Path to IND - Moving from the bench to the bedside

The journey from promising preclinical discovery to human clinical trials represents a critical, yet complex, transition in drug development. Central to this transition is the successful submission of an Investigational New Drug (IND) application to regulatory authorities like the FDA. However, the path to IND is fraught with challenges, demanding rigorous scientific data, strategic planning, and a deep understanding of evolving regulatory expectations across preclinical development, Chemistry, Manufacturing, and Controls (CMC), and clinical trial design.

Greta Wodarcyk, PhD is a scientist and biotech executive with expertise bridging product development, preclinical/toxicology, CMC, and clinical operations with a record of successful regulatory filings and clinical operational efficiency. Greta is a Co-Founder and Principal of CatalystBio, an advisory firm dedicated to moving first-in-class, first-in-kind technologies off the bench and into the clinic. Previously, Greta was the Sr. Director of Clinical Operations and Program Development at COUR Pharmaceuticals, where she oversaw COUR's product development pipeline and led IND and clinical operations efforts, opening four INDs and building out COUR's internal clinical operations capabilities for early phase studies. Greta obtained her doctorate in biological sciences at Northwestern University and Bachelor of Arts in chemistry and in music from St. Olaf College.

Michael Boyne, PhD is an accomplished scientific professional and an unabashed drug developer, having served as a regulator, consultant, and executive in biotech. Michael is a Co-Founder and Principal of CatalystBio, a Global Life Sciences Advisory Firm dedicated to moving first-in-class, first-in kind technologies off the bench and into the clinic. Michael has authored ~50 peer-reviewed publications and is an internationally recognized speaker on drug development. He currently serves on the Executive Advisory Board for Northwestern's Chemistry of Life Process Institute and the Gower Foundation.