Insights
Practical thinking on CMC strategy, regulatory navigation, and the realities of taking a biologic from bench to first-in-human.
A pre-IND meeting with FDA is one of the most valuable tools available to a development-stage company — and one of the most frequently misused. Here's how to walk in prepared and walk out with actionable guidance.
Selecting a contract development and manufacturing organization is one of the highest-stakes decisions in early biologics development. Experience overseeing CDMO relationships reveals the questions that separate capable partners from costly ones.
iPSC-derived programs carry a unique set of CMC complexities that differ substantially from conventional biologics. Drawing on direct experience authoring a first-in-human IND for autologous iPSC-derived cardiac cells, this piece covers the issues that routinely catch teams off guard.
Receiving a clinical hold is not the end of the road — but how you respond determines whether you emerge stronger or stall indefinitely. A structured approach to crafting responses that satisfy FDA and advance your program.
For early-stage companies preparing for their first GMP manufacturing campaign, the quality system can feel like an insurmountable bureaucratic hurdle. It doesn't have to be. A phased approach that scales with your program.
FDA's expedited designation programs offer real advantages — but only when pursued strategically and at the right moment. A clear-eyed look at eligibility, timing, and what each designation actually delivers.
If something you read here connects to a challenge you're facing, I'd welcome the conversation. Most of the best consulting relationships start with a single direct question.
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