basic research

Cuts to basic research funding could threaten the health of Kentucky

Written by Jay Blanton, executive director of UK Public Relations & Marketing.

Colorectal cancer incidence rates have declined by 25 percent in Kentucky in less than 10 years. Death rates have dropped by 30 percent.

Why?

Among other reasons, screenings have increased significantly, led by University of Kentucky and UK HealthCare researchers along with changes in state policy.

It’s one example of the impact that basic scientific research combined with outreach into communities can have in Kentucky. Basic scientific research is at the cornerstone of each innovation and, led by UK, it’s making a difference across Kentucky.

“Everything that we do came from a research question that was originally asked by someone either in the U.S. or internationally, so it impacts every part of our day-to-day lives,” said Lisa Cassis, UK’s vice president for research, who is nationally known and funded for her research in metabolic and obesity-associated diseases.

“Screening for colorectal cancer, for example, is a practice that most of us probably assume is routinely applied according to clinical guidelines. However, research makes a difference by asking the question: Is the screening routinely applied? And if not, then why, and how can we increase screening for this condition?” Cassis said.

Researchers at universities across the country have expressed concern over a recent proposal for next year to cut funding for biomedical research by nearly 20 percent.

U.S. Senator Mitch McConnell, the majority leader, recognizes the value of research and recently supported an increase in the budget of the National Institutes of Health by $2 billion for the remainder of this fiscal year.

McConnell and Kentucky Congressmen Andy Barr and Hal Rogers also were vocal supporters last year of the 21st Century Cures Act, which authorized federal funding increases for research on Alzheimer’s disease, cancer and opioid abuse  all issues of concern for Kentuckians. And McConnell and Barr reaffirmed their support for UK’s research efforts recently during a news conference to announce $11.2 million in federal funding to launch a new Center for Cancer and Metabolism at UK.

Nevertheless, the threat of cuts looms large and would, if enacted, hamper UK’s ability to continue to make progress in addressing the state’s health disparities, as well as threaten thousands of jobs and hundreds of millions of dollars annually in economic impact for Kentucky.

Specifically, Cassis and UK President Eli Capilouto recently cited several economic and health statistics regarding the impact in Kentucky of federal funding for basic scientific research:

  • With the proposed reduction of National Institutes of Health (NIH) funding for next year, an estimated 219 jobs at UK alone would be cut, with an effective loss of 339 jobs across the Commonwealth.
  • UK’s research enterprise has an annual economic impact of more than $580 million and more than 8,000 jobs.
  • Increasing research activity by just 15 percent means an additional nearly $90 million in economic impact and nearly 220 jobs.
  • Institutions in Kentucky earn $163.6 million ($92.4 million earned by UK) of NIH’s $26.4 billion in funding. At an estimated 13 jobs per $1 million in NIH awards, this support generates 2,886 intra/interstate jobs and has an estimated $431.6 million economic impact in Fiscal Year 2016.
  • The proposed cuts would significantly hamper UK’s ability to conduct research – and provide advanced medical healthcare – related to challenges where Kentucky is among the nation’s leaders in incidence rates for cancer, heart disease, diabetes, Alzheimer’s and death from opioid abuse. The CDC estimates hundreds of lives are lost in Kentucky’s Fifth Congressional District every year due to these largely preventable illnesses.
  • The National Institute of Food and Agriculture provides funding to 112 land-grant institutions in the U.S. to support: agriculture, food safety, agribusiness, bioenergy, 4-H, youth development and family consumer sciences.
  • One in six patents in agriculture science nationally grew from land-grant university research.
  • Six of the 10 major vaccines currently used to protect against equine infectious diseases were developed by faculty in UK’s Department of Veterinary Sciences.

Capilouto said UK’s goal with basic scientific research is to translate it as quickly as possible into treatments and solutions for communities across the Commonwealth.

“What we want to do is get the very best of our research quickly to the bedside,” Capilouto said. “We want to be able to take what we’ve learned and translate it quickly to a community to make a difference. We systematically and successfully do that at the University of Kentucky because of our capacity, our depth.”

“We can’t cut back on the pace of progress now,” Capilouto said. “Doing so threatens Kentucky’s future.”

Watch the video below to learn more about the impact basic research has on the health and wellness of Kentucky.


Next steps:

Dr. Mark Evers

Dr. Mark Evers elected to group for leading physician-scientists

Dr. Mark Evers

Dr. Mark Evers

UK surgical oncologist and Markey Cancer Center Director Dr. Mark Evers was recently elected into the Association of American Physicians (AAP).

AAP is a nonprofit organization founded for the purpose of advancing scientific and practical medicine and is composed of members who are leading senior physician-scientists.

Its goals include the pursuit of medical knowledge and the advancement through experimentation and discovery of basic and clinical science and their application to clinical medicine. Every year, individuals who have attained excellence in achieving these goals are nominated by the Council of the AAP and competitively selected as members.

Evers is the Markey Cancer Foundation Endowed Chair and professor and vice-chair for research in the UK Department of Surgery. He also serves as the physician-in-chief of the oncology service line for UK HealthCare.

His research has been continuously funded by the National Institutes of Health for more than 20 years, including an NIH MERIT Award, multiple R01s and training grants. He has authored more than 400 peer-reviewed publications, book chapters and reviews. Throughout his career, he has received more than 30 awards, including the prestigious Flance-Karl Award from the American Surgical Association, and held numerous leadership positions in national and international organizations.


Next steps:

  • Markey is Kentucky’s only NCI-designated cancer center, providing world-class cancer care right here in the Commonwealth. Learn more about why patients choose Markey for their cancer treatment.
  • Watch our new TV spot, which features Markey’s molecular tumor board, a powerful tool in the fight against cancer.
Nurses Week

We’re celebrating our awesome nurses during Nurses Week!

It’s Nurses Week and we’re celebrating all the excellent nurses at UK HealthCare who care for our patients every day.

UK HealthCare has more than 4,000 nursing service employees, including more than 2,000 full-time registered nurses. They are the best at what they do and play a vital role in enhancing our patients’ healing process. Through patient care, education and research, our nurses are instrumental in providing the world-class care available at UK HealthCare.

In fact, UK HealthCare is part of an elite group of hospitals that has achieved Magnet status – the gold standard for nursing excellence. Out of nearly 6,000 healthcare organizations in the United States, fewer than 7 percent have achieved Magnet designation.

Kudos to our nurses for being so awesome!

Interested in working at UK HealthCare?

Are you interested in working in nursing at UK HealthCare? We’re hiring! Find out more during an open house this Thursday, May 11 from 1-3 p.m. in Room H-178 of UK Chandler Hospital. Recruiters will be available to answer questions about employment opportunities.

Parking is available in the UK HealthCare parking garage at 110 Transcript Ave., directly across South Limestone from Chandler Hospital. Take the free shuttle from Level A of the garage to Stop 2. After entering Pavilion H, take hallway on your immediate right to Room H-178. Bring your parking ticket with you and we will validate it for you so that parking is free.


Next steps:

Dr. F. Douglas Scutchfield

UK public health professor awarded prestigious honor

Dr. F. Douglas Scutchfield, a renowned public health leader at UK, will be awarded the 2017 UK Libraries Medallion for Intellectual Achievement on Tuesday in recognition of his career achievements.

Scutchfield served most recently at UK as the Bosomworth Professor of Health Services Research and Policy in the Department of Health Management and Policy and Department of Preventive Medicine and Environmental Health in the UK College of Public Health and in the Department of Family & Community Medicine in the UK College of Medicine. He officially retired from UK in January, but remains active in teaching, research and mentorship. He was founding director of both the School of Public Health at UK and the UK Center for Health Services Research and Management. He has also held the administrative positions of chair of the Health Services Department and Preventive Medicine Department, and is a past associate dean of the UK College of Medicine.

“Dr. Scutchfield’s life story represents all that is good about Kentucky and those who achieve and reach back to help others follow their success,” said Dean of UK Libraries Terry Birdwhistell. “As a scholar, teacher, mentor, administrator and public health advocate, he has never forgotten his Floyd County roots even as he became internationally recognized and honored.”

Scutchfield’s illustrious career has taken him from Kentucky to leadership and academic positions at institutions in Alabama, California and Israel. He has been asked to serve as a consultant to government and non-governmental organizations in Panama, China, Saudi Arabia, Israel and Germany, as well as the U.S. He has successfully acquired extramural support for research, educational and service programs. His most recent research focused on community health, public health organization and delivery, quality of care issues and democracy in health care decision making.

The UK Libraries Medallion for Intellectual Achievement is one of UK’s most prestigious awards. It was created in 1990 to recognize high intellectual achievement by a Kentuckian who has made a contribution of lasting value to the Commonwealth. The award also promotes education and creative thought. Past recipients of the honor include: John Anthony, Wendell Berry, James Still, Bobbie Ann Mason, Thomas D. Clark, Laman A. Gray Jr., Guy Davenport, George C. Herring, Adalin Wichman, John Egerton, Karl Raitz, George Wright and James C. Klotter.


Next steps:

molecular tumor board

Watch: Our new TV spot highlights precision cancer care at Markey

Our new TV spot tells the exciting story of how the UK Markey Cancer Center is using precision medicine to target cancer treatment to patients’ unique cancer cells. Watch the video below and learn more about how we’re harnessing the power of advanced medicine to find the best treatment for each patient.

Treating cancer at the molecular level

The future of cancer treatment is fighting the disease at the level of an individual gene, breaking down a diagnosis by analyzing each patient’s unique genetic characteristics. At Markey, our Molecular Tumor Board is leading this fight, bringing personalized, precision medicine to patients across Kentucky.

The Molecular Tumor Board, which is made up of more than a dozen leading clinicians and scientists, meets monthly to review individual cancer cases from across the Commonwealth, diving deep into patients’ genetic information, then collectively tailoring a precision treatment specifically for them.

Tailoring a precision treatment

Dr. Jill Kolesar

Dr. Jill Kolesar

“It’s well accepted that cancer is chiefly a genetic disorder,” says Dr. Jill Kolesar, a founding member and co-director of Markey’s Molecular Tumor Board. “The first genome that was sequenced took 13 years and $2.7 billion dollars. Now we can sequence a genome in an afternoon.”

Such significant advances in technology have helped spur precision medicine, but have also created large quantities of genetic information, Kolesar said. It’s up to the Molecular Tumor Board to interpret that vast amount of data and apply it to an individual’s cancer diagnosis and treatment.

Dr. Susanne Arnold

Dr. Susanne Arnold

Medical oncologist Dr. Susanne Arnold, Markey’s associate director for clinical translation and member of the Molecular Tumor Board, is helping lead this individualized approach to cancer treatment. A precision approach to diagnosis and analysis is the future of care, she said.

“You take a biopsy and do the genomic analysis, called next-generation sequencing, which helps us understand exactly what happened with that cell that resulted in cancer,” she explained.

But what might sound like a routine test in modern medicine is much more remarkable in these particular cases.

“Molecular medicine is actually discovering the information about a unique cancer in a specific person at a precise point in time,” she said. “Pinpointing this allows us to understand why it happened, why our treatment did or didn’t work, and how we can potentially stop (the cancer).”

In short, these tests allow for a remarkably detailed understanding of what goes wrong in cancerous cells. And that sort of comprehensive knowledge helps the tumor board choose the best treatment from among the many options available at Markey.

How the molecular tumor board works

Markey’s Molecular Tumor Board is not the first of its kind, but it is the first in Kentucky. And that’s significant, given the unprecedented rates of cancer across the state, most notably in the rural, eastern parts of Kentucky.

With the board meeting twice monthly, oncologists across the state can reach out for a recommendation for therapy based on their patient’s molecular signature.

There are more than a dozen scientific specialties represented on the board, and more than 300 years of experience in total. All of this is applied to a single patient as cases are presented to the board, and the inclusion of each patient’s own physician in the process ensures an intimate understanding of that patient’s condition and outlook.

Each patient’s cancer will be tested for all genetic mutations that are known to cause cancer, regardless of what type of tumor the patient has. The tumor board then uses the results of that test to choose possible treatment options that target the genetic mutations. Each mutation is evaluated for FDA-approved therapies for the patient’s tumor type, FDA-approved off-label therapies and any clinical trials available related to the patient’s specific mutations.

Taking into consideration the available treatment options, the Molecular Tumor Board will make a recommendation based on the best possible outcome for the patient.

For a single patient, for all of Kentucky

As more tumor boards are established across the country and more cases are reviewed, a bank of information will be available to doctors to help them determine the best course of action for patients with similar cases.

“Everything we discover is designed to help you, and by sharing this information in an anonymous way, it can help people across the country suffering with cancer. We’re all being connected through this process, and that’s a beautiful, beautiful story to tell,” Arnold said. “Imagine you are ‘Anne’ from Pikeville, Kentucky, but behind you is your doctor, the Markey Cancer Center, other NCI-designated cancer centers, the National Cancer Institute … and ‘John’ in New York City, who has the same mutation as you. The six degrees of separation suddenly disappear, and ideally you each benefit from the experience of the other.”

Dr. Mark Evers

Dr. Mark Evers

That is the crux of Markey’s ambitions: an individualized approach to each patient, but on a large scale. In an open letter released at the end of 2016, Dr. Mark Evers, director of Markey, made public a goal of the organization: to significantly reduce cancer incidence and mortality across the state, and the region, by the year 2020. It’s a lofty aspiration, but initiatives like the Molecular Tumor Board position Markey for success.

As Kolesar said, “When researchers and clinicians at the Markey Cancer Center decide something is going to benefit patients, like the Molecular Tumor Board, they say, ‘Let’s do it.’”

This team spirit spans the entire organization. Kolesar noted the collegiality and support for accomplishing goals at UK HealthCare.

“Dr. Evers, says, ‘You just tell me what you need, and we’ll make it happen, because that’s what we think the patients of Kentucky need,’” she said.

Such sweeping change, especially when it comes to issues as complicated and extensive as healthcare, rarely happens quickly. But a series of small successes, over time, can have an enormous ripple effect. The experts who make up the Molecular Tumor Board understand this, and it’s their reason for participating in and offering their time to such programs.

“By understanding the genetic makeup of our patients and their tumors, we can then help to direct their therapy,” Evers said.

The future of advanced medicine

Treatment options at UK HealthCare are more abundant than ever before. The Early Therapeutics Clinical Trials Center focuses on increasing patient access to phase I and phase II clinical trials will also have a major impact for Markey patients.

“[Previously,] if patients in Kentucky needed an earlier-phase clinical trial, they would have to go out of state,” said Kolesar, explaining the advantage of the initiative.

These early-phase studies can offer patients new treatment avenues for cancers that have proved difficult to target using standard therapies. Essentially, it allows Markey to participate in the development of new and novel treatments while offering patients first access.

Being at the forefront of medicine means incredible discovery, but for every breakthrough, there are new unknowns. This uncharted territory is a product of advancement and a reason for optimism.

“Do we have a therapy for every gene that’s broken? No. But we do have therapies for genes that are broken in non-small cell lung cancer, melanoma, breast cancer, colon cancer and a growing list every day. They are defined by their gene signature and by the gene that’s broken. That’s called targeted therapy,” Arnold said.

The hope is that this sort of targeting can be applied to all types of cancer, and Markey’s patients could be among the first to benefit.

“The Power of Advanced Medicine” is more than a slogan. It’s a guiding principle and a reminder that UK HealthCare prioritizes discovery in the name of our patients.


Next steps:

  • Markey is Kentucky’s only NCI-designated cancer center, providing world-class cancer care right here in the Commonwealth. Learn more about why patients choose Markey for their cancer treatment. For a second opinion or appointment, call Markey at 859-257-4488 or 866-340-4488 (toll free).
  • Learn more about the power of advanced medicine at UK HealthCare.
Meet the Researcher Day

UK cancer researchers welcome middle, high school students

Middle and high school students from across the region came to UK and UK HealthCare last week for an up-close look at what it’s like to be a cancer researcher.

“Meet the Researcher Day,” hosted by the UK Markey Cancer Center and the Leukemia & Lymphoma Society (LLS), is a field trip reward given to schools in the region that successfully raise more than $1,000 for the LLS’s Pennies for Patients campaign.

This year, students from Shelby County West Middle School, Mercer County Senior High School, Henry County Middle School and New Albany High School in Indiana won the opportunity to visit the Biomedical/Biological Sciences Research Building on UK’s campus and learn more about how the money they raised for Pennies for Patients will help further cancer research.

After an introduction by UK researchers Tianyan Gao and Craig Vander Kooi, the students received a tour of different cancer research labs and learned how to use basic lab equipment. The event also featured remarks from Dr. John D’Orazio, a pediatric oncologist and cancer researcher as well as LLS Honored Hero Brad Wilson, a UK chemical engineering student and two-time leukemia survivor. The students also heard a panel discussion about careers in science featuring D’Orazio and UK students Michael Gosky and Payton Stevens.

“I think it’s important that students get to see the lab spaces, meet the researchers and understand what the Leukemia & Lymphoma Society and Markey Cancer Center mission is: The cure for cancer,” said Shelia Gustafson, campaign director for the Kentucky and Southern Indiana Chapter of LLS.

Pennies for Patients is the annual fundraiser for the Student Series of the LLS. It encourages students to collect spare change during a three-week period early in the year. Funds raised support leukemia, lymphoma and myeloma research; patient and community service; public health education; and professional education.

For this year’s campaign, 485 schools across the region participated, raising more than $400,000 – a new record. The schools participating in Pennies for Patients had to raise a minimum of $1,000 to win the chance to attend Meet the Researchers Day. The four schools at Meet the Researchers Day this year were chosen in a random drawing, raising more than $10,000 combined for LLS.

Check out the video below for highlights from this year’s Meet the Research Day.


Next steps:

  • Learn more about clinical trials at Markey, which give patients access to the most up-to-date cancer research and innovations.
  • Markey is Kentucky’s only NCI-designated cancer center, providing world-class cancer care right here in the Commonwealth. Learn more about why patients choose Markey for their cancer treatment.
UK Markey Cancer Center Affiliate Network

Markey extends cancer network to Somerset

Lake Cumberland Regional Hospital in Somerset has announced a new affiliation with the UK Markey Cancer Center, the state’s only National Cancer Institute-designated cancer center.

The UK Markey Cancer Center Affiliate Network was created to provide high-quality cancer care closer to home for patients across the region and to minimize the effects of cancer through prevention and education programs, exceptional clinical care, and access to research.

By becoming a Markey affiliate, Lake Cumberland Regional Hospital will now be able to offer its patients access to additional specialty and subspecialty physicians and care, including clinical trials and advanced technology, while allowing them to stay in South Central Kentucky for most treatments.

The Markey Cancer Center Affiliate Network supports UK HealthCare’s overall mission of ensuring no Kentuckian will have to leave the state to get access to top-of-the-line healthcare.

“UK HealthCare doesn’t just serve Lexington and Central Kentucky – our mission is to provide all Kentuckians with the best possible care right here in the state,” said Dr. Michael Karpf, UK executive vice president for health affairs. “The Markey Cancer Center Affiliate Network allows us to collaborate with community hospitals to provide top-notch cancer care much closer to home – saving both travel expenses and time for the patients, in addition to keeping them close to their personal support system.”

Established in 1976, Lake Cumberland Regional Hospital is a 295-bed acute care facility, providing healthcare services for an 11-county service area in South Central Kentucky. With more than 40 physician specialties and nearly 200 physicians on staff, Lake Cumberland offers the most comprehensive services in the region.

“As we work toward fulfilling our mission of ‘Making Communities Healthier,’ it is clear to me that the relationship between Lake Cumberland Regional Hospital and the Markey Cancer Center will go a long way in achieving that goal,” said Tim Bess, Lake Cumberland Regional Hospital chief executive officer. “Our community will benefit greatly from this relationship. We are honored to partner with the UK Markey Cancer Center.”

Markey is one of only 69 medical centers in the country to earn an NCI cancer center designation. Because of the designation, Markey patients have access to new drugs, treatment options and clinical trials offered only at NCI centers.

Moving forward, Markey is working toward the next tier of designation – an NCI-designated Comprehensive Cancer Center. Currently, 47 of the 69 NCI-designated cancer centers in the country hold a comprehensive cancer center status. The Markey Cancer Center Affiliate Network will play a significant role in bringing that next level of cancer funding to Kentucky.

“The burden of cancer in Kentucky is huge, and unfortunately we have some of the worst cancer rates in the country,” said Dr. Timothy Mullett, medical director of the UK Markey Cancer Center Affiliate Network. “By collaborating with our affiliate hospitals across the state, we have the potential to make a serious impact on cancer care here in the Commonwealth.”

The UK Markey Cancer Center Affiliate Network began in 2006 and currently has 17 member hospitals across the state of Kentucky. Learn more.


Next steps:

UK HealthCare anesthesiologist Dr. Rae Brown has led the FDA advisory committee since last year, providing expert recommendations on opioid regulation.

UK anesthesiologist brings expertise to FDA’s opioid review committee

Raeford E. Brown Jr., MD, FAAP

UK HealthCare anesthesiologist and professor Dr. Rae Brown has led the Food and Drug Administration (FDA) advisory committee since last year, providing expert recommendations on opioid regulation and developing strategies to mitigate opioid risks in society.

In July 2016, Brown was named chair of the FDA Advisory Committee on Analgesics and Anesthetics. He was nominated to serve on the committee by the Commissioner of FDA in 2015 and served on the committee for a year prior to being named chair.

The committee is composed of physicians and scientists from across the nation with expertise in anesthesiology, opioid pharmacology, clinical research and epidemiology. The advisory committee meets monthly at FDA headquarters in Silver Spring, Maryland.

Tackling the opioid crisis

During the past year, the committee has reviewed risk mitigation strategies that serve as a major agency response to the current opioid crisis. In addition, the committee has evaluated 10 abuse deterrent formulations of opioids, discussed the risks and benefits of increasing the availability of naloxone – a drug to treat opioid overdose – and reviewed the risks of codeine in the pediatric population. Brown said the committee is cautious and deliberate in scrutinizing every product reviewed for the market, as the availability of new opioids can make the ongoing epidemic in America much worse.

“My first question is, ‘Is it safe?’” Brown said of reviewing opioid deterrents presented to the committee. “Is it a safe medication for the group it is marketed to, and is it effective? My second question is, ‘Do the data support whether or not it has a real deterrent properties that are going to stand up to all the chemists in the U.S.?’ ”

Developing new clinical trials for pediatric patients

In September 2016, Brown served as the chair of an FDA symposium on the lack of clinical trials demonstrating the safety and effectiveness of opioids in infants, especially the premature. Brown, a professor of pediatric anesthesiology, is now involved in the development of an international consortium designed to provide large numbers of pediatric patients for unique safety trials.

Brown will serve as the chair of this committee for three more years. He also currently serves as the chair-elect of the Section on Anesthesiology and Pain Medicine of the American Academy of Pediatrics and will be appointed chair in November of 2017.


Next steps:

  • At the National Rx Drug Abuse and Heroin Summit in Atlanta, UK clinicians, researchers and health policy leaders led discussions on how to combat the opioid drug crisis.
  • Surgical procedures, both major and minor, require pain management. UK Anesthesiology & Pain Management provides comprehensive anesthesiology services following surgeries, as well as for chronic and cancer-related symptoms.
Gilson Capilouto, PhD, along with Tommy Cunningham, PhD, created a device that can measure and improve neonatal feeding, which some infants struggle with.

First-of-its-kind infant feeding device gets its start at UK

Since the early days of her career, Gilson Capilouto, PhD, has been interested in pediatric feeding, but it wasn’t until she joined the UK’s multidisciplinary team in the Neonatal Intensive Care Unit (NICU) that she became especially interested in feeding challenges for children who are born early or with illnesses. Around 15 million babies are born prematurely in the U.S. each year, and up to 70 percent of them, as well as about 10 percent of full-term babies, experience difficultly transitioning to oral feeding.

“My interest in neonatal feeding began in earnest when I came to UK 15 years ago. It seemed a natural extension of the work I was doing as part of the UK NICU multidisciplinary team, following high-risk infants after they’re discharged from the hospital,” Capilouto said.

Feeding is important for a baby’s nutrition, of course, but it also has implications for long-term development and eating. Neonatal sucking is considered the most complex behavior of a newborn. Research suggests that infant sucking may provide an early window into the overall integrity of the central nervous system, possibly predicting long-term neurodevelopmental outcomes. Studies have shown that early sucking correlates with overall development at six months, one year and two years. Infant feeding problems can also spill over into eating difficulties with solid food, especially in cases where feeding might have been an unpleasant experience during infancy, and can cause great distress for caregivers.

Skip ahead a few years, and Gilson and her business partner Tommy Cunningham, PhD, now run an award-winning company, NFANT Labs, LLC, based on a device they developed to measure the strength and coordination of an infant’s ability to suck. The device, called the nfant Feeding Solution, is essentially a “smart” baby bottle that uses low-energy Bluetooth technology and a mobile app to provide immediately actionable information about what’s going on with an infant’s feeding. It displays the impact of feeding interventions in real time, tracks and charts infant progress, and creates a continuity of care among caregivers. It’s also the first “internet of things” medical device cleared by the Food and Drug Administration for use in the NICU. (You can see the device here.)

UK’s multidisciplinary NICU initiates research

This journey began as a simple research question that came to Capilouto during a continuing education conference focused on feeding preterm and sick term infants in the NICU.

“This whole thing started when I was attending a conference and the speaker was talking about the fact that for adults who aren’t orally fed for a while, their tongue muscle atrophies in a short period of time,” Capilouto said. “But we didn’t know if this was true in pre-term babies, who could go many weeks before they’re ever allowed to feed orally, sometime around 32-34 weeks gestation. So if baby is born at 28 weeks, for example, it will be many weeks before they can start to use their tongue muscle.”

When she got back to UK, Capilouto assembled a multidisciplinary team that could undertake the task of trying to measure infant sucking. The group included an expert in muscle biomechanics (Dr. Tim Butterfield also in the UK CHS), a muscle biologist, a clinical radiologist, and Cunningham, who at that time was at UK as a PhD student in biomechanics. An inventor with a couple patents under his belt, he’d also started a small engineering firm to help clinicians develop the tools they needed to conduct their research. His particular focus was, and remains, using evidence-based medicine to inform product development.

“Gilson came to me and Dr. Butterfield and said, ‘I need a bottle that can measure the strength of a baby’s tongue.’ She specifically wanted to be able to measure tongue strength during actual bottle feeding. Dr. Butterfield and I were intrigued by the challenge and after a couple of months, we had a proof-of-concept device.”

With a grant from the Kentucky Science and Engineering Foundation in 2011, they developed and tested the device, hypothesizing that both tongue force and tongue size would be different between preterm infants beginning to orally feed and full term infants. Results of that first study provided support for their hypothesis, as pre-term infant tongue force was found to be significantly less than full-term infants relative to nutritive sucking; interestingly, simple pacifier sucking strength was not different between the two groups.

“When we got those results, we were pretty excited, we knew we wanted to continue this line of research, but we needed instrumentation that was more NICU-friendly. Ultimately we saw the clinical utility of what we were doing, so we wanted to build an instrument not just for research purposes, but also a tool that could be used in clinical practice at the bedside,” Capilouto said. “We knew we were on to something, but the methods were cumbersome – it required a bank of computers and four people to collect the data, and we knew for the long term that would not be feasible.”

Following release of the Intellectual Property from the University, Capilouto and Cunningham sought further funding from the Office of Research in the UK College of Health Sciences in 2012 to help them develop a second prototype that could be used bedside in the NICU.

“We leveraged a lot of technologies out there, like what’s in your cell phone, and built it on a scale to fit around a baby bottle so it could be easily incorporated to bedside work flow. We also wanted the final device to be easy to use and low cost. Millions of cell phones are made, so that drives down prices of the components,” Cunningham said.

Testing the second prototype provided the necessary confirmation for the new design and also provided important feedback about desirable features and characteristics from NICU bedside nurses. Armed with this information, Cunningham, who had moved to Atlanta after he finished his PhD at UK, left his job to devote himself full-time to development of the device. After rapid prototyping and validating the final device, Capilouto and Cunningham founded NFANT Labs, LLC, based in Atlanta, in 2013. The company has two patents and a third one pending.

In the fall of 2015, the nfant Feeding Solution device was cleared by the FDA and that following January, Capilouto took a one-year, university-approved entrepreneurial leave of absence and relocated to Atlanta to work with the company. During this time, they were able to introduce the product in NICUs around the country and establish partnerships for conducting clinical trials. The company also developed, tested and launched a second product — a line of high quality silicone bottle nipples.

UK offers its support

Currently, a novel methodology award from the UK Center for Clinical and Translational Science and the UK College of Health Sciences supports a research study to determine if the measures of sucking performance from the nfant Feeding Solution can be used to identify infants who are most likely to experience ongoing feeding problems after discharge. Dr. Peter Giannone, chief of the division of neonatology at UK, serves as co-investigator on the grant.

The study is following preterm infants at high risk for developmental concerns from hospital discharge through their first year. For those babies whose one-year developmental testing reveals cognitive or motor issues, the team will go back to data from their early feeding behaviors in the hospital in the hopes of identifying sucking performance variables that could possibly have predictive power.

“We want to identify babies who we are at risk for poor developmental outcomes as early as possible, so we can get them the help they need as soon as possible and take advantage of the mechanisms of neuroplasticity.” Capilouto said.

NFANT Labs has earned several accolades for its pioneering work. In March of this year, the Technology Association of Georgia, the state’s leading association dedicated to the promotion and economic advancement of Georgia’s technology industry, named nfant Feeding Solution as the Breakthrough Technology of the Year and NFANT Labs one of its Top 10 Innovative Technology Companies in the state. Last year, NFANT Labs was named a Silicon Labs “Internet of Things Hero” and also received Georgia Bio’s coveted Innovation Award. In 2015, the company received the E-Achiever Award from the Lexington Venture Group.

With this strong foundation, NFANT Labs is experiencing rapid growth. To date, they have raised $3.5 million of private capital and are gearing up to raise another $5 million to expand their sales force, create additional products and take the company to the next level. The device is being used in NICUs across the country to assist healthcare teams in clinical decision making regarding a fragile infant’s transition to oral feeding. UK is currently in the process of purchasing and integrating it into their standard of care. It is also being used in several of the top children’s hospitals in the country to study important research questions, including the relationship between early sucking performance and neonatal brain injury.

Capilouto and Cunningham both emphasize the necessity of a team that takes advantage of multiple fields of expertise.

“To get us to this point, we assembled a distinctive interdisciplinary research team consisting of basic, translational and clinical investigators with expertise in pediatric feeding and swallowing, muscle physiology, muscle biomechanics, biomedical engineering, diagnostic radiology and neonatology,” Capilouto said.

Cunningham added that “the idea is just one thing. You need clinical research, executive leadership, capital backing, sales and marketing, manufacturing, etc. It takes a vast amount of resources to go from an idea to a sustainable business focused on improving patient care.”

As their company grows, the team hopes to broaden the use of the nfant Feeding System to learn more about feeding behaviors and neurodevelopment of specific groups of infants, as well as extend their capacity to support caregivers.


Next steps:

The 29th annual Barnstable Brown Kentucky Derby Eve Gala will take place Friday, May 5 in Louisville. It has raised over $13 million over the past decade.

Celebrity guests announced for this year’s Barnstable Brown Kentucky Derby Eve Gala

The 29th annual Barnstable Brown Kentucky Derby Eve Gala will take place Friday, May 5 in Louisville. The gala benefits the UK Barnstable Brown Kentucky Diabetes and Obesity Center.

Even if you aren’t able to attend the Barnstable Brown Derby Eve Gala, you can still support the groundbreaking diabetes research at the UK HealthCare Barnstable Brown Diabetes Center. Donations can be sent to: UK HealthCare Office of Philanthropy, Attn: Barnstable Brown Diabetes Center, PO Box 34184, Lexington, KY 40588.

The annual star-studded bash is held at the home of Patricia Barnstable-Brown, who co-hosts the event with her twin sister, Priscilla Barnstable. The event is internationally recognized as the “premier” Kentucky Derby gala and counted among the “Ten Best Parties in the World” by Condé Nast.

This year’s guests will include:

  • Tom Brady
  • Kid Rock
  • Tracy Morgan
  • Katie Couric
  • Larry David
  • Kacey Musgraves
  • Aaron Rodgers
  • Sammy Hagar
  • Richie Sambora
  • Harry Connick Jr.
  • Brian McKnight
  • Maren Morris (Grammy-winning country music artist)
  • Rob Gronkowski (New England Patriots)
  • Kix Brooks (Brooks & Dunn)
  • Justin Hartley (This is Us)
  • Boyz II Men
  • Rickie Fowler (PGA Tour golfer)
  • Brooks Koepka (PGA Tour golfer)
  • Justin Thomas (PGA Tour golfer)
  • Jimmy Walker (PGA Tour golfer)
  • Johnny Gill
  • Montgomery Gentry
  • Orianthi
  • Stephen Amell
  • Josh Henderson
  • Travis Tritt
  • Terri Clark
  • Cam (Grammy-nominated country music artist)
  • Clay Walker
  • Giada De Laurentiis
  • Chrishell Stause
  • Lynyrd Skynyrd’s Rickey Medlocke
  • Jordan Smith (The Voice)
  • Taylor Dayne
  • Joey Fatone
  • Bode Miller
  • Mary Wilson
  • Randall Cobb (Green Bay Packers)
  • Jay Gruden (NFL head coach)
  • Wes Welker (former All-Pro NFL player)
  • Matt Cassel (Tennessee Titans)
  • Mike Vrabel (Houston Texans)
  • Larry Izzo (Houston Texans)
  • Rob O’Neill (Decorated U.S. Navy Seal)
  • Larry Birkhead
  • Justin Cornwell (Training Day)

Next steps: