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Wednesday, June 30 • 2:00pm - 3:00pm
#342 SL: Scientific Advances in Biosimilar Development

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-622-L04-P; CME 1.00; IACET 1.00; RN 1.00

Current biosimilar development timelines are long and ultimately require a clinical study, even though the clinical study is confirmatory. This session will discuss the need for better science to limit the need for clinical data.

Learning Objectives

Discuss the challenges to demonstrating biosimilarity without clinical data; Describe the future of biosimilar development and advancing science to speed these products to market.

Chair

Rachel Turow, JD, MPH

Speaker

FDA Update
Stacey Ricci, DrSc

Health Canada Update
Denis Arsenault, MA

Industry Update
Martin Schiestl, PhD

Can a Biosimilar Be Unique? Differentiation Opportunities for Biosimilars
Leah Christl, PhD

Industry Update
Gopinath Ranganna, FFPM



Speakers
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →
DA

Denis Arsenault

Manager, Policy Development, Health Canada, Canada
Denis Arsenault is a manager in the Office of Policy and International Collaboration within Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD). In this capacity, Mr. Arsenault leads policy development initiatives for BRDD on a number files including regulatory... Read More →
avatar for Leah Christl

Leah Christl

Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Dr. Leah Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS with responsibility for development and execution of global regulatory strategy for Amgen’s... Read More →
avatar for Gopinath Ranganna

Gopinath Ranganna

Associate Vice President, Global Clinical Development, Viatris, India
Gopi Ranganna is currently Associate Vice president, Global Clinical Development at Viatris, based in India. In this role, he provides strategic clinical leadership and plans, designs, and oversees the biosimilar clinical studies across multiple therapy areas. Before joining Viatris... Read More →
SR

Stacey Ricci

Director, Scientific Review Staff, OTBB, OND, CDER, FDA, United States
During her 15-year tenure at FDA, Dr. Ricci’s work has focused on the scientific and regulatory review of biotechnology-derived therapeutic proteins, including major contributions to FDA guidance and standards development for biosimilars and other protein therapeutics. As Director... Read More →
avatar for Martin Schiestl

Martin Schiestl

Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria
Martin Schiestl received his doctoral degree in chemistry with a specialization in bioanalysis from the University of Innsbruck in Austria in 1996. In the same year, he started his work on Biosimilar medicines at Sandoz where he built up the analytical and pharmaceutical development... Read More →


Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session