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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.


Signature initiatives of the subcommittee include:
   

2018-2019 Subcommittee Members     

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Kenneth C. Anderson, MD
Subcommittee Chairperson
Program director and chief, Division of Hematologic Neoplasia, Kraft Family professor of medicine
Harvard Medical School, Dana-Farber Cancer Institute
Boston, Massachusetts


James L. Abbruzzese, MD, FACP
Chief, Division of Medical Oncology, Department of Medicine, associate director for Clinical Research
Duke Cancer Institute
Durham, North Carolina
 
José Baselga, MD, PhD
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, MD, PhD
Head of Oncology Innovative Medicines
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
Senior vice president, VP Global Development and Medical Affairs, Lilly Oncology
Eli Lilly and Company
Indianapolis, Indiana
 
Richard B. Gaynor, MD
President, Research and Development
Neon Therapeutics
Cambridge, Massachusetts
 
Roy S. Herbst, MD, PhD
Ensign professor of medicine, associate director for Translational Research
Yale Cancer Center
New Haven, Connecticut
 
Sandra J. Horning, MD
Global Head of Product Development, Chief Medical Officer
F. Hoffman-LaRoche Ltd.
South San Francisco, California
 
Pasi A. Jänne, MD, PhD
Director, Lowe Center for Thoracic Oncology
Scientific director, Belfer Institute for Applied Career 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
Executive vice president and CSO
Bristol-Myers Squibb Co.
New York, New York
 
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 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
 
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 Cancer Center
Baltimore, Maryland
 
Laura J. van 't Veer, PhD
Professor, Department of Laboratory Medicine
UCSF Helen Diller Family Comprehensive
San Francisco, California
 
Victor E. Velculescu, MD, PhD
Co-director of cancer biology and professor of oncology
Johns Hopkins Kimmel Comprehensive
Baltimore, Maryland

AACR Staff Contact

Sarah Martin, MS, PhD
Senior Regulatory Science and Policy Analyst

AACR Office of Science Policy and Government Affairs
Email or call 267-765-1029

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