University of Rochester Clinical and Translational Science Institute Annual Report 2019-2021 by University of Rochester Medical Center

TWO YEARS & TWO PANDEMICS ANNUAL REPORT

Table of Contents About the UR CTSI

UR CTSI Directors’ Message

COVID-19 Response

Diversity, Equity & Inclusion

Supporting Research

Education

Working Together

About the UR CTSI The UR CTSI helps research teams produce results better, faster and cheaper, with the ultimate goal of improving the health of communities and populations. We link researchers with the connections, resources and education they need for success.

Mission The University of Rochester Clinical and Translational Science Institute (UR CTSI) develops, demonstrates and disseminates methods and approaches to advance translational research by providing education and training, supporting transdisciplinary teams, improving quality and efficiency, and engaging community and national stakeholders. Vision The UR CTSI will be a replicable model environment for research across the translational spectrum, from molecules to populations, that is responsive to community priorities, conducted by transdisciplinary, patient- and community-engaged teams, and that improves population health. Values The UR CTSI shares the University of Rochester Medical Center’s ICARE values: Integrity, Inclusion, Compassion, Accountability, Respect and Excellence. We believe that exceptional patient care starts with exceptional research. Integrity

Respect

The UR CTSI promotes research that is reproducible, community-engaged and compliant with rules and regulations.

The UR CTSI actively solicits community input to guide its work and acts upon that input. We respect the differing values of the communities we serve: students, researchers, patients and community members. We are committed to the value of team science, which includes fostering a culture of transdisciplinary respect and active engagement with scientists of every background and perspective.

Inclusion

The UR CTSI strives to create an inclusive and welcoming environment for all. Compassion

The UR CTSI manifests its compassion through our goal of improving population health and reducing health disparities in our communities. Accountability

The UR CTSI meets the commitments it makes to funders and the community. We are accountable to the University, funding agencies, and local and global communities, for whom we provide research and education programs. We are committed to developing metrics of accountability consistent with these values.

Excellence

The UR CTSI strives to be a national model for excellence in translational science and research education programs. We are dedicated to training and supporting researchers to enable them to achieve the highest quality of work in their fields. We are committed to excellence in translational research at a national level, balancing efficiency, integrity and timeliness.

UR CTSI Annual Report 2019–21

UR CTSI Directors’ Message

TWO YEARS & TWO PANDEMICS It feels trite to say the past two years have been difficult and unprecedented. Not only did we face a global pandemic that has continually posed challenges for science and medicine, but we were awakened to the realities of racism by the graphic killing of George Floyd and, locally, Daniel Prude in the spring of 2020. In the face of these two immense external pressures, the UR CTSI rose to meet the occasion. Our faculty, staff and trainees reacted and adapted quickly, contributing to fast-paced COVID-19 research and developing new programs to examine and address racism within our institution.

and vaccines rapidly to patients, the groups sought and promoted studies for treatments and interventions that covered the full spectrum of patients’ needs: from outpatient care to the ICU. The working groups also ensured studies had the resources they needed to succeed by promoting collaboration and helping teams avoid competing for study participants. (Read more on page 4.)

In March of 2020, when the COVID-19 outbreak was officially declared a pandemic, so much was unknown. Never before had so many researchers pivoted to study a single virus and disease. When scientists started studying COVID-19 at the University of Rochester, the UR CTSI took immediate action to help coordinate and support their efforts.

Our team hosted community engagement studios and developed a Vaccine Advisory Committee to bring COVID-19 researchers and community members together to improve study design and increase trial participation. We rapidly stood up a COVID-19 Biobank with thousands of blood samples and linked de-identified clinical data from both COVID-19-positive and negative patients (see page 7). We helped our human subject researchers pause their studies at the beginning of the pandemic and restart them when it was safe to do so. We filled a resource gap by establishing a new, specialized clinical research unit to test infusion treatments to prevent and treat COVID-19 (see page 5).

The UR CTSI team pulled working groups together that reviewed, approved and tracked over 280 COVID-19-related research studies across the university. With a focus on large national studies that held promise for getting effective therapies

Working closely with members of the community, the UR CTSI team led the award-winning Six Feet Saves campaign (see page 7) to encourage our community to socially distance and, a later effort to encourage community members to get

COVID-19: Air Traffic Control and Community Outreach

UR CTSI Annual Report 2019–21

the COVID-19 vaccine and booster. In December of 2020, Nana Bennett, M.D., was appointed as special advisor to the Monroe County Commissioner of Public Health and co-chair of the Finger Lakes COVID-19 Vaccine Task Force to coordinate vaccination efforts and ensure equitable access to the vaccine for all community members. The task force drove two additional outreach campaigns, Bring Roc Back and You Deserve Answers, giving community members the information and encouragement they needed to participate in vaccine studies and get vaccinated when eligible. This work has continued as we vaccinate children and provide boosters to adults. The UR CTSI and the broader Clinical and Translational Science Awards Program were built to respond to pressing health challenges, like the COVID-19 pandemic. Over the past two years, we have used our experience, connections and expertise to help our researchers respond quickly to this global threat. Translational science is more important now than ever before, and the UR CTSI remains committed to our goal of accelerating research to improve health. Renewing Our Commitment to Diversity, Equity and Inclusion The summer of 2020 proved to be a flashpoint for racial justice in the U.S. Protests were held across the country seeking justice for George Floyd, Daniel Prude and many others, through reforms in the criminal justice system. It was a moment of awakening to the many injustices and inequities that weave their way through every facet of American society – and a call to action to undo them. Healthcare and health research have certainly not been immune to the history of structural racism in the U.S.

The UR CTSI is also part of larger anti-racism efforts at the University of Rochester Medical Center. In October of 2020, URMC unveiled a five-year Equity and Anti-Racism Action Plan to strengthen diversity and inclusion at the Medical Center, address inequities in patient care and reduce health disparities in the Rochester community. As part of that plan, the UR CTSI is establishing a new Office for Health Equity Research that will foster a deeper understanding of the root causes of health disparities by supporting health equity research across URMC (see page 9). But our anti-racism efforts don’t stop there. They extend nationwide. The Center for Leading Innovation and Collaboration, a national translational science coordinating center that is part of the UR CTSI, led an educational anti-racism initiative called Cohorts for Change. The six-month anti-racism workshop series aims to foster structural and administrative anti-racism efforts at institutions across the CTSA Program. These efforts, led by the UR CTSI, have resulted in the CTSA Program consortium of 61 universities and their partners working together to enact lasting and effective change. (see page 8). All of these initiatives and programs – and the many others we didn’t have space to mention – demonstrate the importance of investing in translational science. We often operate in the background, unsung. But we lay the foundation upon which pandemics are thwarted, cures are discovered and disseminated, and systemic changes are made. There is still much work to be done, and the UR CTSI is working to create and sustain a better and more equitable future through translational research.

Many of us know about infamous experiments like the “Tuskegee Study of Untreated Syphilis in the Negro Male,” in which Black men were misled and denied available treatments. But that is just the tip of the iceberg. There have been many abusive medical studies and practices since the time of slavery to present day, which cause mistrust between communities of color and the healthcare establishment, and have led to devastating health disparities. In 2021, the UR CTSI worked with professionals in the Rochester community to develop a course examining this history and its lasting impacts. The Structural Racism in Healthcare and Research Course, which is rooted in critical race theory, teaches that racism – not race – causes health disparities. Critically examining that fact and acknowledging our fraught history is essential to closing the health equity gap.

Martin Zand, M.D., Ph.D., and Nancy Bennett, M.D., M.S., Co-Directors of the UR CTSI

UR CTSI Annual Report 2019–21

COVID-19 Response UR CTSI Coordinates Coronavirus Research to Maximize Impact When the first COVID-19 cases hit the University of Rochester Medical Center’s intensive care unit in March of 2020, there were no proven treatments available, but experimental therapies were cropping up around the world. Quickly, a team of clinicians and researchers – led by the UR CTSI – mobilized to bring the most promising clinical trials to the Medical Center. Since then, the group has helped URMC join a range of clinical trials that have provided extra treatment options for COVID-19 patients.

“Our goal has always been to promote effective therapies through clinical trials,” said Martin Zand, M.D., Ph.D., senior associate dean for clinical research at URMC and co-director of the UR CTSI. “Our team is working hard to make sure that the trials we bring to URMC have the greatest chance of benefiting our own patients, and significantly advancing the science of COVID-19 to benefit patients around the world.” But the group’s work doesn’t end there. The group, which is co-chaired by Christopher Palma, M.D., assistant professor of Allergy, Immunology and Rheumatology, and Lisa Beck, M.D., the Lowell A. and Carol A. Goldsmith Professor in Dermatology, also helps get promising studies off the ground. “Once we determine that a study is a good fit for our community, we want to get that study up and running as quickly as possible,” said Palma. “If there’s something our team can’t help researchers with directly, we connect them with other institutional resources that can.” For instance, the group has worked with the UR CTSI Regulatory Support team to fast-track IRB approvals for COVID-19 treatment trials and has collaborated with the university’s Office of Human Subjects Protection and Academic IT to get an electronic clinical trial consenting system (eConsent) up and running in just 10 days.

The COVID-19 Interventional Trials Working Group, which was assembled by the UR CTSI early in the pandemic, coordinates coronavirus-related research across URMC to maximize its impact and its ability to move the needle on combatting COVID-19. With an eye toward meeting the broad spectrum of patient needs, the group reviews and prioritizes COVID-19 clinical trials that will provide the most promising treatment options for local patients without competing with one another.

UR CTSI Annual Report 2019–21

UR CTSI-affiliated members of the working group have also adapted the university’s health research registry to allow users to opt to be contacted about coronavirus/COVID-19 studies and have helped researchers find clinical research coordinators for their trials through the UR Connected platform. All of these efforts and leadership from the UR CTSI were pivotal in helping URMC researchers quickly adapt and refocus to meet the challenge of the global COVID-19 pandemic.

UR CTSI Opens New Space to Study Infusion Therapies at URMC After months of planning and renovations, the UR CTSI opened a new Clinical Research Infusion Center at the University of Rochester Medical Center in May of 2021. The new center, which was funded by the University of Rochester School of Medicine and Dentistry, provides a safe space for researchers to test new infusion drugs, like monoclonal antibodies or convalescent plasma. The 1,600-square-foot space located in the Medical Center includes four infusion bays, a staff office and a workroom that serves as touchdown space for researchers. With an upgraded air handling system and four adjacent designated parking spots, the center is handicap accessible and meets regulations for treating COVID-19-positive study participants. As an added safety measure, a direct entrance to the center from the parking lot allows COVID-19-positive participants to avoid walking through the Medical Center. “We have needed this space for some time, and the need became apparent during the COVID-19 pandemic,” said UR CTSI Co-Director Martin Zand, M.D., Ph.D., who is also senior associate dean for Clinical Research at URMC and led the charge to create the new space. “Our existing infusion spaces were devoted to clinical care of patients, many of whom are ill and/or immunocompromised. We needed a space dedicated to research studies where we could safely infuse COVID-19-positive research subjects without putting other patients at risk.” The center was initially devoted to testing COVID-19 infusion therapies and seeing COVID-19-positive study participants. Michael Keefer, M.D., professor and interim chief of Infectious Diseases at URMC, was the first to use the space for an NIH study testing monoclonal antibodies in patients who have COVID-19. In fact, Keefer and others in the Infectious Diseases Division at URMC were key partners in planning and developing this new, specialized extension of the UR CTSI’s existing Clinical Research Center. “This new center is advantageous not just for COVID-19, but for conducting research with patients who have any contagious infection,” said Keefer. “We’re focused on COVID-19 now, but the center will allow us to study other infectious diseases and will help us be prepared in the event of future outbreaks.” UR CTSI Annual Report 2019–21

COVID-19 Response Nana Bennett Leads Regional COVID-19 Vaccination Effort reaching out to communities and making sure everyone had equal access to these life-saving vaccines.” Bennett assembled a team of six leads, tapping into operations, technology, logistics and administrative leaders from across URMC. The team included the UR CTSI’s Elissa Orlando, tapped by Bennett to lead communications and community engagement for the Vaccine Hub. In the span of several weeks, the Vaccine Hub was distributing vaccines across the Finger Lakes region, and working hand in hand with the task force to ensure equitable vaccine distribution. Distribution sites included all regional public health departments, recreation centers, churches and neighborhood centers from the center of Rochester to rural western New York.

In December 2020, UR CTSI Co-Director Nancy “Nana” Bennett, M.D., M.S., was appointed as a special advisor to the Monroe County Commissioner of Public Health. In that role, Bennett led the Finger Lakes COVID-19 Vaccination Task Force alongside Wade Norwood, CEO of Common Ground Health. The task force orchestrated the COVID-19 vaccine rollout across the region, taking extra pains to do so with equity and fairness. The task force was commissioned by Monroe County Executive Adam Bello and Monroe County Commissioner of Public Health Michael Mendoza, M.D., M.P.H., to coordinate the efforts of all agencies involved in vaccination delivery in the Finger Lakes region. In that same month, Governor Andrew Cuomo designated the University of Rochester Medical Center as the Finger Lakes Regional COVID-19 Vaccine Hub, responsible for carrying out the New York State Vaccination Administration plan in the Finger Lakes region. The main mission of both the task force and hub is to ensure equitable, transparent and efficient vaccination of at least 70 percent of the adults in the nine-county Finger Lakes region, including Genesee, Livingston, Monroe, Ontario, Orleans, Seneca, Wayne, Wyoming and Yates counties. “This was an unprecedented challenge, but we have a strong team that is passionate about protecting every resident of our community,” said Bennett, who is also the director of the Center for Community Health & Prevention at the University of Rochester Medical Center. The team has done tremendous work

UR CTSI Annual Report 2019–21

After a year – during which vaccine approval has expanded to children – over 70 percent of people five years and older have received at least one dose of a COVID-19 vaccine and over 70 percent are fully vaccinated in our nine-county region. That’s an amazing feat. And yet, the Task Force continues its work to ensure all people within our region are protected.

The Finger Lakes COVID-19 Vaccine Hub gathered in the summer of 2021. Back row: Clayton Stieve, Mark Cavanaugh, Vincent Esposito. Middle row: Elissa Orlando, Kim Povec, Amy DeMott, Michelle Clark, Jherell Drain, Wendy Parisi, Nana Bennett, Ali Loveys, Irena Boyce. Front row: Michael Mendoza, Adam Bello, Katy Stevenson, Rebecca Youmell. Photo credit: Robert Calihan.

Six Feet Saves: Outreach Campaign Saves Lives, Receives Award Shortly after COVID-19 made its way to the U.S., the UR CTSI and 14 other community organizations developed the “Six Feet Saves” outreach campaign, urging community members to stay home or stay six feet apart. Leveraging a variety of media channels - from television ads to murals, lawn signs and sidewalk paint – the campaign reached hundreds of thousands of Monroe County residents and likely helped keep the county’s COVID-19 death rate down in the early days of the pandemic. On September 11, 2020, the campaign – and the community coalition that developed it – received the W. B. Potter Founders Award at Causewave Community Partners’ Annual Wavemaker Celebration. The award recognizes a results-oriented collaborative initiative that both fills a community need and serves as a role model for other partnerships.

“We are committed to supporting the Department of Public Health and engaging the community to promote health and prevent disease,” said UR CTSI Co-Director Nancy Bennett, M.D., M.S., who is also the director of the Center for Community Health & Prevention. “When faced with this unprecedented health crisis, we knew we had to do whatever we could to help our community stay safe.” The UR CTSI also helped lead the charge to engage other community partners, including Monroe County’s Community Engagement Task Force, which helped identify and distribute messaging to the county’s most vulnerable communities and neighborhoods. But the campaign could not have been successful without all of the collaboration and contributions of the full Six Feet Saves Coalition.

“When our community faced its biggest health challenge in 100 years, it was clear we needed something to rally around. So many people and organizations answered the call,” said Causewave President and CEO Todd Butler. “This was a joint effort like I’ve never seen. Everyone was hungry to do their part in saving lives.” The UR CTSI and its National Center for Deaf Health Research were on the ground floor of developing the campaign with the Monroe County Department of Public Health, lending community engagement expertise and ensuring the campaign met the unique needs of our Deaf and Hard-of-Hearing community.

UR CTSI Launches Biobank of COVID-19 Blood Samples, Clinical Data In the early days of the pandemic when information about the new coronavirus was scant, the UR CTSI launched a COVID-19 Biobank to help researchers answer critical questions about the virus and infection. Developed with the help of a $280,000 grant from the Harry T. Mangurian, Jr. Foundation, the Biobank held thousands of blood samples from COVID-19-positive and -negative patients that could be safely and securely linked to patients’ clinical data, while protecting their identities. UR CTSI Annual Report 2019–21

Diversity, Equity & Inclusion A Change Is Gonna Come: Education to Build Anti-Racism Initiatives In October of 2021, the UR CTSI’s Center for Leading Innovation and Collaboration, the coordinating center for the Clinical and Translational Science Awards Program, kicked off a new anti-racism education initiative. Cohorts for Change, a six-month workshop series and training program, aimed to help participants from across the CTSA Program develop and expand structural and administrative anti-racism initiatives within their institutions. The series launched in the fall of 2021, but the seeds of the initiative were germinating in early 2020. “Our team had been looking at the CTSA Program training landscape and didn’t really see anything being done for the consortium as a whole to move the needle on issues of diversity, equity and inclusion,” said UR CTSI Director of Research Education Alfred Vitale, Ph.D., who led development of the initiative. “Given CLIC’s role as a central space for education resources, we wanted to create something that would utilize existing expertise in the consortium to help hubs create actionable structural changes.” The series combines asynchronous learning opportunities with monthly live group discussions facilitated by diversity, equity and inclusion experts from across the country. To provide a safe space for these sensitive conversations, workshops and discussion sessions were limited to nominated participants and were not recorded.

UR CTSI Annual Report 2019–21

“As uncomfortable as it may be, conversations about race are necessary, and we need to lean into this discomfort if we are to grow as individuals and organizations,” said UR CTSI Director of Diversity and Inclusion John P. Cullen, Ph.D., who helped develop the series and facilitated the third session. Each participating institution nominated two representatives to participate in the program. Pairs worked together in the workshops to develop tangible recommendations and action steps for their institutional directors as well as the CTSA Program community. Though the workshops were only accessible to nominees, resources and materials from each workshop are available on the CLIC website for the broader research community to further develop, structure, and strengthen their diversity, equity, and inclusion initiatives. The CLIC team that developed this initiative also included: CLIC Metrics Implementation & Dissemination Director Raquel Ruiz, M.S., CLIC Assistant Director Rebecca Laird, M.B.A., M.Div., CLIC Education Engagement Specialist Musawar Ahmad, M.S.Ed., CLIC Communication & Education Engagement Specialist Megan Petty, and CLIC Lead Web Developer Melissa Trayhan, M.S.

UR CTSI Launches New Office for Health Equity Research The UR CTSI is launching a new Office for Health Equity Research, as part of the University of Rochester Medical Center’s Equity and Anti-Racism Action Plan. The plan aims to establish URMC as a national leader in health equity research and education, focusing on the impact of racism on health and development. The Office for Health Equity Research supports the fifth pillar of the plan, “to engage in equitable health care” in part by “reducing disparities through research, active listening and collaboration with community partners.” The office supports innovative health equity research across URMC to foster a deeper understanding of the root causes of health disparities and the burdens experienced by excluded groups. In the future, the office will provide pilot funding, promote new research partnerships and develop training and technical resources. The office has already begun assessing the current health equity education needs and research capacity at URMC. The Office for Health Equity Research is also actively collaborating with community partners to identify key areas of focus for this type of research. The URMC Community Advisory Council members are choosing from among 15 possible focus areas that would have the greatest impact on health equity in our community. With the Council’s input, the office will prioritize research that improves access to safe, secure and affordable housing; promotes well-being to prevent mental health and substance use disorders; prevents violence; decreases re-incarceration rates through policy; and/or improves chronic disease prevention and management.

UR CTSI Annual Report 2019–21

Supporting Research The UR CTSI provides seed funding to researchers at all career stages to support highly innovative clinical and translational research. Our Pilot and Career Development grants, ranging from $10,000 - $200,000, help researchers gather preliminary information and lay a foundation for future extramurally funded research projects and programs. This early-stage research funding is critical to bridging the gap between scientific discovery and improving human health.

Five More Years! UR CTSI Receives $24M to Continue its Mission Near the beginning of the COVID-19 pandemic in July of 2020, the UR CTSI was awarded its fourth consecutive Clinical and Translational Science Award from the National Center for Advancing Translational Science. The five-year renewal brought UR CTSI’s total funding from NCATS to $132 million, dating back to 2006 when it was one of the first 12 institutions in the nation to receive one of these awards. “The COVID-19 pandemic highlights the clear and urgent need for biomedical research – especially translational research,” said University of Rochester President Sarah Mangelsdorf Ph.D. “As one of the nation’s leading research universities, we are devoted to advancing scientific understanding and promoting health and this award will help us continue those efforts.”

UR CTSI Annual Report 2019–21

“The UR CTSI has been a leader in translational science since its inception” said University of Rochester Medical Center CEO Mark Taubman, M.D. “The institute has brought nearly $132 million to the university, which it used to build a research infrastructure that is helping our researchers move quickly at a time when the entire world is experiencing a shared crisis and desperately awaiting solutions.” Though the grant proposal was written in the summer of 2019, its central theme, “research without walls” was eerily prescient of the coming coronavirus pandemic and world of virtual work. With the grant, the UR CTSI is moving beyond the physical confines of institutions to help researchers conduct studies remotely, integrate research with clinical practice and break down barriers to diversify our research workforce. “Long before COVID-19 began spreading around the globe, the UR CTSI was working to address critical issues that slow or impede research,” said Nancy Bennett, M.D., co-director of the UR CTSI and director of the Center for Community Health & Prevention at URMC. “The current crisis highlights the important work of our faculty, students and staff.” Martin Zand, M.D., Ph.D., UR CTSI co-director and senior associate dean for Clinical Research at URMC, added to the accolades. “Our nearly perfect score and the fact that we were awarded nearly all of the funds we asked for is a testament to our incredible team and our broader research workforce.” With the latest funding, the UR CTSI will continue to provide crucial support for research across the university through 2025.

Bringing research to the community Before a global pandemic forced the world to stay home, the UR CTSI was working on ways to bring research to the community. To help more people – and a more diverse set of people – participate in health research, the UR CTSI has improved the university’s remote research capability and plans to build a research bus that can bring the research clinic to the community. This will help researchers across the university connect with Black, Latino, Deaf, pediatric, elderly and rural communities that experience health disparities and are typically underrepresented in health research. Integrating research with clinical practice The UR CTSI is a partner in the University’s effort to build a “learning health system” in which researchers, clinicians and diverse communities work together to identify health challenges and build solutions that the community and health system can easily adopt. Beyond connecting the people behind research and medicine, the UR CTSI is also actively working on integrating the data from each of those realms, giving researchers a broader view and helping them connect dots they might not have otherwise seen. Including diverse voices and viewpoints in research In addition to ensuring diversity among research participants, the UR CTSI has renewed its commitment to diversifying the research workforce. The institute is breaking down the “walls” that keep members of the Black and Latino communities, women, and people with disabilities from advancing in biomedical research careers. In the coming years, the UR CTSI vows to recruit more faculty and students from underrepresented groups and to build a more inclusive and welcoming environment in which a diverse workforce can thrive. Learn more in the URMC Newsroom.

UR CTSI Annual Report 2019–21

Supporting Research TAKING FLIGHT UR CTSI Pilot Awardees Launch New Projects The UR CTSI funds innovative, early-stage clinical and translational research through its faculty and trainee pilot awards, which provide up to $50,000 for faculty and up to $25,000 for trainees over the course of one year. This funding helps researchers lay a solid research foundation upon which they can build new research programs. See what our latest crop of pilot awardees are up to. Predicting Alzheimer’s Disease Andrew J. Anderson, Ph.D., research assistant professor of Neuroscience and 2020 faculty pilot awardee, is tapping into language comprehension to predict mental decline. While neuropathological warning signs can arise years before patients experience mental decline, there is still no established way to identify early neural dysfunction or to forecast dementia. Because Alzheimer’s pathology first develops in brain circuits that process language, Anderson and his team are exploring whether story comprehension can predict Alzheimer’s disease. Investigating Breastmilk Fortifiers Bridget Young, Ph.D., assistant professor of Pediatric Allergy/Immunology and Public Health Sciences who received a faculty pilot award in 2021, is getting to the bottom of a NICU mystery by studying breastmilk fortifiers. To help premature babies thrive, breastmilk is fortified with added nutrients. Young is investigating the possible link between the new fortifiers and mysterious anecdotal reports of low blood glucose in premature infants. She hopes her findings will lay the groundwork for larger studies linking individual feeds with infant outcomes and developing interventions to prevent feed-related low blood glucose in infants. Predicting Heart Failure Alan Brooks, M.D., Ph.D., a 2020 trainee pilot awardee and Cardiology fellow, is tapping into URMC’s heart tissue bank to compare gene expression in hearts from left ventricular assist device (LVAD) patients who developed right heart failure and those who did not. He hopes to discover biomarkers and develop a diagnostic test to predict which patients will develop right heart failure if they receive an LVAD.

UR CTSI Annual Report 2019–21

Understanding Intellectual Disabilities Carlos Diaz-Balzac, M.D., Ph.D., Endocrinology fellow and 2020 trainee pilot awardee, aims to better understand the genetic mutations that disrupt normal brain function and cause intellectual disabilities. Using the nematode C. elegans as a model, he will study genetic mutations of a transcription factor known to cause intellectual disabilities, hoping to open the door for new therapeutic and diagnostic approaches to intellectual disabilities. Building Back Better (Jaw)bones David Fraser, D.D.S., clinical assistant professor of Dentistry, who is also a 2021 trainee pilot awardee and a member of the UR CTSI’s Translational Biomedical Science PhD Program, is developing a way to rebuild damaged jawbones. Therapeutic approaches to serious chronic gum disease that use stem cells to regenerate jawbone have shown promise but have run into issues when it comes to delivering the cells to the area of damage. Fraser is working to develop a special hydrogel scaffold in which periodontal ligament cells can be embedded. Improving Deep Brain Stimulation for Dystonia Patients Angela Hewitt, M.D., Ph.D., instructor of Child Neurology and 2021 trainee pilot awardee, is working on developing a set of brain activity biomarkers to facilitate deep brain stimulation (DBS) optimization for patients with dystonia, a brain disorder that causes involuntary, sustained and often painful muscle contractions. Using the recently FDA-approved PerceptTM PC DBS system, Hewitt will monitor how DBS impacts firing patterns within the globus pallidus internus, the brain area often impacted in dystonia. Learn more about awardees and their projects: 2020 awardees, 2021 awardees.

GAINING ALTITUDE Past UR CTSI Pilot Awardees Are Now Flying Solo Past Pilot Awardee Obtains $2M Grant to Study MicroRNA Using Better Statistics In 2020, Matthew McCall, Ph.D., associate professor of Biostatistics, was awarded his first R01 grant from the National Institute of General Medical Sciences to develop statistical methods to improve the analysis of microRNAsequencing data. The new award builds on previous work supported by a Novel Biostatistical and Epidemiological Methods Pilot Award from the UR CTSI. MicroRNA regulate gene expression and contribute to a variety of human diseases if they malfunction. But our ability to understand the role of microRNAs “is hampered by a lack of statistical methods designed specifically to analyze microRNA-sequencing data,” said McCall. With UR CTSI funding, McCall developed statistical methods to better estimate where microRNAs are expressed in human cells and tissues. With his R01, McCall is developing new statistical methods to more accurately measure expression levels of microRNAs. Read the full story. Cancer Screening Research Has Roots in UR CTSI-Funded Pilot Study A 2018 pilot study funded by the UR CTSI helped lay the foundation for an expanding research project testing whether a text-messaging intervention can boost screenings for cervical, colon and lung cancers. The UR CTSI-funded study, led by David Adler, M.D., M.P.H., professor of Emergency Medicine and Public Health Sciences and an investigator at the Wilmot Cancer Institute, provided preliminary evidence that motivational text messages could increase cervical cancer screening rates. Those results helped Adler and co-investigator Beau Abar, Ph.D., associate professor of Emergency Medicine, obtain a $1.5 million grant from the National Cancer Institute in 2020 to further explore the use of text messages to improve cervical cancer screening rates. In the fall of 2021, that study was expanded to include colon and lung cancer screenings with the help of a University of Rochester Research Award and a URMFG Healthcare Innovation two-year pilot award, respectively. While their studies are ongoing, Adler and Abar hope this research can lead to better screening rates and earlier detection of these preventable diseases.

UR CTSI Incubator Project on Social Ties and Aging Leads to $3.6M NIH Grant Kathi Heffner, Ph.D., Kimberly Van Orden, Ph.D., and Feng (Vankee) Lin, Ph.D., R.N. were awarded a $3.6 million grant in early 2020 to establish the new Roybal Center for Social Ties and Aging Research. The new center fosters collaboration among researchers and funds pilot studies to combat social disconnection in older caregivers of individuals with Alzheimer’s Disease and other related dementias. According to Heffner, a 2017 Incubator Award from the UR CTSI laid the foundation for this new project grant. “The project grant continues our focus on social connectedness for healthy aging that we began with our Incubator pilot studies,” Heffner said. “The Incubator Award supported development of research infrastructure that we will now grow and continue with support from this grant – namely, a registry and process for recruiting older adults for healthy aging research.” While the 2017 Incubator project sought to develop interventions that promote social connectedness in older adults broadly, the new grant takes a more targeted look at the impact of caregiving. Read the full story.

UR CTSI Annual Report 2019–21

Education The UR CTSI is dedicated to training the next generation of clinical and translational researchers. With educational programs tailored to pre- and postdoctoral trainees and faculty at all career stages, we have something for everyone. Our offerings range from certificate programs and week-long, intensive trainings to a fully accredited doctorate program.

TBS Student Denisse Vega-Ocasio Selected as a Yale Ciencia Academy Fellow UR CTSI Translational Biomedical Sciences PhD Program student Denisse Vega-Ocasio was among 40 young science leaders selected for a year-long fellowship at the Yale Ciencia Academy for Career Development in February of 2020. This highly-competitive program provides opportunities for mentoring, networking, skills development and science outreach to doctoral students who are underrepresented in life and health sciences. The program is led by Ciencia Puerto Rico, a non-profit organization with one of the largest networks of Hispanic/Latino scientists in the world, in collaboration with Yale University. Vega-Ocasio, who aims to use translational science to contribute to the control and eradication of infectious diseases in Latin American countries, took advantage of in-person and online opportunities throughout the year and designed a science outreach project that put her new skills into practice.

TBS Student Wins First Place in International Mini-Documentary Competition Jishyra Serrano, a student in the UR CTSI’s Translational Biomedical Sciences PhD Program, took first place in a mini-documentary competition hosted by the American Association for the Advancement of Science (AAAS) and the American University School of Communication in February of 2020. “The Capturing the Future: A Smartphone Mini-Documentary Competition” was open to college students the world over and solicited two-minute videos related to natural or social sciences, engineering, medicine and innovation. Serrano, who studies how prenatal stress and immune factors affect childhood development, was announced as the first place winner at the AAAS meeting in Seattle, WA, on February 14, 2020, where her mini-documentary was aired alongside other winners’.

UR CTSI Annual Report 2019–21

Education Career Development Awardees Grow Through Mentored Research The UR CTSI’s KL2 Career Development Award provides two years of support for early-career clinical and translational scientists. With the guidance of a mentor team, KL2 scholars develop research projects that set the stage for further K- or R-award applications. Exploring New Treatment Targets for e-Cig Flavoring-Induced Lung Disease

Using Network Health Tools to Prevent Teen Suicide

Matthew D. McGraw, M.D., assistant professor of Pediatric Pulmonary Medicine and 2020 KL2 awardee, is investigating lung disease induced by e-cigarette flavoring chemicals. Inhaling certain chemicals, like diacetyl, which is found in foods, wine and e-cigarettes, is associated with a fibrotic lung disease called bronchiolitis obliterans. Currently, lung transplantation is the only treatment option for patients with bronchiolitis obliterans. McGraw is investigating the mechanisms by which this chemical causes airway stem cell death and exploring new medical therapies for treatment of lung disease associated with inhalation of toxic flavoring chemicals.

Ian Cero, Ph.D., postdoctoral fellow in Psychiatry and a 2021 KL2 awardee, is exploring a network health intervention for adolescents hospitalized for suicide attempts. Over 30 percent of adolescents who are hospitalized for a suicide attempt will reattempt within one year. For his KL2 project, Cero is adapting a previously validated network health intervention, called Wingman-Connect, to help this particularly high-risk group better regulate their emotions and engage support-guidance relationships.

Investigating Frailty in Older Cancer Survivors Frailty is a significant problem for survivors of colon cancer over the age of 65. It disproportionately affects African American/ Black people who also bear the highest burden of colon cancer. 2020 KL2 awardee Nikesha J. Gilmore, Ph.D., research assistant professor in the Department of Surgery, Cancer Control Division and Geriatric Oncology, is investigating whether an anti-inflammatory dietary supplement can reduce frailty and improve post-treatment outcomes for older colon cancer survivors. But her investigation didn’t stop at colon cancer survivors. In March of 2021, Gilmore published a study linking frailty to inflammation in breast cancer patients. According to the study, women with breast cancer are more likely to be frail after chemotherapy if they have greater increases of inflammation in their blood during chemotherapy. These findings confirm that oncologists should consider inflammation and frailty in their patients, and perhaps personalize treatment, especially in older adults, to avoid undue risks of chemotherapy toxicity. Read more about our 2020 awardees.

UR CTSI Annual Report 2019–21

A Better Way to Detect Pulmonary Hypertension Current diagnostics for pulmonary hypertension (a rare, life-threatening disorder characterized by high blood pressure in the arteries of the lungs) are cumbersome, expensive and unreliable. Daniel LaChant, D.O., assistant professor of Pulmonary Diseases and Critical Care and a 2021 KL2 awardee, hopes to supplement or supplant current diagnostics with a new measure: cardiac effort (the number of heart beats required for a person to walk a given distance). He is also developing a remote, mask-free assessment of cardiac effort and heart rate expenditure that patients can perform in their own homes. Developing New Tools to Measure Small Intestine Function Diseases of the small intestine can be quite debilitating, but there are few measures of small intestine function. Nicole Wilson, Ph.D., M.D., assistant professor of Pediatric Surgery and Biomedical Engineering, is developing and validating a digital tool that can non-invasively measure the physical properties and function of the small intestine. She hopes this new tool will make it easier to assess patients’ intestinal health and predict their ability to thrive. Read more about the 2021 awardees.

The University of Rochester Has Regulatory Science Talent Each year, University of Rochester students compete in the annual America’s Got Regulatory Science Talent student competition hosted by the UR CTSI’s Regulatory Science Program. Individual students or teams propose novel solutions to current areas of need in regulatory science for a shot at first prize: to present their novel regulatory science ideas to a panel of scientists from the Food and Drug Administration. Here are the top prize winners of the 2020 and 2021 competitions: 2020: Data Science for Food Safety Sydney Simpson, doctoral candidate in Microbiology and Immunology Pathogen outbreaks in food are common, but current methods to trace contamination through the food supply chain are labor intensive, time consuming, imprecise and often end in the disposal of healthy produce. Simpson proposed using blockchain software, which is already commercially available and utilized for supply chains by some businesses, to record transactions involving nationally distributed, high-risk produce such as romaine lettuce. Blockchain would record each transaction, linking it to previous transactions and building a digital scaffold that can be easily traced – decreasing trace-back time from over a week to seconds. Read more about Sydney and the second and third place winners from 2020. 2021: Preparing for 3D Printing in Hospitals Alex McMullen, trainee in the Biomedical Engineering PhD Program Aaron Craig, trainee in the Biomedical Engineering Master’s Program Megan Luzenski, trainee in the Biomedical Engineering Master’s Program The field of healthcare-related 3D printing has advanced by leaps and bounds in the past few years, and point-of-care printing could be right around the corner. It’s not unreasonable to think an organ or piece of tissue could be printed right in the hospital before implanting in a patient in the near future. The trouble is: there is currently no regulatory framework to ensure the safety and effectiveness of point-of-care implants. McMullen, Craig and Luzenski proposed creating a database with mandatory reporting of point-of-care implants to track their quality over time, as well as a system for validating implants and the equipment used to make them. Equipment would be registered and tested on a regular basis. Read more about the 2021 winners.

UR CTSI Annual Report 2019–21

Working Together The UR CTSI provides research teams with various opportunities to partner with other clinical and translational researchers - both near and far - as well as physicians, research staff and the community. We help you make the connections you need to move your research forward.

Dipping Our Toes in Rising Waters: UR CTSI Joins Planetary Health Alliance Decades of research has proven that humans are changing the global climate – and those changes impact human health. In November of 2020, the UR CTSI expanded the scope of its mission by joining the Planetary Health Alliance (PHA), a global consortium committed to understanding and addressing global environmental change and its health impacts. “The UR CTSI has always been devoted to improving the health of individuals and populations,” said UR CTSI Co-Director Martin Zand, M.D., Ph.D., “and we are excited to make this foray into the new area of planetary health – to explore the relationship between people, health and the natural world.” The idea to join forces with the PHA came from David Adler, M.D., M.P.H., professor and director of research for the Department of Emergency Medicine at the University of Rochester Medical Center and past UR CTSI Career Development KL2 scholar. “Climate change is the biggest threat to human health,” Adler said. “I was looking for an opportunity to engage in this area with an external partner. The PHA came to my attention because it is the pre-eminent, U.S.-based, academically-oriented organization working in the area.” The PHA, which was launched in 2016 with the support of the Rockefeller Foundation, aims to foster research into the ways human-caused disruptions of Earth’s natural systems impact health. The PHA strives to create a world where all people thrive by protecting and regenerating Earth’s natural systems. Through its vast international network, the alliance aims to fundamentally shift how humans interact with each other and nature, by sharing evidence-based information and training the next generation of planetary health practitioners.

UR CTSI Annual Report 2019–21

By joining the alliance, the UR CTSI has tapped into a wealth of educational resources and access to planetary health experts and mentors from around the world. Researchers from across the University can take advantage of planetary health research opportunities through the network. Healthcare providers can join the PHA’s Clinicians for Planetary Health (C4PH) initiative to help develop outreach materials that encourage individual and community-level planetary health action.

Engaging Patients in Person Nearly Triples Research Registry Enrollment Recruiting participants is a major challenge for clinical trials, but a pilot program nearly tripled enrollment in a local clinical research registry simply by directly asking patients if they would like to join. Funded in part by the UR CTSI, the pilot aimed to increase enrollment in two clinical research participant registries: the University of Rochester Research Participant Registry and ResearchMatch.org, a national registry. Once a person is in the registry, they will be contacted with opportunities to participate in future clinical studies that match their interests. During the three-month pilot, members of the Emergency Department Research Associate (EDRA) Program asked visitors in the Strong Memorial Hospital Emergency Department if they would like to enroll in the two registries. Of those approached, 73 percent agreed to register for one or both of the registries. That was nearly three times as many registrants as signed up during the same three-month period the previous year.

“Approximately 25 percent of national studies fail to attract any participants and about 50 percent of national studies are under-enrolled,” said Carrie Dykes, Ph.D., director of research services at the UR CTSI. “From this pilot, we learned that patients are really interested in participating in research. They just have to be asked.” The direct approach also helped increase diversity among registrants. The proportion of Hispanic/Latino participants was nearly double that of pre-pilot enrollees, and more men were represented in the pilot as well. Dykes added that the UR CTSI has continued to utilize the direct-ask approach in the Emergency Department since the end of the pilot program and the registry continues to grow by leaps and bounds. A report detailing the pilot program’s results was published in Clinical and Translational Science. In addition to Carrie Dykes, report authors are EDRA Supervisor Joseph Glick, Beau W. Abar, Ph.D. and Ann M. Dozier, Ph.D.

UR CTSI Annual Report 2019–21

Working Together On average, these activities helped safety-net practices increase screening rates for colorectal and breast cancers, but not cervical cancer. Over the seven years, average colorectal cancer screening rates climbed significantly, and average breast cancer screening rates trended upward – likely due to the use of mobile mammography units and at-home colorectal cancer screening options.

Leveraging Primary Care Networks to Increase Breast, Colon Cancer Screening Safety-net primary care practices across upstate New York boosted rates of colorectal and breast cancer screenings after receiving education and support from affiliated academic medical centers, according to a seven-year project involving the UR CTSI’s Greater Rochester Practice-Based Research Network (GR-PBRN). The quality improvement project, which was part of a broader cancer prevention initiative of the New York State Department of Health, involved 12 primary care practices across Rochester, Buffalo and Syracuse. All practices primarily serve disadvantaged populations and are members of Practice-Based Research Networks administered by the University of Rochester Medical Center, the State University of New York (SUNY) Upstate Medical, or SUNY University at Buffalo. Local implementation of this project was led by GR-PBRN Co-Directors Gary J. Noronha, M.D., and Carlos M. Swanger, M.D., who are both associate professors of Clinical Medicine at URMC, as well as GR-PBRN Network Coordinator Karen Vitale, M.S.Ed. Each network provided primary care practices with annual education on updated breast, cervical, and colorectal cancer screening guidelines and ways to improve screening rates. Professional facilitators also helped practices implement evidence-based strategies to increase screening, like offering at-home screening options for colorectal cancer.

UR CTSI Annual Report 2019–21

On the other hand, cervical cancer screening rates dropped over the seven-year period, possibly because many patients seek cervical cancer screening through obstetric or gynecological specialists. According to project results, a lack of communication between specialists and primary care clinics was a major barrier to improving cancer screening. While facilitation provided by the project resolved smaller barriers, like workflow inefficiencies and lack of transportation, overcoming these larger issues will require sustained attention and resources. Despite the COVID-19 pandemic striking the globe in the final year of this project, cancer screening rates at these safety-net primary care practices held fairly steady, with each screening type changing by less than two percent over that year. During the pandemic, the practices relied more heavily on telehealth services, which probably accounts for their ability to maintain cancer screening rates. However, telehealth services are less effective for financially or technologically disadvantaged patients. Cancer screening saves lives, and this project showed that engagement between academic medical centers and safety-net primary care practices can prevent underserved patients from falling through the cracks. Annual education and professional support helped practices break down barriers and get more patients screened. Outcomes of this project were published in three papers in the Journal of Patient-Centered Research and Reviews led by SUNY Upstate Medical researchers Christopher P. Morely, Ph.D., M.A., Laura A. Brady, Ph.D., and Laura A. Schad, M.P.H.: ■ Improving Cancer Screening Rates in Primary Care via Practice Facilitation and Academic Detailing: A Multi-PBRN Quality Improvement Project ■ Increasing Breast, Cervical, and Colorectal Cancer Screenings: A Qualitative Assessment of Barriers and Promoters in Safety-Net Practices ■ Impact of COVID-19 on Screening Rates for Colorectal, Breast, and Cervical Cancer: Practice Feedback From a Quality Improvement Project in Primary Care.

Community Input Crucial for New Childhood Tooth Decay Prevention App Poor prenatal oral health has been linked to poor birth outcomes and higher risk for tooth decay in children. A group of researchers at the University of Rochester Medical Center are developing a smartphone app to help parents in under-resourced communities detect severe tooth decay in their kids. Leveraging smartphones to reach communities that are typically low-income may not feel intuitive, but the idea came directly from members of those communities. A group of URMC researchers and community partners gathered input from low-income parents in Rochester, NY on barriers they faced to prenatal dental health. The focus groups and in-depth interviews were part of a UR CTSI-funded Community-Based Participatory Research Pipeline-to-Pilot Award led by Jin Xiao, D.D.S., Ph.D., associate professor of Dentistry at URMC, Kevin Fiscella, M.D., M.P.H., professor of Family Medicine at URMC, and Sherita Bullock, executive director of the Healthy Baby Network. The parents’ suggestions boiled down to four actionable recommendations, which were published in BMC Oral Health in the fall of 2020. The parents recommended using social media or smartphone apps to educate and improve access to prenatal dental health, interweaving dental care into all healthcare,

and creating innovative education programs and specialized prenatal dental facilities for underserved communities. According to Xiao who is leading the smartphone app project, the community input gathered under the UR CTSI award “fostered our ideas of using cutting-edge translational research to address poor maternal and infant oral health among underserved groups.” Xiao’s team, which includes Fiscella and Jiebo Luo, Ph.D., professor of Computer Science and expert in artificial intelligence, built a prototype of the app, AICaries, in 2020 to detect tooth decay in its early reversible stage. Parents or caregivers can take a photo of a child’s tooth in the app and it will inform them if the tooth has decay. The app will then guide them to an interactive educational component to help them understand ways to prevent further decay through diet and oral hygiene and will provide information on local dentists and insurance. The app is being develop with support from U.S. Senators Charles Schumer and Kirsten Gillibrand and a two-year grant from the National Institutes of Health.

UR CTSI Annual Report 2019–21

What is the UR CTSI? The University of Rochester Clinical and Translational Science Institute is the clinical and translational research engine for the University of Rochester Medical Center, helping research teams work faster and better. Investigators, research coordinators and administrators will all find helpful programs and services at the UR CTSI, which is centrally located in the Saunders Research Building at URMC. Not sure what you need, or how to find it? Contact the Research Help Desk at researchhelp@ urmc.rochester.edu for access to research-related services and expertise provided by the UR CTSI and many other organizations across the University. Planning a new study? Get a roadmap of helpful services and required approvals. Need space or experienced staff for your clinical study? The Clinical Research Center has skilled nursing and bionutrition staff available in the conveniently located inpatient unit in the main URMC building. Find out what’s happening! The UR CTSI Weekly Update starts your week off right with research-related news, events and funding opportunities. The UR CTSI Stories blog provides useful information on programs, services and more. Interact! Follow the UR CTSI on Facebook, LinkedIn, Twitter and YouTube. There is more! Check the UR CTSI website, ctsi.urmc.edu, for all the details.

Clinical and Translational Science Institute Saunders Research Building, Suite 1.200 265 Crittenden Blvd, | Rochester, NY 14642-0708 (585) 275-0653 | ctsi.urmc.edu