Cell & Gene Therapy Solutions
Navigate the Complexities of Cell & Gene Therapy Development with PPD
The unique demands of cell and gene therapy (CGT) clinical trials call for a uniquely prepared development partner. PPD’s extensive breadth and depth of therapeutic and functional expertise have guided a diverse range of cell and gene therapy assets through the development pipeline.
Our comprehensive, end-to-end cell and gene therapy CRO solutions leverage over two decades of experience – including more than 130 clinical trials in the past five years – to meet the distinct needs of patients, sites, caregivers and sponsors.
Moreover, PPD, as part of Thermo Fisher Scientific, is the only CRO that can seamlessly integrate manufacturing, laboratory services, ultra-cold chain logistical support and clinical trial management to better serve sponsors needing a streamlined process to reduce vendor management risks and burden.
Cell and Gene Therapy Institute (CGTI)
Our cross functional team of experts help enable faster delivery and operational efficiencies in clinical research.
The promise of cell and gene therapy explained
Cell and gene therapies require unique operational, regulatory and safety considerations. PPD’s Cell and Gene Therapy Institute focuses on the development of guidance documents, operational tools, education and thought leadership aimed at expediting in vivo gene- and cell-based clinical trials.
Expertise is built into every component of our cell and gene therapy CRO capabilities so that our customers can be confident they are receiving high-quality services at every stage. PPD’s record of partner success in cell and gene therapy clinical trials speaks for itself.
Expertise is built into every component of our cell and gene therapy CRO capabilities so that our customers can be confident they are receiving high-quality services at every stage.
PPD’s record of partner success in cell and gene therapy clinical trials speaks for itself.
In the past five years alone, PPD’s cell and gene therapy experts have supported:
Over 130 CGT clinical trials across a wide range of therapeutic areas, including hematology, rare disease, oncology, immunology, urology, neurology, cardiovascular and more
More than 55 cell therapy trials spanning both autologous and allogeneic cell types, including T cell infiltrating lymphocytes (TILs), CAR-T, CAR-NK, B cells, and dendritic cells
Over 75 gene therapy trials across adenoviral, AAV, lentiviral, and gamma retroviral vector delivery platforms
More than 300 peri- and post-approval projects in cell and gene therapy value demonstration, market access and commercial strategy
Advancing Cell Therapy in China
While initial strides in CAR-T therapies were primarily made in US markets, the focus is now shifting to China – but can both foreign and domestic players win in China’s CGT market? Explore the challenges and opportunities to advance cell therapy clinical trials in China in this European Biopharmaceutical Review article.
End-to-end services provide the ease of a single partner across the full development lifecycle
PPD offers specialized support for customers’ needs at every stage of the CGT development journey. Working with a single cell and gene therapy CRO partner across the development lifecycle means better integration of services and capabilities at each stage, continuous support and a better experience for every stakeholder in the clinical trial landscape.
Preclinical/Early Phase
- First-in-human planning and protocol optimization
- Feasibility and regulatory strategy
- Development of patient pathways
Clinical Stage
- Expert operational support for complex CGT studies across all phases
- Deep, established relationships with investigators at FACT- and JACIE-accredited sites worldwide
- Dedicated patient support services to facilitate participation in CGT clinical trials
Peri- and Post-Approval
- Extensive experience in long-term follow-up of patients
- Expertise in registry programs to track dosed patients for 15+ years
How PPD supports CGT customers across all phases
Accelerate your gene therapy trial
Gene therapies are changing outcomes for rare neurological diseases.
We create streamlined gene therapy study protocols and designs to help you meet your goals effectively.
Extensive education & support ensure patient retention in CGT trials
Participation in a cell and gene therapy trial can place significant burdens on patients, from identifying trials to contending with a complicated trial experience that often requires five to 15 years of study follow-up. To best support patients and strengthen our understanding of their needs, we engage with patient advocacy groups and other stakeholders to bring patient voices into the trial development process as early as possible. This enables us to better recognize, appreciate and understand patient and caregiver challenges at each step of the patient journey.
Because of the high level of patient commitment and compliance required in CGT studies, we provide ongoing education and support to patients and caregivers to ensure that patients start and stay with the trial to the very end, including:
- Robust education and awareness campaigns to connect patients with trial opportunities
- “White glove” patient concierge service, which assigns a “personal assistant” to support each patient and caregiver
- Decentralized and digital study capabilities, including eConsent, home health and telemedicine
Together, these services ease the burden on patients to yield better engagement so that patients are retained for the entire duration of the study.