resilience underpinned their work. These "seven aspects of forming resilience" contributed to an initial understanding of how paediatric oncology nurses develop resilience in the face of their personal and professional challenges. Several key strategies derived from the findings, such as improved rostering, support to a nurse's friend and family, and a clinical support nursing role, could be implemented at an organizational level to support resilience development within the paediatric oncology setting.

  13. Integrative Oncology: Best of Both Worlds—Theoretical, Practical, and Research Issues

    Directory of Open Access Journals (Sweden)

    Holger Cramer

    2013-01-01

    Full Text Available More and more cancer patients use complementary therapies. As the majority of patients do not disclose their use of complementary therapies to their oncologists, they expose themselves to possible detrimental effects from the therapies due to drug interactions. To meet the needs of patients and health care professionals on valid information on complementary therapies, the collaborative research project “Competence Network Complementary Medicine in Oncology—KOKON”, an interdisciplinary network for complementary medicine research in oncology, was established. Moreover, Integrative Oncology, a combination of conventional and evidenced-based complementary therapies delivered using a comprehensive approach, is now increasingly used in the United States and Europe. A variety of different Integrative Oncology models have been established worldwide including an expert-based model at the Kliniken Essen-Mitte, Essen, Germany and a patient-centered, evidenced-based approach at The University of Texas MD Anderson Cancer Center. Both models are briefly reviewed. More research is needed and Comparative Effectiveness Research that places strong emphasis on the comparison of different treatment options in usual care settings by including more heterogeneous patients, using less standardized treatment protocols, and measuring patient-centered outcomes would provide useful information for decision-making. To improve the quality of care and research in Integrative Oncology, sustainable financial models for Integrative Oncology and more funding for research are needed.

  14. Challenges and opportunities for monoclonal antibody therapy in veterinary oncology.

    Science.gov (United States)

    Beirão, Breno C B; Raposo, Teresa; Jain, Saurabh; Hupp, Ted; Argyle, David J

    2016-12-01

    Monoclonal antibodies (mAbs) have come to dominate the biologics market in human cancer therapy. Nevertheless, in veterinary medicine, very few clinical trials have been initiated using this form of therapy. Some of the advantages of mAb therapeutics over conventional drugs are high specificity, precise mode of action and long half-life, which favour infrequent dosing of the antibody. Further advancement in the field of biomedical sciences has led to the production of different forms of antibodies, such as single chain antibody fragment, Fab, bi-specific antibodies and drug conjugates for use in diagnostic and therapeutic purposes. This review describes the potential for mAbs in veterinary oncology in supporting both diagnosis and therapy of cancer. The technical and financial hurdles to facilitate clinical acceptance of mAbs are explored and insights into novel technologies and targets that could support more rapid clinical development are offered. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Clinical microdialysis in neuro-oncology: principles and applications

    Institute of Scientific and Technical Information of China (English)

    J. Clay Goodman

    2011-01-01

    Clinical microdialysis allows a discrete volume of the brain to be sampled for neurochemical analysis of neurotransmitters, metabolites, biomarkers, and drugs. The technique can be safely used in humans intraoperatively, in the intensive care unit, and in ambulatory settings. Microdialysis probes, micropumps, and analytical equipment are commercially available and have been used extensively for neurochemical monitoring in traumatic brain injury, stroke, and subarachnoid hemorrhage. There has been very limited use of micredialysis in neuro-oncology, but this technique has groat promise in the study of the basic neurochemistry of brain tumors, alterations in neurochemistry in response to therapy, and the pharmacokinetics of chemotherapeutic agents. Microdialysis probes may also be used to deliver drugs while simultaneously permitting monitoring of neurochemical changes induced by this therapy.

  16. Application of liposomal technologies for delivery of platinum analogs in oncology

    Directory of Open Access Journals (Sweden)

    Liu D

    2013-08-01

    Full Text Available Demin Liu1, Chunbai He1, Andrew Z Wang2, Wenbin Lin1 1Department of Chemistry, University of Chicago, Chicago, IL, USA; 2Laboratory of Nano- and Translational Medicine, Department of Radiation Oncology, and Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA Abstract: Platinum-based chemotherapy, such as cisplatin, oxaliplatin, and carboplatin, is one of the most widely utilized classes of cancer therapeutics. While highly effective, the clinical applications of platinum-based drugs are limited by their toxicity profiles as well as suboptimal pharmacokinetic properties. Therefore, one of the key research areas in oncology has been to develop novel platinum analog drugs and engineer new platinum drug formulations to improve the therapeutic ratio further. Such efforts have led to the development of platinum analogs including nedaplatin, heptaplatin, and lobaplatin. Moreover, reformulating platinum drugs using liposomes has resulted in the development of L-NDPP (Aroplatin™, SPI-77, Lipoplatin™, Lipoxal™, and LiPlaCis®. Liposomes possess several attractive biological activities, including biocompatibility, high drug loading, and improved pharmacokinetics, that are well suited for platinum drug delivery. In this review, we discuss the various platinum drugs and their delivery using liposome-based drug delivery vehicles. We compare and contrast the different liposome platforms as well as speculate on the future of platinum drug delivery research. Keywords: liposome, platinum analog, drug delivery, cancer

  17. Interventional radiology in pediatric oncology

    Energy Technology Data Exchange (ETDEWEB)

    Hoffer, Fredric A. [Division of Diagnostic Imaging, Department of Radiological Sciences, St. Jude Children' s Research Hospital, 332 N. Lauderdale St., Memphis, TN 38105 (United States)]. E-mail: fred.hoffer@stjude.org

    2005-01-01

    There are many radiological interventions necessary for pediatric oncology patients, some of which may be covered in other articles in this publication. I will discuss a number of interventions including percutaneous biopsy for solid tumor and hematological malignancy diagnosis or recurrence, for the diagnosis of graft versus host disease after stem cell or bone marrow transplantation, and for the diagnosis of complications of immunosuppression such as invasive pulmonary aspergillosis. In the past, tumor localization techniques have been necessary to biopsy or resect small lesions. However improved guidance techniques have allowed for more precise biopsy and the use of thermal ablation instead of excision for local tumor control. A percutaneously placed radio frequency, microwave, laser or cryogen probe can ablate the primary and metastatic tumors of the liver, lung, bone, kidney and other structures in children. This is an alternative treatment for the local control of tumors that may not be amenable to surgery, chemotherapy or radiotherapy. I will also describe how chemoembolization can be used to treat primary or metastatic tumors of the liver that have failed other therapies. This treatment delivers chemotherapy in the hepatic artery infused with emboli to increase the dwell time and concentration of the agents.

  18. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology.

    Science.gov (United States)

    Zon, Robin T; Frame, James N; Neuss, Michael N; Page, Ray D; Wollins, Dana S; Stranne, Steven; Bosserman, Linda D

    2016-03-01

    The use of clinical pathways in oncology care is increasingly important to patients and oncology providers as a tool for enhancing both quality and value. However, with increasing adoption of pathways into oncology practice, concerns have been raised by ASCO members and other stakeholders. These include the process being used for pathway development, the administrative burdens on oncology practices of reporting on pathway adherence, and understanding the true impact of pathway use on patient health outcomes. To address these concerns, ASCO's Board of Directors established a Task Force on Clinical Pathways, charged with articulating a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. These recommendations have been approved and adopted by ASCO's Board of Directors on August 12, 2015, and are presented herein.

  19. Omics-based nanomedicine: the future of personalized oncology.

    Science.gov (United States)

    Rosenblum, Daniel; Peer, Dan

    2014-09-28

    The traditional "one treatment fits all" paradigm disregards the heterogeneity between cancer patients, and within a particular tumor, thus limit the success of common treatments. Moreover, current treatment lacks specificity and therefore most of the anticancer drugs induce severe adverse effects. Personalized medicine aims to individualize therapeutic interventions, based on the growing knowledge of the human multiple '-oms' (e.g. genome, epigenome, transcriptome, proteome and metabolome), which has led to the discovery of various biomarkers that can be used to detect early stage cancers and predict tumor progression, drug response, and clinical outcome. Nanomedicine, the application of nanotechnology to healthcare, holds great promise for revolutionizing disease management such as drug delivery, molecular imaging, reduced adverse effects and the ability to contain both therapeutic and diagnostic modalities simultaneously termed theranostics. Personalizednanomedicine has the power of combining nanomedicine with clinical and molecular biomarkers ("OMICS" data) achieving improve prognosis and disease management as well as individualized drug selection and dosage profiling to ensure maximal efficacy and safety. Tumor's heterogeneity sets a countless challenge for future personalized therapy in cancer, however the use of multi-parameter 'omic's data for specific molecular biomarkers recognition together with versatile drug delivery nanocarriers, which could target concomitantly and specifically tumor cells subpopulations, might heralds a brighter future for personalized cancer management. In this review, we present the current leading technologies available for personalized oncology. We discusses the immense potential of combining the best of these two worlds, nanomedicine and high throughput OMICS technologies to pave the way towards cancer personalized medicine.

  20. Outcomes assessment of a pharmacist-directed seamless care program in an ambulatory oncology clinic.

    Science.gov (United States)

    Edwards, Scott J; Abbott, Rick; Edwards, Jonathan; LeBlanc, Michael; Dranitsaris, George; Donnan, Jennifer; Laing, Kara; Whelan, Maria A; MacKinnon, Neil J

    2014-02-01

    The primary goal of seamless care is improved patient outcomes and improved standards of care for patients with cancer. The pharmacy service of the Newfoundland Cancer Treatment and Research Foundation conducted a randomized control study that measured clinical and humanistic outcomes of a pharmacist-directed seamless care program in an ambulatory oncology clinic. This article focuses on the intervention group, particularly the identification of drug-related problems (DRPs) and utilization of health care services as well the satisfaction of 3 types of health professionals with the services provided by the pharmacist-directed seamless care program. Overall, the seamless care pharmacist (SCP) identified an average of 3.7 DRPs per intervention patient; the most common DRP reported was a patient not receiving or taking a drug therapy for which there is an indication. The SCP identified more DRPs in patients receiving adjuvant treatment compared to those receiving palliative treatment. On average, family physicians, oncology nurses, and hospital pharmacists were satisfied with the SCP intervention indicating that they agreed the information collected and distributed by the SCP was useful to them. Pharmacist-directed seamless care services in an ambulatory oncology clinic have a significant impact on clinical outcomes and processes of patient care. The presence of a SCP can help identify and resolve DRPs experienced by patients in an outpatient oncology clinic, ensuring that patients are receiving the highest standard of care.

  1. 77 FR 70434 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-11-26

    ... Advisory Council will hold a meeting on Monday, December 10, 2012 in the Commission Meeting Room, from 1 p..., DC 20554. FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: The FCC Technological...

  2. 77 FR 52332 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-08-29

    ... Advisory Council will hold a meeting on Monday, September 24, 2012 in the Commission Meeting Room, from 1 p..., DC 20554. FOR FURTHER INFORMATION CONTACT: Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; Walter.Johnston@FCC.gov . SUPPLEMENTARY INFORMATION: The FCC Technological...

  3. Psycho-oncology: Searching for practical wisdom?

    Science.gov (United States)

    Butlin, Helen

    2015-10-01

    The debate is vigorous in psycho-oncology about whether spiritual, existential, and psychosocial are the most comprehensive terms for academic research discourses investigating meaning and purpose. A call-to-action email from the International Society of Psycho-Oncology included the term soul. The current essay highlights the historical and contemporary uses of "soul" to suggest that the re-emergent soul signifies a tacit quest for an "intangible" that seems missing in current constructs of clinical domains reflected in the vigor of the debates. It is suggested that the re-emergence of the pre-Medieval meaning(s) of the notion of soul affirms a growing need for integrative paradigms on "being human" to guide psycho-oncology practitioners and their research. As a paradigmatic example, a clinical support group entitled Soul Medicine is described as employing the term soul to open up the more marginal discourses about experiences of illness arising from philosophical reflection, arts, humanities, and spirituality within a clinical oncology context. A link between soul and wisdom is suggested for further exploration with the view that phronesis ("the virtue of practical wisdom"), an emerging concept in health professional education research, is of ultimate value to the people psycho-oncology seeks to serve. This group holds that garnering wisdom from the expertise of those living with cancer should be a central aim of our field.

  4. 75 FR 2923 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-01-19

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces that its Motor Carrier Safety Advisory Committee (MCSAC)...

  5. 75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-11-26

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces that the Agency's Motor Carrier Safety Advisory Committee...

  6. 75 FR 29384 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-05-25

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee meeting. SUMMARY: FMCSA announces that its Motor Carrier Safety Advisory Committee (MCSAC)...

  7. 77 FR 56909 - Aviation Rulemaking Advisory Committee (ARAC); Renewal

    Science.gov (United States)

    2012-09-14

    ... Federal Aviation Administration Aviation Rulemaking Advisory Committee (ARAC); Renewal AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Renewal. SUMMARY: The FAA announces the charter renewal of the Aviation Rulemaking Advisory Committee (ARAC), a Federal Advisory Committee that works with...

  8. 78 FR 20685 - Aviation Security Advisory Committee (ASAC) Meeting

    Science.gov (United States)

    2013-04-05

    ... SECURITY Transportation Security Administration Aviation Security Advisory Committee (ASAC) Meeting AGENCY... Committee Meeting. SUMMARY: The Aviation Security Advisory Committee (ASAC) will meet in Arlington, VA. This.... L. 92-463). The Aviation Security Advisory Committee (ASAC) provides advice and makes...

  9. 75 FR 60493 - Aviation Rulemaking Advisory Committee; Renewal

    Science.gov (United States)

    2010-09-30

    ... Federal Aviation Administration Aviation Rulemaking Advisory Committee; Renewal AGENCY: Federal Aviation... Regulations, the FAA gives notice it has renewed the Aviation Rulemaking Advisory Committee (ARAC) for a 2..., Executive Director, Aviation Rulemaking Advisory Committee. BILLING CODE 4910-13-P ...

  10. 77 FR 4370 - NASA Advisory Council; Commercial Space Committee; Meeting

    Science.gov (United States)

    2012-01-27

    ... SPACE ADMINISTRATION NASA Advisory Council; Commercial Space Committee; Meeting AGENCY: National... announces a meeting of the Commercial Space Committee (CSC) of the NASA Advisory Council (NAC). DATES... Admission to the NASA Advisory Council (NAC) Commercial Space Committee (CSC).'' For security...

  11. 75 FR 51169 - OTS Minority Depository Institutions Advisory Committee

    Science.gov (United States)

    2010-08-18

    ... Office of Thrift Supervision OTS Minority Depository Institutions Advisory Committee AGENCY: Department... Minority Depository Institutions Advisory Committee will renew for a two-year period beginning August 2... Depository Institutions Advisory Committee (MDIAC). The purpose of the OTS Minority Depository...

  12. 75 FR 28275 - Homeland Security Science and Technology Advisory Committee

    Science.gov (United States)

    2010-05-20

    ... SECURITY Homeland Security Science and Technology Advisory Committee AGENCY: Science and Technology...: On April 12, 2010, the Homeland Security Science and Technology Advisory Committee announced in the... supplements that original meeting notice. DATES: The Homeland Security Science and Technology Advisory...

  13. 75 FR 22553 - Technology Innovation Program Advisory Board

    Science.gov (United States)

    2010-04-29

    ... National Institute of Standards and Technology Technology Innovation Program Advisory Board AGENCY.... SUMMARY: The Technology Innovation Program Advisory Board, National Institute of Standards and Technology... Technology Innovation Program (TIP) Advisory Board is composed of ten members appointed by the Director...

  14. 76 FR 43988 - National Technical Information Service Advisory Board

    Science.gov (United States)

    2011-07-22

    ... National Technical Information Service National Technical Information Service Advisory Board AGENCY: National Technical Information Service, Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces the next meeting of the National Technical Information Service Advisory Board (the Advisory...

  15. 78 FR 61337 - National Technical Information Service Advisory Board

    Science.gov (United States)

    2013-10-03

    ... National Technical Information Service National Technical Information Service Advisory Board AGENCY: National Technical Information Service, Commerce. ACTION: Notice of open meeting SUMMARY: This notice announces the next meeting of the National Technical Information Service Advisory Board (the Advisory...

  16. 78 FR 16255 - National Technical Information Service Advisory Board

    Science.gov (United States)

    2013-03-14

    ... National Technical Information Service National Technical Information Service Advisory Board AGENCY: National Technical Information Service, Commerce. ACTION: Notice of Open Meeting. SUMMARY: This notice announces the next meeting of the National Technical Information Service Advisory Board (the Advisory...

  17. 77 FR 57559 - National Technical Information Service Advisory Board

    Science.gov (United States)

    2012-09-18

    ... National Technical Information Service National Technical Information Service Advisory Board AGENCY: National Technical Information Service, Commerce. ACTION: Notice of open meeting. SUMMARY: This notice announces the next meeting of the National Technical Information Service Advisory Board (the Advisory...

  18. 76 FR 14647 - Sabine National Forest Resource Advisory Committee Meeting

    Science.gov (United States)

    2011-03-17

    ...; ] DEPARTMENT OF AGRICULTURE Sabine National Forest Resource Advisory Committee Meeting AGENCY: Forest Service, USDA. ACTION: Notice of Public Meeting, Sabine National Forest Resource Advisory Committee. SUMMARY: In.... Department of Agriculture, Forest Service, Sabine National Forest Resource Advisory Committee (RAC) meeting...

  19. 76 FR 19952 - Davy Crockett National Forest Resource Advisory Committee

    Science.gov (United States)

    2011-04-11

    ... Davy Crockett National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of Public Meeting, Davy Crockett National Forest Resource Advisory Committee. SUMMARY: In accordance.... Department of Agriculture, Forest Service, Davy Crockett National Forest Resource Advisory Committee (RAC...

  20. 75 FR 3913 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2010-01-25

    ... SECURITY National Communications System President's National Security Telecommunications Advisory Committee...: The President's National Security Telecommunications Advisory Committee (NSTAC) will be meeting by... telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee Act (FACA),...

  1. 75 FR 29781 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2010-05-27

    ... SECURITY National Communications System President's National Security Telecommunications Advisory Committee... meeting. SUMMARY: The President's National Security Telecommunications Advisory Committee (NSTAC) will be... preparedness telecommunications policy. Notice of this meeting is given under the Federal Advisory...

  2. 78 FR 53497 - Commercial Space Transportation Advisory Committee; Closed Session

    Science.gov (United States)

    2013-08-29

    ... Federal Aviation Administration Commercial Space Transportation Advisory Committee; Closed Session AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory... closed session of the Commercial Space Transportation Advisory Committee (COMSTAC). The special...

  3. Pyruvate Dehydrogenase Kinase as a Novel Therapeutic Target in Oncology

    Directory of Open Access Journals (Sweden)

    Gopinath eSutendra

    2013-03-01

    Full Text Available Current drug development in oncology is non-selective as it typically focuses on pathways essential for the survival of all dividing cells. The unique metabolic profile of cancer, which is characterized by increased glycolysis and suppressed mitochondrial glucose oxidation provides cancer cells with a proliferative advantage, conducive with apoptosis resistance and even increased angiogenesis. Recent evidence suggests that targeting the cancer-specific metabolic and mitochondrial remodeling may offer selectivity in cancer treatment. Pyruvate dehydrogenase kinase (PDK is a mitochondrial enzyme that is activated in a variety of cancers and results in the selective inhibition of pyruvate dehydrogenase (PDH, a complex of enzymes that converts cytosolic pyruvate to mitochondrial acetyl-CoA, the substrate for the Krebs’ cycle. Inhibition of PDK with either small interfering RNAs or the orphan drug dichloroacetate (DCA shifts the metabolism of cancer cells from glycolysis to glucose oxidation and reverses the suppression of mitochondria-dependent apoptosis. In addition, this therapeutic strategy increases the production of diffusible Krebs’ cycle intermediates and mitochondria-derived reactive oxygen species (mROS, activating p53 or inhibiting pro-proliferative and pro-angiogenic transcription factors like nuclear factor of activated T-cells (NFAT and hypoxia-inducible factor 1α (HIF1α. These effects result in decreased tumor growth and angiogenesis in a variety of cancers with high selectivity. In a small but mechanistic clinical trial in patients with glioblastoma, a highly aggressive and vascular form of brain cancer, DCA decreased tumor angiogenesis and tumor growth, suggesting that metabolic targeting therapies can be translated directly to patients. Therefore, reversing the mitochondrial suppression with metabolic-modulating drugs, like PDK inhibitors holds promise in the rapidly expanding field of metabolic oncology.

  4. The oncologic radiotherapy experience for patients: a poison-drug La experiencia de los pacientes sometidos a radioterapia oncológica: una medicina-veneno A experiência da radioterapia oncológica para os pacientes: um remédio-veneno

    Directory of Open Access Journals (Sweden)

    Rosani Manfrin Muniz

    2008-12-01

    Full Text Available The study aimed at understanding the patients' experience with oncologic radiotherapy. The anthropological interpretative approach and the ethnographic method guided the investigation. Ten patients took part in the study. They were of both genders, within the age range from 34 to 80 years old and monitored during radiotherapy treatment. Data were collected through semi-structured interviews, participative observation and medical records. The analysis of the respondents' statements allowed for the identification of the units of meaning: The encounter with radiotherapy, the body as a vehicle for radiotherapy action and alternative healthcare practices that relieved the effects of the treatment. We understand that the oncologic radiotherapy experience meant the need to submit to a therapy with a characteristic of a poison-drug, which causes fear, but was necessary, whether the goal was cure or even cancer survival.El estudio tuvo como objetivo comprender la experiencia de los pacientes sometidos a radioterapia oncológica. El abordaje de la antropología interpretativa y el método etnográfico orientaron la investigación. Los participantes del estudio fueron diez pacientes de ambos sexos, en el intervalo de edad de 34 a 80 años, acompañados durante el tratamiento radioterápico. Los datos fueron recolectados por entrevistas semi-estructuradas, observación de participante y levantamiento en registros. El análisis de los discursos de los informantes posibilitó identificar las unidades de significado: el encuentro con la radioterapia, el cuerpo como vehículo de acción de la radioterapia y las prácticas alternativas de cuidado para aliviar los efectos del tratamiento. Comprendemos que la experiencia de la radioterapia oncológica significó para esos pacientes la necesidad de someterse a una terapéutica con una característica de medicina-veneno que causa temor, sin embargo que era necesaria, si la meta fuese la cura o la sobre vivencia al c

  5. 75 FR 33814 - Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee...

    Science.gov (United States)

    2010-06-15

    ... HUMAN SERVICES Food and Drug Administration Tobacco Product Constituents Subcommittee of the Tobacco... Administration (FDA). The meeting will be open to the public. Name of Committee: Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee. General Function of the Committee:...

  6. 77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation...

  7. 75 FR 47605 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

  8. 76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the...

  9. 76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-07

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and...

  10. 78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-05

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...

  11. 78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-02

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... of Retroviruses and Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines...

  12. 76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center...

  13. 75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the...

  14. 77 FR 65693 - Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-10-30

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... Register of October 17, 2012, FDA announced that a meeting of the Cellular, Tissue and Gene Therapies..., Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA. On...

  15. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-13

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Dental Products Panel of the Medical... and make recommendations on the proposed regulatory classification for dental devices known as...

  16. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced... July 14, 2011, FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of the...

  17. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the Medical...

  18. 76 FR 38667 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-01

    ... deferral for time spent in Saudi Arabia to reduce the risk of variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products and human cells, tissues and cellular and tissue-based products. FDA intends to... HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory...

  19. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-04-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and...

  20. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-02-27

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of... Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...