AACR Task Force to spearhead further opportunities to examine policy issues facing cancer researchers and regulators
During an AACR scientific conference last month, representatives from European and U.S. regulatory bodies joined scientists from academia and industry to discuss the challenges facing rational cancer drug development for targeted drugs.
The discussion revolved around the critical need to identify the most appropriate patient populations for treatment with a given targeted drug. A better understanding of tumor biology will require biopsies during treatment to gain more information from the patients who respond and to ultimately be able to segment patient populations. Speakers also addressed new models of clinical development including novel clinical trial designs for co-development of therapies and biomarkers. The recent approvals of targeted agents vemurafenib (Zelboraf) and crizotinib (Xalkori) and their companion diagnostics were used as core examples to explore the issues surrounding targeted drugs.
Early in 2011, the AACR convened a Task Force on Regulatory Science and Policy, chaired by Dr. Frank McCormick, to further consider important issues surrounding regulation of drugs and devices. This group has spearheaded the development of a Regulatory Science and Policy Track at the Annual Meeting, which will be held in Chicago, Ill., March 31-April 4, 2012. This new track will draw attention to the scientific needs of regulators and examine the policy issues facing both cancer researchers and regulators. The track will consist of sessions on the topics of codevelopment of two or more novel drugs, companion diagnostics, novel clinical trial designs and consideration of comparative effectiveness.
The task force has also been active in submitting formal comments to the FDA as the agency formulates guidances for industry, most recently commenting on the issue of companion diagnostics. Read more about the task force.
AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics
November 12-16, 2011
Rational Cancer Drug Development for Targeted Drugs: The Interface Between Industry, Academia, and Regulators
Chairperson: Frank McCormick, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA
Rational cancer drug development for targeted drugs: Views from academia and the European Medicines Agency (EMA)
- Jonas C. S. Bergh, Karolinska Institutet and University Hospital, Stockholm, Sweden
Rational cancer drug development for targeted drugs
- Richard B. Gaynor, Eli Lilly and Company, Indianapolis, IN, USA
FDA role in smoothing the progress of targeted drug development
- Anthony J. Murgo, Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Silver Spring, MD, USA
- Iordanis Gravanis, European Medicines Agency, London, United Kingdom
- Christopher J. Logothetis, University of Texas MD Anderson Cancer Center, Houston, TX, USA
- Eric H. Rubin, Merck Research Laboratories, North Wales, PA, USA
Read more from the December Edition of the AACR Cancer Policy Monitor: