Goal #1: Advance clinical and translational science

Ana Barac, M.D., Ph.D., a former GHUCCTS KL2 scholar, led the multidisciplinary effort behind the new American Heart Association (AHA) statement on Defining Cardiovascular Endpoints in Oncology Trials, which included contributions from other cardio-oncology experts, clinical trialists, statisticians, and the FDA. The statement, with formal support from the cardiology and oncology communities, provides a framework to enhance and accelerate trial design, support regulatory decision-making, and will ultimately improve care for patients receiving novel cancer therapies.Read Dr. Barac’s full article: <a href="https://www.ahajournals.org/doi/10.1161/CIR.0000000000001417" target="_blank" rel="noopener noreferrer">https://www.ahajournals.org/doi/10.1161/CIR.0000000000001417</a>

Georgetown-Howard Universities Center for Clinical and Translational Science

small_j65pwvr97d9ryox6go1w880im_ghuccts_partners - adjusted - HYBRID.jpg

thumbnail_j65pwvr97d9ryox6go1w880im_ghuccts_partners - adjusted - HYBRID.jpg

j65pwvr97d9ryox6go1w880im_ghuccts_partners - adjusted - HYBRID.jpg

Georgetown University

Georgetown Howard Universities Center for Clinical and Translational Science (GHUCCTS) is delighted to share the discipline spanning translational impact of our former KL2 Scholar, Dr. Ana Barac, who led the multidisciplinary effort behind the new American Heart Association (AHA) statement on Defining Cardiovascular Endpoints in Oncology Trials.

Former Georgetown-Howard Universities Center for Clinical and Translational Science KL2 Scholar Chairs Writing Group for New AHA Scientific Statement

- Any -

Amanda Irish, M.D., M.P.H., M.S., DTMH, has a passion for emerging infectious diseases. A passion that stemmed from somewhat untraditional beginnings: as a young adult Irish read “The Hot Zone” by Richard Preston, a nonfiction book about the origins of deadly viruses like Ebola and Marburg. Irish found herself transfixed by the biosafety lab doctors as they fought to contain dangerous infections. “I imagined myself treating fatally infected villagers in a hospital tent one day while analyzing new virus strains the next,” Irish shared.&nbsp;&nbsp;&nbsp;<h2>Understanding the threat of zoonotic influenza&nbsp;</h2>Irish is now living her dream, researching ways to prevent the next deadly zoonotic influenza before it starts. “We are working to identify effective blocking strategies that reduce viral spillover within modern livestock operations,” Irish explained. “Iowa is at the epicenter, as we are the nation's leading pork producer and first in egg production.”&nbsp;&nbsp;&nbsp;&nbsp;Zoonotic influenzas are diseases caused by animal-originated influenza A viruses, mainly avian or swine, that cross the species barrier to infection of humans. According to the National Institutes of Health, between 2003 and 2024, avian influenza, a zoonotic influenza transferred from birds, killed over 50% of infected humans. Zoonotic diseases are the originators of the three major pandemics of the 20th century which killed 50-100 million people.&nbsp;&nbsp;&nbsp;<h2>From the front lines to infectious disease prevention&nbsp;</h2>Irish’s research is not her first experience on the front lines. She served as a Nuclear, Biological, and Chemical Defense Specialist in the US Marines where she trained personnel to survive worst-case scenarios. “like the doctors in 'The Hot Zone,' I held the lives of thousands in my hands,” Irish stated.&nbsp;&nbsp;&nbsp;&nbsp;After her military service, Irish worked in Dr. Gregory Gray’s Center for Emerging Infectious Diseases, conducting fieldwork around the world and at the US Army Medical Research Institute of Infectious Diseases. “Literally a dream come true,” Irish reflected. &nbsp;During her emergency medicine residency at the height of the SARS-CoV-2 pandemic, “By day, I served on the frontline battling COVID-19 in the ED, and by night, I researched mitigation strategies to save lives.”&nbsp;&nbsp;&nbsp;&nbsp;<h2>A new model for infectious disease prevention&nbsp;</h2>Irish’s research combines mathematical modeling with real-world stakeholder input. Her team is developing the first comprehensive model that can simulate how influenza spreads between three interconnected groups: livestock (both swine and poultry), farm workers, and rural communities. This allows researchers to test prevention strategies virtually and rank their effectiveness without posing a risk to animal or human health. “We’re not just asking ‘what works?’— we’re also asking, ‘what will farmers actually adopt?’” Irish explained. By engaging workers, owners, and public health officials directly, we can develop recommendations that are both effective and realistic.”&nbsp;&nbsp;Irish’s research aims to directly protect Iowa’s agricultural workers, rural communities, and livestock while also recognizing and addressing the potential global threat. With Irish’s research, we can work to stop the spillover of viruses from animals to humans at the source, this work could prevent the next pandemic.&nbsp;

University of Iowa Institute for Clinical and Translational Science

medium_Irish_Amanda_2023_02-002-1.jpg

small_Irish_Amanda_2023_02-002-1.jpg

thumbnail_Irish_Amanda_2023_02-002-1.jpg

Irish_Amanda_2023_02-002-1.jpg

University of Iowa

Amanda Irish, M.D., M.P.H., M.S., DTMH, has a passion for emerging infectious diseases. A passion that stemmed from somewhat untraditional beginnings: as a young adult Irish read “The Hot Zone” by Richard Preston, a nonfiction book about the origins of deadly viruses like Ebola and Marburg. Irish found herself transfixed by the biosafety lab doctors as they fought to contain dangerous infections “I imagined myself treating fatally infected villagers in a hospital tent one day while analyzing new virus strains the next” Irish shared.

How Do We Stop the Transfer of Infectious Diseases From Animals?

X-logo_teal.svg

In_Logo_teal-in.svg

Goal #7:  Training and career support programs for translational scientists

<a href="https://med.umn.edu/dm_profile/173" target="_blank" rel="noopener noreferrer">Stephanie Misono</a>, M.D., M.P.H., had never worked with medical devices before — but her idea to repurpose one for her patients opened new doors in her research. Dr. Misono treats patients who suffer from chronic cough, defined as a cough that lasts longer than eight weeks despite treatment of potentially contributing factors. It’s a debilitating condition that often prevents patients from doing normal things, such as attending meetings at work, going to church, and holding long conversations.Although sometimes a clear cause can be found for the cough, such as asthma or reflux, often the cough can persist even when common causes are ruled out or addressed. Scientists estimate that unexplained chronic cough affects up to 1 in 20 adults worldwide.For years, she had wondered if a device that delivers vibrations to the throat could bring relief to her patients and millions of others worldwide. But until she stumbled across a pilot grant opportunity, the timing never felt quite right to pursue the idea. “I saw this grant opportunity from CTSI and thought, ‘This is the ideal grant for this scenario — I should go for it,’” Dr. Misono recalls.Dr. Misono received comprehensive early support from the the Clinical and Translational Science Institute (CTSI) at the University of Minnesota during the protocol development process, which helped pave the way for a successful pilot study. She has since gone on to publish <a href="https://pubmed.ncbi.nlm.nih.gov/39092681/" target="_blank" rel="noopener noreferrer">promising results</a> in Laryngoscope and secure an R34 grant from the NIH to bring this potentially life-changing innovation to patients.<h2>From idea to breakthrough</h2>An associate professor in the Department of Otolaryngology-Head &amp; Neck Surgery, Dr. Misono built her early career focusing on disorders like voice and airway problems and throat cancer.Venturing into research involving a medical device was unfamiliar territory, but the <a href="https://crsc.umn.edu/" target="_blank" rel="noopener noreferrer">Clinical Research Support Center</a> (CRSC) helped her navigate the challenges. CTSI is one of the many collaborators behind the CRSC, which brings together clinical research experts to help University researchers navigate the complex clinical research environment and set up their studies for success.“Being able to tap into the CRSC is what made the research possible,” she said. “If I were trying to do it on my own, it would have taken so much time and energy that it would’ve been difficult to get the study off the ground.”Through the CRSC, Dr. Misono’s proposal underwent a <a href="https://crsc.umn.edu/services/feasibility-reviews" target="_blank" rel="noopener noreferrer">feasibility review</a> to prepare it for submission to the Institutional Review Board (IRB) and other regulatory requirements.Feasibility reviews are a quick, free way for University researchers to refine a protocol for FDA or IRB submission and set it up for successful implementation. In just one meeting, clinical research experts thoroughly review a researcher’s protocol and study materials, identify potential logistical and compliance challenges, and offer resolutions for overcoming them.“They identified things that needed to be clarified or further developed before submitting,” Dr. Misono says. “A feasibility review set my project up for success — it was much faster than it would have been otherwise.”Available to all faculty, feasibility reviews are completed in one week. It’s one of the many free services available through the CRSC.“It was very efficient and professional. Also, it is so helpful to feel supported through a complex process like this,” Dr. Misono says. “I appreciate that there is the chance to ask follow-up questions and continue the conversation beyond the formal review session.”<h2>How to stop the feedback loop</h2>The idea for the device came from what Dr. Misono was hearing from her patients.“I was thinking about the fact that a lot of my patients will say, ‘I get this kind of itch or tickle sensation, and it makes me feel like I have to cough because otherwise that feeling is never going to go away, and it's uncomfortable and frustrating,’” she says. “It’s really a vicious cycle. So, the idea was to use vibration to introduce a different sensory input to the larynx that could maybe change that feedback loop.”It works like this: a stimulus triggers a cough, which increases the throat’s sensitivity. Over time, this heightened sensitivity means that even minor irritants, like strong smells or temperature changes, can lead to intense coughing fits.Dr. Misono hypothesized that introducing vibrations to the throat could disrupt that cycle and prevent it from recurring.<h2>A device with potential</h2>To test her theory, Dr. Misono turned to a small laryngeal vibrating device developed by Juergen Konczak, a professor in the University’s Department of Kinesiology. Dr. Konczak created the device to treat a different disorder (laryngeal dystonia) with <a href="https://ctsi.umn.edu/odat-translational-research-funding" target="_blank" rel="noopener noreferrer">translational research funding</a> from CTSI, but it fit seamlessly into Dr. Misono’s study.Participants used the device for two weeks, with almost everyone reporting that it was simple and comfortable to use. More importantly, the device, which is applied to the outside of the throat, significantly reduced cough severity for most participants. A few participants were reluctant to return the device at the end of their participation, in case their coughs flared up again.The results were enough to encourage Dr. Misono to apply for the NIH grant. The funding from that grant will allow her to prepare for a larger clinical trial.<h2>A broad portfolio of resources</h2>Dr. Misono’s decision to tap into CTSI resources was a logical step. Since joining the University of Minnesota faculty in 2011, she’s regularly used the institute’s resources.Early in her career, she received a Pre-K grant (now called the <a href="https://ctsi.umn.edu/training/faculty/k-accelerator-program" target="_blank" rel="noopener noreferrer">K Accelerator Program</a>) that helped spur her research trajectory.“At the time, I was trying to start a new line of research as a brand new faculty member, and didn't know very many people here yet. I knew the question I wanted to look at was interesting for my field, but to make an impact and get funded, I needed to engage people outside my area,” she said. “The program helped me find a community of people with whom I could share ideas and strategies. That was really important for refining my ideas and giving them traction.”Dr. Misono was also among the inaugural cohort of a yearlong CTSI program aimed at supporting research-intensive health sciences faculty who are raising young children, now called <a href="https://ctsi.umn.edu/training/faculty/mothers-leading-science-program" target="_blank" rel="noopener noreferrer">Parents Leading Science</a>.In addition, she has participated in two other CTSI offerings: the <a href="https://ctsi.umn.edu/training/faculty/k12-scholars-career-development-program" target="_blank" rel="noopener noreferrer">K12 Scholars Career Development Program</a> (previously called KL2) and the <a href="https://ctsi.umn.edu/training/faculty/k-r01-transition-independence-program" target="_blank" rel="noopener noreferrer">K-R01 Transition to Independence Program</a>, both of which provide funding and mentorship for researchers. These programs helped pave the way for her future grant success, as she notes:“CTSI's career development programs had a major impact on my research career. The incredible ecosystem of support around me was vital to securing my NIH K23."Today, she serves as a mentor to an early-career researcher in that same K12 program.“There’s such a broad portfolio of different resources and educational opportunities in CTSI,” Dr. Misono said. “The richness of the portfolio allows people to connect with an appropriate type or level of resource at any career stage, and makes challenging things possible. I am deeply grateful to CTSI for the wonderful community and opportunities it offers.”

University of Minnesota Clinical and Translational Science Institute

large_ubw3g2y1k27awz480qqxmd0m2_misono-story-cough.jpg

medium_ubw3g2y1k27awz480qqxmd0m2_misono-story-cough.jpg

small_ubw3g2y1k27awz480qqxmd0m2_misono-story-cough.jpg

thumbnail_ubw3g2y1k27awz480qqxmd0m2_misono-story-cough.jpg

ubw3g2y1k27awz480qqxmd0m2_misono-story-cough.jpg

University of Minnesota

Dr. Stephanie Misono had never worked with medical devices before — but her idea to repurpose one for her patients opened new doors in her research. Dr. Misono treats patients who suffer from chronic cough. For years, she wondered if a device that delivers vibrations to the throat could bring relief to her patients and millions of others worldwide. But until she stumbled across a pilot grant opportunity from the Clinical and Translational Science Institute at the University of Minnesota, the timing never felt quite right. Through CTSI, she also received comprehensive early support during the protocol development process, which helped pave the way for a successful pilot study. She has since gone on to publish promising results and secure an R34 grant from the NIH to bring this potentially life-changing innovation to patients. Dr. Misono has participated in a number of CTSI's career development programs, which she credits as having a major impact on her research career.

Following a Hunch into New Research Territory

CTSA CCOS

Home

About

Impact

CTSA Groups and Meetings

Resources

News

Help

CTSA News

Former Georgetown-Howard Universities Center for Clinical and Translational Science KL2 Scholar Chairs Writing Group for New AHA Scientific Statement

Summary

Article