Increasing place of care manufacturing and deployment of cell therapies is a core mission for Jacques Galipeau, MD, who was recently named president of the International Society for Cell and Gene Therapy (ISCT). In this new role, Galipeau, who is also the associate dean for Therapeutics Development at the University of Wisconsin School of Medicine & Public Health, director of the University of Wisconsin Program for Advanced Cell Therapy (PACT), Don and Marilyn Anderson Professor of Oncology, and a member of the Stem Cell & Regenerative Medicine Center (SCRMC), plans to expand this mission to advance cell and gene therapies.
Galipeau will serve as president from June 2022 to June 2024, leading more than 2,400 fellow ISCT members from over 60 countries in their efforts to steward cell and gene therapy translation to the clinic. A board-certified hematologist with an interest in developing personalized cell therapies for immune and malignant disorders, Galipeau joined the organization more than 15 years ago. He says he was drawn to the interdisciplinarity of ISCT which works with individuals in academia, regulatory, and commercialization.
“That’s the combo you need when you’re trying to do early phase clinical trials and thinking about marketing approval and commercialization,” Galipeau said. “We have the regulatory, commercial, manufacturing, and science and that’s a very unique combo.”
In his role as president, Galipeau plans to harness this interdisciplinarity to drive clinical translation of cell and gene therapies. In particular, he plans to investigate how ISCT can better support the advancement of therapies that don’t fit the traditional commercial paradigm. Galipeau explained that traditionally, most cell and gene therapies are manufactured and deployed outside of the clinic, or place of care. Galipeau says this model makes sense for therapeutics that require thousands of doses, but he is concerned that therapies that can be manufactured and deployed in clinic are being overlooked because they don’t fit the traditional model.
“There’s not a lot of the investigational work that follows the place of care manufacturing and deployment model,” Galipeau said. “For example, if the treatment includes using your cells that are manipulated for a couple of days and given back to you, that is a medical service that can be done in clinic, but there’s no precedent for that model. This matters because there’s probably a lot of very, very good cell therapeutics that could help improve human outcomes that are simply not being developed at all because they don’t fit the traditional commercial paradigm of being manufactured and deployed outside of the clinic.”
Galipeau believes that ISCT can help with this challenge as they work across academia, regulatory, and commercialization. Therefore, he feels that ISCT is in the perfect position to assist all three specializations to come together to move in-clinic, or place of care, treatments forward. In particular, he hopes to help regulatory agencies, which he says are currently set up to address traditional manufacturing and deployment, to understand and regulate therapies that are best deployed within an academic health center.
Galipeau is well-versed in the complexities of therapy development. In fact, he is currently a sponsor for five clinical trials and has made it his goal to develop personalized cell therapies that improve outcomes in cancer and immune disease patients.
His most recent clinical trial success includes the use of an in-clinic, living therapeutic that addresses dry mouth in patients undergoing radiation. Living therapeutics is a category of treatment that modifies human and microbial living cells to cure disease. In this case, the cells are taken directly from a patient, manipulated within the clinic, and then injected back into the patient for personalized therapeutic use.
More specifically, Galipeau and his colleague Randy Kimple, associate professor of human oncology at the UW School of Medicine and Public Health, collected interferon-gamma activated marrow stromal cells from patients experiencing dry mouth. The cells, which were collected from the patient’s bone marrow, were then processed in the PACT lab on the University of Wisconsin-Madison campus and then injected into the patient’s saliva-producing glands to restore function and reduce dry mouth.
It’s novel, in-clinic treatments like these that Galipeau is eager to expand and support in his role as ISCT president, but he also knows the importance of training, education, and collaboration opportunities. For Galipeau, hosting an annual meeting and continuing to support the many ISCT committees aimed at addressing scientific, regulatory, and industry focused issues are key aspects of moving cell and gene therapies forward.
Galipeau says that his experience at UW–Madison has further instilled the importance of collaboration and showcases why interdisciplinary and collaborative models produce results.
“One of the reasons why I was interested in working at UW is it is all under one umbrella. UW is a very high-performance research university with a School of Medicine [and Public Health], a large comprehensive cancer center, a School of Veterinary Medicine, and a Department of Engineering. With all the departments, I know there’s going to be an expert in anything I come up with or stumble upon,” Galipeau said. “It’s a very collaborative environment and having it all under the same roof makes it easy for me to connect the dots.”
Galipeau also added that his membership with the UW–Madison Stem Cell & Regenerative Medicine Center provides inspiration for how a center or society like ISCT can provide benefits to its members.
“The Stem Cell & Regenerative Medicine Center is like a club for exchanging ideas and it captures all the diverse activities that otherwise would be difficult to capture,” Galipeau said. “You get to see what the trainees are doing, and the trainees get to see what you’re doing, and that matters a lot. It’s very easy to be tightly siloed when you’re in science, but the center really allows the broader community interested in cell therapeutics to get together and exchange ideas. So, I think it’s an absolutely necessary organization to be had.”
Likewise, Galipeau looks forward to supporting ISCT as a place to exchange ideas and explore the diverse activities and research happening in the cell and gene therapy space.
“There are very, very few scholarly not-for-profit societies that do this work,” Galipeau said. “ISCT is very collegial and translational and all of that matters to me.”