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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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STRENGTHENING A

WORKFORCE FOR
INNOVATIVE
REGULATORY SCIENCE

IN THERAPEUTICS DEVELOPMENT

Workshop Summary

Steve Olson and Anne B. Claiborne, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, N.W.   Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO #158 and HHSF223001003T), American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-22214-3
International Standard Book Number-10: 0-309-22214-1

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2012 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

“Knowing is not enough; we must apply.
Willing is not enough; we must do.”

—Goethe

image

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

PLANNING COMMITTEE FOR THE WORKSHOP ON
STRENGTHENING A WORKFORCE FOR INNOVATIVE
REGULATORY SCIENCE IN THERAPEUTICS DEVELOPMENT1

BARRY S. COLLER (Co-Chair), The Rockefeller University, New York, NY

ELAINE K. GALLIN (Co-Chair), QE Philanthropic Advisors, Potomac, MD

GAIL H. CASSELL, Harvard Medical School (visiting), Carmel, IN

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

JESSE L. GOODMAN, Food and Drug Administration, Silver Spring, MD

HARRY B. GREENBERG, Stanford University School of Medicine, Stanford, CA

STEPHEN GROFT, National Institutes of Health, Bethesda, MD

SHARON HESTERLEE, Parent Project Muscular Dystrophy, Tucson, AZ

PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD

JACK D. KEENE, Duke University Medical Center, Durham, NC

FREDA LEWIS-HALL, Pfizer Inc., New York, NY

MICHAEL E. MENDELSOHN, Merck & Co., Inc., Rahway, NJ

AMY PATTERSON, National Institutes of Health, Bethesda, MD

CARL PECK, University of California, San Francisco

NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC

LESLIE D. WHEELOCK, Food and Drug Administration, Silver Spring, MD

JANET WOODCOCK, Food and Drug Administration, Rockville, MD

Study Staff

ANNE B. CLAIBORNE, Forum Director

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

ANDREW M. POPE, Director, Board on Health Sciences Policy

ROBIN GUYSE, Senior Program Assistant

________________

1Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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FORUM ON DRUG DISCOVERY,
DEVELOPMENT, AND TRANSLATION1

JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA

STEVEN K. GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA

MARGARET ANDERSON, FasterCures, Washington, DC

HUGH AUCHINCLOSS, National Institute of Allergy and Infectious Diseases, Bethesda, MD

LESLIE Z. BENET, University of California-San Francisco

ANN BONHAM, Association of American Medical Colleges, Washington, DC

LINDA BRADY, National Institute of Mental Health, Bethesda, MD

ROBERT CALIFF, Duke University Medical Center, Durham, NC

SCOTT CAMPBELL, Foundation for the National Institutes of Health, Bethesda, MD

C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX

GAIL H. CASSELL, Harvard Medical School (visiting), Carmel, IN

PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY

ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN

TAMARA DARSOW, American Diabetes Association, Alexandria, VA

JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD

GARY L. FILERMAN, Atlas Health Foundation, McLean, VA

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

MARK J. GOLDBERGER, Abbott, Rockville, MD

HARRY B. GREENBERG, Stanford University School of Medicine, Stanford, CA

STEPHEN GROFT, National Institutes of Health, Bethesda, MD

LYNN HUDSON, Critical Path Institute, Tuscon, AZ

THOMAS INSEL, National Center for Advancing Translational Sciences, Bethesda, MD

MICHAEL KATZ, March of Dimes Foundation, White Plains, NY

PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD

JACK D. KEENE, Duke University Medical Center, Durham, NC

RONALD L. KRALL, University of Pennsylvania, Center for Bioethics, Steamboat Springs, CO

FREDA LEWIS-HALL, Pfizer Inc., New York, NY

________________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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MARK B. McCLELLAN, The Brookings Institution, Washington, DC

CAROL MIMURA, University of California-Berkeley

ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY

JOHN ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ

AMY PATTERSON, National Institutes of Health, Bethesda, MD

MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ

JANET SHOEMAKER, American Society for Microbiology, Washington, DC

ELLEN SIGAL, Friends of Cancer Research, Washington, DC

ELLIOTT SIGAL, Bristol-Myers Squibb, Princeton, NJ

ELLEN R. STRAHLMAN, GlaxoSmithKline, Research Triangle Park, NC

NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC

JANET TOBIAS, Ikana Media and Mount Sinai School of Medicine, New York, NY

JOANNE WALDSTREICHER, Johnson & Johnson, Raritan, NJ

JANET WOODCOCK, Food and Drug Administration, White Oak, MD

Study Staff

ANNE B. CLAIBORNE, Forum Director

RITA S. GUENTHER, Program Officer

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

ANDREW M. POPE, Director, Board on Health Sciences Policy

ROBIN GUYSE, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
×

Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report:

William W. Chin, Harvard Medical School

H. Clifford Lane, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Michael Manganiello, HCM Strategists, LLC

Brian L. Strom, University of Pennsylvania School of Medicine

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Hugh Tilson, University of North Carolina at Chapel Hill. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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Acronyms

CBER Center for Biologics Evaluation and Research
CDC Centers for Disease Control and Prevention
CDER Center for Drug Evaluation and Research
CDSS Centre for Drug Safety Science
CERSI Center for Excellence in Regulatory Science and Innovation
CF cystic fibrosis
CFP Commissioner’s Fellowship Program
CRO contract research organization
CTP Center for Tobacco Products
CTSA Clinical and Translational Science Awards

ECPM

European Center of Pharmaceutical Medicine

EMA European Medicines Agency
EU European Union

FDA

U.S. Food and Drug Administration

HRA

Health Research Alliance

IMI

Innovative Medicines Initiative

IND Investigational New Drug
IOM Institute of Medicine
IOTF Interagency Oncology Task Force
IRB Institutional Review Board
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13283.
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MCM

medical countermeasure

MIT Massachusetts Institute of Technology

NCATS

National Center for Advancing Translational Sciences

NCI National Cancer Institute
NDA new drug application
NEWDIGS New Drug Development Paradigms
NIAID National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NINDS National Institute of Neurological Disorders and Stroke

PDP

product development partnership

PharmaTrain Pharmaceutical Medicine Training Programme

RAPS

Regulatory Affairs Professional Society

RFA Request for Application

TB

tuberculosis

UCSF

University of California, San Francisco

UNC University of North Carolina at Chapel Hill
USC University of Southern California
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The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

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