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:

试验方案开发
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