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.

The traditional drug-centric trial model is failing. The next evolution is trials designed to validate the *decision-making process* itself, using platforms to assign the best therapy to heterogeneous patient groups, rather than testing one drug on a narrow population.

Instead of ad-hoc pilots, structure them to quantify value across three pillars: incremental revenue (e.g., reduced churn), tangible cost savings (e.g., FTE reduction), and opportunity costs (e.g., freed-up productivity). This builds a solid, co-created business case for monetization.

To be effective, the patient's lived experience cannot remain a "soft narrative." It must be converted into hard data points—like reduced healthcare utilization for payers or influence on treatment pathways for clinicians—to become a decision-making tool they cannot ignore.

In the rare disease space, success hinges on deep patient community engagement. Smaller, nimbler biotechs often excel at creating these essential personal ties, giving them a significant advantage over larger pharmaceutical companies.

A crucial piece of advice for biotech founders is to interact with patients as early as possible. This 'patient first' approach helps uncover unmet needs in their treatment journey, providing a more powerful and differentiated perspective than focusing solely on the scientific or commercial landscape.

Investing in clinical studies is not just for product validation; it's a powerful marketing strategy. It allows you to make scientifically-backed claims in ads that competitors cannot legally replicate, creating a significant and sustainable competitive advantage.

Instead of relying solely on traditional LPs, Vi Ventures actively brings in families affected by autoimmune diseases as for-profit investors. This model creates a community of highly motivated stakeholders, fostering accountability and a direct connection to the patient experience, while still maintaining market-rate return objectives.

To get company-wide buy-in for CRO, focus reporting on program-level metrics, not just individual test results. Share high-level insights like win/loss rates and cross-departmental impact in quarterly reviews. This frames CRO as a strategic business function, not just a series of tactical marketing experiments.