Description

Continuous manufacturing for pharmaceutical and biopharmaceutical manufacturing is still in its infancy with only a limited number of products approved within the past 5 years. As we begin the third decade of the third millennium, we anticipate that bio/pharmaceutical manufacturing will continue to get smaller, faster, and smarter. In this opening conference session, a broad array of speakers from industry, academia, and regulatory agencies will provide their views on the state of continuous bio/pharmaceutical manufacturing today and predictions for its future.

Moderator(s):

• Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.
• Sharmista Chatterjee, PhD, Division Director, OPF, and Emerging Technology Team Member, CDER/FDA

Speaker(s):

• Rapti Madurawe, PhD, Director, Division of Process Assessment I, CDER/FDA
• John Erickson, PhD, Senior Fellow, NIMBL
• Sarah O'Keefe, PhD, VP Small Molecule Design & Development, Eli Lilly and Company