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Bethesda North Marriott Hotel and Conference Center

Apr 25, 2022 7:00 AM - Apr 27, 2022 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

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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