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.
May 11, 2022
Apr 26, 2022
Apr 12, 2022
Mar 29, 2022
Mar 16, 2022
Mar 2, 2022
If you are wondering how natural history studies are relevant to cell and gene therapy development, listen as Chris Kenwood, Principal Statistician with Veristat, ...
Feb 16, 2022
Developing a successful marketing application involves several strategic steps, as described by Kevin Hennegan, Senior Regulatory Strategist for Veristat. Listen as ...
Dec 16, 2021
The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for ...
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