Ep. 261, Chapter 5: Nurturing A CDMO Relationship And Scaling Up With Amber Salzman, Ph.D.

20:08 – 23:20

Salzman highlights the crucial role a strong CDMO partnership had in Epic Bio’s manufacturing process, particularly for its lead candidate. The company's small team necessitated close collaboration with the CDMO, which Salzman credits to Epic Bio’s CMC lead, who fostered a strong partnership by treating the CDMO as an integral part of the team and showing mutual respect.

Also, Epic Bio's process was built with commercialization in mind from the beginning, a QbD strategy that streamlined interactions with the FDA. This thoughtful planning, combined with a positive working relationship with its CDMO, led to successful scale-up of the manufacturing process. The company is poised to have its first clinical data early in 2026.