What Cell and Gene Therapy Investors Need to See First | Phil Vanek & David Crean

Phil Vanek, PhD, is Chief Commercialization Officer of the International Society for Cell & Gene Therapy (ISCT), chair of the CGT Catapult Technology Advisory Board and founder of Redline Bioadvisors. David H. Crean, PhD, MBA, is founder and managing partner of Cardiff Advisory and the author of Dual Fluency. They explain what a cell and gene therapy founder has to show before an investor conversation goes anywhere: a de-risked asset, evidence the biology is real, and a manufacturing plan that is not left to the appendix. They argue for writing the target product profile first, rank capital, reimbursement and manufacturing cost, compare how the US, the UK and Europe pay for advanced therapies, and explain why deals announced at JPM start many months earlier. (00:00) What founders have to show before the conversation starts(05:12) Target product profile: write the label first(09:53) Show me the data: AI, fabricated evidence, and the three pillars ranked(14:37) Who pays: reimbursement in the US, UK and Europe(19:16) The four-legged stool and the aducanumab lesson(25:10) Should you build to be acquired? Who really picks the asset(31:40) Why JPM deals start nine months earlier(36:06) Hardening the supply chain, and why science needs capital fluency(40:56) Career lessons, and killing a program that works(46:02) Mentorship and advice for emerging founders