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Manufacturing Challenges for Breakthrough Products
Session Chair(s)
Patricia N. Hurter, PhD, MS
Senior Vice President, CMC & Pre-Clinical Development
Vertex Pharmaceuticals, United States
This session will focus on considerations regarding manufacturing development for breakthrough therapies and will highlight related challenges and opportunities for breakthrough drugs.
Learning Objective : 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.
Speaker(s)
Continuous Manufacturing: An Innovative and Collaborative Approach to Bring High Quality Breakthrough Therapies to Market
Hayden Thomas, PhD
Vertex Pharmaceuticals, United States
Vice President, Formulation Development
FDA Perspective
Mahesh R. Ramanadham, PharmD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Industry Perspective
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
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