Challenges and Strategic Approaches to Biosimilar Development

Track:
Project/Portfolio Management and Strategic Planning

Day & Time:
June 26, 1:45PM - 3:15PM

Session Number:
343

Room Number:
104AB

Level:
Advanced

Type:
Forum

Title:
Challenges and Strategic Approaches to Biosimilar Development

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

Description:
This session will focus on understanding the strategic questions companies are facing when developing biosimilars and the drug development approaches that are being adopted. Case studies will be provided followed by an open forum discussion.

Learning Objective(s):
Describe how companies address strategic choices when evaluating new business models, using the advent of biosimilar development as a case study; Discuss different strategic approaches to biosimilar development.

Presentation(s) & Speaker(s):
CMC Challenges to Biosimilar Development
Steve Farrand, PhD,MSc
Vice President and Head Bioprocess Development
Merck Research Laboratories, United States

Clinical Challenges and Strategic Approaches to Biosimilar Development
Andrew J. Rankin
Vice President, Biopharmaceuticals
Prescient Life Sciences, United States

Nonclinical Challenges to Biosimilar Development
David Shen, PhD
Vice President, Global Head of Biologics Development, Global R&D
Teva Pharmaceuticals, United States