Cell & gene therapy (CGT) holds significant promise to advance patient treatments.
As shown by recent trends, such as the growing interest in CAR T-cell therapy and mRNA gene editing, CGT is the future. Despite its potential, CGT often does not progress from the lab to commercial markets. This is in part due to the unique requirements of working with these technologies, and the new challenges they present to clinical trials.
This roundtable reviews the necessary considerations and logistics of conducting CGT trials, and how sponsors and service providers can optimise their clinical research to maximise the prospect of success.
Other discussion points include:
- The need for and management of study stopping rules to mitigate risks - protocol amendments - for patients and sites
- The importance of transportation, including the complexity of handling living materials
- How sequencing on site can reduce both the costs and risk associated with CGT clinical trials?
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Cell and Gene Therapy Global Business Lead, ICON
Tamie Joeckel has over 20 years of experience in both commercialization services and clinical operations for specialty biologics – with the last 6 years focused on cell and gene therapies. Prior to that, she was certified in production and inventory management (CPIM) working as an ERP systems consultant for process manufacturing systems and ISO certification. In commercial distribution, Tamie led teams that designed and implemented commercialization strategies and patient hub services solutions for specialty biologics requiring REMS programs and patient registries for oncology and rare disease therapies. For the last 6 years, Tamie has worked as an operations and logistics orchestration expert for cell and gene therapy programs, designing global depot and distribution strategies for these highly sensitive “living therapies”. Tamie is based in Houston, Texas and is an active member of both the Alliance for Regenerative Medicine and NORD.