HHS Secretary Leavitt Opens FDA Science Forum April 27
This article was originally published in The Pink Sheet Daily
Executive Summary
Annual event includes an update on the new Office of Oncology Products, a “Meet the Center Directors” session, and panels on post-marketing risk management and biological product safety.
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HHS Secretary Michael Leavitt is slated to give the opening keynote address to FDA's annual Science Forum, taking place April 27-28 at the Convention Center in Washington, D.C. FDA describes the forum, entitled "Advancing Public Health through Innovative Science," as the only conference where "scientists from all disciplines and organizational components of FDA meet to share data, knowledge, and ideas on the science-based mission of the agency." The range of topics includes study designs to measure safety and efficacy; biological product safety; biomarkers; and integrating pharmacogenomics and pharmacogenetics. An expected forum highlight is "The Science Behind the Headlines: A Conversation with the FDA Center Directors" on April 28. Panelists include Center for Drug Evaluation & Research Acting Director Steven Galson, Center for Biologics Evaluation & Research Director Jesse Goodman and Office of Regulatory Affairs Associate Commissioner Steve Niedelman, among others. Post-marketing risk management challenges will be addressed at an April 27 break-out session, with presentations by CDER Office of Drug Evaluation III Director Florence Houn and Merck Executive VP Peter Honig. Galson is scheduled to present "The New Office of Oncology Products in CDER: Changes To Enhance Customer Needs" as part of an April 27 break-out session entitled "Emerging Technologies for Cancer Diagnosis and Treatment." The first director of the newly created office will be Richard Pazdur, who has served as director of ODE I's Division of Oncology Drug Products since 1999, FDA announced April 22 (see 1 (Also see "FDA’s Pazdur Tapped For New Oncology Office Director" - Pink Sheet, 22 Apr, 2005.)). [Editor's Note: For the most current information on this and other events, visit "The Pink Sheet" DAILY's Daybook, updated throughout the day.] - Salla Hauvonen |