Explore how cell and gene therapy related experience can promote quality of data and higher patient accrual
During the last five years, the number of cell and gene therapies (CGT) have exponentially increased, stimulated by their efficacy and potential for cure. However, CGT can expose the patients to significant toxicities such as cytokine release syndrome (CRS) and neurotoxicities (ICANS), requiring specialised and accurate management associated with precise data capture and analysis. Timely and unrestricted support is crucial for the safe progress of CGT. In addition, dealing with these “living therapies” represents what’s been called the most complex supply chain in the history of medicine.
This webinar will present and discuss the challenges involved in supporting CGT-related clinical trials. Attendees will gain first-hand learning from members of a multidisciplinary team that was developed at ICON for the successful support of CGT clinical trials.
The participants will learn the following during the presentation:
The participants will learn the following during the presentation:
A – Medical Landscape:
Principles and summary of current CGT in Oncology
Medical Monitoring in CGT clinical trials
COVID-19 impact and risk in CGT clinical trials
Patient Reported Outcomes in CGT.
B – Operational Management:
Operational nuances in CGT versus Traditional clinical trials
Stakeholders requiring solid and effective coordination
Responses to unique operational complexities
C – Commercialization & Logistics:
Early phase consulting supporting regulatory and reimbursement goals
Logistics orchestration
Scaling to commercialization.
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Presenters
Tamie Joeckel
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.