University of Pennsylvania Health System
Cell Therapies: Here comes the next wave!
Robert Richards
Robb Richards has over 20 years of experience in oncology, first with a private practice in Southern New Jersey and more recently the University of Pennsylvania Health System. He has served in different roles throughout his healthcare career: IT Manager for the Center for Cancer and Hematologic Disease in Cherry Hill, Division Chief Operating Officer of Regional Cancer Care Associates (RCCA) in Cherry Hill, New Jersey, and RCCA corporate VP and Chief Information Officer. He unofficially joined Penn’s Cell Therapy and Transplant program (CTT) in 2016 and was the lead in overseeing the operationalizing/implementation of CAR T cell therapy for commercial use. Currently, he is the Corporate Director of The Center for Cell Therapy and Transplant program at Penn Medicine, overseeing commercial and research work and its expansion into community hospitals within the Penn system. He also assists other disease groups within the organization as they are onboarding gene therapies.
Robb received his BS in Information Technology from Drexel University and MS in Informatics and MBA from St Joseph’s University.
Autologous cell therapies in hematologic malignancies (liquid cancer) have been commercially available since 2017. Today there are several CAR T therapies available for lymphoma, leukemia, and myeloma. The therapies have shown promising therapeutic value, moving up from late line use to as early as 2nd line treatments. They have, in some cases, supplanted bone marrow transplant (BMT) as the preferred treatment choice. As a result, arguably, they are creating a shift in care delivery from the academic medical centers (AMC) closer to home in the community.
So here comes cell therapies that target solid cancers. With these therapies come new challenges that their predecessors didn’t bring.
Lymphoma, leukemia, and myeloma CARs are a natural extension of bone marrow transplant; the physicians are the same, and the overall process (less the manufacturing) is similar. Two therapies were FDA-approved in 2024, one for melanoma (tumor-infiltrating lymphocyte, or TIL) and one for synovial sarcoma (T-cell receptor, or TCR), which will further change established transplant/cell therapy programs.
When the program contemplates onboarding a cell/gene therapy, I consider what I call the three pillars: Clinical, financial, and operational aspects. These foundational components help me to decide both how to onboard the therapy today, and, to contemplate where cell therapy is going in the future.
Developing strong relationships between cell therapy programs and disease-specific groups, such as oncology teams managing solid tumors, is essential for planning, as it ensures seamless care coordination, minimizes duplication of efforts, and optimizes resource utilization.
Following the three pillars, from a financial perspective, they are still cell therapies. They have acquisition costs similar to CAR products. They have an episode of care over some period where reimbursement can be like BMT case rate, DRG, or ASP+, depending on the site of care considerations.
But this is where the similarities end.
From an operational perspective, each of the solid cancer cell therapies has different nuances than the liquid cancer cell therapies. The melanoma TIL therapy differs significantly from CAR therapy throughout the patient journey. Where the collection of cells is the source material for CAR, a resection of the tumor is needed instead. This requires a different group of clinicians, and surgeons, and a new workflow to develop. Additionally, the therapy requires a treatment post-infusion that differs from CAR therapy. The sarcoma TCR therapy isn’t quite as complex but requires additional labs before collection.
While these nuances present new challenges, they can be worked out. The larger issue, in my opinion, is clinical.
While I say clinical is an issue, it's not an issue for the reasons one might think. It’s because these therapies represent the first time that the treatment is not a liquid cancer disease (lymphoma, leukemia, myeloma). Relationships will need to be formed, particularly in academic medical centers, by cell therapy physicians and disease groups that they may not have had any relationship with before the onboarding. Defining responsibilities to make sure there is no lapse in the continuity of care between the cell therapy program and the disease group will have implications on operational plans, which in turn will have a potential impact on reimbursement.
Defining these relationships has ramifications on the cell therapy program’s accreditation as well. The Foundation for the Accreditation of Cellular Therapies (FACT) is a regulatory body that oversees participating transplant centers. Currently, changes to FACT standards are trying to give guidance on the relationship between the cell therapy program and different disease groups, centralize the responsibility of source material procurement, etc.
All of this is part of the continued evolution of cell therapy, and there is a need for programs to consider what their cell therapy program will look like in the future. The program at Penn, 8 years ago, was connected to its hematologic malignancies program, which was a part of hematology/oncology. This has been the standard framework for most BMT programs at AMCs. Today, in planning for the next step, the BMT program spun itself out of hematologic malignancies to align with cell therapies, particularly with non-oncology (autoimmune) in mind. Developing these relationships is essential when planning as it will limit duplication of effort, effectively use resources, and coordinate patient care.
