Ep. 384 - Back to School Special: The global FIH trials race

The podcast features BioCentury analysts discussing a comprehensive 10+ story back-to-school package analyzing how different regulatory jurisdictions are reforming first-in-human trial pathways. Simone Pott opens by framing the issue not as competition with China but as patient access and opportunities to modernize outdated drug development timelines. She emphasizes that the core problem involves two competing impulses: managing safety risk while avoiding excessive control mechanisms (overlapping reviews by IRBs and regulators) that create inefficiencies without adding rigor.

Steve Usdin details US efforts divided into pre-IND (mechanical improvements achievable under current FDA authority) and post-IND reforms (requiring legislative changes tied to medical user fee reauthorization by September 2025). He notes 73% convergence across four reform proposals (Reagan-Udall, Duke-Margolis, Operation Trial Blazer, and Representative Auchincloss's discussion draft), indicating these changes represent non-controversial low-hanging fruit. Key US proposals include QRIs (Qualified Research Institutions) to help small biotechs develop pre-IND packages, establishing phase one units outside academic medical centers, and potentially adopting Australia's clinical trial notification pathway.

Lauren Martinez explains Australia's competitive advantage: dedicated phase one units, a 43.5% R&D tax refund for qualifying companies, and a notification system (rather than approval requirement) for standard healthy volunteer studies. However, Australia is reaching capacity and facing competition as other nations adopt similar timelines. Australian CROs are responding by blending phase one healthy volunteer studies with phase two patient data collection and creating online registries to streamline multi-site trials.

Selena Gomez analyzes China's dual pathways: the standard IND route (regulatory timeline not substantially faster than the US) and the investigator-initiated trial (IIT) pathway for cell/gene therapies (increasingly regulated). Data shows US biotech sites in China doubled from 3% in 2021 to 6% in 2025—significant but not the "flocking" narrative suggests. China's real advantage lies in rapid patient accrual through concentrated medical centers on the East Coast, direct specialist enrollment (bypassing primary care gatekeeping), and fast iteration cycles benefiting Chinese companies. Recent IIT regulatory changes are making that pathway more stringent.

Stephen Hansen highlights European developments: Denmark launched a 14-day expedited process for phase one trials using centralized ethics review and queue prioritization, creating competitive speed globally for small biotechs seeking modest patient cohorts. Spain emerged as Europe's leading regulator for clinical trial reviews despite its size, handling the most applications since 2022 and leading the FAST EU initiative. The UK is pursuing NHS integration of trials into routine care alongside notification schemes for low-risk studies. Belgium is also advancing expedited services. Stephen clarifies that best-case timelines (14 days) exclude validation periods and assume no information requests.

Jeff Cranmer's Asia-focused reporting reveals that Japan, Korea, Taiwan, and Singapore are pursuing a different strategy than Australia: rather than becoming standalone FIH hubs, they focus on facilitating inclusion in multi-regional trials by accepting foreign regulatory approvals and trial designs, reducing duplication.

The podcast concludes with recognition that reciprocal peer recognition across IRBs and agencies (honoring qualified decisions made elsewhere) and embedding clinical trials into routine healthcare represent the core systemic changes needed. Simone notes momentum for change is past a critical point across all regions, though infrastructure investment and government expenditure will slow implementation of integrated trial-care systems.