Peer Review of OBP Research Division of Monoclonal Antibodies

Slides:

Advertisements

Similar presentations

Managing Compliance Related to Human Subjects Research Review Joseph Sherwin, Ph.D. Office of Regulatory Affairs University of Pennsylvania Fourth Annual.

Advertisements

Preparation of the Self-Study and Documentation

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDAs website for reference purposes only. It.

Center for Biologics Evaluation and Research

Catholic School Councils A summary of 19 page document listed on school website.

Your Career at Queen’s The annual review process for QUFA faculty Brenda Brouwer Vice-Provost and Dean School of Graduate Studies.

Dr. John E. Niederhuber Director, National Cancer Institute Board of Scientific Advisors June 22, 2009 NCI Director’s Update.

ULS FACULTY LIBRARIAN PEER REVIEW AND MENTORING Margarete Bower Chemistry Library.

The Division of Monoclonal Antibodies Kathleen A. Clouse, Ph.D., Director CTGTAC - July 26, 2007.

NIH Mentored Career Development Awards (K Series) Part 2 Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco.

Office of Biotechnology Products

CBER Regulatory Laboratory Planning & Preparedness for SARS-related Biologics Products Kathryn M. Carbone MD Associate Director for Research, Acting, Center.

Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products Carolyn.

Coordinating Center Overview November 18, 2010 SPECIAL DIABETES PROGRAM FOR INDIANS Healthy Heart Project Initiative: Year 1 Meeting 1.

Center for Biologics Evaluation and Research FDA Overview Site Visit Carolyn A. Wilson, Ph.D. Associate Director for Research.

Brookhaven Science Associates U.S. Department of Energy 1 Brookhaven National Laboratory Protocol Compliance Monitoring Darcy Mallon May 7, 2009.

FDA’s Pharmaceutical Inspectorate Robert Coleman National Expert Drug Investigator Food and Drug Administration.

 The Middle States Commission on Higher Education is a voluntary, non-governmental, membership association that is dedicated to quality assurance and.

Evaluation of research proposals. Experience of Moldovan Advisory Expertise Council Science evaluation as a prerequisite for promoting excellence in research.

Division of AIDS, Behavioral and Population Sciences Risk, Prevention and Health Behavior IRG August, 2014 Reorganization/Realignment of RPHB Addictive.

Science at the FDA: Update for the Science Board Jesse L. Goodman, MD, MPH Chief Scientist and Deputy Commissioner for Science and Public Health November.

International Research & Research Involving Children K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development.

Wishwa N. Kapoor, MD, MPH, Director Doris M. Rubio, PhD, Co-Director Multidisciplinary Clinical Research Scholars Program.

THE ROLE OF STOP TB GHANA PARTNERSHIP Chief Austin A. Obiefuna National Coordinator SECRETARIAT CO-HOSTED BY AFRO GLOBAL ALLIANCE (GH) & GHANA SOCIETY.

Indistar Summit – Coaching with Indistar February 2012 Presenters: Yvonne Holloman, Ph.D. Associate Director, Office of School Improvement Michael Hill.

Associate Director for Research, OCTGT

Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA ACPS Subcommittee on Manufacturing Science: Identification and Prioritization.

REPORT The National Advisory Council on Drug Abuse Work Group On NIDA’s Approach to Grant-Making May 2006 The National Institute on Drug Abuse.

CSR Peer Review of NIH HIV/AIDS Grant Applications NIH Grantsmanship Workshop Diana Finzi, Ph.D. Chief, Pathogenesis and Basic Research Program Division.

Center for Biologics Evaluation and Research Carolyn A. Wilson, Ph.D. Associate Director for Research Applying Regulatory Science to Advance Development.

FDA Science Board Drug Safety Initiative April 15, 2005 Rockville, MD RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research.

IACUC Institutional Animal Care and Use Committee.

Division of Hematology Basil Golding M.D. Division Director Site Visits 2010 Laboratories of Hemostasis, and Plasma Derivatives.

SCHOOL ADVISORY COUNCIL TRAINING  A group intended to represent the broad school community and those persons closest to the students who will.

1 FDA/CDRH Office of In Vitro Diagnostic Devices The Pre-IDE Process Sousan S. Altaie, Ph.D. Scientific Policy Advisor OIVD.

Academic Research Enhancement Award (AREA) Program Erica Brown, PhD Director, NIH AREA Program National Institutes of Health 1.

RESIDENT PROJECTS ROBERT LEONHARD QUALITY IMPROVEMENT MANAGER.

Research Peer-Review at CDER Past and Present Jerry M. Collins, Ph.D. Director, Laboratory of Clinical Pharmacology, OTR Acting Director, Division of Applied.

IAEA International Atomic Energy Agency. IAEA Outline LEARNING OBJECTIVES REVIEW TEAM AND COUNTERPARTS Team Composition Qualification PREPARATORY PHASE.

Center for Biologics Evaluation and Research Carolyn A. Wilson, Ph.D. Associate Director for Research Applying Regulatory Science to Advance Development.

Scientific Merit Review René St-Arnaud, Ph.D. Shriners Hospital and McGill University CCAC National Workshop May 13, 2010, Ottawa (Ontario)

Changes in the Faculty Review Process for United Academics Faculty Presenter: Patricia Linton, College of Arts & Sciences.

Center for Biologics Evaluation and Research, FDA Kathryn M. Carbone, M.D. Associate Director for Research.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

NOAA Cooperative Institutes John Cortinas, Ph.D. OAR Cooperative Institute Program, Program Manager NOAA Cooperative Institute Committee, Chairperson.

DESIGNING A PROGRAM FOR REVIEW OF CDER LABORATORY RESEARCHERS Keith Webber, Ph.D. Acting Deputy Director OPS/CDER/FDA.

Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated.

Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated.

Wishwa N. Kapoor, MD, MPH, Director Doris M. Rubio, PhD, Co-Director Multidisciplinary Clinical Research Scholars Program.

OFFICE OF VACCINES RESEARCH AND REVIEW Center for Biologics Evaluation and Research Michael J. Brennan, Ph.D. Associate Director for Research OVRR Site.

Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.

An Insider’s Look at a Study Section Meeting: Perspectives from CSR Monica Basco, Ph.D. Scientific Review Officer Coordinator, Early Career Reviewer Program.

IAEA International Atomic Energy Agency. IAEA Outline LEARNING OBJECTIVES REVIEW TEAM AMD COUNTERPARTS Team Composition Qualification PREPARATORY PHASE.

CBER Research: OBRR Office Site Visit Kathryn M. Carbone, MD Associate Director of Research CBER/FDA.

Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.

Report of the Committee of Visitors of the Division of Materials Science and Engineering (DMSE) to the Basic Energy Sciences Advisory Committee Review.

Center for Biologics Evaluation and Research, FDA Site Visit Introduction Kathryn M. Carbone, M.D. Associate Director for Research.

Clarifying the Evaluation Focus in a Complex Program Context Howard Kress, PhD* Natalie Brown, MPH** *Battelle Memorial Institute, with National Center.

REQUESTING THE NSF/NCAR GV FOR THE ECLIPSE 2017 MISSION Brigitte Baeuerle, EOL.

OFFICE OF VACCINES RESEARCH AND REVIEW Center for Biologics Evaluation and Research Michael J. Brennan, Ph.D. Associate Director for Research OVRR Site.

CBER Research: OCTGT Office Site Visit Carolyn A. Wilson, Ph.D. Associate Director of Research (Acting) CBER/FDA.

Effective Committees Governing Board Online Training Module.

Institutional Development Award (IDeA) Program – Infrastructure for Clinical and Translational Research (IDeA-CTR) J. Rafael Gorospe M.D. Ph.D. Medical.

6/7/05 Partner Scientist PI privileges within the GSFC Sciences and Exploration Directorate (SED) Scientists working with SED under cooperative agreements.

Continuing Medical Education Guidance for Planners of Regularly Scheduled Series (RSS) To insert your company logo on this slide From the Insert Menu Select.

Promotion: Policy and Procedures for COM Faculty in State College

NSF/NIH Review Processes University of Southern Mississippi

NSF/NIH Review Processes University of Southern Mississippi

Michel BRENON IEC ExTAG Secretary

Purpose Motivation Subcouncils Membership Responsibilities Summary

Presentation transcript:

Peer Review of OBP Research Division of Monoclonal Antibodies Kathleen A. Clouse, Ph.D. Acting Director Division of Monoclonal Antibodies OBP/OPS/CDER/FDA

Discussion Topics Researcher/Reviewer Model (PCE) Committee Program Monitoring External Scientific Review Promotion and Conversion Evaluation (PCE) Committee

Researcher/Reviewer Model Conduct research relevant to FDA mission - On specific products (mechanism of action, toxicity, surrogate measures of efficacy) - Related to product class/disease/therapeutic modality - Associated with the development of methods & standards by which products can be prepared Perform regulatory review - INDs/BLAs Contribute to policy development

Funding of OBP Research Majority of funding provided at the OBP level from Operating Funds and distributed on a per capita basis Additional funds distributed by OBP based on Research Prioritization Competitive funding through CDER Review Science & Research (RSR) program Competitive funding through OWH grants Competitive funding through NIH Intramural grants (AIDS, CBT) CRADAs and Inter-Agency agreements

Program Monitoring Lab Chief Division Director - Does not determine research focus; helps assess research productivity of principle investigators - Evaluates ability to perform regulatory review Division Director - Discusses scientific productivity and regulatory abilities at least twice per year Office Director/Associate Director for Research - Assess scientific productivity via publications External Scientific Review

Purpose of External Scientific Review Determine relevance of research program to FDA mission Evaluate research productivity Assess regulatory contribution Provide input regarding resource allocations

External Scientific Review Frequency - Every 4 years (ideally) Research Group Reviewed - All Principal Investigators (PI) within a specific research lab Site Visit Committee - Chair: Member of parent Advisory Committee (previously BRMAC; currently CTGTAC) - 1 or 2 external scientists with relevant research expertise for each PI under review

External Scientific Review Format Committee reviews scientific program Preliminary written report sent to Center for review Ratification of report by Advisory Committee Copy of official report provided to Center/ Office Directors and individual reports given to scientists under review

Use of Site Visit Report For tenure/conversion (within 2 years) For promotion (GS-14/15; within 4 years) As supporting documentation for internal grant applications

Promotion & Conversion Evaluation (PCE) Committee Purpose - Conversion of Staff Fellows to tenured civil service research/regulatory positions - Promote tenured civil service research/regulatory scientists to the next grade level Committee Members - 2 tenured PIs from each research/review Office - 1 Full-time reviewer - 1 representative from OPM - 1 representative from CBER OD

Promotion & Conversion Evaluation (PCE) Committee Guidances for promotion/conversion - General: CBER “Guide for the Evaluation of research/regulatory scientists from GS-13 to GS-15” - Research Grade Evaluation Guide (from the General Schedule Position Classification Guides) Additional information requested - Publication summary - Regulatory summary & review examples - External review report - Letters of recommendation from experts outside FDA familiar with investigator’s research

Use of Site Visit and PCE Committee Systems for Promotions/Conversions Current advantages - Scientific/technical positions are evaluated by scientists familiar with activities performed - Scientific community expected to have greater confidence in decisions made by peer scientists Current disadvantages - Cost to OBP/OPS/CDER (SV & PCE) - Difficult to coordinate Site Visits across Centers (SV) - Change in expertise of Advisory Committee (SV) - Differences in regulatory workload (PCE) - Differences in systems for performing review (PCE)