TRI’s Budget and Coverage Review Unit has moved from Biomed I to the Jackson T. Stephens Spine & Neurosciences Institute building’s fifth floor. The unit’s five employees completed the move on Monday, joining other TRI colleagues based in the Stephens Spine building. The employees are switching places with those in the UAMS Office of Research and Regulatory Affairs, whose seven employees moved to the first floor of Biomed I, suite 105. The TRI budget and coverage staff now in Stephens Spine are Barbara Adams, Mtonya Hunter-Lewis, Lisa Richardson, Sharon Sandria and Cynthia Spinks. The unit’s move was celebrated with cake and coffee.
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What You Need to Know about the New NIH Biosketch Format
When must you use the new NIH biosketch format?
According to NIH notice #NOT-OD-15-032, the new biosketch format is mandatory for all research, training, and career development grants with due dates on or after May 25, 2015.
What’s different about the new format?
- The new format allows investigators to include a link to a complete listing of their publications in SciENcv or My Bibliography.
- It allows researchers to describe up to five of their most significant contributions to science, along with the historical background that framed their research.
- Researchers may list up to four relevant peer-reviewed publications or other non-publication research products for each scientific contribution.
- The new biosketch format allows up to 20 publications and/or other non-publication research products.
Summary of Biosketch Changes
Old Format | New Format |
4-page limit | 5-page limit |
Personal statement | Personal statement + up to 4 references |
5 contributions to Science + up to 4 references for each contribution | |
15 selected references | Up to 24 selected references |
Link to online bibliography (“in a publicly available digital database”) |
What types of non-publication research products are acceptable?
Acceptable non-publication research products may include audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware that are relevant to the described contribution.
What tools can I use to create my biosketch?
Science Experts Network Curriculum Vitae (SciENcv), which serves as an interagency system designed to create biosketches for multiple federal agencies, supports the current NIH and NSF biosketch formats. Use of SciENcv is not required, but encouraged by the NIH. SciENcv is currently being updated to support the new NIH biosketch format.
Additional Information
The biosketch format includes four major sections. The Contributions to Science section is a new required section that may optionally include references and a link to your complete bibliography.
1. Personal Statement (new options!)
1. May now include up to four peer-reviewed publications that specifically highlight your experience and qualifications for the project
2. May include a description of factors, e.g. family care responsibilities, illness, disability, active duty military service to explain impediments to past productivity
2. Position and Honors (unchanged)
3. Contributions to Science (new!; required)
• Include up to five contributions to science
• Include up to four references for each contribution
• Link to a full list of your published work as found in a publicly available digital database such as My Bibliography.
1. Including this link is currently optional
2. No other links/URLs may be allowed in the biosketch or application
3. The online bibliography link/URL may be either active (clickable) or not active.
4. Whether active or inactive, the link/URL to the online bibliography must be spelled out (http:// etc) and cannot be hyperlinked text/words.
5. This online bibliography link and the up to 24 references included in the Personal Statement and Contributions to Science sections replace the previous 15 reference bibliography used in biosketches.
4. Research Support (unchanged)
Details
Contributions to Science
- Briefly describe up to five of your most significant contributions to science. Be sure to include:
• the historical background that frames the scientific problem
• the central finding(s)
• the influence of the finding(s) on the progress of science or its application to health and technology
• your specific role in the described work
- Each contribution can reference up to four peer-reviewed publications OR other non-publication research products including: audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware.
- The description of each contribution must be no longer than one half page including citations and figures.
URL to Complete List of Published Work (component of Contributions to Science section)
- Start putting together your online bibliography as soon as possible. Here are a couple of tools that NIH recommends:
• My Bibliography in My NCBI: Use the sharing feature to link to your works.
• SciENcv: This is a new tool that is designed to create biosketches for NIH grant applications. This tool eliminates the need to repeatedly enter biosketch information. NOTE: It is recommended that you set up your My Bibliography first.
- Alternatives to My Bibliography (from NIH Biosketch FAQ #10):
“Per NOT-OD-15-032, the new biosketch format allows applicants to include a link to a full list of their published work as found in a “publicly available digital database” such as My Bibliography.
The NIH prefers applicants use My Bibliography. NIH cautions reviewers against accessing URLs that may compromise their anonymity.
Other publicly available sites which include data from a broad spectrum of institutions and maintain anonymity of the users accessing the sites are acceptable (e.g., Google Scholar). Links to sites managed by the investigator or applicant organization or URLS including the applicant organization name should not be used.”
- URL Construction
• Spell the URL out in full, beginning with ‘http://’ (e.g., http://grants.nih.gov/grants/oer.htm).
• Do NOT include the link as hyperlinked text (e.g., NIH Grants Web page) as eRA system processing will not retain the – active link in the assembled application image in eRA Commons.
• The online bibliography link/URL may be either active (clickable) or not active.
Using SciENcv to Create Biosketches
SciENcv is a new tool designed to help researchers complete biosketches efficiently. This tool will link to and pull in biographical information from your eRA Commons account (or other sources) and publications from your My Bibliography account. An ORCID ID can be linked as well to provide a unique author identifier. SciENcv currently includes templates for both new and old NIH biosketch formats as well as for the NSF biosketch format. SciENcv will support additional biosketch formats in the future.
Why should I use SciENcv?
- Eliminates the need to repeatedly enter the same information
- The researcher can control the content and edit it as needed
- Creates multiple profiles so each biosketch can be tweaked to support a particular grant application and funding agency
- Export the results as a PDF or share via a URL
- Grant access to other people (delegates) to view and manage your profiles
To create a biosketch using SciENcv, follow these steps:
- Sign into My NCBI.
- Find the SciENcv box located on the My NCBI home page.
• If this is your first use of SciENcv, select the link “Click here to create a new CV.”
• If you are a returning user, select the link “Manage SciENcv” and then select to “Create a new profile” or edit an existing profile.
- When you create a new profile
• Select the second tab “From an external source.” Enter a name to identify the profile. (You can also elect to create a biosketch profile from scratch (1st tab) or from a copy of an existing profile (3rd tab).
• Choose “New NIH BIosketch” as the type of profile (other choices are “NIH Biosketch” and “NSF Biosketch”
• Select eRA Commons as the external source from which to pull in your biographical information. (Other choices are ORCID or National Science Foundation)
• Choose whether to make your profile public or private.
- Select “Create.” Now your My Bibliography references and eRA commons both linked to the new profile and can be used to generate a biosketch.
- Fill out your biosketch profile, and choose citations to include from your My Bibliography collection.
- Share or download your biosketch by using the URL or PDF.
Where can I get more information?
Biosketch FAQ
Biosketch Templates and Samples
How to Use My Bibliography (Detailed)
My Bibliography (Video)
How to Use SciENcv (Detailed)
SciENcv (Video)
Application Forms and Instructions
NCATS Announces Collaborative Innovation Funding Opportunity
The NIH National Center for Advancing Translational Sciences (NCATS) has issued new funding opportunity announcements (FOAs) to stimulate team-based research across the Clinical and Translational Science Awards (CTSA) consortium. Details of these Collaborative-Innovation Awards are at the links below. Please note there is a pre-application step (X02) followed by an invited full application (U01):
Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01)
PAR-15-172 • April 2, 2015
Pre-Application for Collaborative Innovation Award, CTSA Program (X02)
PAR-15-173 • April 2, 2015
PAR-15-172 and PAR-15-173 solicit proposals for innovative investigations among three or more CTSA hubs to improve research methods at any step of the translational process. Through these awards, NCATS will foster research collaboration by encouraging teams from multiple hubs to work together to develop, demonstrate and disseminate experimental approaches that overcome translational science roadblocks.
Read the Web announcement.
Review PAR-15-172.
Review PAR-15-173.
Learn more about CTSA funding opportunities.
NCATS’ CTSA program supports a national network of medical research institutions — called hubs — that work together to improve the translational research process to get more treatments to more patients more quickly.
TRI Pilot Study Full Applications and IRB Submissions Due June 8
Learn more.
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.
march15
Download PDF
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.