Accelerating the Path to First-in-Human Trials: FDA’s Expedited IND Pilot Program

Summary

Fortrea has the multidisciplinary scientific, regulatory and operational capabilities to serve as a prospective Qualified Research Institution (QRI) in the FDA Expedited Investigational New Drug (IND) Pilot Program. As a global contract research organization (CRO), Fortrea can support biopharmaceutical sponsors with specialist recommendations across pharmacology and toxicology, clinical development, and chemistry, manufacturing and controls (CMC), helping advance efficient, science-based and phase-appropriate planning for first-in-human (FIH) clinical trials in the United States.

Introduction

Bringing innovative therapies to patients begins long before a clinical trial opens its first site. It starts with thoughtful development planning, strong science, effective regulatory strategy and close collaboration across disciplines.

That reality is at the heart of the U.S. Food and Drug Administration's new FDA Expedited Investigational New Drug (IND) Pilot Program, an initiative established under Operation TrialBlazer to evaluate new approaches for accelerating first-in-human (FIH) clinical trials in the United States while maintaining FDA's standards for participant safety and scientific oversight. 

The pilot seeks to reduce the time from initiation of IND-enabling activities to first-in-human trial initiation by evaluating a collaborative model in which sponsors work with prospective Qualified Research Institutions (QRIs) to support more efficient drug development.

For biopharmaceutical companies, this initiative represents an opportunity to rethink how development programs are planned, reviewed and advanced. For Fortrea, it highlights the value of the integrated development experience we bring to sponsors every day.

A New Approach to IND Development

Under the FDA pilot, prospective QRIs collaborate with sponsors to provide specialist recommendations on pharmacology and toxicology, clinical, and chemistry, manufacturing and controls (CMC) components of first-in-human IND submissions. FDA describes QRIs as scientific specialists that apply risk-proportionate judgment and science-based, phase-appropriate regulatory standards to support efficient development.

Importantly, the FDA notes that QRIs may include academic medical centers, healthcare networks, contract research organizations (CROs), regulatory advisors and other research organizations.

The Significance of Rolling Review

One of the most innovative aspects of the pilot is the FDA's willingness to accept and review individual IND components on a rolling basis as they are completed rather than waiting for a complete submission package. Because participating QRIs are expected to contribute substantial scientific knowledge during development, the agency can begin evaluating portions of an IND earlier in the process.

According to the FDA, this approach has the potential to identify and resolve issues in real time, reduce the risk of clinical holds and create a faster, more collaborative pathway from scientific discovery to first-in-human studies.

How Fortrea's Capabilities Align with the Pilot

Fortrea’s multidisciplinary teams bring regulatory experience across nonclinical development, regulatory affairs, CMC, clinical development, project management and early-phase execution. In short, we can offer the experience, capabilities and scale to support sponsors pursuing participation in the program and to serve in a prospective QRI role.

Our teams have experience supporting sponsors across a broad range of therapeutic areas and development stages, combining strategic regulatory guidance with operational execution to help organizations navigate increasingly complex development pathways.

Why This Matters for Sponsors

The Expedited IND Pilot Program underscores an important research trend: development efficiency is achieved by improving planning, coordination and scientific decision-making earlier in the process.

The ability to align regulatory, nonclinical, manufacturing and clinical considerations from the beginning can help sponsors better anticipate challenges, make informed decisions and maintain momentum as programs move toward first-in-human studies.

The FDA's pilot is designed to test whether closer collaboration among sponsors, scientific specialists and regulators can help achieve those goals while preserving the rigorous review process that protects patients and supports confidence in clinical research.

Looking Ahead

The FDA Expedited IND Pilot Program is ultimately an evaluation of a new development framework. If successful, it could help shape future approaches to early-stage drug development in the United States.

As sponsors assess opportunities under the pilot, Fortrea is prepared to bring the integrated experience, regulatory insight and operational discipline needed to support efficient and science-driven development programs. Our experience across regulatory strategy, CMC, clinical development and project management positions us to help sponsors navigate this evolving environment and advance innovative therapies toward first-in-human clinical trials.

Now is the time to review your program strategy. Engage Fortrea's Regulatory Strategy team to evaluate your project objectives, available data, and regulatory pathway options before critical development decisions are made.

Note: The FDA will determine participant eligibility and selection for the Expedited IND Pilot Program. References to Fortrea serving as a prospective QRI reflect Fortrea's assessment that its capabilities align with the pilot's stated expectations and do not indicate FDA designation or selection.