The commercial function isn't just marketing. Its critical purpose is to ensure the healthcare delivery system is equipped to receive a new therapy. A great product is merely "table stakes"; adoption hinges on overcoming systemic barriers between regulatory approval and actual patient access.

Rather than waiting for late-stage development, biotech startups should integrate commercial planning into early trials. This means building in data collection for payers, pricing, and patient access from the start. This "think with the end in mind" approach ensures the company has the right data for pivotal trials and market access.

Don't wait until Phase 3 to think about commercialization. Biotech firms must embed secondary endpoints in Phase 2 trials that capture quality of life and patient journey insights. This data is critical for building a compelling value proposition that resonates with payers and secures market access.

Market access isn't a launch activity; it's a pre-launch strategy. Its most crucial input is during early clinical trial design, ensuring the right comparators and endpoints are chosen to satisfy payers years down the line. Post-hoc fixes are impossible.

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.

Disruptive MedTech ideas attract investment, but they are high-risk. Founders should de-risk these big bets by developing market access and commercial strategies simultaneously with product development, not after FDA approval.

Many biotechs focus R&D solely on regulatory approval. Beren Therapeutics integrates commercial thinking early to ensure clinical development answers a different question: Is what we're building meaningful to patients, payers, and providers? This de-risks the asset for commercial success, not just clinical milestones.

Biotech leaders must stop viewing commercialization as a post-approval task. The critical window is Phase 2 clinical trials. By embedding patient journey and quality of life insights into secondary endpoints, companies can build a compelling value proposition for payers and physicians. Waiting until Phase 3 is too late.

Acadia's R&D process starts by considering what will ultimately matter to patients, physicians, and payers. This "end in mind" approach ensures clinical trials are designed to demonstrate meaningful, commercially relevant benefits. It forces realism about a drug's potential impact early in development, avoiding wasted resources on therapies that won't be adopted.