Indiana Life Sciences Manufacturing 2024 Summit

Event Date: March 7, 2024
Location: 16Tech, 1210 Waterway Blvd. Indianapolis, IN 46202
Priority: No
College Calendar: Show

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The Indiana Life Sciences Manufacturing Summits convene industry, academia, state and local governments, and other relevant organizations to promote life sciences manufacturing, research, education, and business development in Indiana. Now in their third year, the Summits discuss trends, challenges, and opportunities, how to forge global solutions with regional resources, and workforce development strategies needed to keep pace with onshoring and emerging technologies. The theme of the 2024 Summit is Regulatory Perspectives on Life Sciences Manufacturing Innovation.

Dr. Patrizia Cavazzoni, M.D., is the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration. Dr. Cavazzoni received her medical degree from McGill University and was later appointed to the Faculty of Medicine at the University of Ottawa. Dr. Cavazzoni then worked in the pharmaceutical industry for several years, holding senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas, before joining the FDA in 2018. She will be joined in her presentation by Dr. Sau Lee, Ph.D., Deputy Director of Science, Office of Pharmaceutical Quality, CDER.

Registration for the Indiana Life Sciences Manufacturing 2024 Summit is now open. Click the link below to register. Please note that space is limited.

Dr. Patrizia Cavazzoni, M.D.

Dr. Patrizia Cavazzoni, M.D.

Director of the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
Dr. Sau Lee, Ph.D.

Dr. Sau Lee, Ph.D.

Deputy Director of Science, Office of Pharmaceutical Quality, CDER

Sponsor Organizations

  • Purdue's William D. and Sherry L. Young Institute for the Advanced Manufacturing of Pharmaceuticals
  • Biocrossroads

Agenda

8:30-9:20 AM
Breakfast and Registration
Indiana Bioscience Research Institute Conference Room (first floor)
9:20-9:30 AM
Welcome and Introduction
Elizabeth Topp, Director, William D. Young Institute for Advanced Manufacturing of Pharmaceuticals, Purdue University
9:30-10:10 AM
CDER's Perspective and Update on Advanced Manufacturing (Virtual)
Keynote Speakers:
  • Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, Food and Drug Administration
  • Sau (Larry) Lee, Deputy Director of Operations, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration
10:10-10:40 AM
Update on Lilly's new manufacturing facilities in Lebanon, Indiana
Edgardo Hernandez, Executive Vice President and President, Manufacturing Operations, Eli Lilly and Company
Johna Norton, Executive Vice President, Global Quality; Eli Lilly and Company
10:40-11:00 AM
Break
11:00-11:30 AM
Flexible Manufacturing
Rich Osifchin, Executive Director, Merck
11:30-12:00 PM
Indiana CDMO Environment
12:00-12:30 PM
Indiana's EDA Tech Hub
Andrew Kossack, Executive Vice President, Partnerships and General Counsel, Applied Research Institute
12:30-1:30 PM
Lunch and Workforce Training Breakout Session
Led by Jane Dunigan Smith, Senior Vice President and Chief Strategy Officer, Biocrossroads
1:30-2:10 PM
Continuous Manufacturing
Keynote Speaker - Lucy Chang, Associate Vice President, Global Regulatory Affairs CMC Biologics, Merck
2:10-2:50 PM
AI and Pharmaceutical Manufacturing Innovation
Moderator:
  • Doug Kiehl, Senior Director, Eli Lilly and Company
Panelists:
  • Lucy Chang, Associate Vice President, Global Regulatory Affairs CMC Biologics, Merck
  • Gaurav Chopra, Director, Merck-Purdue Center; Associate Professor of Chemistry, Purdue University (invited)
  • Dan Issacs, Chief Strategy Officer, Object Management Group
2:50-3:10 PM
Break
3:10-3:40 PM
Intersection of Semi-Conductor Development and Pharma Manufacturing
Dan Issacs, Chief Strategy Officer, Object Management Group
3:40-4:10 PM
Radiopharmaceuticals Manufacturing in Indiana
Kevin Haehl, Nucleus RadioPharma
4:10-4:40 PM
Presentation (Title) and Closing Remarks
Ann Lathrop, Chief Strategy Officer, Indiana Economic Development Corporation (IEDC)