In this issue: TRI leaders cast vision for next five years, await score on recently submitted NIH CTSA application; pioneering brain imaging research on juvenile sex offenders; celebrating community partners; and a $25,000 research recruitment grant.

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Feb. 18, 2015 | The UAMS Translational Research Institute (TRI) recently received a $25,000 Chancellor’s Circle Award that will support a campaign to recruit research participants.

The award was one of 11 announced by UAMS Chancellor Dan Rahn, M.D., at a Feb. 6 ceremony at the Jackson T. Stephens Spine & Neurosciences Institute. It was presented by William E. Clark II, a long-time UAMS supporter who serves on the Foundation Fund Board as executive vice chair and as a member of the Chancellor’s Circle. The award was accepted by Cornelia Beck, Ph.D., R.N., associate director of TRI and co-principal investigator of the Clinical and Translational Science Award (CTSA), which supports the work of TRI. The CTSA is funded by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS).

“The NIH considers clinical trials the gold standard for assessing the effectiveness of new drugs, devices, diagnostic products, and treatments. Unfortunately, clinical trial recruitment is in crisis,” Rahn said when he announced the award. “Less than 5 percent of all eligible adult patients are enrolled in studies, which is contributing to delays in more than 90 percent of clinical trials.”

He said TRI is helping address this problem with many new communications efforts, including its plans for a new website that will provide lay language information about the benefits of participating in clinical research, demystify research for the general public, and ultimately increase participation in clinical research.

The Chancellor’s Circle received 55 funding priorities, and 11 grants were awarded totaling $325,000.

The Chancellor’s Circle was formed 31 years ago by the Foundation Fund Board to recognize donors who support programs across all areas of UAMS through annual unrestricted contributions. Chancellor’s Circle members provide about $350,000 annually in discretionary funds that allow UAMS to provide additional support of its missions of education, research and patient care.

NCATS has announced its intent to publish funding opportunities for Collaborative Innovation Awards through the Clinical and Translational Science Awards (CTSA) program. Read more at the following links:

NOT-TR-15-005: Notice of Intent to Publish a Funding Opportunity Announcement for Pre-Applications for Collaborative Innovation Award, CTSA Program (X02)

NOT-TR-15-006: Notice of Intent to Publish a Funding Opportunity Announcement for Collaborative Innovation Award, CTSA Program (U01)

Learn more about the CTSA program

Feb. 10, 2015 | A desire to grow as a clinical investigator led Konstantinos Arnaoutakis, M.D., to earn a UAMS certificate in clinical and translational science.

“The clinical research field is evolving, and no matter how good your training may have been, there are many things that need to be learned, refreshed and updated,” Arnaoutakis said. Cancer biology, biostatistics, grant writing and research courses have all been relevant and enjoyable, in addition to meeting other UAMS researchers, he said.

Established in 2007, the UAMS Graduate School’s Clinical and Translational Science (CTS) Track Program is helping ensure that biomedical advances are being translated into patient care by offering a certificate and advanced M.S. and Ph.D. degrees. The CTS also receives support from the Translational Research Institute (TRI).

Arnaoutakis, a UAMS hematologist/oncologist, was so enriched by the certificate program that he went on to pursue a master’s degree in clinical and translational science. Both programs are tailored to his specialty.

“The CTS is a key part of UAMS’ growth as a national translational research leader,” said Robert McGehee, Ph.D., Graduate School dean. “We expect participation in the CTS to accelerate in the years to come.”

McGeehe noted that the Graduate School worked very closely with Issam Makhoul, M.D., the chief of the College of Medicine Division of Hematology/Oncology and the residency fellowship director to develop a tailored graduate certificate for Hem/Onc fellows.

“Dr. Arnoutakis is a wonderful example of how we can all work together in helping with the transition of subspecialty fellows into successful junior faculty positions,” McGehee said. “Working with Dr. Beatrice Boateng and Dr. Suzanne Klimberg, we have also developed similar tailored graduate certificates for pediatric and surgical oncology fellows, respectively. We would also welcome the opportunity to work with other fellowship directors in developing additional tailored programs.”

Boateng is director of the Office of Education in the Department of Pediatrics and director of the Translational Research Institute’s Evaluation Program. Klimberg is the Muriel Balsam Kohn Chair in Breast Surgical Oncology at UAMS.

To date, there have been 41 certificate graduates, eight M.S. graduates, and seven Ph.D. graduates. In addition, 35 are enrolled in the certificate program, 10 in the M.S. program, and five in the Ph.D. program. The CTS track is designed for students holding an advanced degree in a biomedical or health sciences field (e.g., M.D., R.N., Pharm.D., M.P.H., D.P.H. or Ph.D.), but is also available to others having significant clinical research management or clinical experience. Students in the CTS track take coursework designed to build a strong foundation in clinical and translational sciences including biostatistics, epidemiology, data management and analysis, clinical research methodology, clinical trials design, drug development, responsible conduct of research, grant writing and scientific communications. Courses are offered in the colleges of Medicine, Nursing, Public Health, and Pharmacy.

The knowledge he gained helped Arnaoutakis develop a clinical protocol for a UAMS investigator-initiated lung cancer vaccine.

“This is a complex process, developing protocols that are scientifically valid and that adhere to numerous regulations,” he said. “It’s also a multi-group effort, and the complexity underscores the importance of the clinical and translational science certificate.”

Ultimately, he said, the program is helping improve science and health outcomes. “Our patients, researchers and government leaders all want faster results that translate to the patient,” Arnaoutakis said. “Programs like the clinical and translational science certificate are helping us develop smarter and more cost-effective trials that accomplish these goals.”

Researchers (left to right) Misty Stevens, Ph.D.; Brooks Gentry, M.D.; and Michael Owens, Ph.D., are working on drug therapies that can help meth users break their addictions.

January 29, 2015 | A University of Arkansas for Medical Sciences (UAMS) BioVentures startup company, InterveXion Therapeutics LLC, has received two federal grants totaling $14.5 million for development of drug therapies that can help methamphetamine drug abusers break their addiction.

The therapies are designed to reduce or prevent the euphoric rush that drug users crave by keeping methamphetamine in the bloodstream and out of the brain, where the drug exerts its most powerful effects.

The larger of the two grants, $9.55 million over three years, will support research that will determine whether a methamphetamine vaccine may be safely advanced into a clinical trial with human participants. The vaccine is a promising new strategy that could stimulate a patient’s own immune system to generate long-acting, protective anti‑methamphetamine antibodies.

The other grant of $5 million over three years will support production of the anti-methamphetamine monoclonal antibody that has been successfully tested in a first clinical study of healthy adults. The grant will also fund more research to show that the antibody is safe for methamphetamine users. The additional study will prepare researchers for the next clinical trial involving methamphetamine-using participants.

This antibody does not stimulate the immune system, but it selectively and quickly binds methamphetamine in the blood and prevents it from entering the brain and other tissues where it causes multiple health problems, including addiction. It would be the first medication that can reduce methamphetamine’s effects for prolonged periods of time.

The antibody has an immediate impact on the user and is effective for about a month. The vaccine takes several weeks to become effective, and it may blunt methamphetamine’s effects for nine months or longer.

Both grants are to InterveXion from the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA). UAMS is a sub-awardee.

“These grants represent NIDA’s commitment to addressing methamphetamine abuse with promising therapies such as the monoclonal antibody and vaccine,” said UAMS’ Mike Owens, Ph.D., who developed both the vaccine and the antibody and has received NIDA funding since the mid-1980s.

“Our team demonstrated the safety of the monoclonal antibody in a clinical trial completed last year, and we look forward to the next phases of research with both the antibody and the vaccine,” he said.

Owens is co-program director and co-principal investigator on the vaccine grant. He is a professor and director of the UAMS Center for Alcohol and Drug Abuse and InterveXion’s chief science officer.

W. Brooks Gentry, M.D., is co-program director and co-principal investigator on the monoclonal antibody grant. He is a professor and chair of the Department of Anesthesiology in the UAMS College of Medicine and InterveXion’s chief medical officer.

Misty Stevens, Ph.D., M.B.A., is operations director for InterveXion and is co-program director and co-principal investigator for both grants. Ralph Henry, Ph.D., is vice president for biopharmaceutics at InterveXion and a co-investigator on both grants.

Assuming the antibody and vaccine receive federal Food and Drug Administration (FDA) approval, they can be provided as an integral part of a methamphetamine user’s complete treatment program, which consists of counseling and possibly other medications to reduce craving.

“The two drug therapies may also be used together,” Stevens said. “The antibody could provide a patient with immediate protection while the patient is building immunity following administration of the vaccine.”

Neither the monoclonal antibody nor the vaccine should interact with other medications, nor should they impact brain function or interfere with psychiatric counseling. The vaccine would be less expensive than the antibody, but it is expected to be less effective for some people, especially those with compromised immune systems.

InterveXion is a pharmaceutical company whose mission is to discover and advance innovative medications that reduce the impact of human suffering on individuals and communities. Its vision is to be a leader in the development of antagonist therapies that neutralize toxins in the body and thereby improve patient health. InterveXion’s first medications are a monoclonal antibody and an active vaccine for treating methamphetamine abuse. For more information, contact info@intervexion.com.

UAMS is the state’s only comprehensive academic health center, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; a hospital; a northwest Arkansas regional campus; a statewide network of regional centers; and seven institutes: the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens Spine & Neurosciences Institute, the Myeloma Institute, the Harvey & Bernice Jones Eye Institute, the Psychiatric Research Institute, the Donald W. Reynolds Institute on Aging and the Translational Research Institute. It is the only adult Level 1 trauma center in the state. UAMS has 2,890 students and 782 medical residents. It is the state’s largest public employer with more than 10,000 employees, including about 1,000 physicians and other professionals who provide care to patients at UAMS, Arkansas Children’s Hospital, the VA Medical Center and UAMS regional centers throughout the state. Visit www.uams.edu or uams.wpengine.com.

Jan. 22, 2015 | Patricia Brady, R.N., B.S.N., C.C.R.P., recently received the 2014 Bonny Hope Wallace Award for her outstanding work with research participants at Arkansas Children’s Hospital.

The award was presented at a Jan. 16 ceremony by the UAMS Translational Research Institute’s Amy Jo Jenkins, M.S., C.C.R.P., C.C.R.C., C.C.R.A., a past recipient of the award.

Brady, who is also certified by the international Society of Clinical Research Associates, has worked in the Pediatric Clinical Research Unit for 10 years. She was chosen for the award by members of the Certified Research Specialist Program. Recipients must demonstrate dedication to the research participant; respect for the participant’s sacrifice; devotion to research integrity; commitment to mentoring; and enthusiasm for learning.

“Those who nominated Patricia shared that she ‘… consistently demonstrates through her day-to-day activities her awareness of and respect for the choice the subjects make by participating in research,’” Jenkins said. ‘“She is a passionate advocate for her subjects. Her commitment to research integrity is apparent in her communication with everyone involved in the research process, and she is a frequently-suggested resource when I am directing someone where to go for support. Her cheerful attitude and dedication to her career are worthy of admiration and recognition; we are all the richer for it.’”

The late Bonny Hope Wallace was an instructor in surgery and laboratory director for surgical research at the Department of Surgery at UAMS as well as clinical coordinator of research at the Arkansas Children’s Hospital Burn Unit. She was instrumental in pioneering ACH’s Burn Unit. Her efforts were focused on cutting-edge research to promote women’s health. Her accomplishments were many and her awards of recognition are numerous. Wallace was central to the day-to-day research activities of the UAMS Department of Surgery for over 30 years. She is remembered for her respectful treatment of research participants and her commitment to research integrity.

Brady’s work with research participants at ACH is shared by a group of 10 in the Arkansas Children’s Research Institute (ACRI) coordinator pool.

“I work with so many great people who easily deserve this award,” Brady said. “We have a great team, and we work together to make it happen.”

Other nominees for 2014 were David Avery, Lyndsey Avery, Susan Panozzo and Nathan Petty.

“It was a very close race,” Jenkins said. “Each nominee demonstrates dedication and respect for the work they do, and UAMS is greatly appreciative.”

Dec. 3, 2014 | The University of Arkansas for Medical Sciences’ (UAMS) Laura James, M.D., was announced today as an inaugural fellow of the Arkansas Research Alliance (ARA) during a news conference at the state Capitol.

The ARA Fellows program recognizes distinguished university research leaders who are already working in the state. ARA Fellows are nominated by their chancellor and receive a $75,000 grant paid over three years. James is a pediatrician, researcher and director of the UAMS Translational Research Institute.

“Dr. James is an outstanding clinician-scientist who has an exceptionally strong track record of conducting research that spans the translational spectrum from basic to clinical in the area of acetaminophen toxicity,” said UAMS Chancellor Dan Rahn, M.D. “She is a member of a vanishing breed of academicians— ‘triple-threat’ clinician-scientists who maintain excellence in the delivery of clinical care, the conduct of research, and the transfer of knowledge to the next generation of clinicians and researchers.”

James was among five inaugural ARA Fellows welcomed by Gov. Mike Beebe on Wednesday.

“Research is paramount to Arkansas’ future in the knowledge-driven economy of the 21st century,” Beebe said. “As we strive to create opportunities for high-paying, technology-based jobs, partners like ARA are critical and help our state concentrate our energy and resources on the most effective paths to further success and prosperity.”

Rahn noted that among James’ 96 peer reviewed publications are papers that range from describing cellular and molecular mechanisms of acetaminophen toxicity in liver cells to evaluation of acetaminophen-associated hepatic injury in children. He credited her ability to assemble a collaborative team of investigators focused on understanding an important clinical problem.

James_Rahn podium-400Chancellor Dan Rahn, M.D., who nominated Laura James, M.D. (center), for the ARA Fellow award, provided an overview of her research achievements and congratulated her for becoming UAMS’ first ARA Fellow.
Her team’s work has led to the development of a new diagnostic test for measuring a biomarker of liver injury secondary to acetaminophen. Acetaminophen is the most common drug used around the world for the treatment of pain and fever. It is also a very common cause of acute liver injury in the United States and Western Europe. The present diagnostic approaches used by physicians to identify acetaminophen as the culprit of liver injury are inadequate and fail to detect many of the cases. Because acetaminophen is found in hundreds of over-the-counter pain killers, patients may be unaware of the amount of acetaminophen they have received. James and colleagues founded Acetaminophen Toxicity Diagnostics, LLC in 2006. The company has the potential to grow significantly once the diagnostic test obtains regulatory approval.

As an entrepreneur, James and her research team at Arkansas Children’s Research Institute (ACRI) have developed a rapid and sensitive test for detecting acetaminophen protein adducts in blood. Working with UAMS BioVentures, she formed a start-up company, Acetaminophen Toxicity Diagnostics, LLC, to develop and market the diagnostic kit.

“ARA is proud of the new ARA Fellows program because it underscores our mission to stimulate economic opportunities through university innovation and collaboration,” said Jerry Adams, ARA president and CEO. “By identifying and investing in researchers currently working in the state, we are maximizing opportunities for commercialization and economic impact.”

The ARA Fellows program is a companion to the well-established ARA Scholars program, which recruits research talent to Arkansas. UAMS has three ARA Scholars: Peter Crooks, Ph.D., Gareth Morgan, M.D., and Daohong Zhou, M.D.

In addition to UAMS, the ARA Fellows represent Arkansas’ other research universities: Arkansas State University (ASU), University of Arkansas, Fayetteville (UAF), University of Arkansas at Little Rock (UALR), and University of Arkansas at Pine Bluff (UAPB).

ARA Fellows _Chancellors-400In the photo taken following Wednesday’s announcement of the ARA Fellows program are (l-r) UAPB Chancellor Laurence Alexander, ARA Fellow Trace Peterson, ARA Fellow Laura James, UAMS Chancellor Dan Rahn, ARA Fellow Alexandru Biris, UALR Chancellor Joel Anderson, ARA Fellow Alan Mantooth, Gov. Mike Beebe, UA Chancellor David Gearhart, ARA Fellow Argelia Lorence and ASU Chancellor Tim Hudson.
James received her medical degree from the University of South Carolina and residency training in pediatrics at UAMS and Arkansas Children’s Hospital. She also completed fellowship training in pediatric emergency medicine at the University of Alabama, Birmingham and additional fellowship training in pediatric clinical pharmacology/toxicology at UAMS and Arkansas Children’s Hospital. In 1996, she joined UAMS as assistant professor in pediatrics. Today, she is a professor of pediatrics and chief of the Section of Clinical Pharmacology and Toxicology at Arkansas Children’s Hospital in the Department of Pediatrics. Earlier this year she was named director of the Translational Research Institute.

Other inaugural ARA Fellows are:

Alexandru Biris, Ph.D., UALR; Director and Chief Scientist, Center for Integrative Nanotechnology Sciences (CINS); explores the science of nanostructures that can be used to alter properties of substances at the atomic level.
Argelia Lorence, Ph.D., ASU; Co-Lead Plant Imaging Consortium (PIC); leads research for the potential development of crop plants with enhanced nutritional content, better growth, and improved tolerance to multiple environmental stresses.
Alan Mantooth, Ph.D., P.E., FIEEE, UAF; Executive Director, National Center for Reliable Electric Power Transmission; Executive Director, National Science Foundation Center for Grid-connected Advanced Power Electronic Systems; 21st Century Endowed Chair, Mixed-signal IC Design and CAD; continues to build upon his internationally recognized electronics research program; the team’s designs have flown on the International Space Station; latest achievements include developing an electronic charger for Toyota’s new plug-in electric vehicles.
Trace Peterson, Ph.D., D.V.M., UAPB; Assistant Professor, Regulatory Science Center of Excellence; examines transgenic humanized zebrafish used to study human cancers and kidney diseases; researching drug delivery systems and patentable vaccine technology for previously non-preventable food fish diseases, which will enhance worldwide food security.
ARA is a 501(c)(3) organization governed by a board of trustees comprised of chancellors from Arkansas research universities and CEOs from across the state. ARA evolved out of the visioning developed in a 2007 strategic plan developed by Accelerate Arkansas. In 2007, the Arkansas legislature approved the appropriation of start-up operational funding from the state’s general improvement fund. Funding was authorized through the Arkansas Science and Technology Authority. Operating as a public-private partnership, ARA is committed to strengthening the economic competitiveness of Arkansas by maximizing university-based research and innovation in designated strategic focus areas. To learn more, visit www.aralliance.org.