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Moving Toward Clarity on Biosimilar Interchangeability

Presenters

Laura  McKinley, PhD

Laura McKinley, PhD

Director, Global Regulatory Policy and Intelligence, Pfizer Inc, United States

Laura McKinley is a Director of Regulatory Policy at Pfizer. Laura has been with Pfizer for over 10 years and has extensive experience working on biosimilars. Laura represents Pfizer on industry trade association biosimilar committees and was an industry representative during the initial BsUFA negotiations. Prior to joining the Global Regulatory Policy team at Pfizer, she was a Global Regulatory Lead on biosimilar development teams working to advance the development of Pfizer's portfolio of monoclonal antibody biosimilars. She received her Ph.D. in Pathology from University of Michigan in Ann Arbor, Michigan.

Hillel P Cohen, PhD

Hillel P Cohen, PhD

Executive Director, Scientific Affairs , Sandoz Inc., United States

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas of biosimilar education, switching, interchangeability, naming and safety. Dr. Cohen led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in both BsUFA 2 and BsUFA3 negotiations on behalf of industry. Hillel is active on the Education Committees including the Biosimilars Council and the Biosimilars Forum. Dr. Cohen received a BA from New York University and a PhD in Biology from Dartmouth.

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