Welcome – Mark S. Frankel, Director, Program on Scientific Freedom, Responsibility and Law, AAAS and James Kelly, President and CEO, Food and Drug Law Institute (FDLI)

A Historical Perspective on Personalized Medicine
Chair: Deborah Runkle, Senior Program Associate, AAAS
Ruth Schwartz Cowan, Janice and Julian Bers Professor, Department of History and Sociology of Science, University of Pennsylvania [PDF]

Professor Cowan will provide a context for the current discussions of personalized medicine by describing in what ways medicine has been “personalized” throughout history.    

BREAK

State of the Science: Connecting Biomarkers and Diagnostics
Chair: Teri Manolio, Director, Office of Population Genomics, National Human Genome Research Institute, NIH
Rick Hockett, Chief Medical Officer, Affymetrix [PowerPoint Presentation] [PDF]
Leigh Anderson, CEO, Plasma Proteome Institute [PowerPoint Presentation] [PDF]
David Borsook,Co-Director, Imaging Consortium for Drug Development, McLean Hospital, Belmont, MA [PowerPoint Presentation] [PDF]

The panelists will speak about the discovery, validation, and present and future applications of several types of biomarkers.

LUNCH (on your own)

Drug Development, Diagnostics, and Personalized Medicine
Chair: Mark S. Frankel, Director, Program on Scientific Freedom, Responsibility and Law, AAAS
Klaus Lindpaintner, Senior Vice President of Research and Roche Molecular Medicine Laboratories [PowerPoint Presentation] [PDF]

Dr. Lindpaintner will discuss the challenges and opportunities that arise when developing drugs to be used in tandem with diagnostic biomarkers and how this differs from traditional methods of new drug development.       

Taking Research and Development to the Clinic
Chair: Gregory Downing, Project Director, Personalized Health Care Initiative, HHS
William Dalton, President, CEO, and Center Director, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL [PowerPoint Presentation] [PDF]
Howard Levy, Assistant Professor of Medicine, Johns Hopkins University School of Medicine [PowerPoint Presentation] [PDF]
Paula Kim, CEO, Translating Research Across Communities, Solana Beach, CA [PowerPoint Presentation] [PDF]

The panelists will discuss, from a variety of viewpoints, the necessary ingredients for successfully translating research on biomarkers and their accompanying treatments from the laboratory to clinical practice.

Registration and Continental Breakfast

Testing in the Open Market
Chair: Carol Ley, Medical Director, 3M
Linda Avey, Co-Founder, 23andMe[PowerPoint Presentation] [PDF]
Courtney Harper, Acting Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics, FDA [PowerPoint Presentation] [PDF]
Sarah Botha, Attorney, Division of Advertising Practices, Federal Trade Commission [PowerPoint Presentation] [PDF]

Testing in the Open Market (cont.)
Beatrice O’Keefe, Acting Chief, Laboratory Field Services, CA Dept. of Public Health [PowerPoint Presentation] [PDF]
Louis B. Jacques, Division Director of Items & Devices, Center for Medicare and Medicaid Services [PowerPoint Presentation] [PDF]

The panelists will examine how consumer tests are developed, marketed, and regulated.

LUNCH (on your own)

You, Biomarkers, and Your Rights. Looking Beyond the Science
Chair: Juli Staiano, Director of Development, AAAS
Sharon Terry, President and CEO, Genetic Alliance, Washington, DC [PowerPoint Presentation] [PDF]
Jill Davies, Genetic Consultant, Medcan Clinic, Toronto [PowerPoint Presentation] [PDF]
Joe McInerney, Executive Director, National Coalition for Health Professional Education in Genetics [PowerPoint Presentation] [PDF]

You, Biomarkers, and Your Rights. Looking Beyond the Science (cont.)
Pamela Sankar, Fellow, Center for Bioethics, University of Pennsylvania [PowerPoint Presentation] [PDF]
Kathy Hudson, Director, Genetics and Public Policy Center, Johns Hopkins University [PowerPoint Presentation] [PDF]

The panelists will consisder personalized medicine from ethical, educational, and policy perspectives.

Keynote Address -
Chair:James Kelly, President and CEO, Food and Drug Law Institute (FDLI)
Dietrich Stephan, President and CEO, Ignite Institute for Individualized Health [PowerPoint Presentation] [PDF]