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European Biopharmaceutical Review

Transforming Cell and Gene Therapy Trial Design and Execution

The success of cell and gene therapies (CGT) has transformed the delivery of clinical trial services, requiring the design of new workflows, processes, and tools to address the vast differences in how CGT trials are executed compared to traditional trials. Martin Lachs, Vice President and Head of the Oncology and Cell Therapeutics Project Management Group at ICON, an Irelandbased clinical research organisation, understands the difference from first-hand experience. “As an early pioneer in CGT trials, we quickly realised that we couldn’t use our traditional tools and resources. We formed a dedicated solutions group to focus on addressing the nuances and complexities of CGT trials,” he notes. “In the early days, there weren’t any handbooks or standards to rely on. We learned from our mistakes, forcing us to become more agile and flexible. Our ability to regroup and change processes has been extremely important as our work with emerging biotechnology companies continues to grow. We literally become an extension of their teams.”

ICON formed an internal training programme, the ICON CGT Academy, to address the procedural, operational, and technological complexity of CGT trials. “Initially we were learning along with the industry and knew we needed to capture these important lessons. Today, with over 60 CGT trials in our portfolio that encompass multiple therapeutic areas, from cancer to rare and orphan diseases, we’ve captured our experience-based best practices and documented the tools we created to deliver these trials in rigorous curricula. With over 300 ICON CGT Academy members, it serves as a true value add for our clients,” notes Lachs.

The demand for robust best practices will only increase over the next decade. Recent market intelligence projects the global CGT market will grow at a compound annual growth rate of 36.25% between 2019 and 2025 (1). The ever-increasing focus on rare diseases (cardiovascular, ophthalmic etc.) only emphasises the importance of developing innovative and accelerated ways to deliver CGT trials and address the challenges of scaling to commercialisation while optimising the journey for all involved.

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Martin Lachs, Vice President, Project Management, Oncology and Haematology, Clinical Research Services, ICON plc.

ICON is a global provider of outsourced drug and device development commercialisation services to pharmaceutical, biotech, medical device, and government and public health organisations. The company specialises in the strategic development, management, and analysis of programmes that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 97 locations in 40 countries and has approximately 14,650 employees.
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