OIVD: Public Meeting on In Vitro Diagnostic Multivariate Index Assays (IVDMIA) Agenda

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Public Meeting on In Vitro Diagnostic Multivariate Index Assays (IVDMIA) Agenda

February 8, 2007
8:00 AM to 5:00 PM

Hilton Washington DC/Gaithersburg Hotel
620 Perry Parkway
Gaithersburg, Maryland 20877 USA

(Transcript is also available.)

8:00-8:05	*Welcome and Introduction to the Scope of the Public Meeting* Steve Gutman, M.D., Director, OIVD
8:05-8:20	*Overview and Scope of the IVDMIA Guidance Document* Courtney Harper, Ph.D., Associate Director, DCTD, OIVD
8:20–10:00	*Public Presentation Part I* Paul Redensky, M.D., Esq. - McDermott, Will, & Emery LLP Thomas Grogan, M.D. - Ventana Medical Systems, Inc. Steven McPhail - Exzpression Analysis, Inc. Mary Steele Williams, MT(ASCP) SM - Association for Molecular Pathology Richard Samp, Esq. - Washington Legal Foundation Thomas Tsakeris, M.S., M.B.A ., Coalition for 21 st Century Medicine William Clarke, Ph.D. - American Association of Clinical Chemistry Carolyn Compton, M.D., Ph.D. - National Cancer Institute
10:00-10:20	*Break*
10:20–12:00	*Public Presentation Part II* Carolyn Popper, M.D. - Exagen Diagnostics Alan Mertz - American Clinical Laboratory Association Michael Goldberg - Mohr Davidow Ventures Arthur Beaudet, M.D. - Baylor College of Medicine Michael Ostrolenk - The Association of Am erican Physicians and Surgeons Mara Aspinall, M.B.A. - Genzyme Genetics Gail Javitt, Esq. - Genetics and Public Policy Center Craig Shimasaki, Ph.D., M.B.A. - InterGenetics Incorporated
12:00-1:20	Lunch
1:20-3:00	*Public Presentation Part III* David Levison, M.B.A. - Cardio DX Stuart Hogarth, MSc., - University of Cambridge, UK Jonathan Cohen, Esq - 20/20 Gene Systems Inc. Sherry Salway Black, M.B.A. - Ovarian Cancer National Alliance Robert Erwin - Marti Nelson Cancer Foundation Elda Railey - Research Advocacy Network Carol Berry, M.B.A. - Aviara Dx Elissa Passiment - American Society for Clinical Laboratory Science
3:00-3:20	*Break*
3:20-5:00	*Public Presentation Part IV* Colette Saccomanno, Ph.D. - Gene Express Carolina Hinestrosa, M.P.H. - National Breast Cancer Coalition Fund Helen Schiff - Breast Cancer Advocate, NY City Guido Brink - Agendia Judith Wilber, Ph.D. - Expression Diagnostics Sharon Terry, M.A. - Genetic Alliance Carolyn Jones, JD, M.P.H. - AdvaMed
5:00	*Wrap Up* Larry Kessler, Sc.D., Director, OSEL

Updated February 17, 2007

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