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DIA/FDA Oligonucleotide-Based Therapeutics Conference


Session 6 Track C: Control Strategy and Regulatory Considerations for Manufacture of mRNA Drug Substance

Session Chair(s)

Silke  Klick, PhD

Silke Klick, PhD

  • Regulatory Director CMC
  • AstraZeneca, Sweden
Brian  Stultz, MS

Brian Stultz, MS

  • Staff Scientist, Division of Cellular and Gene Therapies
  • FDA, United States
This session will provide an overview of the manufacturing strategy for mRNA Drug Substance and how mRNAs differ from synthetic oligonucleotides. The presentations will address key critical quality attributes, describe control strategies, and provide a regulatory overview. The session will include a panel discussion on regulatory considerations for mRNA Drug Substance.

Speaker(s)

James D. Thompson, PhD

Manufacture and Control of mRNA Drug Substance

James D. Thompson, PhD

  • CMC Therapeutic Area Lead
  • Moderna Therapeutics , United States
Brian  Stultz, MS

Regulatory CMC Considerations for Oligonucleotide-based Gene Therapy Products: A CBER Perspective

Brian Stultz, MS

  • Staff Scientist, Division of Cellular and Gene Therapies
  • FDA, United States
Silke  Klick, PhD

Panelist

Silke Klick, PhD

  • Regulatory Director CMC
  • AstraZeneca, Sweden
Andreas  Kuhn, PhD

Panelist

Andreas Kuhn, PhD

  • Vice President RNA Biochemistry
  • BioNTech RNA Pharmaceuticals GmbH, Germany
James D. Thompson, PhD

Panelist

James D. Thompson, PhD

  • CMC Therapeutic Area Lead
  • Moderna Therapeutics , United States
Brian  Stultz, MS

Panelist

Brian Stultz, MS

  • Staff Scientist, Division of Cellular and Gene Therapies
  • FDA, United States
Christine  Swenson

Panelist

Christine Swenson

  • Head, Global Regulatory Affairs
  • Moderna Therapeutics, United States
John  Talian, PhD

Panelist

John Talian, PhD

  • Senior Vice President
  • CureVac, United States