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Message from the Co-Chairs Gail Cassell and Jeffrey Drazen The Institute of Medicineâs (IOMâs) Forum on Drug Discovery, Development, and Translation was created in 2005 by the IOMâs Board on Health Sciences Policy to foster dialogue among stakeholders and provide ongoing opportunities to discuss issues of mutual interest in a neutral setting. The Forum provides a venue for dialogue and collabora- tion among its membership, which includes leaders from the pharma- ceutical and biotech industries, academia, federal agencies, foundations, and patient groups. The Forum brings ongoing attention and visibility to important issues in drug development; explores new approaches for resolving problem areas; helps define the scope of the field and thus sets the stage for future policy action; provides a catalyst for collaboration on topics where there is synergy among potential partners; and elevates the general understanding of drug discovery, development, and translation among the research, public policy, and broader communities. The Forum is self-governing, with Forum membership convening several times each year to identify and prioritize the topics they wish to address. In 2010 the scientific and business landscape of drug development was fraught with continued uncertainty and risk. New paradigms for discov- ering and developing drugs are being sought to bridge the ever-widening gap between scientific discoveries and translation of those discoveries into life-changing medications. The landscape of the drug development enter- prise is increasingly global, with an attending need to address cross-border issues in the regulatory, scientific, ethical, and economic arenas. With such great challenges comes great opportunity and cause for optimism. The leadership at both the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have emphasized their support for and dedicated efforts to innovation in regulatory science and translational medicine. New collaborative approaches within the federal
agencies, academia, and industry are directing focused attention on the advancement of the drug development enterprise. Forum activities reflect this dynamic environment, focusing on five critical areas: ⢠Addressing the Approach to Drug Development: Problems and Opportunities ⢠Promoting and Enhancing the Scientific Basis for the Regulation of Drugs ⢠Transforming Research and Fostering Collaborative Research ⢠Developing Drugs for Rare and Neglected Diseases and Addressing Urgent Global Health Problems ⢠Promoting Public Understanding of Drug Development We look forward to another groundbreaking and productive year for the Drug Forum in 2011. Gail Cassell Jeffrey Drazen Co-Chair Co-Chair