Forum on Drug Discovery, Development, and Translation: Annual Report 2009 (2010)

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Promoting the scientific Promoting Regulatory Sc ience basis for the regulation of drugs  The Forum held a series of public meetings on drug safety throughout 2009. The first addressed personal- ized medicine and the genetic basis of adverse events. The second featured the new FDA commissioner, IOM President Harvey Fineberg and Peggy Hamburg, and her vision for the FDA. The third FDA Commissioner Peggy Hamburg focused on advances in post-market drug safety since the passage of FDAAA. A fourth meeting, to be held in 2010, will focus on the science infrastructure at FDA and the estab- lishment of centers of excellence to advance regulatory science. A subsequent meeting will address the assessment of therapeutic benefits and risks in decision-making at FDA. History of the Drug Forum 2000 2004 Clinical Research Roundtable,  predecessor to the Drug Forum 

Since 2007, the Forum has hosted public meetings designed to engage congressional staff and the Promoting Regulatory Sc ience broader policy community on current topics in drug development. These sessions are designed to provide concise, balanced, and insightful overviews of current issues—including both science and policy implications—in a neutral, advocacy-free setting. Proceedings are not published, but presen- tations are available on the Forum website. FDA Community Update: Personalized Medicine and the Genetic Basis of Adverse Events Following the publication of the IOM report on the FDA, The Future of Drug Safety: Promoting and Protecting the Health of the Public, and the passage of the FDA Amendments Act of 2007, the Forum initiated the FDA Community Update discussion series to keep the Washington policy community apprised of the agency’s progress on implementing its safety initiatives. In March 2009, the Forum invited speakers from the FDA, academia, industry, and major policy think tanks to update the pub- lic on the FDA’s work on personalized medicine, and to consider the potential policy challenges for the future in pharmacogenomics. FDA Community Update: Postmarket Drug Safety In September 2009, the Forum gathered experts from various sectors to ad- dress the agency’s progress in postmarket safety science. Speakers provided updates on the Sentinel Initiative, Risk Evaluation and Mitigation Strategies, Observational Medical Outcomes Project, and other safety initiatives man- dated by FDAAA legislation two years ago. In an interactive discussion with the audience, the speakers emphasized the need for correct and urgent implementation of postmarket initiatives, and outlined possible policy issues that may rise in the FDA’s safety-oriented environment. Joanne Meyer, Novartis March – Co-Chair Gail Cassell and Ed Holmes convene the first meeting of the Drug Forum 2005 November – Workshop on Adverse Drug Event Reporting