Molecular Diagnostics and the Changing Landscape: Considerations and Implications

Wednesday, March 23 – Thursday, March 24, 2011 Washington, DC Metro Area The Liaison Capitol Hill 415 New Jersey Avenue, NW Washington, DC 20001 Molecular Diagnostics And the Changing Landscape is an interactive two day seminar hosted by the Medical Technology Learning Institute, the educational arm of AdvaMed,that includes government and industry speakers addressing current regulatory, reimbursement and legislative topics in the evolving field of molecular diagnostics. Attendees will participate in sessions ranging from the latest government policies aimed at molecular diagnostics, healthcare reform and implications for diagnostic; FDA oversight and regulation of molecular diagnostics; key regulatory considerations in developing molecular diagnostics and what it takes to make to create a good submission; developments impacting personalized medicine; co-development and the future of companion diagnostics; the changing landscape of molecular diagnostics reimbursement; and an afternoon on future proposals that could foster the introduction of new molecular diagnostics.

Who Should Attend

This seminar is especially designed for personnel involved in the development, regulation, or reimbursement of molecular diagnostics or strategies for their adoption in clinical practice.


Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council Carolyn Compton, MD, Ph.D., Director, Office of Biorepositories and Biospecimen Research and Executive Director, Cancer Human Biobank, NCI, NIH Barbara Conley, MD, Associate Director, Cancer Diagnosis Program, DCTD, NCI, NIH Maryellen de Mars, Ph.D., Chief Operating Officer, USDS., Inc. Robert DiTullio, Vice President, Global Regulatory Affairs & Clinical Affairs, Alere Inc. Cathy Fomous, Ph.D., Senior Health Policy Analyst, NIH Office of Biotechnology Activities Alberto Gutierrez, Director, FDA/OIVD Thomas Gustafson, Senior Policy Advisor, Arnold & Porter Marjorie Kanof, MD, Health Policy Alternatives Teresa L. Lee, Senior Vice President, Payment & Health Care Delivery Policy, AdvaMed Jennifer Luray, Director, Public Policy & Government Relations, BD Amy Miller, Ph.D., Director of Public Policy, Personalized Medicine Coalition Richard Naples, Vice President, Corporate Regulatory Affairs, BD G. Gregory Raab, Ph.D., Raab & Associates, Inc Uwe Scherf, Associate Director, Microbiology Devices, FDA/OIVD Elizabeth Pika Sharp, Vice President, Government Affairs, AdvaMed

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