Additional news stories, reports and information with implications for cancer research policy
AACR Science Series at the FDA
As part of the ongoing partnership between the AACR and the Office of Oncology and Hematology Drug Products (OHOP), Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), an AACR Science Series at FDA session was held on Monday, November 4. The series brings scientific leaders to the FDA campus to present cutting-edge advances in cancer biology to FDA scientific review staff and to foster the development of relationships between FDA reviewers and external scientific experts.
AACR board members Kenneth C. Anderson, M.D., Ph.D. (Hon.) Kraft Family Professor of Medicine, Harvard Medical School, Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, MA and Lewis C. Cantley, Ph.D., Director, Cancer Center, Weill Cornell Medical College, New York, NY, spoke about current approaches to develop targeted therapies in multiple myeloma and the Stand Up to Cancer (SU2C) dream team’s work in targeting the phosphatidylinositol 3 kinase (PI3K) pathway in gynecologic cancers respectively.
Staff from all three medical product review divisions at FDA (CDER, CBER and CDRH) attended and participated in a rich discussion of how emerging data from basic research will impact clinical development of cancer therapies and the related regulatory issues that lie therein.
AACR signs-on to letter encouraging Congress to protect FDA user fees from sequestration
The AACR co-signed a letter addressed to Reps. Anna Eschoo (D-CA) and Leonard Lance (R- NJ) supporting passage of a bill introduced by them (H.R. 2725), the Food and Drug Administration Safety Over Sequestration (“S.O.S.”) Act. The bill seeks to protect FDA user fees from being subject to sequestration.
The full-text of the letter can be viewed here.
Regulatory Science and Policy plenary session at AACR-NCI-EORTC meeting
The closing plenary session at the recent AACR-NCI-EORTC meeting was devoted to discussing the regulatory challenges in combining targeted therapies with immunotherapies. 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 responses in patients. However, the regulatory approaches, standards, and requirements that are necessary for approving combination immunotherapies are still evolving. The session examined both the scientific promises and regulatory standards needed to develop 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. Click to watch the video of the session.
Meetings and Workshops
January 6-9, 2014, San Diego, CA, AACR-IASLC Joint Conference on the Molecular Origins of Lung Cancer
January 18-21, 2014, San Diego, CA, AACR-Prostate Cancer Foundation Conference on Advances in Prostate Cancer Research
March 13, 2014, Washington, DC AACR Congressional Briefing on the Cancer Progress Report 2013
April 5-9, 2014 San Diego, CA, AACR Annual Meeting