Terminkalender FDA/CMS Summit.
06.12.2017, 1:00 PM
Rare Diseases: Trends, Developments, and PRVs With more generics on the horizon that will increase competition and drive down costs in the “big drug” market, the industry is fast “rediscovering” the commercial opportunity in orphan drug development, helped along by expedited approvals and the potential for expanded exclusivity periods. This opportunity is not only good for new revenue streams but more importantly, offers hope to those patient populations living with rare diseases by shining a new light on orphan drug development. At the intercept of capitalism and altruism, what will be the end result? This session will discuss the implication of recent trends and developments in orphan drugs, priority review vouchers, and the renewed interest in this market. What are the implications for these patient populations? Moderator: InVentiv Health Panelists: Ron Cooper, President and CEO, Albireo Pharma Michael Spector, President and CEO, Caelum BioSciences Jonathan Goldsmith MD, Associate Director Rare Disease Program, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
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