Cell and Gene Therapies
Tailored solutions for cell and gene therapy programs.
Expertise and services to amplify your clinical trial approaches, streamline complex processes and minimize risk.
Strategic support
Access multidisciplinary, multimodality experience to support your studies.
Centered on patients
Get a patient-centric approach to optimize the development of your product.
Expert problem-solving
Rely on our team to navigate complex logistics and implement practical solutions.
Reduce risk for your cell and gene studies
Fortrea delivers strategic insights to enable efficient, cost-effective development of your cell and gene therapies and reduce risk across critical milestones. Our expertise across multiple modalities, clinical conduct insights, operational solutions and customized training enable us to deliver the experience you need for your study.
Enable seamless delivery
Apply our know-how and infrastructure
-
Expertise with multiple modalities
- CAR T and AAV
- Other viral and nonviral delivery systems (e.g., adenovirus, LNP)
- Cell therapies (immune cell/stem cell, autologous/allogeneic, modified/non-modified)
- Gene editing (e.g., CRISPR, meganucleases)
- Advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms
-
Scientific and medical insights
We understand how these treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:
- Protocol development
- Long-term follow-up (LTFU)
- Development of companion diagnostics
- Global regulatory requirements
- Vendor qualification
- Medical monitoring
-
Global operational solutions
The complexity of these therapies calls for best practices, solutions and technologies and operational flexibility to optimize the conduct of your trial, including:
- Early development planning to manage complex cell and gene therapy trials
- Logistics support for autologous CAR T-cell therapies
- Site selection, activation and overall study setup
- Defining regulatory and GMO pathway timelines along with approvals
- Reducing the patient burden for LTFU studies
- Designing and implementing regulatory strategy, including early engagement (e.g., INTERACT, pre-IND) and when working with rare diseases and pediatrics
-
Customized training
To ensure all team members keep up with rapidly evolving technologies, our rare diseases, advanced therapies and pediatrics team and oncology SMEs provide targeted, study-specific training, as well as a formal cell and gene therapy training curriculum.
Cell and gene therapy experience that matters
In the last 5 years, we have supported:
Advance your cell therapy studies
Fortrea has supported and designed dozens of cell therapy programs, including all 6 FDA-approved CAR T-cell therapies.
Global gene therapy experience
No matter where you are or where you intend to go, you can rely on our global experience and expertise in advancing gene therapy trials.
Oncology in cell and gene therapy development
From targeted therapies and immunotherapies to advanced cell and gene therapies, we have helped develop biomarker-driven strategies to bring precision medicines to market.
Insights
Get the latest updates from our cell and gene therapy team
Addressing the implications for long-term follow-up in discontinued gene therapy studies
Download White Paper
Practical considerations for cell and gene therapy trials in neonates and young children living with rare diseases
Download White Paper
Designing an optimal long-term follow- up program for gene therapies and genetically modified cell therapies
Download White Paper
Exploring Applications of CAR-T Therapy Outside Oncology: Strategies for Applying Lessons Learned
Watch Exploring Applications of CAR-T Therapy Outside Oncology: Strategies for Applying Lessons Learned
Advancing cell and gene therapy frontiers
Discover Fortrea's advancements in cell and gene therapy. Read our blog for insights into the latest breakthroughs and innovative treatments in genetic medicine.
Read Advancing cell and gene therapy frontiers
Examining the role of genetic counselors
Learn how to genetic counselors promote patient centricity in cell and gene therapy clinical trials.
Download White Paper
The journey of Advanced Therapy Medicinal Product (ATMP) studies in the European Union
Sponsors developing combined advanced therapy medicinal products (CATMPs) play an important role in advancing potentially groundbreaking opportunities and addressing unmet healthcare needs.
Read The journey of Advanced Therapy Medicinal Product (ATMP) studies in the European Union