Regulatory Science and Policy Subcommittee

The AACR established the Regulatory Science and Policy Subcommittee in March of 2011 to support the FDA’s endeavor to modernize the regulatory process and accommodate the fast pace of innovation in science and technology. The subcommittee leads the AACR’s efforts to facilitate scientific exchange among stakeholders from academia, industry, advocacy, and government to unleash the true potential of regulatory science to serve patients. In order for the latest research to inform regulators, regulatory guidelines and regulatory policy, regulators must keep abreast with developments in cancer research. Scientists also benefit from an understanding of the regulatory process, which can facilitate their own research programs and speed the translation of discoveries into new and improved interventions.

The subcommittee is dedicated to bringing together and providing an open forum for stakeholder engagement. It is also actively engaged in the development and implementation of programmatic and policy initiatives to improve the development, evaluation and regulation of cancer drugs, biologics and diagnostics.

Subcommittee Members

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James L. Abbruzzese, MD, FACP
Chief, Division of Medical Oncology, Department of Medicine, Associate Director for Clinical Research
Duke Cancer Institute
Durham, North Carolina

Chris Boshoff, MD, PhD
Chief Development Officer
Pfizer Oncology
New York, New York
William S. Dalton, PhD, MD
Founder and Chief Executive Officer
M2Gen
Tampa, Florida

Raymond N. DuBois, MD, PhD
Dean, College of Medicine
Medical University of South Carolina
Charleston, South Carolina

Susan M. Galbraith, MBBCh, PhD
Executive Vice-President, Oncology R&D
AstraZeneca
Cambridge, England

Judy E. Garber, MD, MPH
Director, Center for Cancer Genetics and Prevention
Dana-Farber Cancer Institute
Boston, Massachusetts

Levi A. Garraway, MD, PhD
Global Head of Product Development, Chief Medical Officer
F. Hoffman-LaRoche Ltd.
South San Francisco, California

Richard B. Gaynor, MD
President, Research and Development
Neon Therapeutics
Cambridge, Massachusetts

William N. Hait, MD, PhD
Global Head of External Innovation
Johnson & Johnson Pharmaceutical R&D
Raritan, New Jersey

Eric B. Haura, MD
Senior Member
Moffitt Cancer Center
Tampa, Florida

Roy S. Herbst, MD, PhD
Ensign Professor of Medicine, Associate Director for Translational Research
Yale Cancer Center
New Haven, Connecticut

Pasi A. Jänne, MD, PhD
Director, Lowe Center for Thoracic Oncology
Scientific Director, Belfer Institute for Applied Cancer Science
Dana-Farber Cancer Institute
Boston, Massachusetts

Chitkala Kalidas, PhD
Vice President, Head Oncology Regulatory Affairs
Bayer
New York, New York

Peter F. Lebowitz, MD, PhD
Senior Vice President, Global Therapeutic Area Head, Oncology
Janssen Research and Development, LLC
Wayne, Pennsylvania

John E. Leonard, PhD
Senior Vice President, Development
Vaccinex Inc.
Rochester, New York

Thomas J. Lynch, Jr., MD
President and Director, Fred Hutchinson Cancer Research Center
Seattle, Washington

Elaine R. Mardis, PhD
Co-executive Director, Institute for Genomic Medicine
Nationwide Children’s Hospital
Columbus, Ohio

David M. Reese, MD
Vice President, Medical Sciences
Amgen Inc.
Los Angeles, California

Eric H. Rubin, MD
Vice President and Therapeutic Area Head, Oncology Early Dev.
Merck Research Laboratories

Charles L. Sawyers, MD
Chair, Human Oncology and Pathogenesis Program
Memorial Sloan Kettering Cancer Center
New York, New York

Howard I. Scher, MD
Co-chair, Center for Mechanism Based Therapy
Memorial Sloan Kettering Cancer Center

Mehdi Shahidi, MD
Corporate Vice President, Global Head of Medicine, Oncology
Boehringer Ingelheim
Sutton, England

Ellen V. Sigal, PhD
Chairperson and Founder
Friends of Cancer Research
Washington, D.C.

Suzanne L. Topalian, MD
Professor, Surgery and Oncology, Johns Hopkins University School of Medicine
Director, Melanoma Program, Sidney Kimmel Cancer Center
Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland

Laura J. van ‘t Veer, PhD
Professor, Department of Laboratory Medicine
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California

Victor E. Velculescu, MD, PhD
Co-director of Cancer Biology and Professor of Oncology
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland

Verena Voelter, MD
Head of U.S. Clinical Development and Medical Affairs
Novartis Oncology
East Hanover, New Jersey

AACR Staff Contact

Jon Retzlaff, MBA, MPA
Chief Policy Officer
Vice President, Science Policy and Government Affairs
Email