2023 AcCELLerate Forum Encourages Discussion on Cell Therapy Landscape, Management, Future

Today marks the start of the 2023 AcCELLerate Forum, a joint partnership event between American Society for Transplantation and Cellular Therapy ™, Center for International Blood and Marrow Transplant Research ® (CIBMTR), and National Marrow Donor Program®/Be The Match®, held October 2-3 virtually and in Arlington, Virginia. The forum aims to offer increased educational and advocacy opportunities to treating physicians, regulators, industry representatives, scientists, National Institutes of Health (NIH), Centers for Medicare & Medicaid Services, health insurance professionals, patients and other health care professionals involved in the area of cellular therapy. The 2-day workshop aims to discuss the changing therapeutic landscape and opportunities for collaboration, share a variety of perspectives to advance the field, and prioritize patient needs and access to novel therapies.

“The forum is addressing topics on cellular therapies that impact multiple stake holders in the field, from the regulatory landscape to important operational aspects of patient care to management and understanding of upcoming toxicities. It wraps up with a review of the pipeline of several new products and how they will impact patient care,” Marcelo Pasquini, MD, Senior Scientific Director, CIBMTR, and Professor of Medicine, Medical College of Wisconsin, who is also chairing the first main session, told CGTLive.

The forum’s main sessions include:

• Day 1: Regulatory Landscape for Approval of New Products, featuring speakers Bruce Levine, PhD, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine; Nicole Verdun, MD, super office director, Center for Biologics Evaluation and Research (CBER), FDA; and Peter Marks, MD, PhD, director, CBER, FDA
• Day 1: 80/20 Updates and Logistics for CAR-T, featuring speakers Robert Sokolic, MD, chief, malignant hematology branch, CBER, FDA; Sarah Nikiforow, MD, PhD, Assistant Professor of Medicine, Harvard Medical School and Dana-Farber Cancer Institute; Rayne Rouce, MD, associate professor, department of pediatrics, section of hematology-oncology, Baylor College of Medicine; Armin Ghobadi, MD, Associate Professor of Medicine, division of medical oncology, Washington University School of Medicine; and Adrian Gee, PhD, director, clinical applications laboratory, Center for Cell and Gene Therapy, Baylor College of Medicine
• Day 2: Emergent Toxicities and Management Thereof, featuring Michael Jain, Md, PhD, associate member and ICE-T medical director, department of blood and marrow transplant and cellular immunotherapy, Moffitt Cancer Center; Bianca Santomasso, MD, PhD, neurologist and neuro-oncologist, Memorial Sloan Kettering Cancer Center; Kevin McNerney, MD, pediatric hematologist-oncologist, blood and marrow transplantation and cancer immunotherapy, Lurie Children's Hospital of Chicago; Marion Subklewe, MD, PhD, Professor of Internal Medicine, cellular immunotherapy, hematology/oncology, LMU University Hospital Munich, Germany; and Nirali Shah, MD, MHSc, Head of the Hematologic Malignancies Section, Pediatric Oncology Branch, NIH
• Day 2: Future Directions and Competing Therapies, featuring speakers Jay Spiegel, MD, assistant professor, division of transplant and cellular therapy, Sylvester Comprehensive Cancer Center; Rouce; Veronika Bachanova, MD, PhD, Professor of Medicine, University of Minnesota; Elizabeth Shpall, MD, Smith Professor of Cancer Research, MD Anderson Cancer Center; and Matthew Frigault, MD, assistant professor, Harvard Medical School and clinical director, cellular immunotherapy program, Massachusetts General Hospital

“[The regulatory landscape] session will focus on the impact of a rapidly evolving field, the excitement with new therapies and the challenges to bring them up to patients. As new therapies are being developed and need to be tested in clinical trials, but patients are receiving existing and approved cellular therapies in the clinic, how can new products be established? Are there any potential modifications in the regulatory approval process to address this challenge. There are no easy answers here and the session will open up with many questions,” Pasquini shared about the session he is chairing.

In looking forward to the AcCELLerate Forum, Pasquni highlighted Levine’s talk, the CAR T-cell logistics session, and the toxicity session on Day 2 as sessions he was looking forward to. He shared his excitement for the Forum, in which questions and discussions are the main focus to help “address these emerging issues and to optimize further development of the field.”

“The field of cellular therapy is growing rapidly with a tremendous impact in the practice of oncology. The forum attempts to align several important topics, including understanding of the wave of novel products coming to the clinic, expanding to newer indications, new and optimal ways to delivery therapy, understanding the concepts of point of care manufacturing, toxicities and their management,” Pasquini said.

More information can be found on the AcCELLerate Forum’s home page, linked here.