Proceedings of a Workshop

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This activity was supported by contracts between the National Academy of Sciences and Aetna Foundation (Contract No. 18-8876); Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Burroughs Wellcome Fund (Contract No. 1023129); Chan Zuckerberg Initiative; Critical Path Institute; Eli Lilly and Company; FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable Inc.; Merck & Co., Inc. (Award No. MRLCPO-23-166623); National Research Council President’s Circle Fund; National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007, 75N98021F00006): National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of the Director; New England Journal of Medicine; Robert Woods Johnson Foundation; Sanofi (Contract No. 77646387); Takeda; The University of Pittsburgh; U.S. Food and Drug Administration (Contract No. 1R13FD007302-01); W.K. Kellogg Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-71856-1
International Standard Book Number-10: 0-309-71856-2
Digital Object Identifier: https://doi.org/10.17226/27755

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Preparing the future workforce in drug research and development: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27755.

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PLANNING COMMITTEE ON PREPARING THE FUTURE WORKFORCE IN DRUG RESEARCH AND DEVELOPMENT¹

CHERIÉ BUTTS (Co-Chair), Medical Director, Therapeutics Development Unit, Biogen

JONATHAN WATANABE (Co-Chair), Professor of Clinical Pharmacy; Associate Dean of Assessment and Quality; Director of Center for Data-Driven Drugs Research and Policy, University of California, Irvine, School of Pharmacy & Pharmaceutical Sciences

OLUJIMI A. AJIJOLA, Associate Professor of Medicine; Associate Director, University of California, Los Angeles (UCLA)–Cardiac Arrhythmia Center & EP Programs; Director, Neurocardiology Research Programs; Co-Director, UCLA–Caltech Medical Scientist Training Program (MSTP), University of California, Los Angeles

DOWIN BOATRIGHT, Vice Chair, Research, Emergency Medicine, New York University Grossman School of Medicine

TAMMY COLLINS, Program Officer, Burroughs Wellcome Fund

LOLA FASHOYIN-AJE, Associate Director, Oncology Center of Excellence; Deputy Director, Division of Oncology III, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

MARCUS HODGES, Lead, Intramural Trainee Development, Division of Preclinical Innovation, National Center for Advancing Translational Sciences, National Institutes of Health

HEATHER PIERCE, Senior Director for Science Policy and Regulatory Counsel, Association of American Medical Colleges

DAMANI PIGGOTT, Associate Vice Provost for Graduate Diversity and Partnerships; Associate Professor of Medicine and Epidemiology; Director, Vivien Thomas Scholars Initiative, Johns Hopkins University

AMIR TAMIZ, Director, Division of Translational Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health

PAMELA TENAERTS, Chief Science Officer, Medable Inc.

LAMONT TERRELL, Diversity, Equity and Inclusion Lead, Research and Development, GlaxoSmithKline

BENJAMIN WILFOND, Professor, Divisions of Bioethics and Palliative Care and Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington School of Medicine

___________________

¹ The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Health and Medicine Division Staff

CAROLYN SHORE, Director, Forum on Drug Discovery, Development, and Translation

ANDRÉ PORTER, Director, Roundtable on Black Men and Black Women in Science, Engineering and Medicine

KYLE CAVAGNINI, Associate Program Officer

MAYA THIRKILL, Associate Program Officer (until May 2023)

BRITTANY HSIAO, Associate Program Officer (as of September 2023)

NOAH ONTJES, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

CLARE STROUD, Senior Director, Board on Health Sciences Policy

Consultants

ERIN HAMMERS FORSTAG, Science Writer

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION¹

GREGORY SIMON (Co-chair), Kaiser Permanente Washington Health Research Institute; University of Washington

ANN TAYLOR (Co-chair), Retired

BARBARA E. BIERER, Harvard Medical School; Brigham and Women’s Hospital

LINDA BRADY, National Institute of Mental Health, National Institutes of Health

JOHN BUSE, University of North Carolina, Chapel Hill School of Medicine

LUTHER T. CLARK, Merck & Co., Inc.

BARRY S. COLLER, The Rockefeller University

TAMMY R. L. COLLINS, Burroughs Wellcome Fund

THOMAS CURRAN, Children’s Mercy, Kansas City

RICHARD DAVEY, National Institute of Allergy and Infectious Diseases, National Institutes of Health

KATHERINE DAWSON, Biogen

JAMES H. DOROSHOW, National Cancer Institute, National Institutes of Health

JEFFREY M. DRAZEN, New England Journal of Medicine

STEVEN K. GALSON, Retired

CARLOS O. GARNER, Eli Lilly and Company

SALLY L. HODDER, West Virginia University

TESHEIA JOHNSON, Yale School of Medicine

LYRIC JORGENSON, Office of the Director, National Institutes of Health

ESTHER KROFAH, FasterCures, Milken Institute

LISA M. LaVANGE, University of North Carolina

ARAN MAREE, Johnson & Johnson

CRISTIAN MASSACESI, AstraZeneca

ROSS McKINNEY JR., Association of American Medical Colleges

JOSEPH P. MENETSKI, Foundation for the National Institutes of Health

ANAEZE C. OFFODILE II, Memorial Sloan Kettering Center

SALLY OKUN, Clinical Trials Transformation Initiative

ARTI RAI, Duke University School of Law

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¹ The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

KLAUS ROMERO, Critical Path Institute

JONI RUTTER, National Center for Advancing Translational Sciences, National Institutes of Health

SUSAN SCHAEFFER, The Patients’ Academy for Research Advocacy

ANANTHA SHEKHAR, University of Pittsburgh School of Medicine

ELLEN V. SIGAL, Friends of Cancer Research

MARK TAISEY, Amgen Inc.

AMIR TAMIZ, National Institute of Neurological Disorders and Stroke, National Institutes of Health

PAMELA TENAERTS, Medable Inc.

JONATHAN WATANABE, University of California, Irvine, School of Pharmacy & Pharmaceutical Sciences

ALASTAIR WOOD, Vanderbilt University

CRIS WOOLSTON, Sanofi

JOSEPH C. WU, Stanford University School of Medicine

Forum Staff

CAROLYN SHORE, Forum Director

KYLE CAVAGNINI, Associate Program Officer

MAYA THIRKILL, Associate Program Officer (until May 2023)

BRITTANY HSIAO, Associate Program Officer (as of September 2023)

NOAH ONTJES, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

CLARE STROUD, Senior Director, Board on Health Sciences Policy

ROUNDTABLE ON BLACK MEN AND BLACK WOMEN IN SCIENCE, ENGINEERING, AND MEDICINE¹

CATO T. LAURENCIN (Chair), University of Connecticut

OLUJIMI A. AJIJOLA, University of California, Los Angeles

MARK ALEXANDER, 100 Black Men of America, Inc.

GILDA BARABINO, Olin College of Engineering

MARIE A. BERNARD, National Institutes of Health

CHARLES R. BRIDGES, CorVista Health

CEDRIC M. BRIGHT, Brody School of Medicine at East Carolina University

L. D. BRITT, Eastern Virginia Medical School

KIMBERLY BRYANT, Black Girls CODE

ANDRÉ L. CHURCHWELL, Vanderbilt School of Medicine

THEODORE CORBIN, Rush University Medical Center

GEORGE Q. DALEY, Harvard Medical School

IVORY DEAN, Chan Zuckerberg Initiative

WAYNE FREDERICK, Howard University

GARTH GRAHAM, Google, Inc.

PAULA T. HAMMOND, Massachusetts Institute of Technology

EVELYNN M. HAMMONDS, Harvard University

IAN HENRY, Procter & Gamble Company

LYNNE HOLDEN, Albert Einstein College of Medicine; Mentoring in Medicine, Inc.

CAMARA PHYLLIS JONES, Morehouse School of Medicine

JOHN R. LUMPKIN, Blue Cross Blue Shield of North Carolina Foundation

SHIRLEY MALCOLM, American Association for the Advancement of Science

CORA BAGLEY MARRETT, University of Wisconsin–Madison

ALFRED MAYS, Burroughs Wellcome Fund

RANDALL C. MORGAN, W. Montague Cobb/National Medical Association

ELIZABETH O. OFILI, Morehouse School of Medicine

JACQUELINE PHILLIPS, Johnson & Johnson

VIVIAN PINN, National Institutes of Health

JOAN Y. REEDE, Harvard Medical School

VALERIE MONTGOMERY RICE, Morehouse School of Medicine

___________________

¹ The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

LOUIS W. SULLIVAN, Morehouse School of Medicine

LAMONT R. TERRELL, GlaxoSmithKline

HANNAH A. VALANTINE, Stanford University

CLYDE W. YANCY JR., Northwestern University

Roundtable Staff

ANDRÉ PORTER, Roundtable Director

JOHN VERAS, Associate Program Officer

KARLA RILEY, Senior Program Assistant

MARIA LUND DAHLBERG, Director, Board on Higher Education and Workforce

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by HUGH TILSON, The University of North Carolina at Chapel Hill. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

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Acknowledgments

Support from the sponsors of the Forum on Drug Discovery, Development, and Translation and Roundtable on Black Men and Black Woman in Science, Engineering, and Medicine is crucial to support this and other work of the National Academies.

The National Academies’ staff wish to express their gratitude to the speakers whose presentations helped inform workshop discussions on preparing the future workforce in drug research and development; to the members of the planning committee for their work in developing the workshop agenda and shaping the discussions; and to additional National Academies staff, without whom this workshop and the accounting thereof would not have been possible: Christie Bell, Lori Brenig, Samantha Chao, Robert Day, Alexandra Molina, Marguerite Romatelli, and Taryn Young.

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Contents

ACRONYMS AND ABBREVIATIONS

1 INTRODUCTION

Overview of the R&D Workforce

Organization of the Proceedings

2 EXPLORING THE FUTURE STATE OF THE CLINICAL TRIALS WORKFORCE

Expertise, Knowledge, and Skills

3 EXAMINING THE CURRENT STATE OF THE CLINICAL TRIALS WORKFORCE

The Science of Outreach and Engagement

Critical Gaps and Anticipated Needs

4 OVERCOMING BARRIERS TO PROGRESS

Myths in STEM

A Diverse Medical Student Body

Barriers, Challenges, and Potential Solutions

5 ENVISIONING THE FUTURE LANDSCAPE

Discipline: Precision Medicine

Discipline: AI/Machine Learning

Role: Study Coordinator

Role: Investigator Physician

Discipline: Community Engagement

6 SCALING AND SUSTAINABILITY OF WORKFORCE PROGRAMS

Strategies, Approaches, and Success Stories

The Power of Collaboration

7 POLICIES FOR WORKFORCE SUSTAINABILITY AND FUTURE-PROOFING

Person-Centered Approaches

Roles and Responsibilities

8 CONSIDERING A PATH FORWARD

Opportunities for Stakeholders

Considering Next Steps

Closing Remarks

REFERENCES

APPENDIXES

A WORKSHOP AGENDA

B APPENDIX B BIOGRAPHICAL SKETCHES OF THE WORKSHOP PLANNING COMMITTEE, SPEAKERS, AND PANELISTS

Box and Figures

BOX

1-1 Workshop Statement of Task

FIGURES

1-1 Drug development pipeline: Roles by stage

1-2 Using a train map to illustrate potential career pathways for clinical research professionals

4-1 Percentage of UC Davis School of Medicine matriculants from groups underrepresented in and historically excluded from medicine (2000—2020)

6-1 NIH model of inclusive excellence

7-1 Evidence-based deep medicine iceberg

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Acronyms and Abbreviations