texte alternatif texte alternatif

Thérapies cellulaires

Accelerate your development journey

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:

82

Cell therapy studies

865

Centres

5 409

Patients

Our therapeutic area experience in cell therapy

Of these 82 cell therapy studies, 71 % were in oncology indications. Our experience also spans hematology, ophthalmology, bone and joint disease, immunology, hepatology, neuroscience, cardiovascular, endocrinology and metabolism, gastroenterology and pulmonary/respiratory indications.

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

En venant nous greffer à votre équipe, nous vous offrons :

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:

  • Développement de protocoles
  • 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.

Serving as your agile partner for complex and novel clinical trials

Let our multidisciplinary experts put their insights and experience to work to advance your program. Ensemble, nous œuvrerons à votre succès et mettrons au point un projet unique dans la mise au point de traitements médicaux non disponibles.

Explore our related areas of expertise. 

Recevoir les dernières actualités :
inscrivez-vous pour recevoir les actualités et les annonces de Fortrea.