03.04.21 -- 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.

The biotherapeutics market is evolving, and emerging companies are advancing cutting-edge therapies to keep pace with innovation. Although patient focus is constant, regulatory concerns and investment capital needs evolve as biopharma startups move their products from development to approval. This article addresses how early-stage biotherapeutic companies can avoid common pitfalls and access support while bringing novel therapeutics from research to market.

Gap analysis is defined as the process of reviewing all the available information for a candidate product to assess current development status, identify potential gaps in information, and determine the subsequent steps required to develop a strategy to fill those gaps. It is a fundamental and ongoing exercise. In a recent Business Of Biotech podcast, Dr. Valenzuela, CEO at Andes Biotechnologies, and Cristian Hernández-Cuevas, COO at Andes Biotechnologies, offered collective reflections and advice on gap analysis execution.

From its beginnings in 2016, Celularity Inc.’s Dr. Robert Hariri knew his company would face a particularly acute challenge with the FDA. The company’s therapeutic approach — the development of medicine from allogeneic placental-derived cells — is entirely dependent on its ability to do something that had never been done before: accomplish the at-scale harvest and preservation of healthy, postpartum fetal stem cells from maternity wards far and wide.