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2025年10月01日 (水) 午後 12:00 - 2025年10月01日 (水) 午後 1:00

(US Eastern Standard Time)

Unleash the Power of Biosimilars: Navigating the Regulatory Landscape for Transformative Therapies

A discussion on the regulatory challenges to biosimilar development and uptake in the global market today.

Presenters

Mariana  Socal, MD, PhD, MS

Mariana Socal, MD, PhD, MS

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States

Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain. Dr. Socal has testified before the U.S. Congress, the Food and Drug Administration, and several U.S. state legislatures. Prof. Socal is a physician trained in adult Neurology. She holds a Master’s in Public Policy from Princeton University and a PhD in Public Health/Health Systems from Johns Hopkins University.

Rachel  Goode, PhD

Rachel Goode, PhD

Senior Vice President, IP and Legal, Biosimilars , Fresenius Kabi , United States

Rachel Goode is Senior Vice President, Patents and Legal at Fresenius Kabi. She leads a global team of in-house attorneys and is responsible for the global patent and legal strategy of the biosimilars business. Prior to working for Fresenius Kabi, Rachel worked at the Teva where she acted as in-house counsel for the biosimilars business. Before joining Teva, Rachel worked as a patent attorney for the Merck Serono biosimilars unit where she was the Patents Lead for several biosimilar products. Rachel began her career in intellectual property as a patent attorney in a law firm in the UK. She is licensed as a Patent Attorney under European patent law and is a member of the UK chartered Institute of Patent Attorneys (CIPA).

Antonio J. Trujillo

Antonio J. Trujillo

, University of Central Florida, United States

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