Post-Discovery Priorities: Streamlining Your Molecule's Route To IND

Time to market is paramount for many companies starting to consider post-discovery development and strategic plans for bringing a molecule into clinical trials and beyond. Strategies and tactics for shortening timelines often involve trade-offs related to risk and future needs, making early-phase decision-making a balancing act for even the most promising molecules.

A panel discussion hosted in June by BIO Digital 2021 brought together four experts in post-discovery strategy to answer questions about critical considerations that impact timelines and commercialization and to share insights related to methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and lifecycle approaches. The panel was moderated by Sue Behrens, PhD, Rathmann Professor in Bioprocessing and Director of the Amgen Bioprocessing Center at the Keck Graduate Institute. The panelists’ responses to key questions about getting to first-in-human studies while establishing a strong foundation for future scale-up and commercialization are shared here.*

*Panelist responses have been edited for clarity and brevity.

Ruby Casareno, PhD
Senior Vice President of Technical Operations at Allakos, Inc.

John Foy
Vice President of Business Management at Thermo Fisher Scientific

Jonathan Zmuda, PhD
Director of Cell Biology at Thermo Fisher Scientific

Senior Director
of Manufacturing at Biopharma company