A $3.5 million philanthropic gift is helping Cleveland-based University Hospitals Seidman Cancer Center triple its clinical trial capacity by 2030 — part of a broader push to expand cancer research and innovation while decentralizing early-phase trial access across its 23-hospital system.
Leading the charge are Theodoros Teknos, MD, president and scientific director of the UH Seidman Cancer Center and the Jane and Lee Seidman Chair in Cancer Innovation, and Quintin Pan, PhD, deputy director for research of the UH Seidman Cancer Center and the Dr. Lester E. Coleman, Jr. Chair in Cancer Research & Therapeutics.
They spoke to Becker’s about their clinical trial expansion strategy, how AI will enable streamlined trial enrollment and their mindset amid federal funding uncertainty.
Editor’s note: Responses have been lightly edited for clarity and length.
Questions: The research funding environment is shifting, with pressures on federal dollars and growing interest from industry partnerships. How are these external forces influencing UH’s strategy to expand its clinical trial portfolio?
Dr. Theodoros Teknos: Federal funding is becoming more difficult to come by. The pay line for NIH grants continues to be ever more challenging. Cooperative group trials — which are really trials coming out of the National Cancer Institute — are becoming much more challenging for hospitals to afford, because from a financial standpoint, most institutions lose money on these cooperative group trials.
But we remain committed to accruing to these large cooperative group studies because it’s the right thing to do and they answer some very big questions. We’ve creatively changed our portfolio so that much of our clinical trial accrual is in early-phase clinical trials — phase 1 in particular. We have one of the biggest programs in the nation, and about 40% to 45% of our clinical trial accruals are in these early phase 1 and phase 1/2 clinical trials. These are the first-in-human trials and offer new hope.
A lot of these trials are industry-sponsored and in partnership with our donors like Kathy [Coleman]. We also fund drugs that are discovered here at University Hospitals and Case Western Reserve Comprehensive Cancer Center to go from the bench to the bedside, using philanthropy and internal donor funds.
We really believe clinical trials are the reason why individuals choose certain cancer hospitals for their care. Being able to offer cutting-edge trials is a major differentiator for us. Ms. Coleman’s gift is allowing us to expand our portfolio and go even beyond our current geographic confines. She’s been very passionate about early-phase clinical trials, especially as her husband was battling lung cancer. With this gift, she’s now given a total of approximately $14 million to UH, specifically to expand our clinical trial capabilities.
Q: With so many health systems reassessing clinical trial strategy, how do you see UH differentiating itself as a destination for early phase trials and innovative studies?
Dr. Quintin Pan: CAR-T technology is one of our differentiators here at UH Seidman Cancer Center. We have a number of faculty members rapidly developing in-house technologies around this CAR-T space, and we’ve prioritized several of these into clinical trials.
Most of these CAR T investigator-initiated trials are funded internally. Our hospital system sees it as an investment to bring this technology from the bench to our patients.
One technology we’re developing — and I think it’s fair to say we’re the first — is a rapid CAR-T program where we can turn around the CAR-T cells in one day, versus the traditional 10 to 14 days. We have a phase 1 clinical trial active in this space.
TT: Another differentiator is our robust capabilities in theranostics. These are emerging treatments where we conjugate both imaging and radiation delivery to antibodies. Pluvicto for prostate cancer is an example that’s commercially available, but we have many molecules developed by our scientists that are being translated to the clinic.
Q: How do you balance building one of the nation’s premier phase 1 programs while ensuring access for diverse, safety-net populations?
QP: We’ve been thoughtful in our expansion to ensure that all patients in our catchment area have access to our clinical trials. One aspect of Kathy’s award is to expand our phase 1 program. We’ve been intentional in how we’re designing the new space so everything is co-localized in one area.
To ensure access for the underserved, we have community-based programs to educate the public about availability and benefits of clinical trials. We also have robust systems to identify patients, including underserved populations, who match to clinical trials. Our goal is for every eligible patient to get access.
Q: Looking ahead, what emerging areas of innovation do you think will most redefine the clinical trial landscape by the end of the decade?
QP: AI is absolutely a major area of interest. There’s a lot of opportunity for AI in cancer, from drug development to patient selection. Right now, patient selection is still done manually but we’ve piloted and begun using AI approaches to better match patients to clinical trials.
That technology will only become more robust. In terms of drug design and development, there’s also a lot of opportunity. Right now, it takes 10 to 15 years and about $2 billion to bring a drug from bench to bedside. With AI, we hope to reduce both the time and cost.
Q: How should health systems prepare for the changing role clinical trials may play in routine cancer care in the future?
TT: To triple clinical trial accruals really does require operational and significant expertise. As a 23-hospital system with 17 Seidman Cancer Center sites, we’ve learned that there can be a lot of missed opportunities. Patients don’t want to travel. They want care close to home.
We believe bringing the trials to the patients is going to be a winning strategy. We’ll need not only exceptional capabilities on our main campus, but also robust infrastructure in the community. That means doing all phases of trials locally. We’ll probably focus on certain trials at certain sites but plan to set up phase 1 programs at larger community locations with investigational pharmacy and short-term stay capacity.
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