Session 1 - Cellular Immunotherapy Treatments as a Standard of Care: Clinical Sites, Professional Societies, and Industry Collaboration to Minimize Redundancy
ASTCT 80/20 Task Force Overview
The first general session of the 2021 AcCELLerate Forum, presented on November 18, was chaired by Drs. Sarah Nikiforow and Fred Locke, who kicked off the session by presenting an overview of the ASTCT 80/20 Task Force. The Task Force is comprised of eight experts in the field of immune effector cell clinical onboarding and operations who represent large centers with transplant programs. This expert group was assembled to standardize the onboarding process for commercial cell therapy products for cancer.
Currently, the launching of new cell therapies at clinical sites can be time consuming and labor intensive. It has been suggested that 80% of the workflows are common, and 20% have unique requirements. Thus, the task force aims to advocate for the standardization, identification of common versus unique workflow requirements, streamlined programs, and leveraged entities and infrastructure to implement the 80% of common workflows. The Task Force aims to provide specific deliverables such as a consensus of common workflows, an outline of the current and optimal future states, the identification of required steps for achieving an optimal state, and the establishment of clinical site representation, through ASTCT, as a stakeholder in key initiatives.
Kite, a Gilead Company: Incorporating FACT Accreditation in the Hospital Qualification Process
Tracey Hlucky, a Senior Manager of Quality Assurance at Kite Pharma (Kite), presented on Kite’s qualification audit process for apheresis centers and treatment sites. The Foundation for the Accreditation of Cellular Therapy (FACT) provides accreditation for institutions which offer stem cell transplantation.
Kite aimed to accelerate their audit process by leveraging FACT accreditation for each hospital site, creating an abbreviated audit process. Sites were able to participate in the abbreviated process by sharing their FACT report and responses.
This abbreviation resulted in a more refined audit process which required fewer SOPs to be reviewed, took significantly less on-site audit time, and required less time from the treatment site. To date, 16 hospitals are now qualified for this process and, on average, are more satisfied with the audit process since it decreases overall audit burden.
Accelerating Patient Access through Standardization
As part of this session, we heard from Dr. Joy Aho, a Senior Product Manager from Be the Match BioTherapies (Be the Match). To improve patient access, there is an unmet need for standardization and streamlining across the cell therapy workflow.
One focus of Dr. Aho’s presentation was the need to standardize accreditation reviews and inspections. To address this, Be the Match has created a Quality System Audit Program (QSAP) which is a licensable quality system audit program. QSAP allows a single apheresis center to complete one audit, which can then be used for additional groups. This program saves time and money, since developers are not required to build audit infrastructure.
A second point of focus was the use of order management platform technologies at treatment centers. Currently, several different technology platforms may be used in healthcare facilities. Since staff must be trained on different programs, this increases the administrative burden and can lead to quality issues. Be the Match and several other groups are currently investigating standardization solutions to address this issue. Through partnering with centers, a standardized technology solution can be implemented.
Streamlining Onboarding of Cell Therapy in Solid Tumors
Next, Dr. Jagasia, the Senior Vice President of Medical Affairs at Iovance Biotherapeutics (Iovance), presented on the ecosystem involving the biopharma industry, hospitals, and the impact on patient outcomes. Iovance’s approach is to understand the center’s infrastructure, standardize the intake of information using Iovance tools, perform a gap analysis, and collaborate with the center.
Currently, the majority of time is spent evaluating what the staff responsibilities are and performing gap analyses. Since staff at different centers can have varying responsibilities, Iovance hopes to align and standardize this across treatment centers. Standardization efforts such as these would help address 80% of common workflows.
Shared CAR-T REMS
The final presentation of the session, Dr. John-Peter Zak, Associate Director and Oncology REMS Lead at Janssen Pharmaceuticals, focused on the benefits, considerations, challenges, and status of shared CAR-T Risk Evaluation and Mitigation Strategy (REMS). The current benefits of shared REMS are the reduced burden on health care providers and patients, improved effectiveness, and the ability to aggregate FDA monitoring of product risks for CAR-T therapy.
As CAR-T therapies evolve and become more diverse, challenges such as the emergence of different safety profiles or risks are presented. Additionally, since CAR-T therapy is relatively new, a deeper understanding is still required.
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