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For cell and gene therapy programs, product quality is the leading cause of FDA clinical holds – more often than safety, toxicology, or clinical concerns.
In a funding-constrained biotech market, most early-stage teams still try to reinvent the AAV and advanced-therapy CMC playbooks the industry has already solved a dozen times over.
AspireBio Consulting, founded six years ago by Sarmitha "Sam" Sathiamoorthy, is the back-room CMC, regulatory and quality bench small biotechs reach for when they need someone who has already put an AAV gene therapy or an advanced therapy into the clinic. Trained in molecular and cellular biology, with experience spanning big pharma (Sanofi) and start-up organisations, Sam guides early- to late-phase clients across the full product development life cycle, with a hard focus on not over-building and not repeating work the regulator has already approved. Her pitch is simple – engage with someone who has done it before, then use that knowledge to streamline your data package, your IND filing, and your investor conversations.
At Meeting on the Med 2026, reporting for Onyx, Federico Citterich sat down with Sarmitha Sathiamoorthy to find out more.
A special thanks to our Onyx Live sponsors:
Cellares - delivering cell therapy manufacturing excellence at scale across a global network of IDMO smart factories https://www.cellares.com/
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