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  1. University of Arkansas for Medical Sciences
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  4. Page 37

Newsroom

National Meetings to Address Changes to Human Subjects Research

Representatives from the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) Program and patient advocacy groups are collaborating to host four national one-day meetings in October and November to seek comment on proposals to better protect human subjects while facilitating valuable research and reducing burden, delay and ambiguity for investigators.

These meetings follow the Sept. 8, 2015, Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects, which was promulgated as a Common Rule in 1991. The NPRM was released by federal agencies including the U.S. Department of Health and Human Services.

The goals of these meetings are to:

  • Enhance understanding of the NPRM
  • Facilitate a robust exchange of ideas among a broad range of research stakeholders about the proposed changes and their implications
  • Promote informed public engagement in the policy making process

Attend via live webinar or join one or more of the following scheduled meetings in person:

  • Requiring Consent for Research with Biospecimens and Allowing Broad Consent

o   Nashville, TN

o   Date:  October 14, 2015

  • Streamlining IRB Review

o   Location:  San Diego, CA

o   Date:  October 29, 2015

  • Revising and Expanding the Scope of the Common Rule

o   Location: Chicago, IL

o   Date: November 5, 2015

  • Enhancing and Clarifying Consent Forms and Establishing Standard Safeguards

o   Location:  Philadelphia, PA

o   Date: November 18, 2015

Filed Under: News, Newsroom

‘Spirit of Teamwork’ Led to Strong CTSA Grant Renewal Submission

Submitted on Sept. 25, TRI’s 1,263-page renewal application for a Clinical and Translational Science Award (CTSA) was made possible thanks to the dedication of faculty and staff across UAMS and its affiliated institutions, said TRI Director Laura James, M.D.

“Faculty reviewers and writers from across all colleges tackled this project in a spirit of teamwork that allowed us to develop the strongest possible application,” James said. “This was a cross-college, cross-department, cross-institution effort that involved basic scientists, clinical researchers, community engagement researchers, etc.”

Reviewers were Larry Cornett, Ph.D., Charlotte Hobbs, M.D., Ph.D., Donald Mock, M.D. Ph.D., Mike Owens, Ph.D., Paula Roberson, Ph.D., and Nancy Rusch, Ph.D. This group’s work included nine two-hour meetings. Other major contributors to the review group were DeAnn Hubberd and Peggy Brenner from the UAMS Office of Grants and Scientific Publications (OGSP).

Meanwhile, Mary Aitken, M.D., Pedro Delgado, M.D., and Rusch spent countless hours writing the application’s two training components, James said.

Other primary writers were Beatrice Boateng, Ph.D., Barry Brady, Mathias Brochhausen, Ph.D., Cornett, Geoff Curran, Ph.D., Gloria Richard-Davis, M.D., Ellen Fischer, Ph.D., Kristie Hadden, Ph.D., Hobbs, Laura Hutchins, M.D., Greg Kearns, Pharm.D., Ph.D., Brad Martin, Pharm.D., Ph.D., Pearl McElfish, Ph.D., Jean McSweeney, Ph.D., R.N., Mock, Pope L. Moseley, M.D., Alison Oliveto, Ph.D., Owens, Tamara Perry, M.D., Fred Prior, Ph.D., James Raczynski, Ph.D., Paula Roberson, Ph.D., Kate Stewart, M.D., M.P.H., Dennis Sullivan, M.D., Billy Thomas, M.D., and Pam Williams, Ph.D.

Valuable expertise was contributed by Hari Eswaran, Ph.D., as well as Barry Brady and Phaedra Yount from the Arkansas Children’s Research Institute (ACRI), and OGSP staff. TRI’s staff was critical to the process, James said, including Pamela Christie, Amy Jo Jenkins, Donna Mattingly, Anthony McGuire, and Laura Wilson, and many others who provided information for the grant.

If the application is successful, UAMS will receive about $24.4 million over five years. The CTSA Award is funded by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS).

Filed Under: Front, News, Newsroom

Dean Emphasizes Academic Mission at Research Town Hall

While the launch of the Integrated Clinical Enterprise is a focus point for UAMS this year, Dean Pope L. Moseley, M.D., assured faculty researchers at a Sept. 15 Town Hall meeting that a key objective of the service lines, and his top priority, is strengthening research and education programs.

College of Medicine Dean Pope Moseley, M.D., discusses his vision for strengthening research.
College of Medicine Dean Pope Moseley, M.D., discusses his vision for strengthening research.

“My goal is to make us better as an academic enterprise,” said Moseley, who is internationally known for his laboratory research in cellular adaptations to exercise and his expertise in biomedical informatics. He became dean in July after chairing the Department of Internal Medicine at the University of New Mexico School of Medicine for 14 years.

The forum, co-hosted by pediatrics Professor and Executive Associate Dean for Research Charlotte Hobbs, M.D., Ph.D., was well received by faculty members.

Stavros Manolagas, M.D., Ph.D., lauded Moseley’s arrival and strong support for the research enterprise as well as the commitment of UAMS leaders to support research with greater funding resources that are anticipated to be generated through the new clinical service lines.

“This is the most exciting news, I believe, at this institution in the 20 years that I have been here,” said Manolagas, a distinguished professor and director of the Division of Endocrinology and the internationally recognized UAMS Center for Osteoporosis and Metabolic Bone Diseases. “I want to wish you the best of luck,” he said, drawing a round of applause for Moseley.

Moseley noted that research and education are not self-supporting and that clinical revenue is by far the largest funding source for UAMS. “Research and education need fuel from the clinical engine,” he said.

An institution could hypothetically optimize the clinical delivery system at the expense of everything else, Moseley said.

“But that’s not who we are,” he said. “We didn’t come here to be a multi-specialty practice group. We came here to be a community of scholars. We are here to develop new knowledge and to train the next generation of scientists and clinicians.”

Moseley said he came to UAMS because he was impressed that an academic medical center had “the will” to completely change the clinical delivery model and system for managing the flow of its revenue in an effort to improve patient care while also generating new revenue for strategically planned research and education initiatives. “What we are all trying to do is to find that balance point,” he said.

Moseley outlined priorities for enhancing the research environment, including working with chairs to recruit outstanding researchers at all levels and in key areas that support research. He cited the recent recruitment of Fred Prior, Ph.D., from Washington University in St. Louis as the inaugural chair of the Department of Biomedical Informatics.

He said the college will work to support successful, established research programs and develop a systematic, central approach to bridge funding for successful investigators who experience lapses in extramural funding. Additionally, Moseley said he will work with research leaders to “lower the activation energy” required for successful research by addressing any barriers in areas such as human subject and animal care review.

Emphasizing the importance of chairs in determining how funds are allocated for research, he said a research-focused strategic retreat is being planned. Investigators can have input in the process through their chairs, he added.

An immediate priority is obtaining renewal of the Clinical and Translational Science Award (CTSA) from the National Institutes of Health National Center for Advancing Translational Sciences, which Moseley said is a “defining grant of an academic medical center.”

The UAMS Translational Research Institute (TRI), under the leadership of pediatrics Professor and TRI Director Laura James, M.D., has been preparing the CTSA renewal application to meet the Sept. 25 deadline. Moseley urged faculty members to support the final efforts that were underway.

Longer-range major institutional initiatives include building the biomedical informatics program under Prior’s leadership and preparing the Winthrop P. Rockefeller Cancer Institute’s application for National Cancer Institute designation in a couple of years, Moseley said.

The majority of the meeting was devoted to questions and comments about research priorities and needs. Recommendations from faculty members included developing an inpatient clinical research unit, improving access to research core services, and working more closely with the Central Arkansas Veterans Healthcare System (CAVHS) and leveraging VA grant opportunities for both basic and clinical researchers.

“Compared to other institutions that have VA facilities next door, we tend to underutilize their Career Development Program and the VA Merit Review Program,” said Curt Hagedorn, M.D., a Professor in the Division of Gastroenterology and Hepatology who serves as vice chair for VA Affairs in the Department of Internal Medicine and chief of Medicine at CAVHS.

Michael Jennings, Ph.D., professor and chair of the Department of Physiology and Biophysics and executive associate dean for Basic Sciences, said there is a misconception that VA awards aren’t available for basic scientists and lack of understanding about how to get into the VA system. “But this is something we can really take advantage of,” he said.

Moseley and faculty members spoke about the importance of growing the numbers of physician-scientists through recruitment, mentoring, training programs and other means.

John Arthur, M.D., Ph.D., director of the Division of Nephrology, used a football analogy in advocating for maximizing training grant opportunities, such as the NIH’s career development K awards.

“If you really want, over the long term, to have a team that can compete for the SEC championship year after year, you really have to grow it from the bottom up,” Arthur said.

The meeting opened with a presentation by Hobbs on new services for researchers, including improvements to the COM research website and the UAMS Grant Repository, which will provide junior faculty researchers with examples of submitted grant applications as a training resource to help them to improve their applications and chance of funding.

Hobbs showed a graph reflecting the downturn in NIH funding over the past five years. “We are really focused on turning that around,” she said.

Moseley also referred to the downturn in his remarks. “That is behind us,” he said. “It is our job to change course, and I am excited because we are going to do that.”

For more of Moseley’s thoughts on the importance of research and the academic mission, read his Executive Blog posts on the Inside UAMS intranet.

Learn More:

For information about eligibility and applying for VA grants, contact Sue Theus, Ph.D., deputy associate chief of staff/research, CAVHS, at (501) 257-4841 or Sue.theus@VA.gov.

Editor’s note: A version of this article also appears in the September COMmunication newsletter.

Filed Under: Front, News, Newsroom

Collaboration Station

Discover Your Next Collaborator With UAMS Profiles

profiles

Finding collaborators doesn’t have to be a scavenger hunt. UAMS Profiles, a new online research networking tool, eliminates the mystery and the miles separating researchers from potential collaborators.

Created at Harvard University, Profiles was obtained and customized for use at UAMS by the Translational Research Institute (TRI), the Winthrop P. Rockefeller Cancer Institute and the Department of Biomedical Informatics. Through its service to researchers, UAMS Profiles delivers on a key team science objective of the NIH National Center for Advancing Translational Sciences (NCATS), which oversees 62 Clinical and Translational Science Award (CTSA) institutions across the United States, including TRI.

Profiles (TRI.uams.edu/Profiles) combines a key-word directory with illuminating interactive visualizations that show each faculty member’s collaborations or networks with other researchers, and it shows how those networks have evolved over time.

UAMS faculty information is currently shared within the UAMS network and may be viewed by Profiles members at the main UAMS campus, Arkansas Children’s Hospital and its Research Institute (ACRI), the UAMS Northwest Arkansas campus, and by faculty at the Central Arkansas Veterans Healthcare System. In 2016, UAMS Profiles will be linked nationally with other research institutions that use Profiles or similar networking programs.

Profiles accounts were automatically established for all UAMS faculty with information imported from UAMS FacFacts (Faculty Facts), TRACKS and PubMed. Each faculty member’s Profile Page includes biographical information, contact information and their researcher networks. A researcher’s network may be viewed on the website as:

Filed Under: Front, News, Newsroom

September TRIbune

You’ll want to check out the September TRIbune, which features UAMS Profiles, the exciting new platform for finding collaborators.  This issue also highlights a TRI-supported stroke researcher who received a Genentech grant, as well as TRI-cited publications by your colleagues.

TRIbuneSeptember2015

Download PDF | View Newsletter Archive

Filed Under: Front, News, Newsroom

UAMS BioVentures Director to Researchers: ‘Call Me’

Nancy Gray, Ph.D., has spent her first six months as UAMS BioVentures director focused on getting to know researchers and staff. She’s met with researchers interested in generating intellectual property, those who have generated intellectual property, and some who aren’t sure if they have.

“What I’ve found is that most researchers are so involved in the day-to-day of their programs that, generally, they aren’t thinking about whether they have invented something,” she said. “I believe there’s a lot more intellectual property here that we can capture.”

Gray’s outreach so far as generated an increasing number of researcher phone calls and emails, but she would like to receive more.

“If you have a question, call BioVentures,” she said. “Even if we don’t have an answer, we’ll find an answer. I would like to see BioVentures viewed as a resource as people think about their research work and what it might lead to in terms of commercialization.”

Gray has encountered a few misconceptions here, as well, such as that intellectual property relates only to patents, while in reality it may also involve copyright material and know-how.

BioVentures’ role includes finding licensees for a researcher’s intellectual property if the researcher chooses not to create a spin-off company. Gray has also focused on finding partners for UAMS researchers either through licensing of intellectual property or for sponsored research. While BioVentures does not manage sponsored research agreements, she said, there are opportunities for corporate sponsorships to develop early stage intellectual property through sponsored research or product licenses.

“If a researcher knows a certain company might be interested in their work, I would encourage them to reach out to BioVentures,” she said.

Another misconception Gray noted is that BioVentures offers a source of funding, as implied by its name. Although it doesn’t provide funding, Gray is in a position to help with that too.

“We’re not a venture group, per se, but we have the expertise here,” she said, noting BioVentures staff with business and financial backgrounds and her more than 30 years in biomedical industries, including medicinal chemistry research, management of pharmaceutical research and development, and business operations. Her experience and professional connections allow Gray to direct researchers to the right people.

“Each piece of intellectual property might have a different audience,” she said. “If it’s diagnostic based, the audience of companies would be much different than if it’s a therapeutic or vaccine or device.”

Gray’s experience also includes that of researcher and product developer. She is the inventor on 31 issued U.S. patents and the author of 23 publications. Her research on central nervous system diseases resulted in three products being accepted for clinical development in five years. She was also instrumental in the development of two marketed second generation antihistamines, Allegra and Xyxal.

UAMS Translational Research Institute (TRI) Director Laura James, M.D., noted that BioVentures is important to UAMS’ mission to improve its translation of new knowledge and discoveries into better health and health care. Gray participated in TRI’s strategic planning retreat just weeks after she arrived in March and is working with TRI on a program to reach a broader audience of researchers with an introduction to the concepts of intellectual property and the importance of protecting inventions.

Gray came to UAMS from the Southern Research Institute in Birmingham, Alabama, where she was vice president for corporate development. There, she led corporate development opportunities, including mergers and acquisitions, strategic alliances, joint ventures, minority investments, technology licenses and divestitures for the life sciences, engineering, and environment and energy business. Gray completed one joint venture agreement, 30 license agreements and 37 collaboration agreements.

Prior to her time at the Southern Research Institute, Gray worked in various executive roles at Beijing Med-Pharm Corporation, Vaxinnate Corportation and Elan Corporation.  She received her bachelor’s degree in chemistry from Bucknell University and her doctorate in medicinal chemistry from the University of Illinois.

Gray can be reached at nmgray@uams.edu or (501) 686-6696.

Filed Under: Front, News, Newsroom

UAMS Research Employees Take Initiative, Earn Certifications

Jan. 22, 2015 | Eighteen University of Arkansas for Medical Sciences (UAMS) employees in research-related fields received Certified Research Specialist (CRS) certificates at a Jan. 16 ceremony.

Laura James, M.D., director of the UAMS Translational Research Institute, who spoke during the ceremony, praised the recipients for their dedication to excellence in research. After taking over leadership of the Translational Research Institute in February 2014, James said she became more familiar with their work.

“I have experienced firsthand your expertise and your dedication to ensuring that UAMS produces quality research,” James said. “The fact that you put in the extra effort to earn the CRS certification exemplifies your commitment to research excellence.”

The certification program, administered by the UAMS Office of Research Compliance, ensures an understanding of, and respect for, the principles of research integrity and the protection of those who participate in research. Although the certification is not required by all departments, UAMS research employees routinely complete the 26 hours of coursework and the comprehensive CRS proficiency exam.

The 2014 recipients are:

• Syed Abid, Institute on Aging
• Amy Ballard, Translational Research Institute
• Keith Bracy, College of Medicine—Psychiatry
• Rita Brown, College of Medicine—Pediatrics
• Gina Calhoun, Quality Improvement
• Jean Chen, Institutional Studies
• Hannah Coleman, Pathology
• Judith Cooper, Myeloma Institute
• Kenya Eddings, College of Public Health
• Jaclyn Fite, Myeloma Institute
• Sara Jones, College of Nursing
• Jacqueline Jung, Information Technology – EMR Services
• Priscilla Newman, Myeloma Institute
• Pallavi Ramu, College of Medicine—Pediatrics
• Nicole Robertson, Myeloma Institute
• Monica Smith, Myeloma Institute
• Topeka Stacey, UAMS IT (former employee)
• Samina Waheed, Myeloma Institute

In addition, 84 UAMS employees were acknowledged for maintaining their certification, which requires that they remain current on Collaborative Institutional Training Initiative (CITI) Human Subject Protection training and complete six hours of continuing education each calendar year.

Filed Under: News, Newsroom

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