Accelerating first-in-human studies: Why the FDA’s Expedited IND pilot signals a new era for early development

On June 22, 2026, the FDA launched the proposed Expedited Investigational New Drug (IND) Pilot Program as part of the Department of Health and Human Services’ Operation Trialblazer— a sweeping initiative aimed at modernizing clinical development and maintaining U.S. leadership in early-stage innovation. At the center of this effort, the pilot aims to accelerate the path from drug identification to first-in-human (FIH) studies, with the goal of reducing development timelines by up to 6 to 12 months.

For an industry defined by lengthy pre-IND prerequisites, this is a meaningful shift. While attention has focused on speed, the deeper transformation is about precision. Sponsors now have an opportunity to accelerate their time to FIH stage, but success will depend on making critical decisions earlier, and with greater rigor.

A new model for early development

The Expedited IND Pilot Program is designed to streamline one of the most complex phases of drug development. Historically, sponsors have faced long periods before initiation of their first-in-human (FIH) trials. This is often due to uncertainties regarding regulatory requirements and the consequent tendency to conduct unnecessary studies, as well as long wait times to receive IRB study approval or FDA approval of protocol amendments. The Expedited IND Pilot Program aims to address these challenges through several changes: 

• Pre-submission collaboration with Qualified Research Institutions (QRIs), including CROs, to establish IND readiness
• Rolling IND submissions, allowing sponsors to submit completed sections of the IND application incrementally to the FDA
• Clarification of phase-appropriate expectations, particularly in Chemistry, Manufacturing, and Controls (CMC), to focus on the most relevant studies and reduce unnecessary early-stage data collection

The objective is clear: remove regulatory uncertainty, streamline IND-enabling studies and procedures for IND submission, and accelerate time to FDA clearance for clinical testing.

Speed without compromise

Importantly, the FDA is not lowering regulatory standards for early phase trials. Instead, it is redefining when and what data should be generated at this stage. The agency is signaling increased acceptance of phase-appropriate data, along with greater flexibility in how evidence is structured. This creates tangible advantages:

• Biotechs may reach proof-of-concept faster, improving capital efficiency and accelerating valuation milestones
• Biopharmaceutical companies may increase pipeline velocity and compound value across multiple assets

However, these benefits come with a trade-off. As development timelines compress, the margin for error narrows. For example, when the FIH trial is also intended to provide critical dosing, safety and efficacy information and potentially serve as a pivotal study, early-phase decisions must be made with greater foresight and precision.

Rethinking Phase I: From first-in-human to first-in-strategy

With the FDA’s Expedited IND Pilot, Phase I has become an even more critical strategic foundation for downstream success. Now sponsors must align clinical, nonclinical, and CMC strategies even earlier.  

For example:

• Understanding that FDA is shifting to a risk-proportionate approach to data requirements for FIH trials, sponsors must more carefully plan the types and timings of IND-enabling studies, deciding which are sufficient start and which must subsequently be completed to allow rapid progression to later phase development. 
• Similarly, FDA’s risk-proportionate approach necessitates that sponsors carefully plan their supportive data when considering more complex FIH designs such as seamless Phase I/II trials or master protocols. 
• The pilot program affords greater opportunities for sponsors to apply model-informed approaches to support nonclinical safety, as well as to guide dose selection and study design.
• To take the most advantage of the IND rolling submission, sponsors must engage early with partners experienced in both preparing quality and complete IND applications, as well as the coordination of progressive preparation and submission of inter-related CTD modules. 

With the FDA’s new approach, Phase I becomes a critical inflection point—shaping not just safety evaluation, but the trajectory toward potential approval.

A more integrated approach to IND readiness

A key element of the Expedited IND Pilot Program is the creation of a network of Qualified Research Institutions (QRIs), including CROs, to support sponsors throughout IND preparation and review.

The inclusion of CROs in the QRI network reflects a broader shift in how the FDA views development partners, positioning their role as active contributors to regulatory strategy, beyond study execution. This formalizes what leading CROs have increasingly become: strategic partners that help shape development programs long before a trial begins.

Designed to support sponsors across CMC, pharmacology-toxicology, and clinical components of an IND, QRIs are intended to provide early scientific and regulatory guidance that help sponsors align their programs with FDA expectations earlier in the process.

How Parexel is supporting sponsors

In this environment, the CRO becomes a regulatory co-architect, helping sponsors to conceive their development programs, leveraging regulatory flexibilities for innovation, without compromising quality or regulatory standards.

As sponsors seek to capitalize on accelerated pathways, Parexel is already well aligned with the QRI model, with established capabilities in IND readiness: CMC and non-clinical development strategy and critical assessment of resultant data; as well as FIH trial design and overall clinical program development. Parexel already supports sponsors in several critical ways:

• Regulatory strategy: Developing innovative early-phase programs that are scientifically rigorous and aligned with regulatory expectations from the outset.
• Program design: Creating streamlined Phase I/II study designs that maximize collection of endpoints essential to establishing safety and ascertaining preliminary evidence of efficacy.
• Scientific rigor: Applying translational science, model-informed drug development, and real-world evidence methodologies to strengthen early decision-making.
• Execution at speed: Leveraging global early-phase capabilities and digital-enabled operations to deliver high-quality studies within compressed timelines.

As the FDA evolves its pathways and resources for early development, sponsors without deep internal regulatory infrastructure will depend even more on experienced partners to navigate the regulatory changes. For emerging biotechs in particular, these capabilities are increasingly crucial.

Through initiatives like the Parexel Biotech Incubator, we are engaging companies even before IND submission—helping define development strategies, regulatory pathways, and clinical designs at the point where they matter most.

The path forward

The Expedited IND Pilot Program represents a meaningful step toward reducing the current friction in U.S. drug development— one where collection phase-appropriate evidence and streamlined FDA procedures can accelerate initiation of clinical trials without compromising scientific rigor or regulatory standards. As timelines compress and development becomes more interconnected, CROs will increasingly serve as strategic partners, helping sponsors translate regulatory flexibility into sound development decisions, mitigate risk, and maintain scientific rigor.

At its core, the program will enable sponsors to generate more decision-relevant data earlier, improving clarity at the point of first-in-human evaluation. Over time, this approach has the potential to streamline development pathways while maintaining a strong scientific foundation, ultimately supporting faster, more efficient translation from drug discovery to clinical testing.

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