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Manufacturing Challenges for Breakthrough Products

Track:
Pharmaceutical Quality

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
244

Room Number:
4

Level:
Intermediate

Type:
Session

Title:
Manufacturing Challenges for Breakthrough Products

Chair(s):
Patricia N. Hurter, PhD, MS
Senior Vice President, Global Pharmaceutical Development and Regulatory Affairs
Vertex Pharmaceuticals, United States

Description:
This session will focus on considerations regarding manufacturing development for breakthrough therapies and will highlight related challenges and opportunities for breakthrough drugs.

Learning Objective(s):
Outline specific manufacturing challenges and regulatory considerations for breakthrough therapies; Discuss possible submission strategies related to manufacturing process development and breakthrough products; Describe potential strategies for CMC submissions that support breakthrough products.

Presentation(s) & Speaker(s):
Continuous Manufacturing: An Innovative and Collaborative Approach to Bring High Quality Breakthrough Therapies to Market
Hayden Thomas, PhD
Vice President, Formulation Development
Vertex Pharmaceuticals, United States

FDA Perspective
Mahesh R. Ramanadham, PharmD, MBA
Team Leader, Office of Compliance, CDER
FDA, United States

Industry Perspective
John Groskoph, MBA
Senior Director, Global CMC
Pfizer Inc, United States