Back to Agenda
Session 6 Track 3: CMC Considerations in Development of mRNA-based Therapeutics
Session Chair(s)
Brian Doyle
Director, LNP Process Development
Moderna, United States
The breadth of mRNA-based vaccines in clinical and commercial development has continued to mature beyond SARS-CoV-2 vaccines, with the platform nature of mRNA supporting common CMC principles between products. As the landscape of mRNA-based therapeutics in development expands and evolves, thoughtfully adapting principles from mRNA-based vaccines to meet the unique CMC requirements of therapeutic development across diverse therapeutic areas will be needed. This session will include industrial and regulatory perspectives on CMC challenges specific to mRNA-based therapeutics and opportunities to efficiently support their development.
Learning Objective : - Compare differences in technical requirements and regulatory expectations between vaccines and therapeutics
- Discuss how platform principles can be adapted to the development of mRNA-based therapeutics
- Identify topics or challenges where collaboration between industry and regulators will be needed to successfully
Speaker(s)
Speaker
Representative Invited
Roche, China
Speaker
Eric Levenson, PhD, MS
FDA, United States
Biological Reviewer
Speaker
Representative Invited
Biontech SE, Germany
Speaker
Representative Invited
Paul-Ehrlich-Institute, Federal Agency of Vaccines and Biomedicines, Germany
Have an account?