What's in an IND? Guide to Writing IND For Biologics

This talk was presented by Dr. Zahra Shahrokh, a NINDS consultant at STC Biologics. Dr. Shahrokh addresses the requirements to file an Investigational Drug Application for a biologic therapy and describes the different sections of the IND with a focus on therapeutic proteins. The presentation ends by providing examples of common deficiencies and mis-steps that Sponsors are likely to make.