Cell and gene therapies have made impressive clinical progress but continue to face big hurdles. Nothing is standard about study design, study conduct or regulatory process in this specialized area.
Below is a series of podcasts where experts address key elements of what it takes to bring these revolutionary therapies to market.
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Nov 17, 2021
Post-marketing requirements within the European submission process offer conditional approval more flexible than FDA. Rachel Smith, Portfolio Director for Veristat, ...
Nov 6, 2021
The selection of endpoints for a clinical trial relies on clinical relevance combined with statistical reasoning. Robin Bliss, VP of Strategic Consulting for ...
Oct 21, 2021
Aug 12, 2021
Scaling up from phase 1 to global phase II/III trials to beyond marketing approval has several implications on a sponsor’s commercial strategy. Hear from Rachel ...
Jul 15, 2021
Jul 1, 2021