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.

To ensure a successful drug launch, biotech companies must start their commercialization planning at least 18 months in advance. This lead time is essential for deeply understanding the patient journey, identifying treatment barriers, and aligning clinical trials with outcomes that truly matter to patients and payers.

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.

Iolyx CEO Elizabeth Jeffords insists on commercial input even in preclinical stages. This meant killing an ointment formulation—which patients find 'greasy' and 'disgusting'—in favor of developing a more patient-friendly eyedrop. This avoids creating a product that is clinically sound but has poor real-world adoption.

For a successful drug launch, biotech companies must abandon a sequential, siloed approach. The key is to start early, using an agile model where all functions (medical, commercial, regulatory) work in an integrated way from the outset. Rushing this complex process leads to costly mistakes.

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.

Don't wait until after FDA approval to think about reimbursement. Smart biotechs engage with payers early and build payer-valued outcomes directly into Phase 2/3 trials. This creates a ready-made value dossier for payers alongside the regulatory submission package.