American Association for Cancer Research

AACR Regulatory Science and Policy Subcommittee

Bookmark and Share

The U.S. Food and Drug Administration (FDA) plays a vital role in the process of advancing breakthrough cancer therapies to the public, and the AACR is, therefore, committed to leveraging the vast scientific expertise of the AACR membership to help ensure that the agency can excel in its critical role as a science-based regulatory agency.

The AACR established the Regulatory Science and Policy Subcommittee in March 2011 with the goal of supporting the efforts of the FDA to modernize the regulatory process and accommodate the fast pace of innovation in science and technology. The subcommittee will, therefore, lead AACR efforts to work with the FDA to facilitate scientific exchange and provide FDA reviewers an opportunity to hear about relevant scientific advances.

The group, a working body of the AACR Science Policy and Government Affairs Committee, is also actively engaged in the development and implementation of programmatic and policy initiatives related to issues such as co-development of two or more novel therapies and therapeutic/diagnostic co-development. In addition, it spearheads the development of a dedicated regulatory science and policy track at the AACR Annual Meeting, which showcases high-quality regulatory science and illuminates the scientific challenges facing regulators.


On October 29, 2013, the AACR and AdvaMedDx partnered on a symposium titled “Transforming Cancer Care Through Diagnostics and Personalized Medicine,” in Washington, D.C.

Harold Varmus, M.D., director of the NCI, gave the opening keynote talk on “Why Diagnostics Matter?.” During lunch, Charles Sawyers, M.D., president of the AACR facilitated a conversation between Francis Collins, M.D., director of the NIH, and Margaret Hamburg, M.D., commissioner of the FDA, to discuss “The Path to Personalized Medicine: Where are we Today?”

AACR AdvaMedDx Cancer Diagnostics Symposium

More than 250 scientists, patient advocates, NIH and FDA staff, and drug and diagnostic company representatives participated in the symposium. The purpose of the meeting was to shine a spotlight on the state of genomic understanding and discuss the exciting science that is enabling the development of molecular diagnostic tests, which are essential for advancing personalized cancer therapies. In addition, the participants at the conference discussed numerous policy issues, including how diagnostic regulatory pathways can promote patient safety and innovation, how the current payment systems are valuing new diagnostic technologies, and how to ensure that all patients have access to the latest diagnostic technologies. 


 

 AACR-NCI-EORTC Conference 2013

Combining Immunotherapies, Immune Modulators, and Targeted Therapies: Regulatory Opportunities and Challenges

Combining two immunotherapy agents has been shown to produce better tumor regression in early clinical studies. As a result, researchers are now combining immunotherapies, immune modulators, and targeted therapies to achieve better and more durable responses in patients. However, the regulatory approaches, standards, and requirements that are necessary for approving combination immunotherapies are still evolving. Therefore, this timely session examined both the promises and challenges inherent in evidence-based regulatory approval of these therapies. Short presentations from a representative from the U.S. Food and Drug Administration, as well as leaders from academia, industry, and the patient advocacy community were followed by a moderated panel discussion and audience Q and A.

Speakers and Panelists:

  • Stephen Hodi, M.D., Director of the Melanoma Center at Dana-Farber/Brigham and Women’s Cancer Center and Assistant Professor of Medicine at Harvard Medical School – (Chair and Moderator)
  • Ke Liu, M.D., Ph.D., Director, Oncology Branch, Office of Cellular Tissue and Gene Therapies (OCTGT) at the FDA Center for Biologics Evaluation and Research (CBER)
  • Michael Postow, M.D.,  Memorial Sloan Kettering Cancer Center and Recipient of the 2013 Conquer Cancer Foundation, Oncology Young Investigator Award
  • Renzo Canetta, M.D., Vice President of oncology global clinical research at Bristol-Myers Squibb
  • Louise Perkins, Ph.D., Chief Scientific Officer, Melanoma Research Alliance

Watch the video here.


AACR Annual Meeting 2013

Regulatory Science and Policy Track

Underscoring the importance of the U.S. Food and Drug Administration (FDA) in advancing progress in the prevention, detection, diagnosis and treatment of cancer, the 2013 Annual Meeting of the AACR, held in Washington, D.C. from April 6-10, featured nine sessions highlighting cutting-edge issues in regulatory science and policy.

Slides and video now available.

 



Subcommittee Documents:

[*Adobe Acrobat Reader required]

 

Subcommittee Members:

Frank McCormick, Ph.D., F.R.S., Chairperson
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF School of Medicine

San Francisco, CA

Kenneth C. Anderson, M.D.
Dana-Farber Cancer Institute

Boston, MA

William S. Dalton, Ph.D., M.D.
H. Lee Moffitt Cancer Center and Research Institute

Tampa, FL

Ethan Dmitrovsky, M.D.
UT MD Anderson Cancer Center

Houston, TX

Raymond N. DuBois, M.D., Ph.D.
UT MD Anderson Cancer Center

Houston, TX

Michael A. Friedman, M.D.
City of Hope

Duarte, CA

Judy E. Garber, M.D.
Harvard Medical School

Boston, MA

Richard B. Gaynor, M.D.
Eli Lilly and Company

Indianapolis, IN

D. Gary Gilliland, M.D., Ph.D.
Merck Research Laboratories

North Wales, PA

Roy S. Herbst, M.D., Ph.D.
Yale Cancer Center

New Haven, CT

Sandra J. Horning, M.D.
Genentech Inc.
F. Hoffmann-LaRoche, Ltd

South San Francisco, CA

Perry D. Nisen, M.D., Ph.D.
GlaxoSmithKline Oncology

Collegeville, PA

Gilbert S. Omenn, M.D., Ph.D.
University of Michigan

Ann Arbor, MI

David R. Parkinson, M.D.
Nodality Inc.

South San Francisco, CA

Mace L. Rothenberg, M.D.
Pfizer Oncology

La Jolla, CA

David Reese, M.D.
Amgen, Inc.

Las Angeles, CA

Eric H. Rubin, M.D.
Merck Research Laboratories

North Wales, PA

Jason A. Sager, M.D.
Sanofi-Aventis

Cambridge, MA

Laura K. Shawver, M.D.
The Clearity Foundation

La Jolla, CA

Peter G. Shields, M.D.
The Ohio State University Medical Center

Columbus, OH

Ellen V. Sigal, Ph.D.
Friends of Cancer Research

Arlington, VA

Suzanne L. Topalian, M.D.
Johns Hopkins University School of Medicine

Baltimore, MD

Laura J. van 't Veer, Ph.D.
UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, CA

Eric P. Winer, M.D.
Dana-Farber Cancer Institute

Boston, MA

 

AACR Staff contact:

Rasika Kalamegham, Ph.D., Senior Science Policy Analyst

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

 

Top