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Challenges and Strategic Approaches to Development of a Novel Biologic Versus a Biosimilar
Session Chair(s)
Jayanthi Reddy, MBA, MS
Director, Global Project Management
Merck & Co., Inc., United States
Through a case study approach, this session will address the strategic approaches adopted by companies to deal with the unique challenges faced in the development of a novel biologic versus a biosimilar.
Learning Objective : Describe the challenges involved in biologics drug development; Discuss the unique challenges of a novel biologic versus a biosimilar; Describe about the strategic approaches companies are adopting to deal with the challenges in developing novel biologics and biosimilars.
Speaker(s)
Introduction and Overview of Challenges in Development of a Novel Biologic Versus a Biosimilar
Jayanthi Reddy, MBA, MS
Merck & Co., Inc., United States
Director, Global Project Management
Biologics CMC Development: Strategies for Biosimilars, Novels, and Breakthrough Therapies
Steve Farrand, PhD, MSc
Merck Research Laboratories, United States
Vice President BioProcess Development
Challenges for Attaining Biosimilar Success in the Regulated Markets
Andrew Rankin, PhD
Pharnaceutical Consultant, United States
Pharmaceutical Consultant
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