texte alternatif texte alternatif

Oncology Cell and Gene Therapies

Advancing revolutionary treatments for cancer

A focus on oncology in cell and gene therapy development

From targeted therapies and immunotherapies to advanced cell and gene therapies, our subject matter experts have helped develop biomarker-driven strategies to bring precision medicines to market.

We apply our extensive depth of experience across all critical points of the oncology clinical trial process to deliver scaled capabilities that meet your needs.

Across 19 countries and 669 global sites, our experience working with specific type/cell constructs in oncology includes:

  • 17 CAR-T studies
  • 2 TIL/γδ T Cell studies
  • 3 TCR studies
  • 19 other studies (vaccines/TCE/oncolytic virus)

Our experience supporting oncology patients in cell and gene therapy trials

4 923

Patients screened

1 906

Apheresed patients in autologous studies

3 328

Patients dosed

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

  • Développement de protocoles
  • Apheresis
  • Site training
  • Complex cell therapy logistics
  • Long-term follow-up (LTFU)
  • Development of companion diagnostics
  • Global regulatory requirements for GMO and ATMP products
  • Safety risk management
  • Vendor qualification
  • Medical monitoring
  • Patient burden

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
  • Training sites in managing acute infusion phase for management of cytokine release syndrome, neurotoxicity or graft versus host disease
  • Reducing the patient burden including 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

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.