03.03.21 -- Biotech Founders Share Insights On FDA, CMC, And GMP
As you gear up for your first-in-human studies, your chemistry, manufacturing, and controls (CMC) and medical affairs leaders will come together to play principle — and interdependent — roles in the success of those initiatives. On a recent episode of the Business of Biotech podcast, Dr. Perez, chief medical officer, and Dr. Ihle, VP of CMC and quality, at Bolt Biotherapeutics, Inc., shared their collective advice for emerging biotech leaders who are new to first-in-human studies.
While GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching chemistry, manufacturing, and controls (CMC) strategy. Dr. Shabbir Anik, chief technical operations officer at Sutro Bio, discusses his company’s holistic view of CMC and how it dovetails into its GMP quality assurance initiative and budgetary planning efforts.