ICON helps navigate the Cell and Gene Therapy journey by overcoming challenges and mitigating risks
Almost every cell and gene therapy clinical trial is novel in some way. Working with living therapies presents new and unique challenges to the traditional clinical trial model. With over 400 dedicated CGT professionals globally, ICON has developed tools and best practices to transform CGT trial design and execution. From site selection to study startup through execution, ICON provides project management, clinical services, product-specific logistics solutions, data flow, regulatory strategy and central laboratory services.
ICON's CGT experience:
59Cell and Gene Therapy trials
Cell and Gene Therapies require new ways to execute your trials
Working with living therapies requires special resources and training; and when there is a lack of standard best practices, sites are challenged when supporting multiple programs. CGT trials add the complexities of product handling and often require stops and starts due to protocol amendments and safety issues. The sheer number of stakeholders involved – both internally and externally – requires significant coordination and communication to protect both the patient and product. ICON's targeted approach to site selection and on-boarding addresses specific processes and resources unique to your protocol to support a patient-centric approach.
Offering transformational promise, giving patients new hope
In cell and gene therapies, ICON understands that some patients may not have a second chance for treatment. Integrated into the Mission and Values of every colleague at ICON is the realization that these treatments provide curative premise, creating new hope for patients. In many cases, the therapy uses the patients’ own cells to manufacture the dose. From supporting patient and caregiver concierge services to providing education resources and remote nursing care through our Symphony nursing group, ICON can help you design and deploy the services your patients require throughout their journey.
The most complex supply chain in the history of medicine
Each product journey is unique. ICON understands that working with live cells & tissue requires careful, country-by country, site-by-site and 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.
For autologous therapies where the patient’s own cells are used to manufacture their individual doses, sites must coordinate the patient schedules with apheresis centers and manufacturing centers that are often constrained by available capacity. In CGT trials, we find that patient rescheduling is often the norm rather than the exception – a challenge that creates additional burdens for site personnel. All of 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.
Regulatory knowledge and expertise is paramount for accelerated filings
ICON works as a trusted partner with Sponsors and regulatory bodies to identify and navigate the ever-changing regulatory pathways for approval. ICON’s experts assist in managing interactions with regulators. We understand that early and frequent dialogue with regulators is a key component of successful expedited review programs such as RMAT and PRIME. Meetings between the sector and regulatory bodies, similar to liaison meetings with the FDA, help identify challenges for sponsors and the regulator.
ICON has successfully submitted three Biologic License Applications with five more in process.
Data management in Cell and Gene Therapies is unique
ICON understands that CGT studies require more external data collection than non-CGT clinical trials. Our experience has also revealed that high volumes of data are generated early after patient screening and sites need to be prepared to meet the demands. ICON has developed tools and best practices to meet aggressive deadlines.