

【BioSpark RoundTable】Drug development reflection - What If Phase 1 Was Enough?
On May 17, 2025, Montana State announced a groundbreaking policy shift: drugs can now be commercialized after Phase 1 trials, bypassing traditional Phase 2 and 3 requirements. Wild idea, right? Or maybe it’s the start of something? Whether this becomes a blueprint or an outlier, it invites us to reimagine the foundations of drug development.
At this closed-door discussion, we’ll bring together drug developers, biotech builders, and policy thinkers to explore this potential paradigm shift: What if drug development actually did stop after Phase 1? What opportunities would that open up? What risks would explode? And what frameworks—regulatory, financial, ethical—would be needed to make such a system even even minimally viable?
This is not a debate, but a mind-stretching exercise in future thinking. Bring your sharpest questions, wildest ideas, and an open mind. Let’s stretch the edges of what drug development could look like.
Biotech folks, thinkers, and skeptics welcome.