Articles tagged with “genome-editing”

FDA CGT Guidance 2026: Knowledge Reuse & CMC Submissions

Analyze the June 2026 FDA draft guidance on cell and gene therapies. Understand how reusing platform knowledge streamlines CMC submissions and development.

40 min read

5/16/2026

fda guidance cell and gene therapy cmc submissions platform knowledge genome editing regulatory affairs cgt development

AI Gene Editing: Analyzing the Eli Lilly-Profluent Deal

Examine the $2.25B Eli Lilly-Profluent deal. Learn how generative AI and protein design are creating novel recombinases for kilobase-scale genome editing.

40 min read

4/24/2026

ai gene editing generative protein design site-specific recombinases genetic medicine protein language models genome editing computational biology