Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1)

By Kimberly Chew and Odette Hauke

China now registers more clinical trials than the United States. In 2024, China surpassed the U.S. in total registered trials — more than 7,100, roughly 39 percent of the global total¹ — a crossover that would have been hard to imagine a decade ago, and the clearest signal yet that competitive pressure has moved upstream to how trials start rather than how drugs are approved. Operation TrialBlazer, the HHS road map announced on June 22, 2026, is the most ambitious U.S. response to that trend to date.

The initiative diagnoses the problem correctly and takes real steps toward solving it. But its center of gravity is the regulatory portion of the pre-trial timeline — IND quality and review — while the operational bottlenecks that actually determine speed-to-first-patient remain largely unaddressed. The FDA’s comment window on the Expedited IND pilot (Docket No. FDA-2026-N-4699) closes July 22, 2026, a narrow opening to shape the pilot before it launches.² This article — the first of two — identifies where the initiative succeeds and where the structural gaps begin. Part 2 addresses the legal architecture, compliance asymmetries, and what sponsors should say before the comment deadline.

What The Pilot Gets Right

Pre-IND uncertainty is a real problem, and qualified research institutions (QRIs) — the network of academic medical centers, health networks, CROs, and regulatory advisors the pilot would establish — are a credible response to it. Sponsors without a standing regulatory affairs function, particularly smaller biotechs and academic programs, routinely spend months assembling an IND package without a reliable read on whether the FDA will accept their CMC approach, their nonclinical package, or their proposed starting dose. That uncertainty is expensive in two directions: It inflates the defensive work sponsors do to preempt questions they cannot anticipate, and it produces submissions that draw information requests or clinical holds that earlier alignment would have resolved. A qualified institution that gives sponsors an informed, FDA-aligned reading before formal submission attacks that uncertainty at its source.

Parallel IRB review and site activation is the right conceptual move. Among the responsibilities the RFI proposes for QRIs is “supporting parallel activities such as IRB review and clinical trial site activation to facilitate timely trial initiation.”³ If the pilot delivers on that language, it begins to dismantle the sequential, one-step-at-a-time structure that is the single largest source of avoidable delay in U.S. start-up.

The CMC and dose selection reforms address specific, identifiable sources of pre-IND delay. Phase-appropriate CMC expectations reduce the overpreparation sponsors undertake when the required standard is unclear; the FDA’s own example is the submission of full long-term stability packages where data covering the proposed Phase 1 duration would suffice.⁴ Model-informed dose selection replaces conservative iterative dose justification with a quantitative path. Both target concrete delay, not abstract efficiency.

What China And Australia Actually Do Better

The U.S. IND review clock is rarely the variable sponsors are waiting on. The statutory 30-day period after which a study may proceed absent a clinical hold (21 CFR 312.40) is, on paper, competitive; China’s 2018 reforms grant implied approval if its Center for Drug Evaluation raises no objection within 60 working days,⁵ and Australia’s notification pathway involves no agency protocol review at all. The FDA’s own road map concedes the point — U.S. INDs take effect 30 days after receipt, “comparable to China and Australia.”⁶ On the narrow question of how long the regulator takes, the U.S. is not the outlier.

The bottleneck is everything between IND readiness and first patient dosed. In the U.S., that path runs sequentially: nonclinical and CMC work completed under uncertainty, protocol development and internal review, IRB review, and, most consequentially, site contracting and activation. The numbers in the FDA’s own road map are stark. The interval from pre-IND meeting request to IND submission averages 380 days, with a range approaching 700. Once an IND is in hand, IRB approval and contract negotiation can add up to 13 months before a single patient enrolls, and site activation routinely exceeds 160 days against the National Cancer Institute’s 90-day gold standard.⁷ These delays are structural, not regulatory.

China and Australia’s advantage is not a faster clock; it is an integrated system that also governs what happens after approval. Australia’s Clinical Trial Notification scheme inverts the U.S. order of operations: a Human Research Ethics Committee reviews and approves the trial first, the sponsor then notifies the Therapeutic Goods Administration, and the TGA does not re-review the protocol. Trials can begin in fewer than 70 days from final protocol, with ethics approval in 21 to 28 days and sites activated within six to 12 weeks.⁸ A standardized national clinical trial agreement template removes much of the site-by-site contract negotiation that stalls U.S. start-up, and a 43.5 percent refundable R&D tax offset sharpens the incentive further.⁹ China pairs implied approval with a mechanism the U.S. lacks entirely: Its 2025 reforms add an optional 30-working-day review track for eligible innovative drugs and require applicants to commit to initiating the trial within 12 weeks of application.¹⁰ Approval and initiation are treated as one continuous obligation, not two disconnected phases.

The implication for Operation TrialBlazer is direct. A pilot that improves IND submission quality but does not touch site activation speed or participant access will not close the competitive gap, because the gap was never primarily about the IND clock.

The Missing Metric: Enrollment Infrastructure

The pilot’s qualification criteria require the right infrastructure but set no standard for how fast it performs. The RFI asks QRIs to demonstrate “clinical trial infrastructure supporting Phase 1 studies, including IRB and clinical trial site capabilities,” alongside expertise in pharmacology-toxicology, clinical development, CMC, and regulatory affairs.¹¹ Those criteria test whether the infrastructure exists. They say nothing about whether it moves.

That distinction is the whole problem. A QRI can hold a fully staffed IRB and an affiliated site network, satisfy every criterion listed, and still leave the sponsor exactly where it started if those sites take eight months to contract and activate. Capability is not speed. Regulatory advisory quality and start-up velocity are different competencies, held by different functions and measured in different ways. Qualifying an institution on the first while staying silent on the second re-creates the sequential bottleneck the pilot exists to break, now with an advisory step in front of it.

The RFI compounds the gap on the evaluation side. It asks commenters what metrics should define pilot success and lists time, quality, and safety as categories to address (Question B.3.ii), but it does not itself commit to measuring time-to-first-patient — as distinct from time-to-IND-clearance — as a success criterion. A pilot assessed only on submission quality and review speed will report success on the metrics it chose to measure while the competitiveness problem it was created to solve goes untouched.

Two corrections are available now, in the comment record. First, qualification should require a demonstrated activation and enrollment track record — historical site activation timelines, prequalified site networks, evidence of participant identification infrastructure — not merely the existence of IRB and site capabilities. Second, the evaluation framework should define time-to-first-patient-dosed as a primary success metric from the first cohort. What the pilot measures at launch will define what QRIs are built to deliver; enrollment performance must be in that measurement set from day one.

What Comes Next

Operation TrialBlazer is a serious effort that deserves serious engagement. The QRI framework, rolling IND review, updated CMC guidance, and dose selection reforms all target real problems. But the initiative will close the gap with China and Australia only if QRIs are evaluated on the full pretrial timeline — site activation and enrollment included — rather than on regulatory submission quality alone.

Part 2 of this series addresses the legal architecture the pilot leaves unresolved: the Anti-Kickback Statute questions raised by the QRI fee structure, the compliance asymmetry between academic medical centers and commercial CROs, and the specific comments sponsors should submit before the July 22 deadline.

References:

1. U.S. Dep’t of Health & Human Servs., Operation TrialBlazer: HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development (June 22, 2026) (China surpassed the U.S. in total registered trials in 2024: more than 7,100 trials, roughly 39 percent of the global total).
2. U.S. Food & Drug Admin., Request for Information: Expedited Investigational New Drug (IND) Pilot Program, 91 Fed. Reg. 37,996 (June 24, 2026) (Docket No. FDA-2026-N-4699). Comments due July 22, 2026.
3. FDA RFI, supra note 2, at 37,998 (“supporting parallel activities such as IRB review and clinical trial site activation to facilitate timely trial initiation”).
4. HHS TrialBlazer Roadmap, supra note 1 (phase-appropriate CMC expectations; FDA example: submission of full long-term stability packages where data covering the proposed Phase 1 duration would suffice).
5. Nat’l Med. Prods. Admin. (China), Announcement No. 50 (2018) (implied approval: a clinical trial application is deemed approved if the Center for Drug Evaluation raises no objection within 60 working days of acceptance).
6. HHS TrialBlazer Roadmap, supra note 1 (“U.S. INDs take effect 30 days after receipt, ‘comparable to China and Australia.’”).
7. HHS TrialBlazer Roadmap, supra note 1 (U.S. start-up-timeline figures: pre-IND meeting request to IND submission averaging 380 days; IRB approval plus contract negotiation up to 13 months; site activation routinely exceeding 160 days against the NCI’s 90-day standard).
8. HHS TrialBlazer Roadmap, supra note 1 (Australia Clinical Trial Notification scheme: ethics approval in 21 to 28 days, sites activated within six to 12 weeks).
9. Austl. Tax’n Office, Research and Development Tax Incentive: 43.5 percent refundable offset for companies with aggregated turnover under AUD $20 million (2025–26 and 2026–27 income years).
10. Nat’l Med. Prods. Admin. (China), Announcements No. 40 (2025) and No. 86 (2025) (optional 30-working-day review track for eligible innovative drugs, with a commitment to initiate the trial within 12 weeks).
11. FDA RFI, supra note 2, at 37,998–99 (QRI qualification criteria, including required demonstration of “clinical trial infrastructure supporting Phase 1 studies, including IRB and clinical trial site capabilities”).

About The Authors:

Kimberly Chew is co-lead of Husch Blackwell’s Psychedelic and Emerging Therapies practice group. She  guides clients through every stage of development, from clinical trial agreements and research collaborations to regulatory compliance and enforcement matters. She represents drug developers, biotechnology companies, and startups, often helping new ventures address early-stage challenges such as corporate formation, trademarks, and governance by collaborating with firm colleagues to deliver integrated legal solutions tailored to each client’s goals and stage of development. She may be reached at Kimberly.Chew@huschblackwell.com.

Odette Hauke is a regulatory scientist and drug development advisor specializing in psychedelic, controlled-substance, and first-in-class therapeutics for serious conditions with significant unmet medical need, with a focus on neuropsychiatry, rare disease, and women’s, maternal, and pediatric health. She is the founder of Regulatory Atelier, a regulatory strategy consultancy operated through Odette Alina, LLC. Across 13 years of global regulatory affairs practice at AtaiBeckley, Vera Therapeutics, Travere Therapeutics, Regeneron, and Memorial Sloan Kettering Cancer Center, she has led regulatory strategy for psychedelic IND programs involving R-MDMA, DMT, and ibogaine. Her expertise spans IND and BLA/NDA strategy, regulatory intelligence, controlled-substance development, AI-enabled regulatory analysis, and direct engagement with the FDA, DEA, EMA, MHRA, and Health Canada. She holds a M.S. in regulatory science from Northeastern University, a certificate in psychedelic science and medicine from Johns Hopkins University, and a B.S. in epidemiology from the CUNY Baccalaureate for Unique and Interdisciplinary Studies.