7.50am Morning Coffee & Networking

8:20 am Chair’s Opening Remarks

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

8:30 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)

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

9:00 am Panel Discussion – An Industry Perspective into the mRNA Regulatory Landscape for Next Generation mRNA Vaccines & Therapeutics

• Peter Marks Director - Center For Biologics Evaluation & Research, US Food & Drug Administration (FDA)
• Marco Cavaleri Head of Anti-infectives & Vaccines, European Medicines Agency
• Antonella Lozito Executive Director, Infectious Disease, Global Regulatory Strategy, Moderna
• Pawel Widomski Senior Director - Global Regulatory Affairs CMC, BioNTech AG
• Kathleen Francissen Global Head of Regulatory PT Cell & Gene Therapies, Roche
• Basim Hilal Vice President - Global Regulatory Affairs CMC, BioNTech US

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

• Darwin Asa Market Development Manager, Thermo Fisher Scientific Inc.

10:15 am Late Breaking Abstracts

10:30 am Speeding mRNA Process Development & Securing Robust Manufacturing by Using Fast in-Process Analytics

• Aleš Štrancar Executive Managing Director, Sartorius BIA Separations

11.00 Morning Break & Networking Poster Session

1.00 Lunch Break & Networking

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

4.00 Afternoon Break & Networking

4:30 pm Moving mRNA from the Research Lab to Commercial Manufacturing

• May Guo Vice President - Nucleic Acids, ReciBioPharm

5:00 pm The IP Landscape in the mRNA Space: Winning with Knowledge, Strategy & Innovation

• Dan Shores Partner, Rothwell Figg

5:30 pm Chair’s Closing Remarks

• YUSUF ERKUL CEO, Kernal Biologics Inc.

5:40 pm End of 3rd annual mRNA-Based Therapeutics Summit