UofL researchers escalate efforts against multi-drug resistant bacteria with FDA contract

Center for Predictive Medicine earns FDA contract to develop model for testing antibiotics
UofL researchers escalate efforts against multi-drug resistant bacteria with FDA contract

Regional Biocontainment Laboratory on University of Louisville ShelbyHurst Campus

Antibiotic resistance is one of the greatest infectious disease threats in the 21st Century. The United States Centers for Disease Control and Prevention (CDC) has estimated that drug-resistant infections are responsible for 23,000 deaths in the United States each year. Among the three most concerning antibiotic-resistant bacteria and fungi identified by the World Health Organization (WHO) is Psuedomonas aeruginosa.

Researchers at the University of Louisville Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases (CPM) are working at the forefront in combating these pathogens. The CPM has been testing the effectiveness of new drugs against P. aeruginosa under a contract with the National Institutes of Health since 2013, and a new contract from the U.S. Food and Drug Administration (FDA) will expand the center’s work in testing new drugs against this pathogen. Under the new two-year, $933,606 contract, CPM will develop a validated model for screening antimicrobial drugs against P. aeruginosa.

“This model likely will play an important role in drug development pipelines leading to identification of new antimicrobial drugs,” said Matthew Lawrenz, Ph.D., associate professor of microbiology and immunology who is leading the research. “Researchers at UofL and from around the world will use the model to screen new antimicrobials against multi-drug resistant bacteria prior to clinical trials.”

Forest Arnold, D.O., hospital epidemiologist for UofL Hospital and associate professor in the Division of Infectious Diseases in the UofL School of Medicine, said multi-drug resistant (MDR) bacteria and XDR bacteria, those with resistance to all existing antibiotics, are evolving faster than the drugs to kill them.

“The germs get smarter as we make new drugs. If we are going to stay on top of them, we need new antibiotics, especially new classes of antibiotics -- those with a new mechanism of action that the germ hasn’t seen before,” Arnold said.

Infections with MDR bacteria are particularly threatening for patients with weakened immune systems, those who have had multiple rounds of treatment with antibiotics, and in patients using devices such as ventilators and blood catheters. Since these bacteria are now resistant to many of the antibiotic drugs used to treat them, they can lead to severe infections and death.

“If you have an infection with a bacterium we don’t have an antibiotic to treat, it could kill you,” Arnold said.

P. aeruginosa is common in the environment and in otherwise healthy people, it may cause relatively minor infections of the ear, skin or eye. However, in people with weakened immune systems or in hospital settings, P. aeruginosa can cause serious, life-threatening infections of the blood, lungs, digestive tract or tissue. Infected wounds will have a green pus or discharge and a fruity smell.

The validated animal model, to be developed by UofL researchers with collaborators at the University of Kentucky and the University of Wisconsin, will be used to test new compounds developed by drug companies and research labs around the world against P. aeruginosa. This model will allow testing against multiple strains of pseudomonas and will give more detailed information about the effectiveness of the drugs being tested.

“The previous methods we used for testing the drugs provided basic information about a compound’s effectiveness. This new model will allow us to test anything from older classes of antibiotics to brand new classes and will provide information on dosing and scheduling. In addition, we will be able to test different strategies, such as immunomodulation – targeting the host to better respond to the infection as opposed to directly killing the bacteria,” Lawrenz said.

The CPM’s new contract with the FDA will take advantage of the sophisticated resources at the Regional Biocontainment Lab, located on the UofL ShelbyHurst Campus, which provide the environment necessary for this work.

“This new contract from the Food and Drug Administration supports the development of a model for understanding how bacteria build resistance to current commercially available antibiotics, which in turn, will lead to the discovery of new drugs or methods to combat a variety of infectious diseases,” said Robert Keynton, Ph.D., interim executive vice president for research and innovation at UofL. “The UofL Center for Predictive Medicine and the Regional Biocontainment Laboratory represents a significant investment in infrastructure, faculty and staff by the university in the field of emerging infectious diseases, which is one of our research and training strategic priorities."



March 4, 2019

Louisville and Lexington Eye Banks merge to better serve Kentucky and beyond

Single eye bank based in Louisville will serve entire state and portions of W. Va., aligns with area served by Kentucky Organ Donor Affiliates
Louisville and Lexington Eye Banks merge to better serve Kentucky and beyond

Kentucky Lions Eye Center

On January 1, 2017, the Kentucky Lions Eye Bank in Louisville and the Lexington Lions Eye Bank merged into a single Eye Bank serving the entire state of Kentucky and portions of West Virginia. The Kentucky Lions Eye Foundation, the University of Louisville and University of Kentucky are proud to announce the unification of all Eye Banking services, including procurement of donor tissue and distribution of corneas for transplant, into one organization serving the entire state of Kentucky.

“This merger is the culmination of 25 years of negotiation and work behind the scenes to better serve the people of Kentucky,” said Tom Van Etten, of Louisville, past Lions Eye Foundation chair.

Previously, the Louisville Lions Eye Bank, affiliated with the University of Louisville, served the western part of the state; the Eye Bank of Lexington, affiliated with the University of Kentucky, served the eastern part of Kentucky and parts of West Virginia. The new Kentucky Lions Eye Bank serves the same geographical area as Kentucky Organ Donor Affiliates (KODA) to effectively coordinate corneal donation with organ and tissue donation statewide. 

Corneal transplantation is a separate procedure that replaces all or part of a diseased cornea, improving sight, stabilizing diseased eyes and improving comfort in patients with severe corneal pathology. In 2015, there were 79,000 corneal transplants performed in the United States, and there were 470 donors of ocular tissue from Kentucky. Cornea transplants have a 95 percent success rate, and the lifetime economic benefit of corneal transplants performed in 2013 in the United States was $5.5 billion. The leading indication for corneal transplantation in 2016 was keratoconus, followed by corneal edema, Fuchs dystrophy and corneal scars.

The newly merged Kentucky Lions Eye Bank positions the state of Kentucky to efficiently coordinate with other eye banks in the United States to provide corneas for transplant in the state of Kentucky and assist with medical needs elsewhere when possible.

For the immediate future, the laboratories at the University of Louisville and the University of Kentucky will remain functional as operations will continue in both cities. They gradually will be centralized in Louisville over the next five years.

“The merged Eye Bank will be an asset to the state of Kentucky and should provide the resources for the state to be a national provider of donor ocular tissue to restore sight and to assist in research of blinding diseases,” said Henry J. Kaplan, M.D., chair of the Department of Ophthalmology and Visual Sciences at the University of Louisville.

For more information or to make charitable donations, contact the Louisville Lions Eye Bank (502) 852-5457 or the Kentucky Lions Eye Foundation at (502) 583-0564. The website of the new organization will be

UofL School of Medicine supports the Obama Administration’s new actions to address prescription opioid abuse, heroin epidemic

UofL School of Medicine supports the Obama Administration’s new actions to address prescription opioid abuse, heroin epidemic

On March 29, the University of Louisville School of Medicine joined with 60 other schools and colleges of medicine from throughout the United States in support of new actions to address prescription opioid abuse and the national heroin epidemic.

President Barack Obama joined individuals in recovery, family members, medical professionals, law enforcement officials and other leaders at the National Rx Drug Abuse and Heroin Summit in Atlanta, Georgia. The annual summit is organized by Operation UNITE, which was launched by Kentucky Rep. Hal Rogers.  As part of the event, the President announced these additional public and private sector actions to escalate the fight against the prescription opioid abuse and heroin epidemic, which is claiming the lives of tens of thousands of Americans each year.

The President has made clear that addressing this epidemic is a priority for his Administration, and today’s actions represent further steps to expand access to treatment, prevent overdose deaths and increase community prevention strategies.  These actions build on the President’s proposal for $1.1 billion in new funding to help every American with an opioid use disorder who wants treatment get the help they need.

As part of the March 29 event, the President announced the following Administration actions:

    Expanding Access to Treatment:

      The Department of Health and Human Services (HHS) is issuing a proposed rule to increase the current patient limit for qualified physicians who prescribe buprenorphine to treat opioid use disorders from 100 to 200 patients with the goal of expanding access to this evidence-based treatment while preventing diversion.  The proposed rule aims to increase access to medication-assisted treatment and behavioral health supports for tens of thousands of people with opioid use disorders.

      HHS released $94 million in new funding to 271 Community Health Centers across the country earlier this month to increase substance use disorder treatment services, with a specific focus on expanding medication-assisted treatment of opioid use disorders in underserved communities.  This funding is expected to help health centers treat nearly 124,000 new patients with substance use disorders.

      The Substance Abuse and Mental Health Services Administration (SAMHSA) is releasing a new $11 million funding opportunity for up to 11 states to expand their medication-assisted treatment services.  SAMHSA also is distributing 10,000 pocket guides for clinicians that include a checklist for prescribing medication for opioid use disorder treatment and integrating non-pharmacologic therapies into treatment.  SAMHSA also will coordinate trainings to increase the number of doctors qualified to prescribe buprenorphine, which will be held in targeted states in greatest need.

        Establishing a Mental Health and Substance Use Disorder Parity Task Force: The President signed a memorandum on March 29 directing the creation of an interagency Task Force, to be chaired by the Domestic Policy Council, to advance access to mental health and substance use disorder treatment; promote compliance with best practices for mental health and substance use disorder parity implementation; and develop additional agency guidance as needed.  Federal parity protections are intended to ensure that health plans’ coverage of mental health and substance use disorder benefits is comparable to their coverage of medical and surgical benefits.  The Task Force will work quickly, with an Oct. 31 deadline, across Federal Departments and with diverse stakeholders to ensure implementation of these important parity protections.

            Implementing Mental Health and Substance Use Disorder Parity in Medicaid:  HHS is finalizing a rule to strengthen access to mental health and substance use services for people enrolled in Medicaid and Children’s Health Insurance Program (CHIP) plans by requiring that these benefits be offered at parity, meaning  that they be comparable to medical and surgical benefits.  These protections are expected to benefit more than 23 million people in Medicaid and CHIP.

                Preventing Opioid Overdose Deaths: SAMHSA is releasing a new $11 million funding opportunity to states to purchase and distribute the opioid overdose reversal drug, naloxone, and to train first responders and others on its use along with other overdose prevention strategies.

                    Expanding Public Health-Public Safety Partnerships to Combat the Spread of Heroin:  The Office of National Drug Control Policy is expanding its heroin initiative among regional High Intensity Drug Trafficking Areas (HIDTAs) by adding Ohio and Michigan to the effort.  These states will join the Appalachia, New England, Philadelphia/Camden, New York/New Jersey, and Washington/Baltimore HIDTAs in accelerating local partnerships between law enforcement and their counterparts in public health to combat heroin use and overdose.

                        Investing in Community Policing to Address Heroin:  The Department of Justice’s COPS program is announcing a $7 million funding opportunity called the COPS Anti-Heroin Task Force Program to advance public safety and to investigate the distribution of heroin, unlawful distribution of prescription opioids and unlawful heroin and prescription opioid traffickers.  These grants will provide funds directly to law enforcement agencies in states with high rates of primary treatment admissions for heroin and other opioids.

                          Tackling Substance Use Disorders in Rural Communities: On March 28, the Department of Agriculture announced that its $1.4 million Rural Health and Safety Education Grant Program to enhance the quality of life in rural areas through health and safety education projects has been expanded to include a focus on addressing the critical challenges related to substance use disorders in rural communities across the country.
                          Implementing Syringe Services Programs: HHS is issuing guidance for HHS-funded programs regarding the use of Federal funds to implement or expand syringe services programs for people who inject drugs.  Syringe services programs are an effective component of a comprehensive approach to preventing HIV and viral hepatitis among people who inject drugs.  The bipartisan budget agreement signed by the President last year revised a longstanding ban on these programs and allows communities with a demonstrated need to use Federal funds for the operational components of syringe services programs.

                            New Private Sector Commitments to Address the Epidemic

                            In connection with the March 29th Federal announcements, more than 60 medical schools announced that, beginning in fall 2016, they will require their students to take some form of prescriber education, in line with the newly released Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, in order to graduate. Schools include:

                            • University of Louisville School of Medicine
                            • A.T. Still University of Health Sciences, Kirksville College of Osteopathic Medicine
                            • A.T. Still University of Health Sciences, School of Osteopathic Medicine in Arizona
                            • Baylor College of Medicine
                            • Boston University School of Medicine
                            • Burrell College of Osteopathic Medicine at New Mexico State University
                            • Chicago College of Osteopathic Medicine of Midwestern University
                            • David Geffen School of Medicine at the University of California – Los Angeles
                            • Dell Medical School at The University of Texas at Austin
                            • East Carolina University Brody School of Medicine
                            • Edward Via College of Osteopathic Medicine - Auburn Campus
                            • Edward Via College of Osteopathic Medicine - Carolinas Campus
                            • Edward Via College of Osteopathic Medicine - Virginia Campus
                            • Georgia Campus – Philadelphia College of Osteopathic Medicine
                            • Hébert School of Medicine Uniformed Services University of the Health Sciences
                            • Icahn School of Medicine at Mount Sinai
                            • Kansas City University of Medicine and Biosciences College of Osteopathic Medicine
                            • Lincoln Memorial University DeBusk College of Osteopathic Medicine
                            • Loyola University Chicago Stritch School of Medicine
                            • Marian University College of Osteopathic Medicine
                            • Marshall University Joan C. Edwards School of Medicine
                            • Mercer University School of Medicine
                            • NYU School of Medicine
                            • Ohio State University College of Medicine
                            • Ohio University Heritage College of Osteopathic Medicine
                            • Oklahoma State University Center for Health Sciences College of Osteopathic Medicine
                            • Oregon Health & Science University School of Medicine
                            • Perelman School of Medicine at the University of Pennsylvania
                            • Philadelphia College of Osteopathic Medicine
                            • Rocky Vista University College of Osteopathic Medicine
                            • Rowan University School of Osteopathic Medicine
                            • Rutgers Robert Wood Johnson Medical School
                            • Saint Louis University School of Medicine
                            • State University of New York Upstate Medical University
                            • The Commonwealth Medical College
                            • The Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo
                            • Touro College of Osteopathic Medicine - New York
                            • Touro University College of Osteopathic Medicine - California
                            • Touro University College of Osteopathic Medicine – Nevada
                            • Tufts University School of Medicine
                            • Tulane University School of Medicine
                            • University of Arizona College of Medicine – Tucson
                            • University of California – Davis School of Medicine
                            • University of Central Florida College of Medicine
                            • University of Colorado School of Medicine
                            • University of Kansas Medical Center
                            • University of New England College of Osteopathic Medicine
                            • University of North Carolina School of Medicine
                            • University of North Texas Health Science Center at Fort Worth, Texas College of Osteopathic Medicine
                            • University of Oklahoma College of Medicine
                            • University of Pikeville - Kentucky College of Osteopathic Medicine
                            • University of Rochester School of Medicine and Dentistry
                            • University of Tennessee College of Medicine
                            • University of Texas Southwestern Medical Center
                            • University of Wisconsin School of Medicine and Public Health
                            • Virginia Commonwealth University School of Medicine
                            • West Virginia School of Osteopathic Medicine
                            • West Virginia University School of Medicine
                            • Western University of Health Sciences College of Osteopathic Medicine of the Pacific
                            • Western University of Health Sciences College of Osteopathic Medicine of the Pacific Northwest
                            • William Carey University College of Osteopathic Medicine

                            Rite Aid has trained over 8,400 pharmacists on naloxone and is dispensing naloxone to patients without needing an individual prescription in 10 states with plans to expand to additional states.  Kroger currently dispenses naloxone without an individual prescription at its pharmacies in seven states with plans to expand to at least 12 more by the end of the year.  AmerisourceBergen/ Good Neighbor Pharmacy will provide educational materials to encourage their 4,000 independently owned and operated retail pharmacy locations to provide naloxone without an individual prescription.

                            Updates on Federal Actions and Private Sector Commitments

                            In October 2015, as part of his visit to West Virginia to discuss the prescription opioid abuse and heroin epidemic, the President announced a number of new public and private sector actions, including a Presidential Memorandum requiring Federal Departments to provide training on appropriate opioid prescribing to Federal health care professionals and requiring Departments to develop plans to address barriers to opioid use disorder treatment in Federal programs.  Departments are ahead of schedule in fulfilling the President’s directive that Federal agencies ensure that all employees who prescribe these drugs are trained in appropriate opioid prescribing practices by 2017.  Approximately 75 percent of federal prescribers have been trained to date.  In addition, since the President’s Memorandum was released, Departments have taken numerous steps to expand access to opioid use disorder treatment, including medication-assisted treatment, such as:

                            • TRICARE: The Department of Defense issued a proposed rule to implement parity protections in TRICARE, including expanding mental health and substance use disorder treatment to include coverage of intensive outpatient programs and treatment of opioid use disorders with medication-assisted treatment.  TRICARE currently has an estimated 15,000 to 20,000 beneficiaries with opioid use disorder who, under the current benefit, cannot access medication-assisted treatment.
                            • FEHBP: The Office of Personnel Management released a 2017 Call Letter to health plans participating in the Federal Employees Health Benefits Program (FEHBP) making opioid use disorder treatment a priority and calling on health plans to review and improve access to medication-assisted treatment.
                            • Medicare: The Centers for Medicare and Medicaid Services (CMS) released a 2017 Call Letter to plans participating in the Medicare Prescription Drug Program reiterating that reducing the unsafe use of opioids is a priority and making clear that Part D formulary and plan benefit designs that hinder access to medication-assisted treatment for opioid use disorder will not be approved.
                            • Medicaid:  CMS released a guidance document to states identifying “Best Practices for Addressing Prescription Opioid Overdoses, Misuse and Addiction” including effective Medicaid pharmacy benefit management strategies, steps to increase the use of naloxone to reverse opioid overdose, and options for expanding Medicaid coverage of and access to opioid use disorder treatment.  This builds on Medicaid’s work with states over the past year to increase access to Medicaid substance use disorder treatment services.
                            • Health Insurance Marketplace: In the last month, CMS finalized a 2017 Marketplace payment notice that clarified that both essential health benefits requirements and Federal mental health and substance use disorder parity requirements apply to qualified health plan coverage of medications to treat opioid use disorder, and additional guidance is forthcoming.

                            Earlier this month, the Centers for Disease Control and Prevention issued its Guideline for Prescribing Opioids for Chronic Pain – the Agency’s first-ever recommendations for primary care clinicians on prescribing opioids.  The Guideline provides recommendations for clinicians on appropriate prescribing, including determining if and when to start prescription opioids for chronic pain treatment; guidance on medication selection, dose, and duration, including when to discontinue medication, if needed; and guidance to help assess the benefits and risks and address the harms of prescription opioid use.

                            The Food and Drug Administration recently announced safety labeling changes for all immediate-release opioid pain medications, including requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death associated with these drugs.  The Agency also issued a draft guidance intended to support the development of generic versions of abuse-deterrent opioids.  Abuse-deterrent drug formulations are designed to make the drug more difficult to abuse, including making it harder to crush a tablet in order to snort the contents or more difficult to dissolve the product in order to inject it.

                            The Drug Enforcement Administration (DEA) recently announced it will hold its 11thNational Prescription Drug Take-Back Day on Saturday, April 30, providing a safe, convenient, and responsible way of disposing of unneeded prescription drugs.  More than 5.5 million pounds of medication have been collected over the last ten Take Back Days.  Local communities are also establishing ongoing drug take-back programs.

                            Examples of private sector actions taken to date include the following:

                            In conjunction with the October event, more than 40 health care provider groups announced a commitment to ensure that more than 540,000 health care providers will complete training on appropriate opioid prescribing in the next two years.  In the first five months of this initiative, the provider coalition reports that more than 75,000 providers have completed prescriber training.  In addition, more than 2,200 additional physicians have committed to completing training to prescribe buprenorphine as part of the coalition’s effort to double the number of buprenorphine prescribers in the next three years.

                            As part of their commitment announced at the October 2015 event, the National Association of Counties, National Governors Association, National League of Cities and United states Conference of Mayors, with the U.S. Communities Purchasing Alliance and Premier, Inc., announced in January they had secured discounts on naloxone and medication-assisted treatment drugs through their purchasing program for State and local agencies.

                            In February, Walgreens announced it will install safe medication disposal kiosks in more than 500 drugstores across the country, primarily at locations open 24 hours. The program will make the disposal of medications — including opioids and other controlled substances — easier and more convenient while helping to reduce the misuse of medications.  Walgreens also will make naloxone available without needing an individual prescription at its pharmacies in 35 states and Washington, D.C. throughout this year.

                            CVS Health has worked to increase access to naloxone by establishing standing orders or collaborative practice agreements.  By the end of March 2016, CVS Pharmacy locations in 23 states will be able to dispense naloxone to patients without needing an individual prescription, increasing to 35 states by the end of 2016 as part of its program expansion announced at the October 2015 event.  CVS Health has also launched a drug abuse prevention program called Pharmacists Teach, which brings CVS Pharmacists into schools across the country to educate students about the dangers of drug abuse.  To date, more than 30,000 students have participated in the program.

                            Interferon not beneficial for most stage III melanoma

                            Final results of trial begun in 1997 show improved diagnostics make aggressive treatment unnecessary for many patients with metastasized skin cancer
                            Interferon not beneficial for most stage III melanoma

                            Kelly M. McMasters, M.D., Ph.D.

                            Final results for the Sunbelt Melanoma Trial, published online this month in the Journal of Clinical Oncology, show that thanks to current diagnostic techniques, most stage III melanoma patients do not benefit from treatment with interferon. Kelly McMasters, M.D., Ph.D., the Ben A. Reid, Sr., M.D. Professor and Chair of the Hiram C. Polk, Jr., M.D. Department of Surgery at the University of Louisville, was the principal investigator and initiated the trial.

                            The first of more than 3600 trial participants were enrolled in 1997. Patients with small amounts of melanoma detected in a single lymph node were either treated with high-dose interferon therapy or simply observed. The patients, representing 79 institutions across North America, were followed for up to 10 years to determine long-term outcomes in terms of disease-free survival and overall survival.

                            Interferon was approved by the FDA in 1995 as a therapy for melanoma based on a study of patients with multiple large, palpable lymph nodes involved with cancer. However, the development of sentinel lymph node (SLN) biopsy in the 1990s made it possible for physicians to detect microscopic amounts of cancer in lymph nodes that could not be detected by hand.

                            Patients in the Sunbelt Trial were those with melanoma detected in a single lymph node by SLN biopsy. They were considered stage III because of the presence of melanoma in the lymph nodes, but the smaller amounts of cancer detected meant they had lower risk of cancer recurrence than previous stage III patients. McMasters, director of the Multidisciplinary Melanoma Clinic and associate director of the James Graham Brown Cancer Center at UofL, said the trial also studied patients with an even smaller amount of cancer in the lymph nodes, detected only at the molecular level using polymerase chain reaction (PCR).

                            “We started the Sunbelt Melanoma Trial to determine whether interferon therapy was warranted in this relatively lower risk group of stage III patients,” McMasters said. “What we found was that there was no evidence that interferon was necessary or helpful for this substantial group of melanoma patients. That saves many patients the toxicity and expense of interferon therapy, which is like having the flu, only worse, for a whole year. While the study did not quite meet its accrual goals and was underpowered to detect very small differences in survival, there was not even a trend for improvement in survival with interferon. Based on these findings, it would be hard to recommend interferon therapy for patients with minimal cancer in just one lymph node.”

                            McMasters said that in practice today, most patients have the smaller level of cancer detected in the lymph nodes.

                            While interferon is still one of the two FDA-approved drugs for adjuvant therapy for high-risk melanoma, McMasters believes options now in the pipeline and further research into the molecular behavior of cancer cells will reveal more advantageous treatments for those with limited lymph node metastases.

                            “Newer studies of melanoma adjuvant therapy using immune checkpoint agents, such as PD-1 inhibitors, show much promise,” McMasters said. “I think more work needs to be performed to understand the significance of molecular detection of melanoma cells in the lymph nodes and in the circulating bloodstream. We now suspect that melanoma, as with other cancers, routinely sheds cancer cells into the lymphatic system and bloodstream, and that a small minority of these cells that have the ability to evade the immune system, attach, invade, develop their own blood supply and grow, will become metastatic tumors.”


                            The Sunbelt Melanoma Trial was funded by Schering Oncology Biotech. The sponsor had no involvement in the design, conduct, analysis or publication of the work

                            February 15, 2016

                            UofL adds cardiothoracic surgeon from Boston

                            Frank A. Pigula, M.D., joins UofL and Kosair Children’s Hospital staff
                            UofL adds cardiothoracic surgeon from Boston

                            Frank A. Pigula, M.D.

                            A nationally and internationally recognized expert in complex congenital heart disease has joined the faculty of the University of Louisville School of Medicine Department of Cardiovascular and Thoracic Surgery. Frank A. Pigula, M.D., comes to Louisville from Boston where he was the clinical director of the pediatric cardiac surgery program at the Children’s Hospital of Boston, rated number one in cardiology and heart surgery by U.S. News & World Report. Pigula also was an associate professor of surgery at Harvard University School of Medicine.

                            Pigula will perform both clinical and laboratory research at UofL. He has ongoing clinical studies to document neurodevelopmental outcomes in neonates using a technique he developed in Boston to reduce circulatory arrest times in an effort to reduce bypass-related neurologic injury. He also is conducting laboratory research on protecting the brain from bypass‑related brain injury during surgery.

                            “We are extremely pleased to bring a world-class clinician and researcher such as Dr. Pigula to UofL. He will be a tremendous asset in training the next generation of physicians in cutting edge cardiovascular and thoracic surgery,” said Mark S. Slaughter, M.D., chair of UofL’s Department of Cardiovascular and Thoracic Surgery.

                            Pigula also will practice with University of Louisville Physicians and will serve as chief of the Division of Pediatric Cardiac Surgery at Kosair Children’s Hospital. He is expected to begin seeing patients next month. He joins Erle H. Austin, III, M.D., who has been chief of cardiovascular surgery at the hospital for 26 years and will now focus on direct patient care, and Deborah J. Kozik, D.O.; both practice with ULP-Cardiovascular and Thoracic Surgery. Pigula and Christopher Johnsrude, M.D., chief of the Division of Pediatric Cardiology at UofL, will serve as co-directors of the Kosair Children’s Hospital Heart Center.

                            “Kosair Children’s Hospital is dedicated to ensuring children needing complex care for heart issues do not need to leave Kentucky,” said Thomas D. Kmetz, Norton Healthcare division president, Women’s and Children’s Services and Kosair Children’s Hospital. “With Dr. Pigula’s leadership, we expect to see the care we can provide to children with heart issues continue to grow.”

                            Pigula earned his medical degree from the University of Vermont College of Medicine and completed his residency in general surgery and surgery research fellowship at Medical Center Hospital, College of Vermont and UVM College of Medicine. He completed a residency in cardiothoracic surgery at the University of Pittsburgh and a fellowship in congenital cardiovascular surgery at the Children’s Hospital of Boston.

                            At the Children’s Hospital of Boston, Pigula served as the clinical director of the pediatric cardiac surgery program since 2004, the director of the neonatal surgical program since 2010, and surgical director of the pediatric cardiac neurodevelopmental program since 2007 before moving to Louisville. He is a member of the American Association for Thoracic Surgery Scholarship Committee and Education Committee.

                            Pigula is widely published and is a nationally and internationally recognized expert in complex congenital heart disease. He is on the editorial board of Pediatric Cardiology, Journal of Thoracic and Cardiovascular Surgery, and Case Reports in Medicine, and is an ad hoc reviewer of The Annals of Thoracic Surgery, Pediatrics, The Journal of Heart and Lung Transplantation, Circulation and Journal of the American College of Cardiology.

                            UofL family and geriatric medicine chair named to U.S. Preventive Services Task Force

                            Diane Harper joins panel charged with making national recommendations on clinical preventive services
                            UofL family and geriatric medicine chair named to U.S. Preventive Services Task Force

                            Diane Harper, M.D.

                            University of Louisville’s Rowntree Professor and Endowed Chair of Family and Geriatric Medicine, Diane Medved Harper, M.D., has beenappointed to the U.S. Preventive Services Task Force, an appointed panel that issues evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications.

                            Harper is one of four new members to the 16-member task force. Other new members are: John W. Epling, Jr., M.D., State University of New York Upstate Medical University.; C. Seth. Landefeld, M.D., University of Alabama at Birmingham; and Carol M. Mangione, M.D., University of California, Los Angeles.

                            The task force is an independent, volunteer panel of national experts in prevention and evidence-based medicine. Members come from throughout health-related fields, including internal medicine, family medicine, pediatrics, behavioral health, obstetrics/gynecology and nursing. Members are appointed to serve four-year terms by the director of the Agency for Healthcare Research and Quality, a part of the U.S. Department of Health and Human Services.

                            “The University of Louisville is proud to congratulate Dr. Harper on this prestigious new appointment,” Toni Ganzel, M.D., dean of the UofL School of Medicine, said. “We are confident that her experience in family medicine and obstetrics and gynecology and her dedication to prevention and evidence-based medicine will serve the task force, health care professionals, patients and the nation well.”

                            In addition to holding an endowed professorship and chair, Harper also serves as a professor of obstetrics and gynecology in the Department of Obstetrics, Gynecology and Women’s Health; a professor of bioengineering at the Speed School of Engineering; and a professor of epidemiology and population health and of health promotion and behavioral health sciences in the School of Public Health and Information Sciences. Her expertise and primary research focus is prevention, diagnosis and treatment of diseases related to human papillomavirus.

                            “On behalf of my fellow Task Force members, I am pleased to welcome Dr. Harper to the Task Force,” said Task Force Chair Albert Siu, M.D., of the Icahn School of Medicine at Mount Sinai Hospital. “Her expertise in the areas of medical education, preventive medicine and obstetrics and gynecology will be an important addition to the Task Force.”

                            “We congratulate Dr. Harper on her appointment to the Task Force,” said Ruth W. Brinkley, president and CEO of KentuckyOne Health, the largest health system in Kentucky and partner in care with the UofL School of Medicine. “It’s an honor for the Commonwealth of Kentucky to be represented on the national level by Dr. Harper. We know her experience will bring significant value to shape health and wellness across the United States.”

                            UofL cancer researcher honored by president of Poland

                            Faculty member who discovered embryonic-like stem cells in adult bone marrow receives Gold Cross of Merit
                            UofL cancer researcher honored by president of Poland

                            Mariusz Z. Ratajczak, M.D., Ph.D., D.Sci., received the Gold Cross of Merit from the president of Poland on January 22, 2016 in Warsaw.

                            Mariusz Z. Ratajczak, M.D., Ph.D., D.Sci., was presented with a Gold Cross of Merit by the president of Poland, Andrzej Duda, on January 22 in Warsaw. Ratajczak, a professor in the University of Louisville Department of Medicine, was recognized for his work in stem cell research and transplantation.

                            Ratajczak, a native of Poland, received the award at a ceremony marking the opening of National Transplantation Congress in commemoration of the 50th anniversary of the first kidney transplant in Poland and the 30th anniversary of the country’s first bone marrow transplant. The Cross of Merit is a civil state award presented by the government of Poland to citizens who have gone beyond the call of duty in their work for the country and society as a whole. The award was established in 1923 to recognize services to the state and has three grades:  gold, silver and bronze.

                            Ratajczak is an internationally known specialist in the field of adult stem cell biology and is director of the Stem Cell Program at UofL’s James Graham Brown Cancer Center, a part of KentuckyOne Health. His 2005 discovery of embryonic-like stem cells in adult bone marrow tissues has the potential to revolutionize the field of regenerative medicine. These very small embryonic-like cells (VSELs) may lead to new treatments for cancer, heart disease, eye disease, diabetes and neurodegenerative disorders.

                            “My work would not be possible without the longstanding support of Donald Miller, M.D., Ph.D., director of the Brown Cancer Center, to my program,” Ratajczak said. “I also consider the award as recognition to my team of collaborators:  Magda Kucia, Ph.D., D.Sci., Janina Ratajczak, M.D., Ph.D., D.Sci., Malwina Suszynska, Ph.D., and Gabriela Schneider, Ph.D., who are working with me to employ VSELs in regenerative medicine.”

                            Recently, Ratajczak’s research team has developed a promising strategy to expand VSELs, opening a door for using the cells in regenerative medicine as a promising alternative to other stem cells.

                            Ratajczak also is known for his work on novel mechanisms of mobilization and homing of stem cells, the biological role of extracellular microvesicles and molecular mechanisms of cancer metastasis. His work is supported by two R01 grants. He holds the Stella and Henry Hoenig Endowed Chair in Cancer Biology.


                            Jan. 28, 2016

                            James Graham Brown Cancer Center first in Kentucky to offer one-day treatment for early-stage breast cancer

                            Intraoperative radiation therapy targets cancer cells, spares healthy tissue
                            James Graham Brown Cancer Center first in Kentucky to offer one-day treatment for early-stage breast cancer

                            Early-stage breast cancer patients now have a new one-day breast cancer treatment option at the University of Louisville’s James Graham Brown Cancer Center, a part of KentuckyOne Health. The cancer center is the first in Kentucky to offer this new technology.

                            Patients who meet specific selection criteria are able to be treated with intraoperative radiation therapy (IORT), a one-day breast cancer treatment option that offers multiple patient benefits, including added convenience, fewer treatments and reduced costs.

                            IORT allows radiation oncologists and breast cancer surgeons to work together to deliver a full, concentrated dose of radiation in one day at the time of lumpectomy, targeting cancer cells and sparing healthy tissue, such as the heart, lungs and ribs. This compares to traditional breast cancer treatment, which involves daily radiation five days per week, for six to eight weeks. With IORT, radiation is delivered from inside the breast rather than externally, as is done during external beam radiation therapy (EBRT).

                            “As one of America’s finest cancer treatment and research institutions, our goal is not just to fight cancer, but to win,” said Donald Miller, M.D., Ph.D., director of the James Graham Brown Cancer Center. “The more advanced technology and research available to our multidisciplinary care teams, the more tools we have at our disposal to save lives. IORT is an exciting advancement in breast cancer care.”

                            “Two major studies have shown IORT is effective, but with fewer side effects than traditional radiation, making it a viable treatment option for appropriate patients,” said Anthony Dragan, M.D., radiation oncologist with UofL Physicians and the James Graham Brown Cancer Center. “In addition to fewer side effects, IORT can also help improve access to care. Some women, such as those who live in more rural areas, women who are in the workforce and women who are caretakers for their families, find it difficult to finish a course of traditional treatment that requires multiple visits.

                            “Since IORT requires only one dose of radiation, patients are able to return to their normal life within days rather than weeks, a huge improvement over traditional radiation treatment.”

                            The technology used is the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®, which is FDA cleared for the treatment of cancer anywhere in the body, including early-stage breast cancer, gynecological cancers and non-melanoma skin cancer.

                            The Xoft System uses a proprietary miniaturized x-ray source, which is inserted into a flexible balloon-shaped applicator, then temporarily placed inside the lumpectomy cavity. A full course of radiation is then administered in a single dose, lasting as little as eight minutes, which directly targets cancer cells.

                            “IORT gives patients with early stage breast cancer an integrated surgical and radiotherapy option, in just one treatment, with the hope for the same outcomes (resulting from treatments currently in use),” said Nicolas Ajkay, M.D., surgical oncologist with UofL Physicians and the James Graham Brown Cancer Center. “Our multidisciplinary team approach leads to constant collaboration among physicians to find the right treatment plan for each patient. IORT furthers our ability to do so in new and exciting ways.”

                            A growing body of favorable clinical data supports the use of IORT in candidates meeting specific selection criteria. iCAD, the maker of Xoft, is currently conducting one of the largest IORT clinical studies to date using the Xoft System, which compares Xoft IORT to traditional external beam radiation therapy. To date, more than 2,000 patients have been treated with Xoft IORT.

                            For more information about IORT at the James Graham Brown Cancer Center, visit or call 502-562-HOPE(4673).

                            Bullitt County invited to ‘Think Pink’ Oct. 18

                            Bullitt County invited to ‘Think Pink’ Oct. 18

                            Shepherdsville and Bullitt County, Ky., are invited to “Think Pink” for breast cancer awareness at an event featuring the stories of three breast cancer survivors and recognition of everyone who has battled the disease.

                            “Think Pink: An Evening to Educate and Celebrate” will be held Tuesday, Oct. 18, from 5 to 7:30 p.m. at the Paroquet Springs Conference Centre, 395 Paroquet Springs Drive, Shepherdsville. Admission is free.

                            Emcee Bryan Shaw of WHAS11-TV will introduce three survivors who will share their individual journeys and accomplishments since being diagnosed: Lara McGregor, Mary Lee Edwards and Alana Auslander Price, all of Louisville.

                            Both McGregor and Edwards became activists as a result of their experience with breast cancer. McGregor is founder of Hope Scarves, a non-profit organization based in Louisville that raises funds for research and provides scarves to patients with breast cancer as a way to show support. Edwards is an instructor of LIVESTRONG classes at the Louisville YMCA. LIVESTRONG is a non-profit organization, based in Austin, Texas, that provides services, raises funds and advocates for patients and families.

                            Participants at “Think Pink” are invited to wear pink to show support for survivors and in recognition of October as Breast Cancer Awareness Month. Only 200 seats are available for the event so reservations in advance are required by calling 502-955-5355.

                            Breast cancer continues to plague the United States: One in eight American women will be diagnosed with breast cancer in her lifetime.

                            Great strides in fighting the disease have been made, however. In 1980, the five-year relative survival rate for women diagnosed with early stage breast cancer -- cancer confined to the breast -- was 74 percent. Today, that number is 99 percent.

                            “Think Pink” is sponsored by the Kentucky Cancer Program at the University of Louisville, Bullitt County Health Department and Bullitt County Cooperative Extension Service.

                            For information, contact Pam Temple-Jennings of the Kentucky Cancer Program, 502-852-6318,






                            ‘Spike It to Cancer’ sand volleyball event benefits cancer center at UofL, June 7

                            ‘Spike It to Cancer’ sand volleyball event benefits cancer center at UofL, June 7

                            Benefactors of a fund to support patients at the James Graham Brown Cancer Center at the University of Louisville are sponsoring their second annual sand volleyball event to raise money for the fund.

                            In 2013, Alex and Tommy Gift established the Mary Jane Gift Quality of Life Fund at the cancer center in honor of their late mother. The fund helps patients and their families enjoy life while facing a cancer diagnosis.

                            To benefit the fund, the Gifts are sponsoring The Second Annual Spike It to Cancer Sand Volleyball Tournament at Baxter Jack’s sand volleyball complex, 427 Baxter Ave. on Saturday, June 7. Registration will be held from 1-2:30 p.m., and games will begin at 3 p.m.

                            Admission is $20 per person. Payment by cash or check will be accepted at the door, or participants can pay by credit card at the cancer center’s secure online link.

                            “All proceeds from this event go to the Mary Jane Gift Quality of Life Fund that pays for extras provided to our patients and caregivers,” Michael Neumann, executive director of development, said. “Additionally, The Brewery on Baxter Avenue directly across the street from Baxter Jack’s has agreed to donate a portion of all food and beverage sales to us during the event.

                            “These gifts go a long way in bringing cheer to our patients and their families. For example, the fund provided Thanksgiving turkeys to many of our patients and their families last November. Also, one of our physicians, Dr. Cesar Rodriguez, used funds raised by the 2013 Spike It to Cancer to give picnic baskets to 26 patients on Easter morning.”

                            For additional details, contact Neumann at 502-562-4642.


                            Preclinical research shows promise in eliminating cataract surgery after vitrectomy

                            Preclinical research shows promise in eliminating cataract surgery after vitrectomy

                            Promising early preclinical research currently underway at the University of Louisville could lead to the elimination of a second surgery now commonly needed after retinal surgery.

                            Shlomit Schaal, M.D., Ph.D., associate professor, Department of Ophthalmology and Visual Sciences, and director of Retina, the Retina Fellowship Program in Vitreo-Retinal Diseases and Surgery and the Diabetic Retinopathy Service, Kentucky Lions Eye Center, is working with Martin O’Toole, Ph.D., assistant professor, Department of Bioengineering, on the project which is funded by the Coulter Translational Research Partnership at UofL.

                            The two are studying a new way for patients undergoing retinal surgery – known as “vitrectomy” – to avoid the need to have subsequent surgery to remove cataracts that develop. During vitrectomy surgery, vitreous gel is removed from the eye; it is this gel that protects the natural crystalline lens from damage caused by free radicals of oxygen.

                            With the gel loss during surgery, free radicals are diffused onto the lens and cause cataracts, and almost all patients undergoing vitrectomy surgery then are forced to undergo a second surgery to remove the cataracts.

                            Schaal and O’Toole have developed an artificial gel that is biocompatible to the vitreous gel present in the eye. Using animal models, Schaal has successfully used the biocompatible gel to create an oxygen barrier next to the lens during retinal vitrectomy surgery.

                            “The biocompatible gel appears to be working as well as the eye’s natural vitreous gel in blocking oxygen damage to the natural lens,” Schaal said.

                            The team hopes to be able to move the research into clinical trials within the next year. “The funding we’ve received from the UofL-Coulter Partnership has been invaluable in enabling us to prove our concept thus far,” Schaal said. “We are excited at the prospect of one day being able to help patients avoid the burden of cataract surgery after retinal surgery.”

                            The five-year, $5 million Coulter Translational Research Partnership in Bioengineering grant awarded in 2011 to UofL fosters the translation of research through successful collaboration between engineers and clinicians, supporting promising technologies.  The partnership funds promising projects in order to move innovative technologies to clinical application with the ultimate goal of accelerating the introduction of new technologies to improve the treatment and diagnosis of disease or reduce health care costs.

                            UofL launches study in quest to decrease hospital readmission of heart failure patients

                            UofL launches study in quest to decrease hospital readmission of heart failure patients

                            Saeed Jortani, Ph.D.

                            Researchers at the University of Louisville are launching a clinical research study to develop an objective approach to discharge patients with heart failure from the hospital with the goal of decreasing their possible readmission.

                            Saeed A. Jortani, Ph.D., clinical associate professor of pathology and laboratory medicine, will lead a team of investigators including cardiologists, emergency medicine physicians, nurses and clinical coordinators in the “Congestive Heart Failure Readmission (CHFR) Trial.” It is now open for enrollment.

                            The team’s goal is to enroll 600 patients with symptoms of congestive heart failure who are admitted to the emergency departments at two KentuckyOne Health hospitals, University of Louisville Hospital and Jewish Hospital. Blood samples will be collected from patients at the time they are admitted and again when they are discharged. These samples will be analyzed for a variety of cardiac and kidney biomarkers.

                            The patients then will be surveyed twice, at 30 days and 6 months after discharge, to learn if their condition required readmission to the hospital.

                            The team will use the data obtained from the blood samples to develop an evidence-based approach that could be used in determining the optimal timing for discharging patients with heart failure and ultimately prevent readmission.

                            “We believe that using an objective, clinically verified approach to discharging heart failure patients initially could reduce the need for future readmission,” Jortani said. “Our thinking is that patients’ biomarkers will indicate when they are ready for discharge from the hospital with hopefully less chance of being readmitted later on.”

                            According to the Centers for Disease Control and Prevention, heart failure affects about 5 million people in the United States, with 550,000 new patients diagnosed each year. Patients with heart failure also have a high incidence of other life-threatening diseases and conditions, such as renal failure, hypertension, diabetes and others.

                            Each year, more than 1 million people are admitted to an inpatient facility for heart failure, and 27 percent of patients with heart failure who are on Medicare are readmitted within 30 days.

                            New guidelines established by the Affordable Care Act limits put limits on readmitting patients within a 30-day time period for the same diagnosis.

                            “Finding the right ‘formula’ for discharge and reducing readmission rates will help us improve the ultimate health outcome for the patient as well as realize significant cost savings in the long run,” Jortani said.


                            About the CHFR Trial:

                            Principal investigator of the CHFR Trial is Saeed Jortani. The research team includes cardiologists Andrew DeFilippis, Shahab Ghafghazi and Jesse Adams; emergency medicine physicians George Bosse, Salvator Vicario and Tadd Roberts; nurses Ashlee Melendez, Kristen Young and Cynthia Lawrence; clinical coordinators Stanislava Prather, Anna Mains, Keivan Hosseinnegad and Louise Isaacs; and biostatistician Richard Baumgartner. Blood sample analysis will be conducted at the Kentucky Clinical Trials Laboratory. The study is funded in part by Roche Diagnostics USA. For information about the trial, contact 502-852-8835 or

                            How smart is the spinal cord? Andrea Behrman will explain at Beer with a Scientist Sept. 14

                            Discover how UofL researchers are training the spinal cord to help children recover from spinal cord injury
                            How smart is the spinal cord? Andrea Behrman will explain at Beer with a Scientist Sept. 14

                            Andrea Behrman, Ph.D.

                            Andrea Behrman, Ph.D., professor in the Department of Neurological Surgery at the University of Louisville, will discuss research and progress in helping children recover from spinal cord injuries at the next Beer with a Scientist. Her research using locomotor training represents a paradigm shift in helping children with spinal cord injury regain mobility below the level of the lesion. She designs therapies based on scientific evidence that the central nervous system changes through training, a process known as activity-dependent plasticity.

                            Behrman is director of the Kosair Charities Center for Pediatric NeuroRecovery and co-director of the Reeve Foundation NeuroRecovery Network.

                            The program begins at 8 p.m. on Wednesday, Sept. 14, at Against the Grain Brewery, 401 E. Main St. A 30-minute presentation will be followed by an informal Q&A session.

                            The Beer with a Scientist program began in 2014 and is the brainchild of UofL cancer researcher Levi Beverly, Ph.D. Once a month, the public is invited to enjoy exactly what the title promises:  beer and science. Follow the link to see a video about a recent Beer with a Scientist event with UofL professor John Pierce Wise, Ph.D.

                            Admission is free. Purchase of beer, other beverages or menu items is not required but is encouraged.

                            Organizers add that they also encourage Beer with a Scientist patrons to drink responsibly.

                            For more information and to suggest future Beer with a Scientist topics, follow Louisville Underground Science on Facebook.


                            NEXT BEER WITH A SCIENTIST, OCT. 12:   

                            As part of Research!Louisville, Beer with a Scientist founder, Levi Beverly, Ph.D., will present:  "The cutting-edge ways that researchers and clinicians are diagnosing and curing cancer right here in Louisville." Beverly will give a series of short presentations on some of the research and clinical trials happening right here in our own backyard.


                            September 6, 2016

                            UofL’s Envirome Institute creates Louisville Data Commons to support community health research

                            Researchers and citizen scientists will be able to access and contribute verified environment data through new portal
                            UofL’s Envirome Institute creates Louisville Data Commons to support community health research

                            Circle of Harmony and Health

                            An important mission of the Christina Lee Brown Envirome Institute at the University of Louisville is to encourage citizens to participate in research to understand and improve the health of our community. A new online data resource hosted by the Envirome Institute will allow citizen scientists and researchers to access and contribute to public knowledge about the health of the air, water and soil in Greater Louisville.

                            Louisville Data Commons is a new online data repository available to anyone interested in the state of our local environment or involved in citizen science or related data-gathering projects.

                            “For many years, we have been fortunate to have a strong Metro Government open data portal, a resource for sharing data gathered by the city. However, there is not a place to store and review data gathered by citizens that could ultimately help us gain a better understanding of our city,” said Ted Smith, Ph.D., director of the Center for Healthy Air, Water and Soil of the UofL Envirome Institute.

                            “The growth of citizen science and the excitement around low-cost sensors has highlighted the great need to have a place where information gathered by our community, in our community, about our community can be made available to our whole community and governed by our community,” Smith said.

                            To provide credibility for the data, Louisville Data Commons is hosted by the Envirome Institute and governed by a volunteer board of community members. These community members will ensure the data sets maintained on the site are reliable, objective and useful to researchers. Members of the volunteer board will review data submitted by the public or non-profit organizations prior to making it available within the portal.

                            An example of the need for objective third-party validation of data is the recently released odor-reporting app, “Smell My City.” Members of the community expressed concern whether the data could be altered and sought assurance that the data was protected. Louisville Data Commons now archives reports from Smell My City that has been validated by a public process and maintained for future research by anyone using the portal.

                            Other sources of data will include information gathered by Brightside and Internet of Things sensors, as well as local environmental information provided by the federal government. As more residents discover new things to measure and share in the future, additional data can be held and shared on this portal.

                            "Louisville Data Commons is a great example of educational institutions, community partners and Louisville Metro Government working together to create a new tool to help local innovators change lives for the better,” said Louisville Mayor Greg Fischer. “That's the type of collaboration and focus on big ideas that we need as we work to become a city where everyone has the opportunity to reach their full potential."

                            Data may be uploaded to by individuals, citizen scientists or non-profit organizations and may include information related to sensor projects, air or water quality, weather, odors, noise or other community health characteristics. Other data related to the city of Louisville also may be approved. The data is reviewed by at least two members of the Louisville Data Commons committee prior to being published to ensure validity and appropriateness.

                            The current Louisville Data Commons committee includes Smith, Grace Simrall, chief of civic innovation and technology for Louisville Metro Government, Aaron Drake, a technology consultant, and Nur Ozgener, a Brightside board member.

                            "Louisville Metro Government is proud to be a part of the Louisville Data Commons. We are focused on using innovation to address the challenges residents face each day and on expanding access to the digital tools and skills of the future,” Simrall said. “As we work toward these goals, the community needs access to data and good partners.”

                            The Louisville Data Commons portal uses open source data portal platform CKAN. 

                            New method developed at UofL enables more extensive preclinical testing of heart drugs and therapies

                            Researchers extend life of heart segments from 24 hours to six days. Process allows better testing for efficacy and toxicity and saves money and time.
                            New method developed at UofL enables more extensive preclinical testing of heart drugs and therapies

                            Tamer Mohamed, Ph.D., Qinghui Ou, B.Sc., and Riham Abouleisa, Ph.D.

                            Researchers at the University of Louisville have developed an easily reproducible system that enables them to keep slices of human hearts alive for a longer period of time, allowing more extensive testing of new drugs and gene therapies.This new biomimetic culture system mimics the environment of a living organ through continuous electrical stimulation and oxygenation, maintaining viability and functionality of the heart segments for six days. Previous culture systems maintained functional heart slices for no more than 24 hours. The extended viability time will enable improved preclinical testing of new drugs for effectiveness and toxicity.

                            “This new method maintains fully functional human heart slices for six days in the culture environment. This facilitates testing efficacy of heart failure therapeutics and cardiotoxins on human heart tissue with no need for a living human,” said Tamer M. A. Mohamed, Ph.D., who led the research.

                            The system provides access to the complete 3D multicellular system that reflects the heart’s functional and structural condition in a living person.

                            “This system will save time and costs of clinical trials during phase one research, which includes testing for toxicity and proof of efficacy,” Mohamed said. “In addition to drugs, we have demonstrated the system’s effectiveness in testing gene therapy.”

                            The optimized medium for sustaining the heart tissue slices is described in an article published online last week in Circulation Research, a publication of the American Heart Association. It will appear in the August 30, 2019, print and online issue. Along with Mohamed, the research was conducted by Qinghui Ou, B.Sc., Riham R.E. Abouleisa, Ph.D., and others at UofL, along with colleagues in California, Colorado, the United Kingdom, Germany and Egypt. UofL has a provisional patent application on this technology.



                            July 25, 2019

                            UofL ends negotiations over KentuckyOne assets

                            Risk to university would be too great

                            The University of Louisville has notified Catholic Health Initiatives and its affiliate, KentuckyOne Health, that it is ending negotiations to purchase KOH’s Louisville assets, which include Jewish Hospital where the university has several service lines and its physicians treat patients and teach medical residents.

                            Talks were halted because UofL could not find a suitable partner to help fund the acquisition. UofL officials were not willing to put the university at financial risk by taking on the acquisition alone.

                            “We regret ending our talks with CHI, but we must do what is fiscally responsible for the University of Louisville,” said UofL President Neeli Bendapudi. “Without a viable partner, we do not have the resources necessary to make the acquisition a reality.”

                            “KentuckyOne Health is disappointed that the university was not able to secure a financial partner,” said Deborah Lee-Eddie, interim market CEO for KentuckyOne Health. “We will now continue our discussions with other interested organizations.”

                            UofL and CHI have agreed to several steps as the two parties work on the changes in their relationship.

                            CHI will extend the Academic Affiliation Agreement to ensure that undergraduate and graduate/resident medical education programs continue at Jewish Hospital and Frazier Rehab Institute. If programs cannot be continued at those facilities, CHI will assign those residencies to another facility requested by the university.

                            The AAA is an agreement that provides conditions under which the university’s physicians and medical residents provide care for patients, serve in leadership roles for various hospital programs and services and conduct clinical trials that offer innovative treatments unavailable anywhere else in the region.

                            CHI also has agreed to continue the current professional services, medical directorships and similar provisions included in the Master Services Agreement while it and UofL discuss transition planning. CHI will provide at least 90 days notice before terminating any of those individual agreements.

                            “Our patients will continue to receive the highest quality care, and our students and residents will continue to receive the education and training they must have to become future providers,” Bendapudi said. “That is our unwavering commitment.”

                            KentuckyOne’s local properties also include Our Lady of Peace, Sts. Mary & Elizabeth Hospital, Jewish Hospital Medical Centers East, South, Southwest and Northeast, Jewish Hospital Shelbyville and the KentuckyOne Health Medical Group.

                            UofL and CHI have negotiated in good faith on the purchase of the portfolio only since December 2018.

                            Services provided by UofL physicians at Jewish Hospital include organ transplantation, cardiovascular medicine and neurological surgery. The hospital is home to the only solid organ transplant facility in the region, and UofL’s renowned clinical care and research in cardiovascular medicine and spinal cord injury are conducted at Jewish and Frazier Rehab.

                            Bendapudi applauded all those who tried to make a deal for the KentuckyOne assets a reality.

                            “Everyone involved in these talks put dedication and hard work into them, and I thank them all,” she said. “This endeavor did not fail for lack of effort on the part of either party.”

                            In her own words: UofL President Neeli Bendapudi, Ph.D., provides more information on ending the negotiations here. 

                            Hope Scarves gift will provide patients with metastatic breast cancer access to more clinical trials at JGBCC

                            Hope Scarves gift will provide patients with metastatic breast cancer access to more clinical trials at JGBCC

                            UofL James Graham Brown Cancer Center

                            For women undergoing treatment for cancer, a little encouragement can mean the world.

                            Lara MacGregor, who lives with metastatic breast cancer, started Hope Scarves in 2012 to provide women undergoing cancer treatment a way to encourage one another by sharing a scarf and a story. In 2015, Hope Scarves established a Metastatic Breast Cancer Research Fund to raise funds to support research and patient care.

                            For 2019, Hope Scarves has provided a gift of $25,000 to the University of Louisville James Graham Brown Cancer Center, with an anonymous match of $25,000 for a total gift of $50,000. The funds are designated to bringing more clinical trials for metastatic breast cancer patients to Louisville.

                            Kentucky has one of the highest rates of breast cancer in the United States, and Jefferson County has one of the highest rates in Kentucky. Participation in clinical trials is one way to improve outcomes, not only for the patients who participate, but by bringing more and better treatments to market for all patients.

                            “Participation in clinical trials benefits not only the patients involved in the trial, but the field of cancer treatment in general,” said Beth Riley, M.D., deputy director for clinical affairs at UofL’s Brown Cancer Center. “Currently, metastatic breast cancer is not curable with standard treatment. By participating in trials, patients in Kentucky not only have early access to novel drugs or drug combinations, but they are helping physicians and scientists learn more about effective treatments and disease characteristics so we can move closer to a cure for this disease. Clinical trials involvement is vital to improve the lives of cancer patients here in Kentucky and worldwide.” 

                            One patient who benefitted from treatment in a clinical trial at the center is Brenda Craig, a Louisville native who was diagnosed with breast cancer in 2013. After several years in remission, her cancer returned; this time it was stage 4 and more challenging to treat.

                            “The treatments I was getting were not making me feel good and were not doing anything for my cancer,” Craig said. “When my doctor said, ‘Would you like to try the clinical trial?’ I wanted to live, so I said, ‘Yea! Sure, I’d try it.’”

                            Her condition improved while she was on the trial treatment, nearly bringing her to remission again. Unfortunately, she had to stop the trial drug when she came down with pneumonia. Nevertheless, she is grateful to have had the opportunity.

                            “The clinical trial brought me a long way. I was on it 8-10 months and I was doing great,” Craig said. She now is on another treatment, but her cancer has remained stable.

                            Craig said one of her most important missions on her cancer journey is to support others with the disease, a mission shared by Hope Scarves.

                            “We are human. We cry and we tell our stories to each other. My story helps you and your story helps someone else. We keep it going,” Craig said. “Even if I don’t make it, I hope I can be an example for someone else, that whatever they did for me, it can help someone else.”

                            MacGregor, a Louisville resident, has seen clinical trials benefit patients at the UofL Brown Cancer Center, and her own treatment includes a drug tested at the center. She wants Hope Scarves’ funds to invigorate that process.

                            “There is a huge burden to participate in clinical trials that are only available in another city. You have transportation and lodging to consider, and you are away from your home support system – your family and friends – who truly make a difference when you are fighting this disease,” MacGregor said.

                            By making more trials available in Louisville, not only local women benefit, but also future patients by allowing more people to participate in the trials, advancing medical research more quickly.

                            “Clinical trials are the future of cancer treatment, not a last resort,” MacGregor said. “These therapies are the next generation of care and may give patients better outcomes, and we are providing these funds to enable more women to have access to them.”

                            Runners in the Kentucky Derby Festival Marathon and Mini Marathon have raised funds for Hope Scarves as a team, Outrunning Cancer, for the past seven years. In 2015, Hope Scarves presented its first gift to the UofL Brown Cancer Center to support basic research. This year, in addition to UofL, Hope Scarves is providing funds for basic cancer research to Johns Hopkins Medical Center and the Dana-Farber Cancer Center at Harvard University.

                            “It is our intentional strategy to fund both basic science and patient access to care,” MacGregor said.



                            June 3, 2019

                            UofL researchers propose new concept on how brain interprets visual information

                            UofL researchers propose new concept on how brain interprets visual information

                            Martha Bickford, Ph.D.

                            One of the many functions of the brain is to collect and process visual information so that people know how to respond to the movement of objects around them. A study published in July in The Journal of Neuroscience by researchers at the University of Louisville provides a new concept for how the brain functions to achieve this.

                            “Looking at the visual pathways of the brain, it had been thought that the thalamus primarily filtered visual signals that it received from the retina,” said Martha Bickford, Ph.D., professor of anatomical biology sciences and neurobiology at the UofL. “We found that the thalamus plays a bigger role in that it actually may help to sort and interpret visual information so that the brain can accurately gauge the movement of surrounding objects”

                            Examining the visual pathways of mice, Bickford and her colleagues, including William Guido, Ph.D., chair of anatomical sciences and neurobiology at UofL, found that the dorsal lateral geniculate nucleus (dLGN), a part of thalamus, not only serves as a filter of information, but may change the information in such a way that it helps us account for our own eye or body movements when tracking the movement of objects around us.

                            “It is very exciting to uncover this expanded role for the dLGN,” Bickford said. “We now have a new avenue to explore the relationships between sensory and motor pathways of the brain. Continued study of these relationships may help us to understand sensory deficits that occur in conditions such as Parkinson’s Disease, other movement disorders and spatial and visual attention disorders.”


                            July 21, 2015

                            Better Breathers Club to discuss nutrition, lung disease

                            Monthly support group offers information for people with chronic lung conditions
                            Better Breathers Club to discuss nutrition, lung disease

                            “Nutrition and Lung Disease” will be the topic when the University of Louisville Better Breathers Club next meets from 2-4 p.m., Thursday, July 9. The free support group is open to the public and meets in room 120 of the UofL Physicians Outpatient Center, 401 E. Chestnut St.

                            Metered parking is available on East Chestnut and parking for a fee is available in the Chestnut Street Garage at 414 E. Chestnut Street, directly across the street from the outpatient center.

                            Participants will discuss the role diet plays in management of lung diseases such as chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis, chronic bronchitis and others. UofL staff will be on hand to answer questions and provide information.

                            Better Breathers Clubs are an initiative of the American Lung Association, giving people with lung disease, their caregivers and loved ones support, education and information. At UofL, the Better Breathers Club is sponsored by the American Lung Association, UofL Physicians-Pulmonology and the UofL School of Medicine.

                            For information, contact the UofL Better Breathers Club at 502-852-1917.


                            UofL lab helps discover new disease that causes kidney failure

                            UofL lab helps discover new disease that causes kidney failure

                            Jon B. Klein, M.D., Ph.D., UofL School of Medicine vice dean for research and professor of medicine, and James Graham Brown Foundation Chair in Proteomics.

                             Researchers at the University of Louisville were part of a group that discovered an insidious new autoimmune disease that causes kidney failure.

                            The discovery of anti-brush border antibody (ABBA) disease was made in the UofL Core Proteomics Laboratory, led by Director Jon B. Klein, M.D., Ph.D., UofL School of Medicine vice dean for research and professor of medicine, and James Graham Brown Foundation Chair in Proteomics. Klein worked with the laboratory’s Co-Director Michael Merchant, Ph.D., associate professor in the Division of Nephrology & Hypertension in the Department of Medicine at UofL.

                            Klein and co-investigators will present their findings Friday, Nov. 3, at the American Society of Nephrology’s annual meeting in New Orleans.

                            “It’s the first time in my career that I’ve described a new disease, and truthfully, most people in their career don’t stumble on this,” said Klein, who is internationally recognized for his expertise in biomarker discovery related to kidney disease and practices with UofL Physicians-Kidney Disease Program. “We don’t know yet whether this causes kidney failure in a lot of people. It’s early in the story.”

                            The UofL lab identified ABBA after analyzing biopsied kidney tissue from 10 patients who had developed acute kidney injury, a sudden episode of kidney failure or damage that happens within a few hours or days. The condition causes a build-up of waste products in the blood and makes it difficult for kidneys to maintain adequate balance of fluid in the body.

                            For the first time, researchers discovered that in the nephrons, the functional units of the kidneys, antibodies had coated a specialized part of cells called brush borders, which help reabsorb and process proteins.

                            “The disease is rather insidious,” Klein said. “It was documented in a group of older men who simply turned up with abnormal kidney function, and there were no symptoms until they had very advanced kidney failure.”

                            Since it is an autoimmune disease, different approaches to suppress the immune system were used to treat the patients, but those efforts were unsuccessful, Klein said.

                            Further research will focus on defining demographics of patients with ABBA and the disease’s prevalence. Also, determining where on the protein megalin – which acts as a sponge to absorb proteins and other compounds that enter the nephron – the antibody binds is key to treating the disease, Klein said.

                            It’s unknown what stimulates the antibody formation.

                            “Antibodies have very specific targets; they bind to only certain proteins in autoimmune kidney diseases, and then to only certain portions of that protein,” Klein said. “That’s where you learn how to begin to block the antibody binding.”

                            Klein said the disease had gone undetected because most people with abrupt kidney failure recover and do not get biopsies. In cases of ABBA, however, kidneys do not improve.

                            Lead investigators of the study are Laurence H. Beck, M.D., Ph.D., of Boston University School of Medicine, and Christopher P. Larsen, M.D., a nephropathologist at Arkana Laboratories in Little Rock, Ark.

                            Co-investigators include: Klein, Merchant, and Daniel W. Wilkey of UofL; Claire Trivin-Avillach, Paige Coles, Hong Ma and David J. Salant of Boston University School of Medicine; A. Bernard Collins, Ivy A. Rosales and Robert B. Colvin of Massachusetts General Hospital and Harvard Medical School; Josephine M. Ambruzs, Nidia C. Messias, L. Nicholas Cossey and Patrick D. Walker of Arkana Laboratories; and Thomas Wooldridge of Nephrology and Hypertension Associates in Tupelo, Miss.