Counter to the lean biotech model, Vivtex avoids outsourcing to CROs. The rationale is that only an internal team, whose survival depends on the technology's success, possesses the existential urgency to solve problems at the breakneck pace required—a speed external partners cannot match.

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.

Vivtex avoids outsourcing critical R&D because external partners and CROs cannot match the speed of a startup team whose very existence depends on solving problems quickly. This internal urgency is a core competitive advantage that is lost when relying on third parties with different priorities.

While operating a lean virtual model, Sarcomatrix's CEO advises against outsourcing three core functions. The CEO provides essential leadership, the company is ultimately responsible for quality systems regardless of its CROs, and owning the regulatory interface directly builds crucial credibility with agencies.

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.

To succeed, biotechs need open, "in the trenches" relationships with their development partners. Isaac Stoner expects his CROs and CDMOs to communicate problems immediately—"we want to know that yesterday"—allowing for real-time, collaborative troubleshooting rather than waiting for issues to escalate.

To ensure a robust tech transfer, biotech companies should first develop and optimize analytical assays internally. This establishes a deep understanding of product characteristics and process parameters before outsourcing, preventing downstream issues and ensuring the CDMO has a well-defined protocol to follow.

Companies, especially in early stages, should resist outsourcing production too quickly. Keeping a new process in-house is essential for understanding its pain points, which is a prerequisite for being able to specify clear, effective requirements to an external vendor later on.