Cereno Scientific chose a Phase 2b trial over a combined 2b/3 to maintain flexibility. A combined trial locks in the design for both phases upfront, whereas a standalone 2b allows for optimization before Phase 3 and creates a cleaner, more attractive asset for a potential acquisition deal.
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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.
The AI-driven antibody engineering firm is moving its lead TSLP compound directly from Phase 1 into two Phase 3 trials. This aggressive timeline demonstrates platform confidence but introduces significant clinical risk by skipping a key data-gathering stage.
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.
Running an unusually long, two-year Phase 2 trial allowed Vera to demonstrate stabilization of GFR, a hard kidney function endpoint. This robust, long-term data was crucial for de-risking their Phase 3 program and ultimately securing a coveted Breakthrough Therapy Designation from the FDA, accelerating their path to market.
ProKidney made the tough call to stop its second Phase 3 study to save $150-170M. This strategic trade-off allowed them to focus resources on the primary US trial under its RMAT designation and crucially extend their cash runway past the 2027 data readout, a vital move for survival in a tough biotech market.
Despite FDA readiness for a final Phase 3 trial, Connect Biopharma chose to run more Phase 2 studies. They discovered their long-term asthma drug worked in hours, not weeks, and are now pivoting to prove its value in acute, emergency situations, which informs a stronger, more targeted Phase 3 design.
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.
Rather than waiting for positive Phase 2 results, Transgene is using part of its €105M financing to prepare its manufacturing processes for a potential Phase 3 trial. This strategic foresight aims to prevent manufacturing delays and accelerate the timeline to market if the data is successful.
The GLORA-IV trial is designed with a dual endpoint, evaluating both patient response rate and overall survival. This structure creates an alternative pathway for regulatory approval based on response rates, which can be assessed faster than survival, strategically de-risking the lengthy and expensive trial process.
Repro Novo licensed a drug that did not meet its primary endpoint in a prior Phase 2b trial. They identified a positive signal in an exploratory endpoint—improved semen quality—and built their new clinical strategy around making that the primary endpoint, salvaging a potentially valuable asset.
