In Biotech, risk is removed pre-FDA approval via clinical trials, making a Chief Development Officer (clinical, regulatory, manufacturing) the most critical hire. In many MedTech sectors, risk is removed post-FDA approval via market adoption, making a Chief Commercial Officer paramount.

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Beyond vision and roadmaps, a CPO’s fundamental role is to act as a steward of the company's R&D investment. The primary measure of success is the ability to ensure that every dollar spent on development translates into tangible, measurable enterprise value for the business.

A CEO's primary role differs fundamentally based on company type. In an asset-centric biotech, the CEO must act as a hands-on program manager, micromanaging execution. In a platform company, the CEO must be deeply embedded in the science to predict and leverage the technology's long-term trajectory.

The old assumption that small biotechs struggle with commercialization ("short the launch") is fading. Acquirers now target companies like Verona and Intracellular that have already built successful sales operations. This de-risks the acquisition by proving the drug's market viability before the deal, signaling a maturation of the biotech sector.

The traditional product management skillset is no longer sufficient for executive leadership. Aspiring CPOs must develop deep expertise in either the commercial aspects of the business (GTM, revenue) or the technical underpinnings of the product to provide differentiated value at the C-suite level.

Successful biotech leadership requires a clear decision-making hierarchy. Dr. Bahija Jallal advocates for a framework where patient welfare is paramount, followed by scientific rigor. Financial success is treated as a byproduct of excelling in the first two areas, not the primary goal.

A common failure mode for well-funded biotechs is growing headcount too rapidly. Immunocore's CEO advises new leaders to pace themselves, emphasizing that drug development is a marathon. Prematurely scaling creates fixed expenses that can drain capital before key scientific milestones are hit.

Unlike software startups that can "fail fast" and pivot cheaply, a single biotech clinical program costs tens of millions. This high cost of failure means the industry values experienced founders who have learned from past mistakes, a direct contrast to Silicon Valley's youth-centric culture.

Unlike most biotechs that start with researchers, CRISPR prioritized hiring manufacturing and process development experts early. This 'backwards' approach was crucial for solving the challenge of scaling cell editing from lab to GMP, which they identified as a primary risk.

Amidst growing uncertainty at the US FDA, biotech companies are using a specific de-risking strategy: conducting early-stage clinical trials in countries like South Korea and Australia. This global approach is not just about cost but a deliberate move to get fast, reliable early clinical data to offset domestic regulatory instability and gain a strategic advantage.

The profile of a company prepared to go public has matured significantly. Unlike the 2020 boom where IND acceptance was a key milestone, today's IPO candidates typically need Phase 2 or even Phase 3 data, raising the quality bar but shrinking the potential pool of companies.