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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• Kenneth C. Anderson, MD, FAACR
  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
• 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
  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
  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
• Sandra J. Horning, MD
  Cambridge, Massachusetts
• 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

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