Introductory Remarks and Review of the Issues

David B. Nash, MD, MBA, Thomas Jefferson University

8:30 AM - 8:45 AM

Keynote Address: Follow-on Biologics: Getting Past the Exclusivity Debate

Michael McCaughan, Editor-in-Chief, The Pink Sheet FDC/Windhover Biopharma Group

8:45 AM - 9:30 AM

Regulatory Review and Approval Processes Under Current US Guidelines and Across the Globe

Brian Harvey, MD, PhD., Vice President Regulatory Policy, sanofi-aventis

9:30 AM - 10:00 AM

Regulatory Review and Approval Processes Under Current US Guidelines and Across the Globe

Gundu H.R. Rao, PhD., Professor, Laboratory Medicine and Pathology, Lillehei Heart Institute, Institute for Engineering Medicine, University of Minnesota

10:00 AM - 10:30 AM

Legislative Update- A comparison of Legislative Proposals and Implications

Ann Witt, JD, Health Counsel to U.S. Congressman Henry Waxman

10:45 AM - 12:00 PM

Is Interchangeability Possible? Understanding and Evaluating the Evidence Base-Implications for Quality and Safety

Geno J. Merli, MD, Professor of Medicine, Jefferson Medical College, Senior Vice President and Chief Medical Officer, Thomas Jefferson University

1:00 PM - 2:00 PM

Panel: The Interplay of Economic and Clinical Issues

Judith K. Jones, MD, PhD., President and CEO, Degge Group, Ltd.

2:00 PM - 2:10 PM

Panel: The Interplay of Economic and Clinical Issues

Laurence J. Kotlikoff, Professor of Economics, Boston University

2:10 PM - 2:30 PM

Panel: The Interplay of Economic and Clinical Issues

R. Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP

2:30 PM - 2:45 PM

Panel: The Interplay of Economic and Clinical Issues (Question and Answer session with entire panel)

Judith K. Jones, MD, PhD, President & CEO, Degge Group, Ltd.
F. Randy Vogenberg, RPh, PhD, Chief Strategic Officer, EPS LLC, Executive Director, Biologic Finance and Access Council
R. Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP
Laurence J. Kotlikoff, PhD, Professor of Economics, Boston University
Geno J. Merli, PhD, Professor of Medicine, Jefferson Medical College, Senior Vice President and Chief Medical Officer, Thomas Jefferson University Hospital

2:45 PM - 3:00 PM