Timely and unrestricted support is crucial for the safe progress of CGT.
September 11, 2020
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:
A – The medical landscape:
- Principles and summary of current CGT in oncology
- Medical monitoring in CGT clinical trials
- The impact of COVID-19 and the associated risks in CGT clinical trials
- Patient reported outcomes considerations
B – Operational management:
- Operational nuances in CGT versus traditional clinical trials
- Effectively coordinating key stakeholders
- Potential responses to operational complexities
C – Commercialisation and logistics
- Early phase consulting supporting regulatory and reimbursement goals
- Logistics orchestration
- Scaling for commercialisation
Join Anne S. Renteria, MD, Medical Director, Medical Affairs, ICON plc, Brandon Fletcher, PhD, Principal, Clinical Project Management, ICON plc and Tamie Joeckel, Business Lead, Cell and Gene Therapy Center of Excellence, ICON plc in a live webinar on Thursday, September 24, 2020 at 10am EDT (3pm BST/UK).
For more information or to register for this event, visit Achieving Quality Cell and Gene Therapies Outcomes Through Multidisciplinary Collaboration.
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