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 Task Force on Regulatory Science and Policy 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 task force 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 Legislative Affairs Committee (SPLAC), is also actively engaged in the development and implementation of programmatic and policy initiatives related to issues such as codevelopment of two or more novel therapies and therapeutic/diagnostic codevelopment. In addition, it is spearheading the development of a dedicated regulatory science and policy track at the AACR Annual Meeting 2012, which will showcase high-quality regulatory science and will illuminate the scientific challenges facing regulators.

---

AACR Annual Meeting 2012

Regulatory Science and Policy Track

 

This new track, spearheaded by the Task Force on Regulatory Science and Policy, consisted of five sessions incorporated into the regular scientific program with the goal of drawing attention to the scientific needs of regulators and examining the policy issues facing both cancer researchers and regulators. Slides and video now available!

 

---

Task Force News:

• AACR Urges Congress to Safeguard Funding for FDA, Cites 35 Drug Approvals in 2011 as Validation of Agency's Effectiveness (AACR, Nov. 10, 2011)
• FDA Seeks Input on Companion Diagnostics (AACR Cancer Policy Monitor, Oct. 2011)
• AACR Events Bring NCI, FDA Leaders to Capitol Hill (AACR Cancer Policy Monitor, Sept. 2011)

Task Force Documents:

• AACR comments on FDA draft guidance on companion diagnostic devices* (Oct. 12, 2011)
• AACR comments on FDA draft guidance on the codevelopment of two or more unmarketed investigational drugs for use in combination* (Feb. 14, 2011)
• AACR comments on Federal Register notice on the co-development of investigational drugs* (Sept. 7, 2010)

[*Adobe Acrobat Reader required]

 

Task Force Members:

San Francisco, CA

Boston, MA

Tampa, FL

Hanover, NH

Houston, TX

Duarte, CA

Boston, MA

Waltham, MA

North Wales, PA

New Haven, CT

South San Francisco, CA

Collegeville, PA

Ann Arbor, MI

South San Francisco, CA

La Jolla, CA

North Wales, PA

Cambridge, MA

La Jolla, CA

Columbus, OH

Arlington, VA

San Francisco, CA

Boston, MA

 

Staff contact:

Pamela Bradley, Ph.D., Director of Science Policy

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

 

Top