Cell and Gene Therapies

Today’s immunotherapy landscape is rapidly advancing. ICON understands the unique challenges these studies present compared to other trials. Our cross-functional team of immuno-oncology, cellular, and gene therapy experts provide end-to-end support for these complex studies that test even the most seasoned project teams. No matter the size or indication of your programme, we have the experience and expertise to help you every step of the way.

ICON has developed tools and best practices to transform CGT trial design and execution. Leveraging our medical informatics data, regulatory intelligence, therapeutic expertise, and operational experience, we develop a strategic approach for every operational plan to ensure the fastest start-up and overall clinical development timelines possible. We achieve this by optimising protocol designs, leveraging data-driven site selection, maximising enrolment potential, and driving efficient data analyses for faster and smarter drug development outcomes.

Our CGT experience encompasses haematology-oncology, rare and orphan diseases, CNS, ophthalmology, musculoskeletal, infectious diseases, and cardio-metabolic diseases.

ICON is integral to the successful planning and delivery of CGT studies. It is a cross-functional team of CGT experts that provides strategic input to sponsors and ICON’s internal project teams on the design, implementation, execution and commercialisation of CGT clinical development programs across a range of therapeutic areas.

CGT Academy

An important component of ICON’s knowledge-driven CGT COE is the CGT Academy, a proprietary internal training program provided to every new employee who begins work in CGT trials with advanced training for experienced staff for ongoing resource development. It provides both beginning and advanced courses based on lessons learned, best practices and documented processes and workflows captured from our experience in executing CGT trials.

CGT Solutions Group

The CGT Solutions Group helps clients navigate the unique complexities of CGT trials and mitigate risks through customised solutions. With over 400 dedicated CGT professionals globally, we have a formal structure that includes CGT principals, medical monitors, global logistics consultancy and dedicated CRAs to support all trials using the proprietary tools and best practices based on our extensive experience and innovation in:

• Site identification
• Regulatory strategy
• Supply chain logistics
• Patient/site management
• Safety education and guidance
• Biometrics including: Database design, Data management, Biostatistics & Programming

Mapping a complex supply chain

ICON understands that working with live cells & tissue requires careful, case-by-case tracking of the Chain of Custody, Chain of Condition, and Chain of Identity by the project team. The product journeys can involve special handling at the sites and are usually time and temperature-sensitive. The data loggers used in these programs can be quite sophisticated, providing additional information such as GPS location. This can be used to assist with site readiness for handling the cells upon arrival by sending an alert when the courier is within a certain radius.

Autologous therapies

For autologous therapies where the patient’s cells are used to manufacture their doses, sites must coordinate the patient schedules with apheresis and manufacturing centres often constrained by available capacity. In CGT trials, patient rescheduling is often the norm rather than the exception – a challenge that creates additional burdens for site personnel. All these considerations ripple into our overall site training methodology.

We understand that the patients at the end of these processes may not survive errors or delays – which is always at the forefront of our focus and risk mitigation planning.