CMC Considerations For First In-Human Studies

As you gear up for your first-in-human studies, your CMC (chemistry, manufacturing, and controls) and medical affairs leaders will come together to play principal—and interdependent—roles in the success of those initiatives. 

Drs. Edith Perez and Nathan Ihle have both been down this road on multiple occasions, Dr. Perez in patient-centric leadership positions at Genentech and The Mayo Clinic, among others, and Dr. Ihle in manufacturing management positions with the likes of Merck, Seattle Genetics, and Immunomedics.

Currently, Dr. Perez serves as Chief Medical Officer and Dr. Ihle, VP of CMC and Quality at Bolt Biotherapeutics, Inc. On a recent episode of The Business of Biotech podcast, Drs. Perez and Ihle shared their collective advice for emerging biotech leaders who are new to first-in-human studies. Here’s a sample of what they shared.