Getting CMC Right For Emerging Technologies

Establishing a chemistry, manufacturing, and controls (CMC) strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics. This is often a herculean effort. Defining the manufacturing processes and product specifications that will help ensure product safety, quality, and consistency necessitates a complex, intensive evaluation that evolves as a program scales.

Shabbir Anik, Ph.D., has amassed decades of experience supporting new drug applications (NDAs) and investigational new drug (IND) filings at companies like Sutro Biopharma, Onyx Pharmaceuticals, Patheon, and Althea Group. This broad background has afforded Dr. Anik a wealth of expertise on executing a successful IND or NDA, avoiding clinical holds, and ultimately achieving regulatory approval. In an episode of The Business of Biotech podcast, Dr. Anik sat down to discuss how companies can develop a CMC strategy that balances near-term financial and logistical considerations with long-term regulatory and commercial goals.