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Ona Therapeutics maintains a small team by following a simple rule: outsource functions that external experts can do better (like CROs and manufacturing) at a reasonable price. This allows them to focus all internal resources on their core, specialized competency of designing novel molecules and advancing their pipeline.
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.
To solve the critical challenge of hiring expensive, specialized talent, Curie.Bio offers its portfolio companies access to a 100+ person team of elite "drug makers" on a fractional, at-cost basis. This provides world-class expertise on demand without the burden of full-time payroll, de-risking early development.
Biotech companies create more value by focusing on de-risking molecules for clinical success, not engineering them from scratch. Specialized platforms can create molecules faster and more reliably, allowing developers to focus their core competency on advancing de-risked assets through the pipeline.
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.
Actuate Therapeutics maintains high capital efficiency by keeping its full-time headcount low. The company is built around a trusted core team and supplemented by an extensive stable of "best of breed" consultants who are engaged on an as-needed basis, minimizing overhead costs.
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.
Founders must distinguish between core competencies unique to their brand (e.g., product design) and commodity tasks (e.g., warehousing). Commodity functions should be outsourced to experts who benefit from economies of scale, freeing up internal resources to focus on what creates true differentiation.
To manage the long, costly timeline of therapeutic development, a biotech can create revenue-generating subsidiaries. One can offer its platform as a service (like a CDMO), while another sells lower-regulation products like cosmetic ingredients for faster market entry. This provides crucial cash flow to sustain the core drug pipeline.
The primary driver for outsourcing in the pharmaceutical industry is no longer just a need for more manufacturing capacity. It has strategically shifted towards seeking specialized expertise and partnerships, particularly in complex areas like CMC (Chemistry, Manufacturing, and Controls) where the process defines the product.