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Challenges and Strategic Approaches to Development of a Novel Biologic Versus a Biosimilar

Track:
Project/Portfolio Management and Strategic Planning

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
258

Room Number:
1A

Level:
Advanced

Type:
Session

Title:
Challenges and Strategic Approaches to Development of a Novel Biologic Versus a Biosimilar

Chair(s):
Jayanthi Reddy, MBA, MS, PMP
Director and Biologics Pipeline Leader,Global Project Management
Merck & Co., Inc., United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Introduction and Overview of Challenges in Development of a Novel Biologic Versus a Biosimilar
Jayanthi Reddy, MBA, MS, PMP
Director and Biologics Pipeline Leader,Global Project Management
Merck & Co., Inc., United States

Biologics CMC Development: Strategies for Biosimilars, Novels, and Breakthrough Therapies
Steve Farrand, PhD, MSc
Vice President BioProcess Development
Merck Research Laboratories, United States

Challenges for Attaining Biosimilar Success in the Regulated Markets
Andrew Rankin, PhD
Chief Operating Officer
Qforma, United States