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