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Session 6 Track 3: CMC Considerations in Development of mRNA-based Therapeutics
Session Chair(s)
Brian Doyle
Senior Director, Technical 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 which warrant differentiated development strategies
- Discuss how platform principles which have accelerated the development of mRNA-based vaccines can be adapted to the development of mRNA-based therapeutics
Speaker(s)
Expanding Horizons: Navigating CMC Challenges and Opportunities for mRNA Therapeutics Beyond Vaccines
Xin (Jack) Yu, PhD
Moderna, United States
Vice President, CLinical Development
Advancing mRNA Vaccine Specifications to Support mRNA Therapeutics
Eric A Levenson, PhD, MS
FDA, United States
Biological Reviewer
Panelists
Andreas Kuhn, PhD
Biontech SE, Germany
Senior Vice President RNA Biochemistry & CMC Development
Panelists
Silke Schüle, PhD
Paul-Ehrlich-Institute, Federal Agency of Vaccines and Biomedicines, Germany
Scientific Assessor