Description
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
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'Keeffe,
PhD,
VP for Small Molecule Design & Development (SMDD),
Eli Lilly and Company
