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How TRI Became a Catalyst for a Governor’s Cup Victory

UAMS’ Amanda Stolarz, Pharm.D., Ph.D., recently celebrated her team’s victory in the Donald W. Reynolds Governor’s Cup business plan competition. The team, Rejuvenics Technologies, won the $25,000 top prize with its idea for commercializing a drug-delivery system to reduce the harmful side effects of chemotherapy.

Just under a year ago, the business side of research was hardly on her radar. Her mindset was: “I don’t want to do business at all; I want to do science.”

But Stolarz, having just received her Ph.D. last summer, soon gained new perspective.

As a postdoctoral fellow, she was encouraged to attend last summer’s Health Sciences Entrepreneurship Boot Camp by Nancy Rusch, Ph.D., who explained that discoveries don’t magically go from the laboratory to the clinic. Rusch chairs the College of Medicine Department of Pharmacology and Toxicology and leads the Translational Research Institute’s (TRI) educational efforts.

“The boot camp opened my eyes,” Stolarz said. “It showed me that if you want to see what you discover in the lab actually help people, you have to go through this process.”

So when she was invited to be part of the business-plan team that won the Governor’s Cup, she was more inclined to participate.

“Without the boot camp, it would have been a much harder sell for me to join the Rejuvenics Technologies team,” she said.

The idea of establishing entrepreneurship training for researchers, Rusch said, stems from TRI. Laura James, M.D., TRI director and vice chancellor for clinical and translational research, broached the idea and it was included as a key feature of TRI’s application for a Clinical and Translational Science Award (CTSA).

When Philip Mayeux, Ph.D., alerted Rusch about a funding opportunity that could support an entrepreneurship boot camp, Rusch was able to borrow from the work she had done for the CTSA application. Working with Nancy Gray, Ph.D., director of BioVentures, they received $50,000 in supplemental funding tied to the National Institute of General and Medical Sciences T32 Systems Pharmacology and Toxicology Training Program grant led by Mayeux.

Entrepreneurial luminaries were brought in to the boot camp, including Carol Reeves, Ph.D., associate vice provost for entrepreneurship at the University of Arkansas, Fayetteville (UAF). Reeves, who has a national reputation for developing entrepreneurs, was excited to be part of the UAMS boot camp and predicted it would lead to meaningful collaborations between the sister institutions.

Stolarz is the chief science officer for Rejuvenics Technologies, a startup at the University of Arkansas, Fayetteville. Its other officers and team members are Joshua Phillips, Tiffany Jarrett and Mary Rivard, all full-time Executive MBA students at the UAF Walton School of Business.

The startup initially worked with a product that didn’t pan out in their market validation study. What they found next turned out to be a great fit for Stolarz: technology with a potentially broad application for preventing a multitude of chemotherapy side effects.

“I got really excited because my dissertation was on finding ways to treat and prevent side effects from chemotherapy,” she said.

The technology being commercialized was developed as a joint collaboration between UAF and UAMS. The lead inventor is Daniel Fologea, Ph.D., formerly at UAF and now at Boise State University, who worked with Michael Borrelli, Ph.D., in the UAMS College of Medicine Department of Radiology.

Rejuvenics Technologies is working with St. Jude Children’s Research Hospital in Memphis and hopes to also collaborate with Houston-based M.D. Anderson Cancer Treatment Center.

Stolarz is hopeful they can develop a product that will lead to improved quality of life for cancer patients.

“This technology is designed to decrease the toxic side effects of chemotherapy while potentially increasing efficacy against tumors so we can beat cancer without beating down the patient,” she said.

The TRIbune is Here!

TRI’s March-April newsletter, The TRIbune, features a breakthrough success in research collaboration with the adoption of SMART IRB by all the CTSA sites across the country, including UAMS. This new single IRB capability is expected to spur inter-institutional collaborations for multisite clinical trials and help avoid trial delays. We also note the numerous cross-CTSA collaborations that involve UAMS researchers and TRI. Along those lines, we highlight a recent retreat on data available to researchers through the Arkansas Center for Health Improvement. The retreat was enlightening for research leaders from UAMS, Arkansas Children’s Research Institute and the Central Arkansas Veterans Healthcare System. Our TRI & Me feature spotlights Donald Mock, M.D., Ph.D., who leads our Pilot Studies Program, and you can view the latest TRI-cited publications.

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TRI Biomedical Informatics Pilot Awards

The UAMS Translational Research Institute (TRI) has approved four research pilot study awards totaling about $166,000.

Nine applicants sought awards of up to $50,000 for one-year projects that utilized translational biomedical informatics approaches to improve health and solve health care issues of rural and underserved populations.
The 2017 pilot awardees and their project titles are:

Kristie Hadden, Ph.D., assistant professor, College of Medicine, Division of Medical Humanities, “Patient health literacy screening: An informatics approach.”
Se-Ran Jun, Ph.D., assistant professor, College of Medicine, Department of Biomedical Informatics, “Genomic surveillance of mumps outbreak in Arkansas using third generation sequencing technology.”
Atul Kothari, M.D., assistant professor, College of Medicine, Department of Internal Medicine, “Molecular epidemiology and transmission of Clostridium difficile infections (CDI) in nosocomial settings.”
Bradley Martin, Ph.D., Pharm.D., professor, College of Pharmacy, “Development, validation, and implementation of an opioid risk prediction tool.”

“The purpose of our pilot awards is to help researchers develop novel technologies and methods and to test the feasibility of their approaches,” said Laura James, M.D., TRI director and associate vice chancellor for clinical and translational research. “This year’s focus on collaborations with experts in biomedical informatics will test state-of-the-art solutions to problems common in Arkansas. Each project also has high potential for extramural funding and for application to individuals beyond Arkansas.”

Applications were reviewed and scored by a study section of 23 faculty and community representatives. The study section, led by Donald Mock, M.D., Ph.D., included independent scientists from a wide range of disciplines and from across the country, and community stakeholders from across Arkansas. Inclusion of trained community stakeholders is a novel venture for this pilot program that helps realize the NIH goal of ensuring that studies have the input of the general public, clinicians and professionals in the health industry. This year was the first time that community stakeholders participated in the full review, discussion, and scoring process.

CTSA Consortium Issues Call for Inter-Institutional Pilot Award Applications

Applications Sought for CTSA Inter-institutional Pilot Awards

The Western States Consortium, which includes the UAMS Translational Research Institute (TRI) and four other Clinical and Translational Science Award (CTSA) institutions, has issued the call to all faculty for pilot award applications.

In addition to TRI, the Western States Consortium members are the University of Kentucky, University of New Mexico, University of Kansas Medical Center, and University of Utah, all part of the national CTSA consortium, supported by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). (Note: The University of Kansas Medical Center is not participating in this pilot program.)

The purpose of the pilot awards is to promote inter-institutional collaboration by funding innovative, translational research projects that involve two or more of the four Western States Consortium members. Awards of up to $25,000 will be provided by each participating institution.

For additional details, view the Request for Applications (RFA) document. If you have any questions, please contact Nia Indelicato at NLIndelicato@uams.edu or 501-614-2287.

Applications are due Jan. 19, 2018, at 5 p.m., (CT). Please submit to NLIndelicato@uams.edu.

The 2017 inter-institutional RFA is the fourth pilot funding opportunity by the Western States Consortium.

Key Dates:

IRB Submission Deadline: Nov. 24, 2017
Application Deadline: Jan. 19, 2018 5:00 pm Central Time
Notice of intent to fund at each CTSA: Feb. 2, 2018
Just In Time Period: Feb. 2, 2018 – Feb. 9, 2018
Submission to NIH for Prior Approval of Human Subjects: Feb. 12, 2018
Funding Cycle: April 1, 2018 through March 31, 2019

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TRI Part of NIH Milestone to Accelerate Multisite Clinical Studies

CTSA Program paves way for nationwide single IRB model.

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

The National Institutes of Health (NIH) is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH’s National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites (including the UAMS Translational Research Institute) have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.

The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously.

The authorization agreement effort was led by Harvard Catalyst, University of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”

In addition, the SMART IRB authorization agreement will provide the foundation for NCATS’ Trial Innovation Network central IRBs. The Trial Innovation Network is a collaborative CTSA Program initiative designed to address critical roadblocks in clinical research, and to optimize and streamline the clinical trial and studies process.

Next steps for the NCATS SMART IRB Platform include the development of education, training and harmonization of best practices for a single IRB review. Learn more at https://ncats.nih.gov/expertise/clinical/smartirb and https://smartirb.org (link is external).

About the National Center for Advancing Translational Sciences (NCATS): To get more treatments to more patients more quickly, NCATS incorporates the power of data, new technologies and strategic collaborations to develop, demonstrate and disseminate innovations in translational science. Rather than targeting a particular disease or fundamental science, NCATS focuses on what is common across all diseases and the translational process. Learn more at https://ncats.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

K Awards Informational Session Recording, Slides Available

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UAMS Visitor Talks Latino Health Paradox and Cinco de Mayo

A couple of common misconceptions about Hispanics were highlighted in talks by David E. Hayes-Bautista, Ph.D., who visited UAMS and the Clinton School of Public Service last week.

Hayes-Bautista, a distinguished professor of medicine from the University of California, Los Angeles, noted that Latinos are often incorrectly lumped with other minorities when health disparities are discussed.

Like other minorities, Hispanics have the commonly cited risk factors of lower income, low education and low access to health care. And yet, for many conditions, the health of Hispanics is just as good as whites and in some cases better. For example, Hispanics in the United States have a 30 percent lower rate of heart disease – the leading cause of death – than whites.

“Whoa, lower?” Hayes-Bautista asked during a presentation to UAMS faculty. “Shouldn’t it be higher?”

The same is true for cancer, the second leading cause of death. Hispanics nationally have a nearly 40 percent lower rate of cancer deaths than whites. In Arkansas, Hispanics have a 70 percent lower death rate from cancer.

Hayes-Bautista said Hispanics/Latinos bring healthy behaviors from their native countries. For example, the smoking rate among Hispanics is about half that of whites in Arkansas.

But those good behaviors are weakened in their U.S.-born children, who have higher rates of poor health behaviors.

For more than three decades he has studied the “Latino Epidemiological Paradox,” the tendency of Latino Americans to have health outcomes comparable to or better than their non-Hispanic white counterparts in the United States, and the implications of this paradox for populations, chronic diseases and communicable diseases.

Hayes-Bautista’s study of Hispanic culture and history led him to write the book El Cinco de Mayo: An American Tradition, a topic he presented at the Clinton School. The public event and reception was sponsored by the UAMS Translational Research Institute and the UAMS Center for Diversity Affairs, as well as the Clinton School.

Cinco de Mayo marks the Mexican military victory over the invading French army on May 5, 1862, but it’s more widely celebrated in the United States than in Mexico. The victory, he explained, prevented an alliance that would have benefited the Confederacy. Hispanics were against slavery and sided with the Union. The May 5 victory was the turning point in France’s attempt to create a monarchy over Mexico that would ally with the Confederacy. For U.S. Latinos from Mexico, the victory became a rallying cry for the Union.

In 1996, Cinco de Mayo got a U.S. postage stamp, and in 2005 it became an annual celebration in the White House and is now recognized widely across the country.

“If you ask these millions of people why are we celebrating, nobody knows. It’s just a party for some,” Hayes-Bautista said.

Billy Thomas, M.D., vice chancellor for Diversity and Inclusion at the UAMS Center for Diversity Affairs, presented David E. Hayes Bautista, Ph.D., with an Arkansas Traveler certificate following his talk at the Clinton School.

His UAMS talks are available at http://bit.ly/2nk4wMI (hosted by Peds Place) and http://bit.ly/2nPG5YW (hosted by College of Pharmacy).

His talk at the Clinton School will be available soon at: http://www.clintonschoolspeakers.com.

Hayes-Bautista is also director of the Center for the Study of Latino Health and Culture at the UCLA David Geffen School of Medicine. For the past five years, he has been chosen one of the 101 Top Leaders of the Latino Community in the U.S. by Latino Leaders Magazine. In 2012, he received the Association of American Medical Colleges Herbert W. Nickens Award for his lifelong concerns about the educational, societal and health care needs of underrepresented groups.

Hayes-Bautista has written or edited nine books on Latino health and culture and is a frequent contributor of opinion pieces to major newspapers. He has published articles in journals ranging from Academic Medicine to Salud Pública de México. He has authored dozens of proposals for funded research projects, and has given hundreds of presentations to medical and lay communities and to government agencies concerned with the nation’s health care system. Some of his center’s research on the emergence of the Latino population and society in California during the Spanish colonial, Mexican Republic, and U.S. statehood periods appears in his recent book, El Cinco de Mayo: An American Tradition (U.C. Press, 2012).

Other co-sponsors of his two-day visit were the UAMS College of Pharmacy, Arkansas Center for Health Disparities in the UAMS Fay W. Boozman College of Public Health, League of United Latin American Citizens, and the Joel E. Anderson Institute on Race and Ethnicity at the University of Arkansas at Little Rock.

‘Budgeting for Grant Applications’ March 24

Renee Raines, CCRP, CRA, director of the Office of Sponsored Programs Administrative Network (OSPAN), will present “Budgeting for Grant Applications” on March 24, 8:30 – 10 a.m., at the Psychiatric Research Institute, room 136.

Her presentation, part of the TRI Research and Career Development Seminar Series, will include information on OSPAN’s services provided to researchers.

Please register via TrainingTracker. The presentation is also available via BlackBoard Collaborate.

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Visiting Latino Leader, Scholar to Give Three Lectures March 16, 17

UCLA Distinguished Professor of Medicine David E. Hayes-Bautista, Ph.D., who has spent decades studying and writing about the links between culture, behavior and health, will give three presentations in Little Rock on March 16 and 17.

The UAMS Translational Research Institute is sponsoring a reception following his March 16 presentation, “Latino Leadership and the Cinco de Mayo in the American West,” from 6-7 p.m., at the Clinton School of Public Service, Sturgis Hall, 1200 President Clinton Ave.

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Hayes-Bautista is director of the Center for the Study of Latino Health and Culture at the UCLA David Geffen School of Medicine. For the past five years, he has been chosen one of the 101 Top Leaders of the Latino Community in the U.S. by Latino Leaders Magazine. In 2012, he received the Association of American Medical Colleges (AAMC) Herbert W. Nickens Award for his lifelong concerns about the educational, societal, and health care needs of underrepresented groups.

For more than three decades he has studied the “Latino Epidemiological Paradox,” the tendency of Latino Americans to have health outcomes comparable to or better than their non-Hispanic white counterparts in the U.S., and the implications of this paradox for populations, chronic diseases and communicable diseases.

To join the March 16 lecture at ACH via live streaming on your PC, MAC, iPad or iPhone:

Visit www.archildrens.org/video
Click on the Peds PLACE icon
Click on the topic and date listed above (or search)
If watching LIVE, remember that you can send in questions for the speaker

New Tool Simplifies and Expands Cohort Searches

Amy Jo Jenkins, M.S., and Ahmad Baghal, M.D.

Tools should make life easier, and that applies to the tools researchers use accessing the Arkansas clinical Data Repository (AR-CDR), formerly the UAMS Enterprise Data Warehouse.

The AR-CDR has been a pillar of UAMS’ translational research infrastructure since its establishment in 2011 with support from the Translational Research Institute (TRI).

In 2015, UAMS leadership made improving researcher access to the AR-CDR a priority with the creation of the AR-CDR work group, led by Charlotte Hobbs, M.D., Ph.D., executive associate dean for research in the College of Medicine. The work group also included representatives from UAMS Information Technology, TRI, and the Department of Biomedical Informatics.

TRI, through its Clinical and Translational Science Award (CTSA) Consortium activities, discovered TriNetX, a federated clinical data network of providers, including pharmaceutical companies and contract research organizations (CROs), as well as 21 CTSA institutions. TriNetX presented to the work group, and TRI Director Laura James, M.D., and TRI Executive Program Manager Amy Jo Jenkins, M.S., led the effort to make UAMS part of the federated network, integrating it with the AR-CDR.

Jenkins organized an onboarding team of 16 people from TRI, the Department of Biomedical Informatics and UAMS Information Technology for acquiring and installing the network’s cohort estimation tool, establishing a security protocol, and training. “The work of our interdepartmental team was phenomenal,” Jenkins said. “UAMS had the fastest onboarding in the network’s history.”

The collaboration began in September, providing all UAMS researchers with three significant benefits:

It includes a user-friendly search tool for exploring the rich clinical data repository as a preliminary step in developing clinical research studies.
It helps match investigators with industry sponsored clinical trials.
It can link cohort data at multiple network sites in the future.

Another key change recommended by the work group is the addition of the AR-CDR’s first director, Ahmad Baghal, M.D., who joined UAMS in October.

Baghal predicts the new search engine, the UAMS Research Cohort Estimation Tool, will be popular with researchers.

“We now have an intuitive cohort estimation tool; anybody can learn to use it in 10 minutes,” he said.

Apples to Apples

The primary tool for research cohort identification has been i2b2 (Integrating Biology and the Bedside). While it remains a component of AR-CDR, it has moved to the background with the UAMS Research Cohort Estimation Tool offering a self-service capability that provides researchers with deidentified aggregates for a study cohort.

“A nice feature of the new cohort estimation tool is the future ability to expand a study cohort by including other collaborating institutions in a query search. The good thing about the tool is that data received from different institutions are mapped to a single, unified ontology,” Baghal said.

Trial Run

Brad Martin, Ph.D., Pharm.D., gave the new system a trial run and came away impressed.

“Comparing the new query tool to the previous platform, i2b2, is kind of like comparing Windows to DOS,” said Martin, a professor in the UAMS College of Pharmacy. “The cohort estimation tool allows for an intuitive approach to understanding patterns in the data warehouse. One of the most impressive features of the new platform is that it allows users to build temporality into the queries. For example, users can build queries that require a diagnosis before some drug exposure or vice versa, which is critical for research and quality improvement analyses.”

The information researchers gather from their cohort estimation queries will help them determine whether to pursue additional, identifying data elements (e.g., demographics, procedures and diagnoses). To receive the identifiable data, researchers must seek IRB approval and submit a data request using the Request Services portal button on the TRI website (tri.uams.edu).

Additional information is also on the TRI website, including an online training tutorial. The Arkansas Clinical Data Repository (AR-CDR) page is in the main menu under Services, or simply type AR-CDR in the search field to find it.

In addition, Baghal will meet with research groups for more specialized training.

New Clinical Trial Opportunities

Another powerful feature of UAMS’ membership in the federated network is the abundance of new prospects for UAMS participation in industry sponsored clinical trials. The network serves as a matchmaker, helping the pharmaceutical industry identify researchers to conduct clinical trials.

“As members of the network, there are mutually beneficial opportunities for our researchers and the pharmaceutical industry looking for collaborators,” James said.

Jenkins has served as the liaison to industry sponsors looking for sites to run their clinical trials. After receiving an inquiry, she attempts to find an interested investigator through the UAMS Service Line research liaisons or the Rockefeller Cancer Institute. She facilitates the required confidentiality agreements and works with the sponsor to get their trial placed at UAMS.

Since becoming part of the network, UAMS has received 22 inquiries about clinical trial opportunities. UAMS faculty are pursuing clinical trials in stem cell transplantation, cytomegalovirus infection, pain management, irritable bowel disease, renal disease, diabetes and prostate cancer.

“The network collaboration is helping UAMS faculty be at the front end of clinical trial opportunities as trials are being rolled out from pharmaceutical sponsors,” James said. “It increases our visibility to the broader research industry, and that’s good for UAMS and our patients.”