Research News
Eric Small's Research Suggests a Cancer Protein Could Be at the Heart of Cardiac Scarring and Disease
The associate professor of Medicine and his colleagues found that the tumor suppressor protein p53 might play an important role in both. Supported in part by the CTSI, the research shows that too much p53 may speed progression of a heart rhythm disease, while too little p53 could lead to scarring after cardiac injury.
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Research Leadership Team Update
Friday, February 14, 2025
There have been many recent federal policy changes that have left us all with questions and concerns. The Department of Medicine is committed to providing clear, coordinated, and consistent guidance on these changes, in alignment with the University of Rochester.
The University has launched a dedicated website to provide our community with updates and guidance on federal policy changes. The site includes:
- FAQs on research, immigration enforcement, and data privacy and legal protections
- The latest University messages on executive orders and announcements
- Guidance for researchers
- Web form for community members can submit questions.
- A new Policy Updates for Researchers web page
- Additional guidance on immigration enforcement and University protocols, including legal parameters, and rights and responsibilities for students, employees, and University officials when interacting with immigration officers.
You are encouraged to share these resources with colleagues who may receive questions or need this information in their roles.
We will continue to provide updates as we receive them. If you have any questions, concerns or ideas to share, related to recent changes and impacts on research specifically, please reach out to us: Valentina Kutyifa, MD, PhD, Laura Calvi, MD, or Stefanie Fingler (Stefanie_Fingler@URMC.Rochester.edu).
Three Faculty Earn Research, Teaching Awards
Wednesday, February 5, 2025
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Brendan Guercia, MD
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Erika Drury, MD
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Rebecca Levy, MBBCh
Nephrology and Hematology/Oncology faculty were awarded research and teaching grants to advance care and education of the next generation of physicians.
Nephrology’s Rebecca Levy, MBBCh, received the 2025 UR CTSI K12 (formerly KL2) Scholar Award to examine outcomes for adolescents and young adults with chronic kidney disease and explore potential interventions to reduce unnecessary hospitalizations. The award provides 75 percent FTE support for two years.
Erika Drury, MD, of Nephrology, was selected as the 2025-2027 Ritchie Teaching Fellow. She will create a cardiovascular-kidney-metabolic health curriculum for the Nephrology Fellowship. The two-year award provides 10 percent FTE support.
Brendan Guercio, MD, of Hematology/Oncology, received a $250,000 Career Development Award from the Bladder Cancer Advocacy Network (BCAN.) He will investigate whether a healthy diet can help the immune system’s ability to fight advanced bladder cancer when coupled with the newest therapy, enfortumab, vendotin, and pembrolizumab (EVP). Guercio previously won a BCAN Young Investigator Award and has already shown that a nutritious diet enhancing the gut microbiome, along with immunotherapy, may lead to better bladder cancer control.
Olga Astapova Honored with Early Career Innovator Award
Thursday, January 30, 2025
Olga Astapova, MD, PhD, assistant professor of Endocrinology, Diabetes & Metabolism, accepted the inaugural Molecular Human Reproduction (MHR) Early Career Innovator Award for “research that exemplifies the innovation, dedication, and rigor that propel the field of reproductive sciences forward.” The honor recognizes young researchers who publish original research articles as part of the Early Career Innovator Series.
Kari Steinmetz Wins CTSI Shark Tank Funding Competition
Wednesday, January 22, 2025
CTSI held its Translational Science Shark Tank event in October, with teams developing solutions to seemingly intractable barriers to recruitment in clinical research.
Kari M. Steinmetz, BA, COA, assistant director of Clinical Trials, and her team, presented creation of an Open Research Round Table Committee to enhance collaboration between research teams and participant recruitment groups. Following the competition, Steinmetz was asked to conceptualize her idea and secured CTSI funding to pursue it.
“With these resources, we aim to eliminate communication barriers that frequently impede clinical-research recruitment” Steinmetz said. “Through a standardized system, we hope to streamline collaboration among research-team members while enhancing participant engagement.”
Communication barriers between researchers and recruitment teams frequently slow the enrollment process in clinical trials, resulting in inefficient recruitment and missed enrollment targets. By identifying barriers to recruitment and discussing potential solutions, the round table committee will help meet research-enrollment targets and better engage research participants.
The committee will consist of coordinators, principal investigators, and study participants, and initially be piloted in Infectious Diseases before expansion across all divisions. The model could also be applied to community engagement, allowing potential participant recruitment groups to contribute ideas.
“My hope is that we can turn this pilot into a long-term project that expands from an internal process to a community effort,” Steinmetz said. “For example, in the community, we could discuss a barrier such as vaccine hesitancy. Researchers would have the opportunity to learn more about the reasons behind this hesitancy and to explain the safety of vaccines.”
New Procedures Launched to Bolster Clinical Trials
Wednesday, January 22, 2025
A new standard operating procedure (SOP) for Department of Medicine investigators was recently introduced to ensure feasibility of clinical trials as part of a new, comprehensive clinical trials platform. Its primary mission is to achieve translation through clinical trials, with the goal of creating a uniformed framework to identify innovative studies that align with the missions of DOM’s various divisions.
“We are launching a novel, innovative clinical trials framework to promote a strategic, managed clinical trials portfolio, effective trial operations and diversity, in alignment with the DOM Strategic Plan,” said Valentina Kutyifa, MD, PhD, vice chair for Clinical Research. “Most importantly, processes for start-up, feasibility, and conduct of clinical trials are being harmonized and modernized across our divisions to set up our investigators for success.”
With this streamlined process, new studies will be identified that are feasible and advance the institution’s strategic priorities. Last week, URMC CEO David Linehan, MD, cited his goal of building an “absolute powerhouse for clinical trials and clinical investigations.”
The DOM is at the forefront of this effort, with more than $247.7 million in research funding is the largest across SMD. This is the first of the DOM Clinical Trials Umbrella procedures aiming to achieve these goals.
The SOP’s scope covers clinical research protocols that prospectively enroll randomized and non-randomized human subjects, including sponsored and investigator-initiated research, clinical trials and FDA-regulated studies.
Key elements of the new DOM clinical trials framework include a Clinical Research Leadership Committee, harmonized organizational structure and mission statement, harmonized use of OnCore across divisions, a Protocol Review Committee and enhancing study start-up activities including IRB support. Other elements include advancing the use of e-consent and electronic study documentation, ongoing feasibility review, PI engagement, improved oversight and training, and competitive staff recruitment, training and retention.
The feasibility assessment of new clinical trials encompasses seven steps: sponsor inquiry, go/no go check, completion of a new, standardized feasibility worksheet, formal risk assessment through OCR, score calculation, protocol review by the DOM Protocol Review Committee and decision.
The next initiative is focusing on harmonizing the use of OnCore across all divisions. DOM hopes to soon implement its usage in all studies, currently at about 80 percent for DOM sponsored studies across all divisions.
“This SOP marks the beginning of a unified approach across all 15 divisions of medicine, providing a clear framework to align clinical trials with our strategic goals and ensuring swift and successful execution of studies that drive our mission forward,” said Stefanie Fingler, MBA, director of Research Operations.
Kari Steinmetz, MBA, assistant director of Clinical Trials, said, “With almost three decades of experience across various departments at the University of Rochester, I’ve seen firsthand how clear, consistent and well-communicated SOPs can serve as a vital tool in driving efficiency, consistency and quality across all levels of an organization. This SOP will help us reduce inefficiencies, foster communication and ultimately drive the success of our organization.”
The new SOP is a pilot that will be evaluated at the end of the year. For questions, contact the Research Leadership team.
URMC Department of Medicine Clinical Trials Framework
Department of Medicine Sponsors Research in DEI and Health Equity Symposium
Wednesday, January 8, 2025
On February 28, 2025, the Department of Medicine invites members of the University and surrounding communities to attend the 3rd annual Research in DEI and Health Equity Symposium. This year’s symposium places a special emphasis on research addressing community outreach and engagement, including but not limited to community-based participatory research, community health literacy, outreach efforts to Rochester community, LGBTQ+ care, engaging patient voice in clinical research and efforts to increase diversity in medical education. We are thrilled to welcome Dr. Wally Smith from Virginia Commonwealth University as our keynote speaker.
For questions about the registration site or process, please email: cmeregistration@urmc.rochester.edu
Jennifer Anolik Named Chief of Allergy, Immunology and Rheumatology Division
Monday, January 6, 2025
Internationally renowned physician scientist Jennifer H. Anolik, MD, PhD, was named chief of the Allergy, Immunology and Rheumatology (AIR) Division in the Department of Medicine, after serving as interim chief since 2021.
“I am delighted that Jen has agreed to continue leading our AIR division as chief,” said Ruth O’Regan, MD, chair of Medicine. “The division is in great hands under her leadership and will continue to benefit from her experience and expertise as a clinician, educator and researcher. I am extremely grateful to her for serving as interim chair over the past few years.”
A faculty member for 22 years, Anolik also serves as associate chair for research in the Department of Medicine, professor of Medicine, Pathology, and Microbiology and Immunology, and director of the Internal Medicine Physician Scientist Training Program.
Anolik earned her MD and PhD at the University, completed her residency in Internal Medicine in 1999 and her fellowship in Rheumatology in 2002, after which she joined the faculty.