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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 8 Track 3: CMC Perspective on mRNA Therapeutics

Session Chair(s)

Nedim Emil Altaras, PhD

Nedim Emil Altaras, PhD

  • Senior Vice President, Technical Development
  • Moderna, United States
The remarkable and rapid advances of SARS-CoV2 mRNA-based vaccines have established the first generation of the many CMC principles for the mRNA-based products. While the industrial manufacturing processes and associated analytical control strategies have been in development for a decade or more, these were scaled-up and readied for commercialization rapidly to meet the needs of pandemic response. The platform nature of mRNA technologies enables common CMC principles, but as application of this flexible technology expands from vaccines to therapeutics, CMC principles will need to diverge or adapt. The sessions will cover these CMC perspectives along with lessons learned and the outlook from both regulatory and industrial viewpoint. The presentations will be followed by a panel discussion with a focus on overcoming the CMC challenges of future mRNA therapeutics.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe and discuss the key CMC themes that enabled the rapid deployment of mRNA-based vaccines
  • Identify the key CMC challenges and potential common ground to overcoming these for the licensure of future mRNA-based therapeutics
  • Discuss regulatory and industrial perspective on key CMC issues on the development of mRNA-based products

Speaker(s)

Andreas Kuhn, PhD

CMC Development of an mRNA-Based Vaccine to Fight COVID-19 – Lessons Learned

Andreas Kuhn, PhD

  • Senior Vice President RNA Biochemistry & Manufacturing
  • Biontech SE, Germany
Keith Peden, PhD

Regulatory Perspectives for the Evaluation of the Quality, Safety and Efficacy of Prophylactic mRNA Vaccines

Keith Peden, PhD

  • Laboratory Chief, Laboratory of DNA Viruses, DVP, CBER
  • FDA, United States
Heide Vera Muckenfuß, DrSc

Panelists

Heide Vera Muckenfuß, DrSc

  • Quality assessor for viral vaccines
  • Paul-Ehrlich-Institut, Germany
Donald Parsons, PhD

Panelists

Donald Parsons, PhD

  • Vice President, Early Technical Development and LNP Process Development
  • Moderna, United States
Olen M. Stephens, PhD

Panelists

Olen M. Stephens, PhD

  • Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP
  • FDA, United States

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