De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool
When cell and gene therapy researchers step into the lab each morning, we envision transforming what may be an early stage experiment into a clinical success. Therapeutics developers spend years working tirelessly to generate pre-clinical data so that, when the time comes, their Investigational New Drug (IND) application (or equivalent outside the USA) will be accepted by the appropriate regulatory agency, allowing the therapy to enter clinical trials. However, IND approval is just the first of many significant hurdles that therapeutics developers face on the path to commercialization.