Below, please find an agenda and links to the presentations for each speaker at the event.

If you have any difficulty accessing your presentation, please contact Jennifer Soup (

AAM Welcome and Introduction – Thurgood Marshall Ballroom
Christine Simmon, JD, Senior Vice President, Policy & Strategic Alliances, AAM, Executive Director, Biosimilars Council – Download Presentation Here

Biosimilars Council Chair Welcome
Bruce Leicher, JD, General Counsel, Senior Vice President and Secretary, Momenta Pharmaceuticals, Inc. – Download Presentation Here

Regulatory Expectations: Biosimilars and Biologics 
Maria-Teresa Gutierrez-Lugo, PhD, Acting Review Chief, OPQ, OBP, DBRRIII, CDER, U.S. Food and Drug Administration – Download Presentation Here

Market Access, Market Success
Rachel Sher, JD, MPH, Deputy General Counsel, AAM – Download Presentation Here

The Promise of Biosimilars: Patient Advocates Educating Around Patient Care
Edward Li, PharmD, MPH, BCOP, Professor, Department of Pharmacy Practice, University of New England College of Pharmacy – Download Presentation Here

Delivering Biosimilars Access in Europe
Adrian van den Hoven, PhD, Director General, Medicines for Europe – Download Presentation Here

The View from Wall Street
Douglas Tsao, MPH, Director, Senior Research Analyst, U.S. Specialty Pharmaceuticals, Barclays Capital, Inc. – Download Presentation Here

Interchangeability – What is Next?
Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals – Download Presentation Here

Lessons Learned from the FDA Approval Process
Tracy Dianis, Director, Global Regulatory Affairs Biosimilars, Pfizer Essential Health – Download Presentation Here

Lessons Learned from the FDA Approval Process
Cindy Cao, PhD, Head, U.S. Biopharmaceutical Regulatory Affairs, Sandoz Biopharmaceuticals – Download Presentation Here

Biosimilars at the Bar: Legal Issues
Stacie Ropka, PhD, JD, Partner, Axinn, Veltrop & Harkrider LLP – Download Presentation Here