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Advance your cell therapy studies

At Fortrea, we’ve seen the cell therapy field evolve and have played a significant role in its development by supporting and designing dozens of cell therapy programs, including all 6 FDA-approved CAR T-cell therapies.

We know that successfully completing a cell therapy program (CAR T, TCR, TIL or other cell constructs) requires managing inherent risks or unexpected delays. From patient screening, through cell product infusion and long-term follow-up, we can take preemptive steps to minimize risks and accelerate your development journey.

Across several therapeutic areas, we’ve worked with multiple modalities (immune cell/stem cell, autologous/allogeneic, modified/non-modified, CAR-T and adeno-associated virus). We have helped advance:

We’re here to seamlessly deliver your next cell or gene therapy trial

Working as an extension of your team, we can offer you:

Scientific and medical expertise 

Not only do we know how to work with these complex entities and recognize real or potential impacts on patient well-being, but we also understand the science behind how they work. For example, beyond cell and gene therapies, we’ve also supported advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms.

We understand how these unique treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:

• Protocol development
• Apheresis
• Complex cell therapy product logistics
• Long-term follow-up (LTFU)
• Development of companion diagnostics
• Global regulatory requirements for GMO and ATMP products
• Vendor qualification
• Medical monitoring

Global operational solutions 

The complexity of these therapies can involve numerous operational challenges defined by the asset in development and reflected in the trial footprint. We offer best practices, solutions and technologies and operational flexibility to optimize the conduct of your clinical trial, including, but not limited to:

• Providing logistics support for autologous CAR-T cell therapies
• Navigating site selection, activation, and overall study setup
• Defining regulatory and GMO pathways timelines along with approvals
• Reducing the patient burden for LTFU studies
• Designing and implementing a program’s regulatory strategy, including early engagement (e.g., INTERACT, pre-IND), and when working with rare diseases and pediatrics

Customized training 

To ensure your team keeps up with complex and rapidly evolving technologies, we provide comprehensive custom training of all team members. Our Cell and Gene Therapy Team provides targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.