Year 4. February 10. Research Will Continue (I Think).
Happy Monday everybody. Late Friday, the National Institutes of Health released a memo outlining new guidance describing an updated policy on the payment of indirect (overhead) costs on all grants supported by the NIH.
Essentially, the notice announced a reduction in indirect rates to 15%. Indirect rates support many of the essential activities required to safely conduct all research in our institution. Not only do they support maintenance and upkeep of our research infrastructure; these funds also support many of the activities necessary for our investigators to comply with federal and safety regulations such as institutional review boards for human and animal research, maintenance of environmental and safety standards and supporting grants administration.
If enacted this policy will cut indirect NIH payments to UCLA by ~ 74%. As you can expect this announcement has caused significant concern across the entire research enterprise across the United States.
The Association of American Medical Colleges (AAMC) issued the following statement on Saturday.
I have heard from many investigators in the UCLA Department of Medicine (DoM) over the weekend, who conduct research, wondering what the UCLA response to this announcement will be. I share your concerns. Given the timing of the announcement on a Friday evening, our UC leadership have not yet been able to fully study the impact of these proposed changes and to draft a coordinated response to faculty. I expect that there will be substantial activity this morning by The University of California Office of the President (UC External Relations and Communications, UC Federal Governmental Relations, UC Legal), the Office of the Vice Chancellor of Research at UCLA, The Dean’s Office and other leaders to put together a coordinated response and issue UC-wide guidance. This is a rapidly developing situation and likely to evolve.
In the meantime, many of the professional societies to which we all belong will be issuing calls for advocacy, see the example below from my professional home, the Endocrine Society.
Please check in with your professional society. As private citizens all of us can contact our representatives on our own behalf, to inform them of the impact of our research on the health of Americans and the potential adverse effects of these budget cuts.
In the interim, I planned to use this week’s newsletter to highlight DoM faculty who are emerging as clinical trialists to inspire clinicians who aspire to take on this important work. I also celebrate the success of clinicians such as Dr. Russ Kerbel who was recently awarded a new grant that seeks to lay the groundwork to test an AI model to predict sepsis.
Research is our lifeblood and represents a core mission of our department from which we will not retreat, even in the face of strong headwinds. So read on…
From Clinician to Clinical Trialist: Shining the Spotlight on Dianne Cheung, MD, MPH
Dianne Cheung, MD, MPH, is an endocrinologist in our department, based at UCLA Torrance Specialty Care. Dr. Cheung is a practicing clinician, holds leadership positions in several professional organizations, co-chairs the highly successful UCLA Diabetes Symposium, and is an associate editor of Proceedings of the UCLA Department of Medicine, among many other responsibilities. Over the past year, she also has taken on the challenging work of becoming a clinical trialist by launching the UCLA South Bay Endocrine Trials program, a dedicated clinical trials program for cardiometabolic research that is led by a team of experienced trial LEADERS. As the lead investigator for these large-scale, industry-sponsored trials, Dr. Cheung is exploring the efficacy of experimental GLP-1 agonists, small interfering RNA (siRNA) and other drugs to treat cardiovascular and chronic kidney disease.
For Dr. Cheung, leading clinical trials is more of a homecoming than embarking on a new adventure. “I’ve always wanted to do research, even before I went to medical school,” she recalled. “I almost didn’t go to medical school because I actually thought about pursuing a PhD — I thought maybe the big dream was to do public health research on preventative medicine for the WHO, NIH or the CDC.”
Dr. Cheung acquired the skills and knowledge needed to excel in clinical research while obtaining an MPH at UCLA prior to medical school, but she chose to lean into her passion for patient care instead. After earning her medical degree at UCSD, she completed her residency training at White Memorial in Boyle Heights, where she developed an interest in treating complications of diabetes in patients from underserved communities. After completing a fellowship in endocrinology at UCLA, she joined a busy private practice in Torrance before returning to the DoM as faculty in 2012. She became active in diabetes research as well as research on thyroid cancer — even developing a first-of-its-kind technique and program that gives patients immediate feedback on thyroid cancer nodules — and took on leadership roles in professional and educational organizations like the Clinical Association for California Endocrinologists. All while still seeing more than two dozen patients a day.
Then, about a year and a half ago, Dr. Cheung shared with me, that she was approached by pharmaceutical companies that knew of her reputation for clinical and educational excellence. They wanted to gauge her interest in running clinical trials. I encouraged her to engage with them and reassured her that the DoM would work closely with her to make this opportunity a reality.
“I had never thought of it, and then they were offering it to me,” Dr. Cheung recalled.
Now, with three Eli Lilly-sponsored trials on new GLP-1 agonists and Lp(a) SiRNA therapy under her belt, Dr. Cheung believes that her experience managing a high patient volume is key to her success as a clinical trialist — as is encouragement from her many DoM colleagues who helped her get the endocrinology division’s clinical trial program off the ground, including Alice Kuo, MD, PhD; Judith Currier, MD; and Raphael Landovitz, MD. Now that the infrastructure is in place, offers from other companies are consistently on the table.
“They are coming to us because they know that we’ve developed a whole process,” Dr. Cheung said. “We had to pave the way, because these kinds of trials had not been done in our division before.”
Dr. Cheung notes that clinical trials have the ancillary benefit of breaking down silos between divisions and even across departments. For instance, although her program is housed within endocrinology, she collaborates closely with the UCLA Divisions of Cardiology and Nephrology for patient referrals, and with the UCLA Department of Ophthalmology for the retinal exams diabetic trial subjects require.
“Even though it’s an endocrine trial and an endocrine office, we’re getting other divisions within the department helping out because they want to see something like this be a success,” Dr. Cheung said. She is more than happy to return the favor: Interventional cardiologist Amir Rabbani, MD, who has served as a sub-investigator on her three Eli Lilly trials, was recently approached by a pharmaceutical company to be a principal investigator for his own drug trial — an opportunity that can be credited in part to his experience working on Dr. Cheung’s trials. Dr. Cheung will in turn support him as a sub-investigator on his trial.
“We are all helping each other,” Dr. Cheung said. “I think that if other faculty knew how collaborative this process is, they would realize that launching a clinical trial is not as hard as they think."
Dr. Cheung noted that getting a trial approved is not as challenging as one might expect so long as one is resourceful and persistent. That said, it still takes a special clinician with a passion for research to be willing to take on the extra work. Being particularly good at time management helps, especially in the beginning. Yet she encourages those who are curious to take a step towards getting involved, because clinician-run trials are the future of medicine. The opportunity to offer these landmark cardiometabolic trials to UCLA patients who otherwise would never have an opportunity to learn about them makes all that effort worthwhile.
“This is where medicine is taking us,” Dr. Cheung said. “We can make a difference.”
Please join me in thanking Dr. Cheung for her outstanding work, courage and dedication to our mission. The department will continue to work together to build upon her success so far, and I hope that others may be inspired to follow her path! If so, please reach out to your clinical and division chief, who will work closely with our department executive vice chair Dr. Judith Currier and her team to review feasibility and provide guidance and other resources.
Learning to Launch a Clinical Trials Program
Clinical trials are a growing part of our research and clinical missions. As you just learned from our spotlight on Dr. Cheung, faculty in sub-specialty divisions like endocrinology have expressed a growing interest in launching clinical trials. Some of you have expressed interest in becoming clinical trialists yourselves.
To give further perspective to those of you who may be interested in this path, I discussed the history of clinical trials at UCLA with Dennis Slamon, MD, PhD and John Glaspy, MD, MPH, both storied LEADERS in the UCLA Division of Hematology Oncology and the Jonsson Comprehensive Cancer Center (JCCC). Dr. Slamon is the director of clinical/translational research; the director of the Revlon/UCLA Women’s Cancer Research Program at JCCC and the chief of the UCLA Division of Hematology Oncology. Dr. Glaspy is the Simms/Mann Family Foundation Chair in Integrative Oncology, clinical chief of the Division of Hematology and Oncology and a professor of medicine. They oversee a clinical trials portfolio in their division of $92 million.
Back in the 1980s, around the time Dr. Slamon developed the breast cancer drug Herceptin — a drug that would go on to save millions of lives — he and Dr. Glaspy set up the infrastructure to give JCCC faculty a way to launch and enroll patients in clinical trials. That required hiring staff who could handle trial contracting, regulatory contracting and patient care issues.
“You need to have staff that will handle all three of those component parts, and from my perspective, that was the most important thing that John and I established for the faculty,” Dr. Slamon recalled.
At UCLA and elsewhere, hematology-oncology is unique from other specialties in that clinical trials “are built into its DNA,” as Dr. Glaspy put it. In the DoM, the division leads in clinical trials not only because of what he and Dr. Slamon built, but because treatments rapidly evolve.
“There is plenty of preclinical work that goes on at companies and institutions like UCLA, but the ultimate test is a clinical trial,” Dr. Slamon explained. “If you’re really interested in moving the agenda forward, you should definitely be interested in participating in clinical research and testing new hypotheses. That’s what an academic division should be about.”
Dr. Glasby noted that clinical trials require a significant time commitment that may make them challenging for busy clinicians to take on. For one, they require spending more time with patients — something many physicians are already squeezed on. Still, “we want to continue to populate our department with people who are willing to make that investment of time, because that’s why they want to be at UCLA,” he said.
“Clinical trials are a recruitment tool for the department,” Dr. Glaspy added. Potential faculty “favor UCLA over other job opportunities, because it gives them a chance to participate in clinical trials.”
Trials are also a recruitment tool for the department and the greater hospital system. While they are in no way a “big profit center,” Dr. Slamon said, “the payoff comes when you’re running clinical research and an active clinical trials program portfolio.”
“You attract patients, you attract referrals, you attract involvement by other physicians outside the institution,” he said.
Take the benefits of collaboration with outside physicians, for example. When they were in the process of launching their clinical trials program in hematology oncology, Dr. Slamon and Dr. Glaspy went out into the community and met with private practice oncologists to engage them in UCLA’s clinical research, not only providing them with the coordinators and data managers they would need to participate but also including them in the small financial upside the division saw from running trials on behalf of pharmaceutical companies. That was enough to incentivize network participants to enroll patients in clinical trials — and to send them to UCLA for other types of care.
“The upside that was dramatically underappreciated was that once you start working with these doctors in this venue, they refer patients to you for other things,” Dr. Slamon said. “You really do engage the community and patients outside our current patient load to come to UCLA, and that’s where you can have a significant impact on generating a margin for the system to grow and sustain the programs.”
Dr. Slamon and Dr. Glaspy emphasized that faculty should be properly incentivized to become clinical trialists on top of their large patient loads and many responsibilities, such as In Basket management. I would like to note that when an infrastructure as robust as that in the hem-onc division is in place, resources are already available to incentivize those who are starting out for the first time. For other specialties, the DoM is building out the infrastructure and providing startup support and mentorship to ensure long-term success and ultimate sustainability. A successful clinical trial portfolio will then allow faculty to buy down their clinical time, because faculty effort can be included in clinical trials budgets.
Thanks John and Dennis for sharing your perspectives and for your dedication in advancing patient care. I encourage those of you who are interested in launching clinical trials in your division will reach out to your clinical or division chief, to Dr. Judith Currier executive vice chair for research, or to me to discuss your plans and review how best the department can support you.
Russell Kerbel, MD to Lead UCLA Arm of Study on artificial intelligence (AI) Sepsis Model
Now I am pleased to share that UCLA is involved in preliminary work to assess the adoptability of special AI models that uses electronic health record (EHR) data to catch the early signs of sepsis, a life-threatening immune response to infection that is the third leading cause of death in U.S. hospitals. The project, called California’s Groundbreaking and Responsible Evaluation of AI Tech for Sepsis Prevention (CALI-GREAT), will assess whether it is technically feasible to implement an AI model called COnformal Multidimensional Prediction of SEpsis Risk (COMPOSER) across three healthcare centers in the University of California system. Russell Kerbel, MD, MBA, medical director for sepsis prevention at UCLA Health, will serve as site principal investigator of the $240,000 grant at UCLA.
“This research directly supports UCLA Health’s Sepsis Initiative, as it aims to evaluate and optimize AI-based models for early detection,” Dr. Kerbel explained. “These efforts have the potential to improve patient survival rates, streamline clinical workflows and ensure that interventions are timely and equitable.”
Dr. Kerbel was awarded this grant to conduct a research project, which will take place over a two-year period at UCLA, UCSD and UCI. Originally developed at UCSD, the model analyzes more than 150 different patient variables to detect early signs of sepsis. It has already shown signs of success in the emergency room at UCSD, where it was associated with a 17% reduction in mortality.
To find out whether COMPOSER can be adopted into workflows at UCLA Health, Dr. Kerbel and his team will start by conducting a comprehensive qualitative needs assessment, which will involve interviews with health system leaders, clinicians and more. They will also study how the model might be integrated technically into existing UCLA Health infrastructure for EHRs and evaluate its accuracy and fairness. All data will be shared between participating UC health systems.
COMPOSER is one of two AI models for sepsis care under evaluation by the Sepsis Initiative. This study will also complement work that Dr. Kerbel’s team is undertaking to evaluate the Epic Version Sepsis 2.0, a model that is built directly into the Epic EHR system.
“By systematically evaluating these models’ feasibility, we are laying the groundwork for safer, more effective, and equitable sepsis care that could serve as a model for healthcare systems nationwide,” Dr. Kerbel said. “The UCLA Health Sepsis initiative is always looking to partner with clinicians throughout the organization and especially looking to collaborate more with department faculty on their research and operational projects.”
I encourage any faculty member who is working on projects that may complement Dr. Kerbel’s research to reach out about opportunities to collaborate. Please join me in congratulating Russ and his team on their exciting new grant!
Antoni Ribas, MD, PhD Appointed Heyman Shostak Endowed Chair
Our news of research and clinical trial excellence this week is complemented by the announcement that Antoni Ribas, MD, PhD was recently appointed the Rosalyn R. Shostak Heyman and Hannah Kully Shostak Endowed Chair at DGSOM. Dr. Ribas serves as director of the Tumor Immunology Program at JCCC, director of the Parker Institute for Cancer Immunotherapy Center and is a professor of medicine, surgery, and molecular and medical pharmacology.
“I am honored to receive the Heyman Shostak Endowed Chair, which recognizes work over the past 20 years that I have done with the members of my laboratory and my colleagues in advancing new treatments for patients with the aggressive skin cancer melanoma,” Dr. Ribas said. His chair appointment is retroactive to July 1, 2024.
As a physician-scientist, Dr. Ribas conducts basic science and translational research on cancer treatments — including adoptive T-cell therapies and PD-1 inhibitors, and the mechanisms responsible for resistance to melanoma drugs. He was instrumental in the clinical development of several landmark cancer therapies, including Keytruda, the first PD-1 inhibitor approved by the FDA.
Please join me in congratulating Dr. Ribas on this well-deserved endowed professorship!
Dale
In uncertain times, it may feel like stars are not aligning.
Maybe this picture of the planets in alignment (the bright one is Venus) taken on my recent trip to Jamaica from the southwest coast, devoid of light pollution, may instill in us some hope regarding the relative transience of immediate crises.
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