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Going to BIO 2011 in Washington, DC? Foley Hoag is a proud sponsor of the BIO International Convention, and co-sponsor of the Achieving Regulatory Approval & Compliance session track.
Foley Hoag in the Exhibition Hall
Stop by Booth #3017 at the Walter E. Washington Convention Center, Washington, DC and get the latest information on our life sciences services.
Tuesday, June 28, 2011 — 10:00 a.m. - 6:30 p.m.
Wednesday, June 29, 2011 — 10:00 a.m. - 5:00 p.m.
Thursday, June 30, 2011 — 10:00 a.m. - 2:00 p.m.
"Common Needs" and Uncommon Cooperation: The State of Joint FDA and CMS Initiatives
June 28, 2011, 10:00 a.m. - 11:30 a.m.
The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) are collaborating more actively and visibly on cross-cutting issues, ranging from regulatory science and product development to comparative effectiveness and postmarket safety. Senior agency managers will highlight recent, key initiatives and explore steps being taken to improve communications, efficiencies and the quality of agency decision-making. Foley Hoag partner, Paul Kim will moderate this panel.
Current Challenges in Payment System Reform
June 28, 2011, 2:00 - 3:30 p.m.
Payment system reform efforts will continue to create a series of challenges and opportunities for the biotechnology industry. From Accountable Care Organizations (ACOs) and Patient Centered Medical Homes to various episode-based payment systems and payment 'bundling' proposals, each option has far reaching and complicated implications. Will these models change incentives to such a degree that they hinder innovation? What are the legal challenges and ramifications of each strategy? This panel, with Foley Hoag partner Thomas Barker, will attempt to provide an overview of the likely proposals under consideration and explore their potential impact on the Bio and Pharmaceutical Industries.
Advanced Molecular Diagnostics: Reforming Regulation and Reimbursement
June 30, 2011, 10:00 a.m. - 11:30 a.m.
Personalized medicine and advanced diagnostics could transform healthcare, but regulation under laws and policies require reexamination or reformation in the U.S. Already underway, this multilateral process is complicated by competing visions of "right-sizing" such regulation, overlapping agency and federal-state jurisdictions, competing public health priorities, limited resources and market and payor pressures on innovation. The panel, moderated by Foley Hoag Senior Health Policy Specialist, Bruce Quinn will look ahead and provide an overview of the prospects for changes in the regulation and reimbursement of advanced molecular diagnostics (Dx).