Feature|Videos|July 18, 2024
Streamlining Rare Disease Drug Development
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.
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Episodes in this series
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
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Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
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