American Biotech Federalism 2.0 - Update Webinar (Invite-Only)
Strictly invite-only. Off the record.
Executive Context
US biotech is asked to compete with China while operating under a regulatory framework designed for a pre-AI, pre-platform era.
Federal leadership—across HHS and the FDA ecosystem—is actively exploring pathways to accelerate approvals, integrate real-world evidence, and deploy AI in regulatory decision-making. But achieving “China speed” through top-down reform alone is unlikely.
A complementary solution lies in a traditional American advantage: federalism.
The Thesis: American Federalism 2.0
States such as Texas, Florida, Utah, Montana, and New Hampshire are beginning to implement novel therapeutic access regimes—expanded Right-to-Try, state-regulated cell and gene therapy pathways, and alternative evidence-generation frameworks.
If properly structured, these state-level regimes can function as regulatory innovation laboratories:
Generating faster, lower-cost real-world outcome data
Enabling rapid manufacturing and clinical iteration
Acting as parallel launch markets that extend effective IP life rather than compress U.S. pricing windows
This approach preserves safety and oversight while unlocking speed, iteration, and learning—particularly for AI-native and platform biotech companies.
Discussion Framework
This is an off-the-record session with updated on the following topics:
State Programs:
Montana just released it's health department rules for SB 535; we'll provide a thorough update on what that means
New Hampshire's HB1734 and HB1735 are currently in session; it would be the most advanced in the country
Federal Efforts:
Update on efforts to build support for safe harbor policy for state-led pathways
Speakers:
Niklas Anzinger, Founder & CEO, Infinita
Stephen Martin, US Lead, Infinita
Ian Huyett, Founder, Granite Bio