7.50am Morning Coffee & Networking

8:50 am Chair’s Opening Remarks

• Elaine Peters Director - Analytical, Individualized Cell & Gene Therapies, Genentech Inc

Driving the Vision of the mRNA Regulatory Environment for First-in-Class Therapeutics & Best-in-Class Vaccines

9:00 am Regulation of the Next Generation of mRNA Vaccines Targeting Infectious Diseases

• Peter Marks Director – Center for Biologics Evaluation & Research, US Food & Drug Administration (FDA)

9:30 am Panel Discussion: An Industry Perspective into the mRNA Regulatory Landscape for Next Generation mRNA Vaccines & Therapeutics

• Constanze Blume SVP - Global Regulatory Affairs, BioNTech AG
• Peter Marks Director – Center for Biologics Evaluation & Research, US Food & Drug Administration (FDA)
• Antonella Lozito Executive Director - Infectious Disease, Global Regulatory Strategy, Moderna
• Pawel Widomski Senior Director - Global Regulatory Affairs CMC, BioNTech AG
• Marco Cavaleri Head of Office, Health Threats & Vaccines Strategy, European Medicines Agency
• Kathleen Francissen Global Head of Regulatory PT Cell & Gene Therapies, Roche

9:45 am Is “GMP Grade” Good Enough? Choosing Materials for Producing mRNA Therapeutics

• Darwin Asa Global Market Development Manager - Nucleic Acid Therapeutics, Thermo Fisher Scientific Inc.

10:15 am Late Breaking Abstracts

10:30 am Session Reserved for BIA Separations

11.00 Morning Break & Networking Poster Session

1.00 Lunch Break & Networking

3.30 Afternoon Break & Networking

Harnessing Innovations & Expertise to Grow Your mRNA Company & Progress Therapies to Market

4:00 pm Opportunities & Challenges for Starting an Early-Stage Venture Company in the mRNA-Based Therapeutics Field

• Gad Berdugo Managing partner, Explorium Capital

4:00 pm Moving mRNA from the Research Lab to Commercial Manufacturing

• May Guo Vice President - Nucleic Acids, Arranta Bio

4:30 pm The IP Landscape in the mRNA Space: Winning with Knowledge, Strategy & Innovation

• Daniel Shores Partner, Rothwell Figg

5:00 pm Chair’s Closing Remarks

• Yusuf Erkul Co-founder & Chief Executive Officer, Kernal Biologics Inc.

5:15 pm End of 3rd annual mRNA-Based Therapeutics Summit