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 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.

Signature initiatives of the subcommittee include:

Subcommittee Members     

Frank P. McCormick, PhD, FRS, Dsc (hon)
Professor Emeritus, UCSF Helen Diller Family Comprehensive Cancer Center, David A. Wood Distinguished Professor of Tumor Biology and Cancer Research and Co-leader of the National RAS Program
San Francisco, California

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

Kenneth C. Anderson, MD
Program Director and Chief, Division of Hematologic Neoplasia
Kraft Family Professor of Medicine, Harvard Medical School
Dana-Farber Cancer Institute
Boston, Massachusetts    

Renzo Canetta, MD
Vice President,
Global R&D Oncology Policy
Bristol-Myers Squibb
Wallingford, Connecticut
William S. Dalton, PhD, MD
Founder and Chief Executive Officer
Tampa, Florida

Raymond N. DuBois, MD, PhD
Executive Director and Professor
The Biodesign Institute
Arizona State University
Tempe, Arizona

Howard Fingert, MD, FACP
Senior Medical Director for Clinical Intelligence
Takeda Pharmaceuticals, Inc.
Cambridge, Massachusetts

Judy E. Garber, MD
Center for Cancer Genetics and Prevention
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Richard B. Gaynor, MD
Vice President
Clinical Development and Medical Affairs
Oncology Business Unit
Eli Lilly and Company
Indianapolis, Indiana

Roy S. Herbst, MD, PhD
Chief of Medical Oncology and Director
Thoracic Oncology Research Program
Yale Comprehensive Cancer Center, Yale School of Medicine
New Haven, Connecticut                                                          

Sandra J. Horning, MD
Executive Vice President
Global Development and Chief Medical Officer
F. Hoffmann-LaRoche, Ltd.
South San Francisco, California

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

Peter F. Lebowitz, MD, PhD
Global Therapeutic Area Head, Oncology
Janssen Research & Development, LLC
Spring House, Pennsylvania

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

Laurie A. Letvak, MD
Vice President
Head, Clinical Development Policy
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey

Mace L. Rothenberg, MD
Senior Vice President
Clinical Development and Medical Affairs
Pfizer Oncology
La Jolla, California

David M. Reese, MD
Vice President
Medical Sciences
Amgen Inc.
Los Angeles, California
Eric H. Rubin, MD
Vice President
Oncology Clinical Research
Merck Research Laboratories
North Wales, Pennsylvania

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

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

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

Laura J. van 't Veer, PhD
Breast Oncology Program and Director, Applied Genomics
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California

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

AACR Staff Contact

Rasika Kalamegham, PhD, Director of Regulatory Science and Policy

AACR Office of Science Policy and Government Affairs
Email or call (202) 898-6499

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