The changing face of cell and gene therapy: impacts on planning and executing trials
Available now ON DEMAND
This webinar will review some of the factors investigational teams should now consider in the planning and execution of cell and gene therapy development programs including regulatory and logistical issues.
We have made considerable strides in the development of cell therapies since Kymriah® (Tisagenlecleucel) was the first autologous CAR-T approved by the US FDA 4 years ago. The breadth of technologies spanning autologous and allogeneic platforms is underpinned by the expansion of receptor/indication targets. Whilst hematological malignancies have formed the bedrock of development, solid tumors are increasingly part of a more complicated arena. Additionally, regulatory requirements have modified. The assumption that all cell therapies are genetically modified organisms does not universally hold true. Furthermore, the vein-to-vein chain of custody requirements are not the same for off the shelf products.
What will you learn?
- A review of the technologies spanning autologous and allogeneic CAR-Ts, TCRs, iPSCs, TILs and significant expansion of receptor and indication targets
- Why solid tumors pose additional challenges from an operational perspective
- How regulatory requirements have modified, and the nuances related to this
- Manufacturing technology of products is ever more diverse which impinges upon the logistics. Discover some of the solutions to assist in managing the logistics across various technologies
Who may this interest?
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- Organizations embarking up the clinical phase of their development programs
- Staff working on first-in-human (FIH) cell and gene therapies
- Advanced therapy developers
- Cell and gene therapy investors
- Biopharma clinical science professionals
Speakers:
Brandon Fletcher
Cell and Gene Principle, ICON (CA, USA)
Brandon is a Biochemist and Cancer Immunologist with over 30 years of research experience; 26 in hematology-oncology and 4 in infectious disease. She has held roles in broad immune-oncology and cell and gene therapy research within academia and industry. Brandon is a collaborator with NCI’s origination of cancer CGTs and co-founded a global immune-oncology research training and support organization.
Martin Lachs
VP Project Management Oncology & Cell Therapeutics, ICON, (London,UK)
Martin heads up ICON’s Oncology and Cell Therapeutics Project Management Group, lending operational and indication expertise across a group of over 260 international project management staff globally, dedicated to oncology and cell therapy drug development. Martin has worked in developing key oncology site networks in the US and the UK and in 2020 was a member of a clinical trial review panel for University of Sydney affiliated hospitals. Martin has produced a number of position papers and presented at numerous international events at scientific and pharma industry meetings. Recently the key focus of his publications has been thought leadership related to Cell Therapies in oncology, e.g. CAR T.
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