Many medtech companies design large trials where a tiny, clinically meaningless response can be statistically significant. Dr. Holman advises entrepreneurs to instead run rigorous trials that prove genuine clinical value, arguing that credible data is the ultimate moat, even if it carries a higher risk of failure.

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.

Many firms view patient engagement as a compliance task that adds cost. However, data shows integrating patient experience into development from the start speeds up clinical trial recruitment and execution, reduces FDA amendments, and accelerates time-to-market, providing clear ROI.

The "time is lives" mantra also applies to the companies themselves. For single-asset biotechs with short financial runways, trial delays can bankrupt the company before the drug has a chance. "Time to first patient" is a critical business milestone, not just a clinical one.

Before starting a trial, define specific safety and efficacy alarms or 'stop rules.' This disciplined approach allows a company to terminate a failing study early, preserving capital and resources, rather than waiting until the end to discover the results are not viable.

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.

Scientists often design trials to answer every possible academic question, which adds complexity and patient burden. Drug development trials should be ruthlessly focused on two things only: safety and efficacy. All other extraneous research can wait for post-approval studies.

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.