Aligning mRNA Progress With Regulatory Streamlining - Episode 4

Streamlining Rare Disease Drug Development

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The discussion explores how the principles of Operation Warp Speed can be applied to expedite rare disease therapeutic development through a new FDA pilot program aimed at streamlining the drug development process.

EP. 1: The Benefits of Working with mRNA for Therapeutics
EP. 2: Public Perception and Communicating the Potential and Safety of mRNA
EP. 3: Lessons from Vaccine Development and Future Possibilities
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EP. 4: Streamlining Rare Disease Drug Development
EP. 5: Navigating Challenges and Embracing Opportunities to Optimize mRNA Therapies
EP. 6: Overcoming Delivery Challenges of mRNA Therapeutics
EP. 7: The Future of Manufacturing, Safety, and Collaboration
EP. 8: Key Takeaways from the Peer Exchange Discussion “Aligning mRNA Progress with Regulatory Streamlining”

The conversation centered around the potential of mRNA technology for therapeutic development, with a focus on project management, meeting efficiency, and the challenges of mRNA production.

Discussion Topics

  • 00:00 - Core aspects of CMC for mRNA as a shared platform for cGMP compliance
  • 2:17 - Adapting mRNA manufacturing processes to quickly produce vaccine variants
  • 5:18 - Differences in quality and purity of mRNA products from various manufacturers
  • 6:12 - Developing guidelines to accelerate rare disease drug development, similar to Operation Warp Speed