A New Decade for Continuous Manufacturing

A New Decade for Continuous Manufacturing 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.

Welcome and Opening Remarks
Christine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy
Merck
Speaker Introductions
Sharmista Chatterjee, PhD, Division Director
OPMA, OPQ/CDER
ICH Q13 Guidance – Continuous Manufacturing of Drug Substance and Drug Product
JRapti Madurawe, PhD, Division Director
FDA/CDER/OPQ/OPPQ
End to End Collaboration to Transform Biopharmaceutical Development & Manufacturing
John Erickson, PhD, Senior Fellow,
National Institute for Innovation in Manufacturing Biopharmaceuticals NIIMBL
Perspectives on the Implementation of Continuous Manufacturing
Sarah O’Keefe, PhD, VP Small Molecule Design and Development
Eli Lilly and Company