NCRAF is fortunate to have long-time members who are willing to share the benefit of their experience with others. For our February talk, Will Lee has generously volunteered to talk about some of the more notable lessons learned from filing INDs during his 20+ years in the field.
Will Lee is Vice President, Regulatory Affairs at Cato Research, a CRO based in Durham. He has more than 20 years’ experience in regulatory affairs dealing with small-molecule drugs, devices, and biologics. His focus is on biologics, mainly cell therapy and gene therapy. Before joining Cato Research, he was Principal Scientist at Viagene/Chiron, a gene therapy start-up based in San Diego. He holds a Ph.D. in Genetics from Cornell University.