With CGT already providing life-changing options to patients worldwide, the science used for treatments that have already been approved offer a foundation for developing therapeutics to target many other conditions.
Just as off-label drug use is credited with a number of successful healthcare initiatives, similar positives are becoming increasingly likely in the CGT space.
This roundtable will explore the significant opportunities and challenges posed by CGT clinical trials, and how a CRO partner may be uniquely placed to help a pharma innovator navigate them.
When there is potential for trials in larger indications where scaling up to meet demand may be required, what are the key considerations and what experience do CROs offer.
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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.