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Archives for 2015
Friday Is LOI Deadline for Pilot Award Applications
Friday, April 10 is the deadline for letters of intent for the Translational Research Institute’s (TRI) request for applications (RFA) for its 2015 Pilot Award Program. This year, TRI is soliciting two categories of pilot study proposals: 1) translational science studies, and 2) studies of research processes. Budgets up to $50,000 will be considered in both categories and a review of the budgeting will be part of the funding decision. All projects must be completed within one year; however, due to the short time line for TRI’s 2015 year, investigators are urged to submit projects that can be completed within 9-10 months. Letter of intent instructions and cover page are at the RFA link above. Contact: TRIservices@uams.edu, or call 501-614-2287.
Key dates (Note IRB deadline changes):
Cover page and letters of intent are due by noon, April 10, 2015
Full applications invited, April 20, 2015
Full application due date/IRB submission date, June 8, 2015
Announce Awardees, July 1, 2015
IRB approval required by Sept. 1, 2015
TRI’s Newsletter, The TRIbune, is Here
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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TRI Receives $25,000 Chancellor’s Circle Award for Research Participant Recruitment
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 to Issue CTSA Innovation Funding Opportunities
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
Clinical Investigator Rewarded by Grad School’s Clinical and Translational Science 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.”
UAMS Startup Gets $14.5 Million to Develop Drug Therapies for Methamphetamine Users
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.
Patricia Brady Honored for Work with Research Participants
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.”