Achieving Quality Cell and Gene Therapies Outcomes Through Multidisciplinary Collaboration

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

Speakers

Anne S. Renteria, MD, Medical Director, Medical Affairs, ICON plc

Anne S. Renteria is US board certified in Hematology, Medical Oncology, and Internal Medicine, and has formal training in Transplantation and Cellular Therapy at Mount Sinai School of Medicine, New York. She has over 20 years of medical practice experience, including 8 years in the field of Hematologic Malignancies and Hematopoietic Cell Therapies (HCT), including allogeneic HCT, CAR-T cell therapies, and autologous HCT. She was the leader of the Acute Lymphoblastic Leukemia (ALL) Research Clinical Program at Mount Sinai Hospital, NY. In the Mount Sinai BMT Program, she developed Graft-versus-Host Disease (GVHD) management guidelines, and as a member of the BMT-Infectious Diseases committee she helped develop related SOPs. She was the PI and co-investigator on several clinical studies of CAR T-cell therapies for Hematologic Malignancies and Solid Tumors, as well as acute and chronic GVHD. She has co-authored several clinical research publications in peer-reviewed medical journals in the areas of Adult ALL, GVHD, and Bone Barrow Transplantation. Dr. Renteria is based in New York, NY.

Message Presenter

Brandon Fletcher, PhD, Principal, Clinical Project Management, ICON plc

Brandon Fletcher, PhD, is a Biochemist and Cancer Immunologist who has dedicated over 27 years to clinical research in various settings, from academic clinical care, pharma and CRO settings. She has served in extensive roles in immunoncology and cell and gene therapeutics, having begun work in the cell therapy setting (TILs) as far back as the 1990’s. She both co-founded and served as vice president of the Melanoma KNOW More activist foundation, served on multiple committees within the Precision Medicine Coalition and co-founded a global immune-oncology research training and support organization in the Middle East. In her current role as Cell and Gene Therapy Principal with ICON, she serves to provide scientific-based strategic and thought leadership, as well as supportive education and training throughout all of their cell and gene therapy projects, clients and teams. Brandon is from Cincinnati Ohio and resides in both Bend, Oregon and Saint Louis, Missouri.

Message Presenter

Tamie Joeckel, Business Lead, Cell and Gene Therapy Center of Excellence, ICON plc

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.

Message Presenter