Only two years ago, the idea of commercializing their future research discoveries was a novel concept for Julia Tobacyk, Ph.D., and Megan Reed, Ph.D. Today they can say they created a startup company as postdoctoral fellows in the Health Sciences Innovation and Entrepreneurship (HSIE) training program, which is the National Institutes of Health’s (NIH) National Research Service Award training core of the Translational Research Institute at the University of Arkansas for Medical Sciences (UAMS).

The HSIE program is unlike traditional academic postdoctoral education — the goal is to transform scientists to think like entrepreneurs and channel their research discoveries into commercial ventures to bring new health care products to patients.

Tobacyk and Reed are in their second year of the HSIE training program, and it is intensive. In addition to mentored laboratory research, HSIE postdocs take business classes in the Graduate Entrepreneurship Program in the Sam M. Walton College of Business at the University of Arkansas, Fayetteville. They attend mentoring workshops from entrepreneurs and venture capitalists, form teams to develop a business plan for a health science discovery with classmates from diverse ethnic and academic backgrounds, and compete in pitch competitions.

“At first, the fast-paced environment is a culture shock for most HSIE postdocs, but we all quickly adapt and develop our inner entrepreneurial spirit,” Tobacyk said.

Tobacyk’s research in the laboratory focuses on developing treatment strategies for opioid use disorder in pregnant women without negatively affecting their babies. Alarming statistics reveal that a baby is born physically dependent on opioids every 15 minutes in the United States. The gold standard treatment for opioid-dependent pregnant mothers is buprenorphine (BUP). Although BUP treatment may prevent pregnant mothers from relapsing, it also contributes to withdrawal in their babies, also known as neonatal opioid withdrawal syndrome (NOWS).

Tobacyk, along with her research mentor, Lisa Brents, Ph.D., assistant professor in the UAMS College of Medicine Department of Pharmacology and Toxicology, filed a provisional patent application with co-workers in September 2022 to protect their invention of a deuterated form of BUP (BUP-D2). Applying precision deuteration is thought to alter the metabolism of BUP to minimize formation of the harmful metabolite that contributes to NOWS.

In January 2023, Tobacyk and Reed formed a company called Pediatrica Therapeutics, LLC, a pharmaceutical startup company dedicated to bringing BUP-D2 through the drug development pipeline. In recent months, the startup team has won or placed in a number of business plan competitions across the U.S. and in Canada. In April, they won first place in the Arkansas Governor’s Cup Collegiate Business Plan Competition, which came with a $20,000 prize. 

Their team finished second with a $10,000 prize in the graduate business plan competition at the 2023 Stu Clark New Venture Championships in Winnipeg, Canada. They also took third place ($750) for their elevator pitch at that competition. The team was a finalist ($1,500) in the Baylor New Venture Competition as well as finalists in the UA Heartland Challenge and the international Rice Business Plan Competition ($1,500).  

The graduate entrepreneurship students and founding business partners of Pediatrica Therapeutics, LLC, are:

• Megan Reed, Ph.D., chief executive officer, who has experience in biochemistry, drug development and patenting of pharmaceutical compounds; she is a HSIE postdoctoral fellow in the College of Medicine Department of Biochemistry and Molecular Biology.
• Julia Tobacyk, Ph.D., chief scientific officer, who co-invented BUP-D2 and performed preclinical studies; she is a HSIE postdoctoral fellow in the College of Medicine Department of Pharmacology and Toxicology.
• Hayot Tuychiev, BA, chief marketing officer, who is a two-time Emmy-winning documentary filmmaker and manages scientific and public communications for the company.
• Veronica Garcia, BA, chief operating officer, who is the former director of Community Engagement and Inclusion at the Springdale, Arkansas, Chamber of Commerce and has assisted 75 entrepreneurs to form businesses.

In addition to their business classes and founding their new company, Tobacyk and Reed continue to work in the laboratory, publish papers and develop their careers as translational scientists. However, the HSIE training program has empowered them to look at their research through a new, entrepreneurial lens.

With the team members concluding their final year of HSIE training in June, Reed, Tuychiev and Garcia are moving on to pursue other career goals.

“Julia and I both agree that academic research holds plenty of unexploited potential to leverage discoveries to improve health care,” Reed said. “Pediatrica Therapeutics will not be our last venture.”

Tobacyk and Brents hope to advance the company’s goals with a Small Business Innovation Research program award, which they will apply for this year as co-principal investigators.

Reed and Tobacyk are supported by the UAMS Translational Research Institute through the NIH National Center for Advancing Translational Sciences, Clinical and Translational Science Award grants UL1 TR003107 and TL1 TR003109. Brents is a graduate of the Translational Research Institute’s KL2 Mentored Research Career Development Scholar Awards Program, also supported through NCATS.

This article was based on a first-person account by Julia Tobacyk, Ph.D.

An American Cancer Society grant will support UAMS study of the Affordable Care Act’s (ACA) influence on racial disparities in the use of a common, life-saving treatment for Arkansas breast cancer patients.

The two-year, $222,000 grant is led by Chenghui Li, Ph.D., an associate professor in the College of Pharmacy Division of Pharmaceutical Evaluation and Policy, and an associate member of the UAMS Winthrop P. Rockefeller Cancer Institute Cancer Prevention and Population Services Program. The new study builds on her work previously funded by the National Center for Advancing Translational Sciences (NCATS).

Arkansas is disproportionately affected by breast cancer, especially among Black women. According to Kaiser Family Foundation 2020 estimates, breast cancer mortality rate among Black women in Arkansas is 42% higher than the national average (27.2 per versus 19.1 per 100,000 women). Arkansas’ breast cancer mortality rate for white women is 19.4%. 

About 80% of breast cancer patients have estrogen receptor positive tumors, which can be treated with endocrine therapy. The therapy slows or stops tumor growth by blocking estrogen production/binding onto breast cancer cells, reducing the five-year recurrence of breast cancer by 40% and mortality by 33%.

“Findings from this study can provide crucial insights into how the Affordable Care Act may have impacted racial disparities in getting this life-saving treatment for breast cancer,” Li said. “Our findings will have important implications for similar states in the South that have not expanded Medicaid.”

“Dr. Li continues to invest her time and expertise into research that is aligned with the vision of UAMS and will positively impact patients,” said Jacob T Painter, Pharm.D., Ph.D., MBA, associate professor and director of the Division of Pharmaceutical Evaluation and Policy in the College of Pharmacy. “The American Cancer Society grant will enable Dr. Li to further her research of racial disparities in breast cancer treatment, and we expect her findings will reverberate beyond Arkansas.”

The ACA took effect in Arkansas in January 2014, resulting in a decrease of uninsured adults from 23% to 10%. Today it provides health insurance coverage to about 300,000 Arkansans.

While the ACA may have helped reduce racial disparities in the use of endocrine therapy, Li said, the ongoing poor health outcomes for Black breast cancer patients raise questions about other barriers to treatment that she will explore in her research.

Li said her study appears to be the first to assess the ACA’s impact on racial disparities in the use of endocrine therapy and cost sharing — how much breast cancer patients must pay out of pocket.

The study uses a unique data source: the linked Arkansas All-Payer Claims Database and Arkansas Cancer Registry, which combines claims data from all payers in Arkansas with the Cancer Registry.

“With this linked data, we will have access to detailed tumor characteristics that are lacking in claims databases with the benefit of detailed prescription information across both public and private insurers,” Li said. “This presents a unique opportunity for us to systematically examine the impact of the ACA on racial disparity in endocrine therapy use.”

Li’s research is supported by the UAMS Translational Research Institute, which is funded by NCATS at the National Institutes of Health, Clinical and Translational Science Award UL1 TR003107.

A $221,000 supplemental award from NCATS in 2020 enabled Li to provide preliminary findings that supported her American Cancer Society grant application. The NCATS grant is supporting an ongoing analysis of racial disparities in endocrine therapy use among early-stage estrogen-receptor-positive breast cancer patients in relation to cancer recurrence and mortality.

The NCATS-funded study also involves interviewing providers and Black and white breast cancer patients who discontinued endocrine therapy within five years to better understand barriers of endocrine therapy adherence, and their perspectives on any racial disparities. The work received assistance from the Translational Research Institute’s Community Engagement Program.

Christi Madden, MPA, has joined the UAMS Translational Research Institute as its executive director.

Madden, a leader with more than two decades of research programmatic management experience, spent most of her career in her home state of Oklahoma at the University of Oklahoma Health Sciences Center (OUHSC), where she worked in the Department of Pediatrics and at the Oklahoma Clinical and Translational Science Institute.

As executive director, Madden oversees all Translational Research Institute staff and services to UAMS researchers. She also serves as a liaison to the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), which funds the UAMS Translational Research Institute with a Clinical and Translational Science Award (CTSA).

“We are thrilled to have Christi on our team,” said institute Director Laura James, M.D. “In her roles at OUHSC, she managed several highly impactful public health research and quality improvement programs. Her skillset and research leadership experience will help our institute provide the highest quality service to our researchers and to our research participants.”

Madden’s management experience includes the IDeA States Pediatric Clinical Trials Network, the Oklahoma Primary Healthcare Improvement Cooperative, the Oklahoma Child Health Research Network and the Healthy Hearts for Oklahoma project.

She has also worked on several projects with rural communities across Oklahoma to implement community-driven initiatives to improve cardiovascular health, increase access to health care and mental health resources, and implement COVID-19-related research.

In 2022, she was recognized by the Public Health Institute of Oklahoma as one of the County Health Improvement Organization’s Top Ten People of the Decade.

“I am excited to be in this new role at TRI and look forward to working collaboratively across UAMS and with our partners such as Arkansas Children’s Research Institute and the Central Arkansas Veterans Healthcare System to improve the health and health care of Arkansans.” 

The Translational Research Institute is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, Clinical and Translational Science Award TR003107.

In this month’s TRIbune newsletter, we feature our second annual TRI Research Day, which drew about 150 people from the UAMS research community, including Arkansas Children’s and the Central Arkansas Veteran’s Healthcare System.

Eight of our TRI-supported researchers gave oral presentations, and there were 33 poster presentations. Our keynote speaker was the University of Florida’s Duane A. Mitchell, M.D., Ph.D., a pioneer in the research of brain tumor immunotherapies.

The TRI Study of the Month features Clare Nesmith, M.D., the UAMS principal investigator on a national study comparing rapid and slow weaning methods for newborns with neonatal opioid withdrawal symptoms (NOWS). Read The TRIbune.

LITTLE ROCK — Laura James, M.D., director of the UAMS Translational Research Institute, has been elected to a second term on the national Association for Clinical and Translational Science (ACTS) Board of Directors.

She joins 13 other directors at large from National Institutes of Health (NIH)-funded Clinical and Translational Science Awards (CTSA) Program institutions across the United States. She was first elected to the board in 2020.

James has been director of the Translational Research Institute since 2014 and is UAMS associate vice chancellor for Clinical and Translational Research. She has a 28-year history of translational research in clinical pharmacology and toxicology at UAMS and Arkansas Children’s Hospital. As a clinician-scientist and founder of the startup company Acetaminophen Toxicity Diagnostics LLC, she is leading development of a rapid diagnostic test for acetaminophen liver injury. In 2014 she was named an inaugural fellow of the Arkansas Research Alliance (ARA).

The role of the ACTS board is to govern, establish policy and make strategic decisions about the future of the organization. ACTS supports research that continually improves team science, integrating multiple disciplines across the translational science spectrum. It is also the academic home for translational research education and career development, and is an advocate for translational science.

“It has been a pleasure over the last three years working with the ACTS board and staff to create new programs and maximize investments that support the professional development of translational researchers,” James said. “I am excited to continue this work building productive collaborations across the association and with other relevant organizations.”

Translational research is the process of taking findings and discoveries (new medicines, health interventions, etc.) and “translating” or applying them to everyday practices that improve health.

The CTSA Program is administered by the National Center for Advancing Translational Sciences (NCATS) at the NIH. TRI received a five-year, $24.2 million CTSA, grant UL1 TR003107 in July 2019 and is one of more than 60 CTSA-supported institutions nationally.

Among Thelma Shorter’s first stops at the University of Arkansas for Medical Sciences (UAMS) Midsouth Black Expo was the UAMS Winthrop P. Rockefeller Cancer Institute’s booth offering take-home colorectal screening kits.

“For colorectal cancer, and all cancers, it’s better to find out if you are at risk sooner rather than later,” said Shorter of Little Rock. “If you can catch cancer before it gets too far then you have a better chance of it being corrected.”

Shorter was among 2,100 attendees at the 19^th annual expo, held Feb. 25 at The Venue at Westwind in North Little Rock. A free event with 25 speakers and 20 performances, the expo celebrated Black History Month with health education, an “Ask the Doctor” segment, a showcase of more than 100 Black-owned businesses, and Black cultural and historical education. In addition, the UAMS MammoVan, a mobile mammography unit, was on-site to provide prescheduled mammograms.

“I’ve been here before, and I always find it interesting with lots of information, plus the entertainment and a little shopping,” Shorter said. “It’s something good for the community.”

Other UAMS booths were represented by the Institute for Digital Health & Innovation, Division for Diversity, Equity and Inclusion (DDEI), and the UAMS Translational Research Institute’s ARresearch registry of potential research volunteers.

Many attendees were happy to learn about and join the research registry, which is available at ARresearch.org.

“I lost my mom to vascular dementia, and if that research comes up I would certainly sign up and participate in that study,” said Melissa Kaiser of Little Rock.

People who join the ARresearch registry provide their contact information and select from a list of 31 health interest areas, such as heart disease, cancer and COVID-19. When studies at UAMS match a registrant’s health interests, UAMS may contact the registrant to ask if they want to volunteer.

Stephanie Wilson of Monticello joined the registry after seeing the value of research as a former employee at the University of Texas Medical Branch in Galveston.

“I know what the benefits to research are, so I’d like to aid if I could, especially being an African American female,” Wilson said, noting the lack of diversity in research.

Hayse Miller of Little Rock said his health experiences motivated him to join the registry.

“I’ve always been interested in doing some type of study, especially when COVID-19 came and I got infected,” Miller said. “As someone who has polio, I’ve also been interested in some physical-related studies.”

Parents and K-12 students were also drawn to DDEI’s Pathways Academy booth, where they learned of opportunities in the science, technology, engineering and math (STEM) fields. The Pathways Academy is a statewide K-12 STEM-Health Science educational and community engagement program with the goal of diversifying the health care workforce. It offers licensed teachers providing hands-on, real world and interactive experiences.

Ophelia Malone of Little Rock and her daughter, Star Hughes, were excited to hear about the Pathways Academy and learn how to apply for the summer 2023 program.

“I first heard about Pathways at a PTA meeting, and I think it would be a great opportunity for Star to engage with other youth who share her interests,” Malone said, noting that as a fifth-grader, her daughter was part of a robotics team that won a Little Rock School District competition.

Come see how we’re translating research into health practice at TRI Research Day 2023 on Tuesday, April 4, from 10 a.m. to 4 p.m. at Heifer International headquarters in Little Rock.

Our keynote speaker (11:10 a.m. – noon) is Duane Mitchell, M.D., Ph.D., professor of neurosurgery and director of the University of Florida Clinical Translational Science Institute (CTSI). He is also assistant vice president for research and associate dean for Clinical and Translational Sciences at the UF College of Medicine.

The event will showcase TRI-supported researchers with oral presentations from TRI’s KL2 Mentored Research Career Development scholars, Implementation Science scholars, TL1 Health Science Innovation and Entrepreneurship trainees, and Pilot Award Program awardees.

A poster session, awards and networking are from 2:50 – 4 p.m., and will include the full array of TRI-supported projects across its funding and training programs.

Register here.

Contact: Chaz England, CEngland@uams.edu

UAMS Principal Investigator: Deanne L. King, M.D., Ph.D., assistant professor and director of Clinical Research, College of Medicine Department of Otolaryngology – Head & Neck Surgery

Summary: A phase 3 multi-center trial will evaluate the safety and efficacy of a new drug candidate for Meniere’s disease.

Significance: There are few treatment options available for Meniere’s disease, a common inner ear disease whose symptoms include hearing loss, dizziness/vertigo and tinnitus. The anti-inflammatory drug candidate has shown promise as a treatment in smaller studies.

TRI Services: Medicare coverage analysis, study budget development, regulatory and nurse/clinical coordinator support, administration of Clinical Trial Management System, and post-award financial management.

Sponsor: Sound Pharmaceuticals Inc.

In this month’s issue of The TRIbune, we feature some significant new efforts in mentorship training for researchers. TRI-supported research leaders have received mentorship facilitator training and will be conducting regular, evidence-based mentor training courses for UAMS-affiliated faculty. TRI’s mentorship training efforts reflect a priority of the National Center for Advancing Translational Sciences (NCATS) at the NIH.

The TRI Study of the Month features Jill Mhyre, M.D., professor and chair, College of Medicine Department of Anesthesiology, who is collaborating with Ronda Henry-Tillman, M.D., chief of Breast Surgical Oncology. 

Read The TRIbune.