American Federalism 2.0 - State-Regulated Pathways for Biotech Acceleration w/ Special Guest Jim O'Neill (DepSec, HHS)
The doors are open from 9am for networking & coffee, the talks will start at 10am. The capacity is highly limited - please cancel if you're not able to make it, to give the spot to someone else.
Executive Context
As JPM 2026 centers on GLP-1s, AI-native drug discovery, and capital scarcity, a structural reality has become impossible to ignore:
Western biotech is being asked to compete with China while operating under a regulatory framework designed for a pre-AI, pre-platform era.
Eli Lilly’s CEO has publicly warned that when access in mature markets is delayed by three to five years, patents are often nearly exhausted by the time patients receive new therapies—compressing returns and undermining the economics that fund future R&D. At the same time, China is executing faster development cycles at materially lower cost, creating mounting pressure across global biopharma.
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 off-the-record session will explore three core questions:
1. Competitive Strategy
What would it mean for large pharma and scaled biotechs if U.S. states—and aligned partner jurisdictions—could serve as parallel launch markets, generating real-world evidence earlier while preserving long-term value?
2. AI-Native Drug Development
How would TechBio and platform companies operate if they could run more, smaller, faster human studies under safety-anchored state oversight—unlocking innovation through iteration rather than delay?
3. Patient Access Without Medical Tourism
Can patients and payors gain earlier access through Right-to-Try, state Right-to-Treat, and allied international frameworks (e.g., Australia’s CTN) while maintaining rigorous ethics, shared standards, and interoperable data?
Agenda
9-10am Networking & Coffee
10 - 10.05am Introductory Remarks
Jim O’Neill, Deputy Secretary, US Department for Health and Human Services (HHS)
10.05-11am Panel & Open Q&A
Joe Betts-Lacroix, CEO, Retro Biosciences
Jason Kelly, CEO, Gingko Bioworks
Patrick Malone, Partner, KdT Ventures
Niklas Anzinger, Founder & CEO, Infinita
Dr. Kevin Bardosh, PhD, Foundation for American Innovation, DC Strategists
What Will Be Shared
Panel will outline how a federalism-first, safety-first approach could reshape the global competitive landscape for U.S. and allied biopharma—and what signals investors and executives should track across Washington, state capitals, and key international markets.
Infinita and DC Strategists will present concrete, already-emerging structures, including:
State-chartered ethics and therapeutic access boards
Allied-jurisdiction trial and treatment hubs
Cross-border data and evidence frameworks operating fully within U.S. oversight
These mechanisms allow companies to test accelerated pathways now, without regulatory arbitrage or reputational risk.
Audience
A tightly vetted group of:
Pharma and biotech executives
R&D and regulatory leadership
Institutional investors and specialist VCs
Strictly invite-only. Off the record.