driving programmes
to the clinic
“When your Board discusses CMC, you know you have a problem.”
— Joan Perelló Bestard, Ysios Capital
For any biotech, the focus is usually on the target, the mechanism of action, the preclinical models, and the clinical study design. You can do everything right on the science—and still see timelines and budgets derailed because you did not pay attention to some “boring” CMC topics.
Chemistry, Manufacturing and Control (CMC) is fundamental to drug development, from the earliest stages through to market approval. It covers everything from the manufacturing of drug substance to final product formulation and packaging, ensuring that the drug meets required quality standards. Adherence to regulatory guidelines is essential to secure approval for your Clinical Trial Application. Focussing on CMC from the beginning plays a vital role in minimizing risks and reducing costs across all phases of drug development.
What does stage-appropriate development look like?
- Early clinical development
CMC is almost always on the critical path for starting Phase 1. Avoid overdeveloping your product at this stage: limit changes to API syntheses and use a simple formulation with limited stability, sufficient for your study needs. Address IMPD gaps efficiently during regulatory review rather than re-engineering the entire program upfront. Late-stage / exit preparation
A Phase 3-ready asset is critical for valuations at exit. Demonstrate reliability and robustness of your supply chain, and ensure sufficient product for clinical supply. Your goal is a program that allows a buyer to “hit the ground running” on pivotal studies, with no major CMC or supply surprises
Every biotech needs a CMC person on the team—someone who can work with clinical to estimate the supply needs for a study, who spots potential pitfalls in a chemical synthesis, and who provides convincing answers to authority questions. A dedicated CMC voice in the room where decisions are made.
Investors and boards increasingly view CMC readiness as a leading indicator of whether an asset will reach market—and whether the equity story will hold. For founders, the message is simple: in today’s environment, your CMC strategy is part of your investment thesis. Treat it that way from day one.
Willuhn Consulting offers fractional CMC leadership for exactly this purpose: senior-level expertise and accountability, integrated into your management team, without the overhead of a full-time hire.
What are fractional resources?
- “Part of a person” rather than “part of the job”
You engage a senior specialist on a part-time or retained basis instead of hiring full-time. You get a fraction of their time but can still expect full accountability for the scope they own. Time commitment can be flexible, enabling future scale-up or scale-down.
- Embedded expert
You get direct access to deep technical knowledge and hands-on leadership within your team. Seasoned professionals operate as if they were internal, driving results without the overhead of permanent staff.