IND Success: Navigate Through The Regulatory Gray

In biopharma, even the most foundational regulatory requirements leave room for interpretation. What is sterile, after all? Yet, a clinical hold can significantly prolong the time and increase the cost of drug development. Bioprocess Online Live welcomed seasoned veterans of the biologics regulatory space for a discussion on the common reasons for clinical holds, tips for avoiding and addressing them, and best practices on how to navigate regulatory nuance and improve your chances for smooth submissions on your journey from development to the clinic. Available on-demand thanks to the support of Thermo Fisher Scientific.