Agenda Archive

A schedule of events for Regulatory Issues in Next-Generation Medicine and Pharmacogenomics is provided below for your convenience.

This one-day conference scheduled for Tuesday, September 3, 2013, at the Southern Management Corporation Campus Center is open to the public. For a printable agenda, please download the conference brochure.

Time	Activity
9:30-9:40 a.m.	Registration and Welcoming Remarks E. Albert Reece, MD, PhD, MBA John Z. and Akiko K. Bowers Distinguished Professor and Dean University of Maryland School of Medicine
9:40 - 10:00 a.m.	Introduction Issam Zineh, PharmD, MPH, FCP, FCCP Director, Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration
10:00 - 11:45 a.m.	Roundtable 1: Generating Evidence for Uncommon Variants and Very Small Populations Overview and Presentation of Case Study Michael Pacanowski, PharmD, MPH Associate Director for Genomics and Targeted Therapy Office of Clinical Pharmacology; Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Participant Group Discussions Overview of Technologies Mickey Williams, PhD SAIC Molecular Characterization Lab Chief National Cancer Institute Clinical Trial Landscape in Oncology Edward Sausville, MD, PhD, FACP Deputy Director, University of Maryland Greenebaum Cancer Center Professor of Medicine and Associate Director for Clinical Research University of Maryland School of Medicine Novel Statistical Approaches to Strengthen Signals of Efficacy: Bayesian Framework Nicholas Schork, PhD Director of Bioinformatics & Biostatistics Scripps Translational Science Institute The Scripps Research Institute Panel Discussion/Audience Q&A
11:45 - 12:50 p.m.	Lunch and Keynote Address Joshua Sharfstein, MD Secretary of Health & Mental Hygiene State of Maryland
12:50 - 2:30 p.m.	Roundtable 2: Developing the Genetic Testing Infrastructure Overview and Presentation of Case Study David Litwack, PhD Personalized Medicine Staff Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health US Food and Drug Administration Participant Group Discussions Clinical Lab Perspective: Interactions and Expectations Penny Keller Health Specialist Division of Laboratory Services Centers for Medicare & Medicaid Services Zivana Tezak, PhD Associate Director for Science and Technology Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health (CDRH) US Food and Drug Administration Centralized Lab Perspective Victoria Pratt, PhD Associate Professor of Clinical Medical and Molecular Genetics Director, Pharmacogenomics Diagnostics Laboratory Indiana University School of Medicine
2:30 - 2:45 p.m.	Break
2:45 - 4:40 p.m.	Roundtable 3: Practical Issues and Barriers Overview and Presentation of Case Study Alan Shuldiner, MD John Whitehurst Professor of Medicine Director, Program in Personalized and Genomic Medicine Head, Division of Endocrinology, Diabetes, and Nutrition University of Maryland School of Medicine Participant Group Discussions Clinical Decision Support Mark Hoffman, PhD Director, Translational Bioinformatics Children’s Mercy Hospital Associate Professor, Biomedical and Health Informatics Director, Bioinformatics Core University of Missouri, Kansas City Ethical and Legal Challenges Frank Pasquale, JD Professor of Law University of Maryland School of Law Patient Perspective Mary Dwight Vice President, Government Affairs Cystic Fibrosis Foundation Payer Perspective Steven Gutman, MD Strategic Advisor, Myraq Panel Discussion/Audience Q&A
4:40-5:00 p.m.	Wrap-Up and Concluding Remarks Alan Shuldiner and Michael Pacanowski Reception to Follow