On Tuesday, May 16, 1:30 – 3:15 pm
DHC COO/MP Katy Spink will co-chair
Comparability Challenges for CMC
The above session includes:
Tal Salz on the topic of CGT Comparability from Here and There: Perspective of an ex-FDA Reviewer from 1:50 – 2:10 pm
On Wednesday, May 17, 8:00 – 9:45 am, as part of
Refinement of NHP usage in gene therapy drug development
Christina Fuentes will present on the topic of Diversifying away from NHPs.
On Friday, May 19, 2023, from 8:00 – 9:45 am,
Kevin Whittlesey will have two roles: first, as a speaker on the topic of Considerations for navigating a regulatory pathway for ultra-rare diseases from 8:50-9:15 am and then as a panelist on the topic of N=1 and Beyond: Small Patient Studies to Enable New Therapies for Genetic Disorders from 9:15-9:40.
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