A Complete Response Letter (CRL) from the FDA due to manufacturing issues can destroy a biotech. CEO Ron Cooper warns leaders to invest heavily in Chemistry, Manufacturing, and Controls (CMC) early, even when the cost exceeds the clinical trial spend. This early investment in professionalizing CMC is critical to de-risk the company's future.

The build vs. outsource decision is strategic. Building in-house is justified when manufacturing is a core competitive advantage or the process itself is your key IP. Otherwise, outsourcing to a CDMO offers critical speed to clinic and preserves capital.

A simple heuristic for the build-vs-partner decision: Does your manufacturing process create unique intellectual property? If so, own it. If it merely consumes capital, partner with a CDMO. This preserves precious resources for R&D, clinical evidence, and commercialization.

A great molecule isn't enough to attract investment. Scientists must demonstrate they've considered manufacturing from day one. Designing a robust process that fits a consistent GMP facility shows investors that the project is not just a scientific curiosity but a viable path to a scalable product.

For small biotechs, the playbook for success extends beyond scientific discovery. It requires creativity and innovation in the operational process itself—finding efficient paths through regulatory checkpoints, securing non-traditional funding, and leveraging external resources to advance development with limited capital.

According to Novartis's CEO, a top reason for rejecting potential biotech partners is their underinvestment in Chemistry, Manufacturing, and Controls (CMC). Startups often neglect this unglamorous work, leading to deal failure because the acquirer can't be sure the drug can be scaled efficiently and safely.

Instead of building costly in-house GMP capabilities early on, a more effective strategy is to concentrate on the core preclinical science. By partnering with established CDMOs and consultants for the translation to GMP, startups can de-risk development and accelerate their timeline to an IND filing.

The primary challenge for many MedTech innovations is not the initial science but translating a lab process into a robust, scalable, and GMP-compliant manufacturing system. This requires a shift from proving a concept to ensuring consistent quality and patient safety.

To leverage modern, faster FDA pathways for biosimilars, robust analytical data demonstrating biosimilarity is critical. Therefore, a startup's choice of a Contract Development and Manufacturing Organization (CDMO) should hinge on their analytical expertise, which can reduce or eliminate the need for lengthy clinical trials.