Research Impact

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Town Hall New Extramural Grant Awards New Intramural Grant Awards a, b Recent High-Impact Publications Warrior Care Economic Development Forum Adult Stem Cell Research a, b Institutional Review Board

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Featured Researcher a, b ASU Research a, b, c, d Office of Clinical Investigative Services a, b Office of Laboratory Animal Services Division of Sponsored Programs Administration a, b, c Office of Technology Transfer & Economic Dvlp.

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Links:

RESEARCH Impact is published quarterly for the GHSU Research Community from the Office of the Vice President for Research.

www.georgiahealth.edu/research

• Mark Hamrick, Ph.D. --Senior Vice President

for Research, and Professor, Cellular Biology and Anatomy, Institute of Molecular Medicine and Genetics (mhamrick@georgiahealth.edu).

• Publications Director—Christine Hurley

Deriso (cderiso@georgiahealth.edu).

• Editor/Designers—Patricia Johnson

(pjohnson1@georgiahealth.edu), Adrian Greer (agreer@georgiahealth.edu) and Tricia Perea (tperea@ georgiahealth.edu).

• Photographers—Patricia Johnson, ASU, Phil

Jones, Samuel Herberg and Stock Exchange.

• Cover- Research Lab of Manuela Bartoli, Ph.D. Patricia Johnson, photographer.

www.experts.scival.com/ghsu Submissions: Please send news and updates for future editions to Mark Hamrick, Ph.D. (mhamrick@georgiahealth.edu).

GHSU Research Important Event:

Dr. Mark W. Hamrick, Senior Vice President for Research at Georgia Health Sciences University,   Dr. Hamrick oversees all aspects of the university's research enterprise, including developing a strategic plan to

advance GHSU's goals related to sponsored research programs and to identify resources to enhance the research mission.

Please plan to attend this important meeting to hear exciting updates about research at GHSU.

New Extramural Grant Awards

Bonnie A. Dadig, Ed.D, PA-C

Manuela Bartoli, Ph.D.

Bonnie A. Dadig, Ed.D, PA-C , Department Chair & Associate Professor, Physician Assistant �

Department, “Physician Assistant Training in Primary Care,” Health Resources & Services Administration. �

Manuela Bartoli, Ph.D., Associate Professor, Department of Ophthalmology, “Characterization of the Thioredoxins System in the Diabetic Retina (Lamoke, Folami)” National Eye Institute.

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Michael Madaio, M.D., Department Chair, Department of Medicine, “MCG Minority-Based Community Clinical Oncology Program,” National Cancer Institute.

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Manuela Bartoli, Ph.D., Associate Professor, Department of Ophthalmology, “Uric Acid and Diabetic Retinopathy,” International Retinal Research Foundation.

Alvin Terry, Jr., Ph.D., Professor, Department of Pharmacology & Toxicology, “Organophosphate-Related Alterations in Myelin and Axonal Transport in the Living Mammalian Brain,” US Army Medical Research Acquisition Activity.

Gary Whitford, Ph.D., Professor Emeritus, Department of Oral Biology, “Analysis of Water and Plasma Samples for Fluoride,” Centers for Disease Control & Prevention.

Yunchao Su , M.D., Ph.D., Professor, Department of Pharmacology & Toxicology, “Calpain Activates Intracellular TGFB1 in Idiopatic Pulmonary Arterial Hypertension,” National Heart, Lung & Blood Institute.

Santhakumar Manicassamy, Ph.D., Assistant Professor, Department of Medicine, “Regulation of Oral Tolerance and Intestinal Inflammation by B-catenin/TCF Pathway,” National Institute of Diabetes & Digestive & Kidney Diseases.

New Intramural Grant Awards

Mohammed Elsalanty, M.D., Ph.D. �

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Extramural Success Awards

Wen-Cheng Xiong, Ph.D.

Scott Barman, Ph.D., FAHA Department of Pharmacology & Toxicology and David Fulton, Ph.D., Vascular Biology Center “Opposing roles of fibroblast Nox4/Cav-1: A pathway to vascular fibrosis in PAH.” Mohammed Elsalanty, M.D, Ph.D, Department of Oral Biology “Acute Removal of Bisphosphonate from bone: A Novel Treatment for BRONJ.”

Patricia Johnson

Wen-Cheng Xiong, Ph.D., Institute of Molecular Medicine and Genetics, “Neogenin and � Hepatocellular Carcinoma.”

New Intramural Grant Awards

Brian McKinnon, M.D., M.B.A.

Pilot Studies Research Program

Matthew Lyon, M.D.

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Brian McKinnon, M.D., M.B.A., Department of Otolaryngology, and David Blake , Jr., Ph.D. Department of Neurology, Brain & Behavior Discovery Institute, “An Animal Model for Cochlear Implantation Using Thin-Film Array Electrodes.”

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Stuart Thompson, Ph.D, Department of Biochemistry & Molecular Biology, and Russel Carlson, Ph.d Complex Carbohydrate Research Center, UGA “Identification and Regulation of Campylobacter Biofilm Polysaccharide.”

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Cheryl Newman-Whitlow, M.D., Department of Medicine, Kristina Kintziger, Ph.D., Department of Biostatistics & Epidemiolog, and Richard Sattin, MD, FACP, Department of Emergency Medicine “HIV Infection in Women: Understanding the Natural History and Ensuring Optimal Outcomes.”

Matthew Lyon, M.D., Department of Emergency Medicine, and Robert Gibson, PhD, OTR/L �

Department of Occupational Therapy “Remote Monitoring for Onset of Sickle Cell Vaso-Occlusive Crisis.”

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Jeffrey Switzer, D.O., Department of Neurology and Susan Fagan, College of Pharmacy, UGA “Minocycline in Acute Cerebral Hemorrhage (MACH) Trial.”

Ryan Harris, Ph.D., CES, FACSM, Department of Pediatrics and Rene Harper, Department of Medicine “Estrogen Mediated Vascular Endothelial Dysfunction in Diabetes.”

Recent High-Impact Publications �

Ciprian B. Anea, Bo Cheng, Shruti Sharma, Sanjiv Kumar, R. William Caldwell, Lin Yao, M. Irfan Ali, Ana M. Merloiu, David W. Stepp, Stephen M. Black, David J.R. Fulton, R. Daniel Rudic.

Increased Superoxide and Endothelial NO Synthase Uncoupling in Blood Vessels of Bmal1-Knockout Mice. Circ Res. 2012 Oct 12;111(9):1157-65. Impact Factor=9.5

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Tracy L. McGaha, Lei Huang, Henrique Lemos, Richard Metz, Mario Mautino, George C. Prendergast, Andrew L. Mellor. Amino acid catabolism: a pivotal regulator of innate and adaptive immunity. Immunol Rev. 2012 Sep;249(1):135-57. Impact Factor=11.1

Phil Jones

Patricia Johnson

Mary A. Zimmerman, Nur-Taz Rahman, Dafeng Yang, Guy Lahat, Alexander J. Lazar, Raphael E. Pollock, Dina Lev, and Kebin Liu. Unphosphorylated STAT1 promotes sarcoma development through repressing expression of Fas and bad and conferring apoptotic resistance. Cancer Res. 2012 Sep 15;72(18):4724-32. Impact Factor=7.8.

Patricia Johnson

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Zhi-Chun Ding, Lei Huang, Bruce R. Blazar, Hideo Yagita, Andrew L. Mellor, David H. Munn, and Gang Zhou. Polyfunctional CD4+ T cells are essential for eradicating advanced B-cell lymphoma after chemotherapy. Blood. 2012 Sep 13;120(11):2229-39. Impact Factor=9.8

Patricia Johnson

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Warrior Care Second Research Advances in Warrior Care Symposium Leads to New Inter-Institutional Research Collaborations

The second Research Advances

in Warrior Care Symposium has stimulated new partnerships among conference attendees.

The second day of the symposium focused

on determining priorities and milestones for collaborative research in support of brain relatedillness and injury, as well as other research needs in support of military troops and veterans. The intended goals of the session outcome were to

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The three areas included:

1. Post-traumatic stress (Team Lead: Almira Vazdarjanova, phD, GHSU/CNVAMC)

2. Traumatic brain injury (Team Lead: John Rigg, M.D., DDEAMC) 3. Pain & addiction management (Team Lead: Lance Evans, M.D., GHSU).

Contact Gen. Jeffrey Foley (jfoley@georgiahealth.edu) for additional information.

Phil Jones

Gen. Peter W. Chiarelli

Phil Jones

assess current capacities of the three medical enterprises (GHSU, Dwight D. Eisenhower Army Medical Center [DDEAMC], and the Charlie Norwood VA Medical Center [CNVAMC]) and to determine how best to proceed with current or additional resources to meet the needs of our military and veteran population. After much discussion the group agreed upon three key focus areas for collaboration and assigned individuals as team leads for the three thematic areas.

Economic Development Forum

Phil Jones

Phil Jones

GHSU Researchers Speak at Chancellor’s Economic Development

Stephen Hsu, Ph.D.

Georgia Health Sciences University

researchers Stephen Hsu, Ph.D. and

David Hess, M.D. will be guest speakers at the Chancellor’s Economic Development Forum.

A Celebration of Research and Innovation by the University System of Georgia on Dec. 3. The forum will be held at the Georgia State University Student Center in Atlanta from noon to 5:30 p.m.

The program will include Chris Cummiskey, Commissioner of the Georgia Department of Economic Development, and Hank M. Huckaby, Chancellor of the University System of Georgia.Topics will include how research universities impact the economy in rural Georgia and creating new industries in Georgia.

A reception and exhibit showcasing Georgia research that has reached commercialization will follow.

Hsu is a professor in the GHSU College of Dental Medicine and serves as Course Director

David Hess, M.D.

for both nutrition and biochemistry. Hsu founded Camellix LLC, a start-up biotechnology and new drug development company, to develop and market the next generation of green tea technology-derived products to treat dry mouth, dandruff, cold sores and viral infections with natural ingredients.

Hess is Chair of the MCG Department of Neurology at GHSU. He was awarded the 2012 Outstanding Faculty Award at the Medical College of Georgia and Georgia Health Sciences University.

He is a co-founder and Chairman of the Board of REACH Health Inc., a telemedicine company spun out of GHSU and now based in Alpharetta, Ga. with 40 employees and operating in more than 150 hospitals nationwide.

Adult Stem Cell Research

Institute for Regenerative & Reparative Medicine (IRRM) Expands Stem Cell Research on Campus:

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Samuel Herberg

New Resources for Adult Stem Cell Research Established at GHSU

of Orthopaedic Surgery (Norman Chutkan, Ph.D), allows isolation of stem cells from bone marrow samples obtained from knee replacement and spinal fusion procedures.

Phil Jones

2. Induced Pluripotent stem cells (iPS): Because

The IRRM was established in

August 2011 and represents GHSU newest cross-campus, crossdiscipline effort to promote both basic

science research, on human and mouse stem cell biology, and translational research on the therapeutic use of adult human stem cells.

IRRM has established a stem cell core facility under the overall direction of Dr. Xingming Shi and Yun Su that collects or provides these tissues to our research faculty for use in clinical trials, research projects or commercial use.

A variety of stem, progenitor cells

or animal models are prepared by this facility and include: 1. Adult-derived, bone marrow mesenchymal

stem cells: In partnership with the Department

of ethical concerns and limitations in the use of embryonic stem cells (e.g teratoma formation), the ability to take any cell in your body (e.g. skin cells) and reprogram it into a stem cell. This allows the capacity to regenerate whole tissues or organs and holds great promise. Dr. Ali Eroglu and are currently studying their use for replacement of human tissues.

3. Adult cord blood stem cells: Dr. Robert Yu,

Georgia Research Alliance Eminent Scholar in Neuroscience, established a cord blood bank for storing umbilical cord blood. These cells can be utilized in the treatment of hematological malignancies or bone marrow failure.

4. Adult-derived, dental pulp stem cells: In

cooperation with the Departments of Periodontics and Oral & Maxillofacial Surgery (Dr. Mark Stevens), College of Dentistry, we are in the process of isolating dental pulp stem cells from tooth extractions from individual patients.These cells can be expanded to differentiate into a variety of tissue types including bone, for oral repair, or stored and then expanded, for use for bone marrow transplantation.

Adult Stem Cell Research

Phil Jones

Institute for Regenerative & Reparative Medicine (IRRM) Expands Stem Cell Research on Campus:

Hypoxic Chamber

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tissues the Stem Cell Core Facility provides a number of research tools and services that include: 1. Hypoxic Chamber for Cell Culture: is a

complete hypoxic system from BioSpherix. A hypoxic environment can be important for experiments involving cells that normally live in low-oxygen tensions (e.g. bone marrow stem cells) or to mimic cell injury (e.g. injury resulting from cardiac or renal ischemia). The overall system includes a multi-chamber incubation system where each of the six chambers can be independently programmed along with a two-chamber hypoxia workstation with procedure and microscope stations that can be

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Samuel Herberg

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adjusted to match the oxygen environment of the incubators, enabling uninterrupted hypoxia when moving cells between the incubator and workstation. The system has a full range O2 control (0.1 percent-99.9 percent) and the system is programmable so that cells can be exposed to increasing oxygen concentrations or hypoxic stress. It can be adjusted for specific experiments (frequency, duration or degree of oxygen drops can be adjusted)

2. Genetic modification of stem cells: Currently,

mouse bone marrow mesenchymal stem cells can be modified (e.g. GFP tagged) and provided to investigators for their research projects. A recent example of their use by one of our investigators was the GFP labeling and administration of mesenchymal stem cells at site of bone fracture to track the repair process over time.

3. FACS sorting of human stem cells, the umbilical

cord facility has a FACS sorter available for sorting of human cells

4. Cryopreservation and storage of stem cells,

the umbilical cord facility has an archival storage system available for storage of human cells.

Institutional Review Board New Oncology Institutional Review Board (IRB-C)

The Office of Human Research Protection and Research Administration is excited to announce the creation of a new internal Institutional Review Board for the GHSU Enterprise. As a result of the continued growth in cancer research and the involvement of principal investigators in investigator-initiated research protocols, an oncology-focused Institutional Review Board was established September 2012 to provide IRB reviews for all cancer-oncology and hematology clinical research trials. The Institutional Review Board is known as IRB-C. IRB-C was established to support the Cancer Center’s goal to become an NCI-designated Cancer Center like Winship Cancer Institute at Emory University, Hollings Cancer Center at Medical University of South Carolina at Charleston, and many others. The State of Georgia has mandated that Georgia Health Sciences University Cancer Center become the second NCI-designated Cancer Center in Georgia by 2020.

The goal of the Cancer Center is to establish a Cancer Research Institute that offers great clinical practices and medical care with innovative research. There are currently over 175 active oncology clinical research protocols at Georgia Health Sciences University. The protocols

consist of complex research study designs and will continue to increase in complexity as the Cancer Center initiates investigator-initiated protocols that target specific cancers. The task to form the IRB C began in January 2012. All details were strategically planned to form an effective committee and administrative support staff that would provide quality service to the Principal Investigators and their staff. Dr. Suzanne PursleyCrotteau is the IRB Administrator. She is a former IRB Administrator for the IRB at the National Cancer Institute. Michelle Harper-Meriwether and Rebecca Miller are the IRB specialists assigned to specific oncology groups to provide administrative analysis and support for all research study submissions. There have been a total of 60 cancer protocols that have been transferred to IRB-C for review. An efficient process has been established to transfer research study protocols from IRB A (formally the Human Assurance Committee) to IRB-C. All IRB-C Committee Members received initial orientation and training and will continue receiving monthly education and/or training that will ensure effective review processes.

The research community is excited about the development of the cancer-focused IRB and looks forward to continued growth in cancer research at GHSU.

Featured Researcher Dr. Kumar Manicassamy, Immunotherapy, GHSU Cancer Center

Background and research focus:

I have a long-standing interest in the field of immunology. My interest in this area stems from a central problem in immunology, how the immune system launches robust immunity against pathogens, while maintaining tolerance to self-antigens. This problem assumes a particular importance in the intestine because of the billions of commensal microorganisms, pathogenic microbes and dietary antigens that confront the intestinal immune system every day.

Thus, my work has focused examining critical mechanisms that regulate innate and adaptive immune responses at the mucosal surfaces of the gastro-intestinal track. New insights from my research will shed light on interactions between commensal microorganisms and how these interactions can become dysfunctional to cause increased risk of inflammatory bowel disease (Crohn’s disease and ulcerative colitis) and colon cancers.

We are using systems biological tools, together with more traditional approaches, to identify the transcription factors in dendritic cells and macrophages in the intestine that critical for regulating immunity and inflammation. The work involves testing of several hypothesis using murine disease models of intestinal inflammation and colon cancer. This will provide the pre-clinical basis for future translational studies aimed at the development of an entirely new class of agents that may have significant therapeutic impact in treating IBD and cancer.

Current funding:

My research is supported by a new R01 grant (NIH/NIDDK) titled Regulation of Oral Tolerance and Intestinal Inflammation by Beta-Catenin/TCF Pathway.

Patricia Johnson

Submitted Photo

Approaches you utilize in your research:

Featured Researcher Continued...

Key publications:

Manicassamy S, Reizis B, Ravindran R, Nakaya H, Salazar-Gonzalez RM, Wang YC, Pulendran B. Activation of beta-catenin in dendritic cells regulates immunity versus tolerance in the intestine. Science. 2010 Aug 13;329(5993):84953.

Manicassamy B, Manicassamy S, BelichaVillanueva A, Pisanelli G, Pulendran B, GarcﾃｭaSastre A. Analysis of in vivo dynamics of influenza virus infection in mice using a GFP reporter virus. Proc Natl Acad Sci U S A. 2010 Jun 22;107(25):11531-6.

Changes you would like to see at GHSU:

窶オncreased opportunities for multidisciplinary research; continued support for the novel high impact research projects; and more opportunity for collaboration and interaction between basic scientist and clinicians.

Patricia Johnson

Pulendran B, Tang H, Manicassamy S. Programming dendritic cells to induce T(H)2 and tolerogenic responses. Nature Immunology 2010 Aug;11(8):647-55.

ASU Research

Samantha Boone, junior chemistry major at Augusta State, working in the laboratory of Angie Spencer, Ph.D., in the Department of Chemistry and Physics at Augusta State University, recently presented their work on stemloop DNA at the Southeastern Regional Meeting of the American Chemical Society in Raleigh, N.C. held Nov. 14-17, 2012.

Spencer and Boone, a spent ten weeks over the summer doing research at Furman University through their Research Experiences for Undergraduates Program sponsored by the National Science Foundation.

Boone’s work focuses on the potential use of stem-looped DNA as the starting material for the generation of DNA aptamers.

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Samantha Boone

ASU Research Research Activities Continued...

David Stone

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David Stone, senior chemistry major, received the outstanding podium presentation award at the 2012 Southeastern Regional Meeting of the American Chemical Society (SERMACS) under the direction of Dr. Shaobin Miao, assistant professor of chemistry.

Stone won for his research on The Synthesis of a Large Dihydroheteroacene which is premised on the synthesis of a specific organic semiconductor he has been working on for the past year and a half.

“The semiconductor that I have been synthesizing, with Dr. Miao as my mentor, has surpassed many of the common issues that generally plague organic semiconductors, such as poorer electron field mobility as compared to silicon, poor solubility in common solvents, and poor stability to light and air exposure,” said Stone.

More than 1,500 chemists and chemistry students from throughout the Southeast including Puerto Rico attend SERMACS, the major regional chemistry meeting of the year.

Stone was one of seven Augusta State students to present at the conference.

According to Tom Crute, chair of the chemistry

and physics department, “This is the most students I can recall that have had abstracts accepted for this annual conference.” The students also were accompanied by four faculty members, some who also presented, and a few ASU research students who did not make presentations.

“Winning this award shows that the undergraduate research done in ASU’s Department of Chemistry and Physics is on the same standard as the research being conducted at some of the biggest research universities in the Southeast, since I won my award while presenting alongside students from Georgia Tech, Furman, UNC, and Vanderbilt,” added Stone.

Written By: Tunisia Williams

ASU Research

ASU Students Win Research Award: from left, Scott Hudson, Kristin Hawkins, John-Michael Garner, Jackie Pabon, Chelsea Mathews, Amy Hunter, Jessica Hanson, Shea Anderson, and Debbie van Tuyll, A.B., M.A., Ph.D,.

18 Eighteen undergraduate communications

majors have transformed their class project into an award-winning, commercially published book about the history of Augusta’s second oldest radio station WGAC-AM. The book, is entitled, Augusta’s WGAC Radio: The Voice of the Garden City for Seventy Years.

Students were required to write chapters about the radio station’s history in their journalism history class and then work together to transform the individual chapters into a cohesive manuscript. They were aided in this second task by students in a second class that taught the fundamentals of book editing and publishing.

The History Press of Charleston, S.C., which specializes in regional histories, published the book, which recently won the Documenting Georgia History Award from the Georgia Department of History and Archives. Student Travis Highfield used his research as the basis of a presentation that won third place for research excellence at the 2012 Southeastern Symposium of the American Journalism Historians Association.

This study of WGAC is particularly important because of the ephemeral nature of radio.

Newspaper histories are common and are more easily researched because of the publication itself constitutes the record of the newspaper. Radio content, however, is lost as soon as it is broadcast.

This was particularly true in the early days of radio when all content was broadcast live.

Student authors used a variety of primary sources to document WGAC’s history. They spent hours interviewing current and former WGAC employees or their family members; they combed through the pages of the Augusta Chronicle, reading both editorial and advertising content that related to the station and to the history of radio in America generally; and they consulted dozens of secondary sources.

The most comprehensive of these private collections belong to the family of George Fisher, a long-time Augusta radio personality who was much beloved by his audience. In addition to interviewing three of Fisher’s daughters for their recollections, students were given access to the papers Fisher accumulated throughout his career.

These materials included letters, memorabilia, and news clippings primarily.

Dr. van Tuyll and Scott Hudson, an ASU honors graduate and investigative reporter at WGAC, led the research effort and served as editors.

Patricia Johnson

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Research Activities Continued...

ASU Research

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Student authors, all of whom are communications majors, included: Daniel Barber Abigail Blankenship Catherine Collingsworth Karl Frazier John-Michael Garner Armani Grant Kristin Hawkins Ron Hickerson Travis Highfield Stephanie Hill Jillian Hobday Lauren Kellems David Lee Tiffannie Meador Chelsea Mathews Rashad O’Conner Jacquelyn Pabon JoBen Rivera-Thompson

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In addition to the student authors, another 22 students served as project editors and helped to copyedit and prepare the raw manuscript for publication: Mary Anderson Jackie Brill Si-Long Chen Christine Clark Catherine Collingsworth Alexandra Eash Amber Forbes John-Michael Garner Kelli Harris Kristin Hawkins

Patricia Johnson

Research Activities Continued...

Jasmine Housey Amy Hunter Patricia Johnson Tamika Lampkin Daphne Maysonet Madia Orlando Megan Petrie Megan Steinberg Sara Tafazoli Stenson Willard Valerie Wooten

Office of Clinical Investigative Services IRB Expansion: As the research enterprise at GHSU

continues to grow, Research Administration determined that it would be beneficial to add additional internal IRBs to address the varied research being conducted. For many years, GHSU has successfully functioned with one internal Institutional Review Board (formerly known as Human Assurance Committee (HAC)). In support of the rapid growth of research at GHSU, an oncology focused Institutional Review Board (IRB C), was established September 2012 to provide IRB reviews for all cancer and hematology clinical research trials. The Human Assurance Committee (HAC), now known as IRB A, will continue to review all other Biomedical studies. Effective January 2013, the Social-Behavioral IRB (IRB B), will be established to review social-behavioral, epidemiological, and educational research.

IRB A Submission to Approval Times Reduced: The GHSU Human Research Protection Pro-

gram is accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). AAHRPP accreditation indicates that our institution follows rigorous standards for ethics, quality, and protections for human research. During the IRB review process, all types of new study submissions have a timeline that are recommended by AAHRPP based on data from all accredited institutions. The following are AAHRPP mean submission to approval timelines mean time from the initial submission to approval: Exempt Submissions: 15.3 days Expedited Submissions: 28.7 days Full Review Submissions: 45.2 days   Due to the dedication and focus on streamlining internal processes, of the OHRP IRB Specialists and IRB A reviewers, we were able to surpass the AAHRPP bench-

mark within 2 weeks of implementing new internal guidelines. As of week ending Nov 16, 2012, IRB A has averaged 14.9 days for submission to approval time for new expedited protocols.

OHRP offers IRB Submissions Pre-Review Service: In an effort to implement faster turnaround

times and minimize stipulations, the OHRP will begin offering a Pre-Review for all new studies submitted in eIRB in January 2013. This service will provide further education on submission requirements and methods and will give the investigator an opportunity to work directly with an IRB Specialist to address revisions or concerns regarding a new study before it is submitted.

eIRB Improvements Coming Soon: Since eIRB

launched in August 2011, the OHRP has been working closely with ITSS, and the research community to identify areas for improvement. We are now working with the vendor, Huron Consulting and ITSS develop more efficient workflow and streamlined Smart Forms. The OHRP has recently published a revised eIRB manual with stepby-step instructions and photos to guide investigators through every type of submission. The OHRP Trainer is developing more eIRB user manuals to address each role in the system (department approver, IRB reviewer, and Ancillary Approver).

Updated Website for Clinical Research:

If

you do clinical research, you’ll want to check out the Office of Clinical Investigative Services (OCIS) updated website at www.georgiahealth.edu/OCIS. New features include a section for study sponsors as well as updated information on how to access the electronic medical record and hospital databases for research. All of the

Office of Clinical Investigative Services current information you may need to obtain hospital resources and schedule services or procedures for a study is also available. On the website you will find “Study Approval Elements” which provides a basic explanation of how to get a clinical study approved. Information on using the hospital i2b2 (Informatics for Integrating Biology and the Bedside) clinical data warehouse is located on the website. We hope you visit the OCIS website soon.

We look forward to assisting you with your clinical research.

Training and Education Update: Coordinator

University 101 took place in April and October 2012. CU 101 was streamlined from 5 half-days to 3 half-days.

Both sessions were very successful and received great reviews. For each session 97 percent of the attendees were new research team members. The data from the Pre-Test and Post- Test (which assess knowledge of Research Ethics and the GHSU research submission process) indicated a significant increase from the beginning of the course until the end. The average post-test score was 85 percent in April 2012, showing a 15 percent increase. The average post-test score in October 2012 was 96 percent, showing a 29 percent increase. Coordinator University 201 was held in June 2012. We received great feedback from the participants and look forward to other sessions.

Investigator University had its major kickoff in July 2012 in the College of Dental Medicine. There were 19 faculty who participated, and the session received great feedback. We have also conducted Investigator and Research Team Member trainings within certain departments throughout GHSU. We look forward to hosting more Investigator trainings in 2013. If you would like to request an Investigator University session for your department or college, please contact Demetric Hillman at 1-1481 or dhillman@georgiahealth.edu.

Research Team Member Orientation, held on a bimonthly basis, has averaged 4-8 attendees at each session, which shows the growth in research and research staff at GHSU. We are excited to continue with the orientation as many participants have expressed that it is a great resource for assisting research team members through the research navigation process, as well as allowing them the opportunity to meet staff from all the divisions of Research Administration.

Lunch-n-Learn sessions have received very positive responses from researchers who have participated. Attendance has averaged 5-15 participants and continues to grow. Some of the topics in 2012 included “Research Studies – Getting Started”, “Regulatory Binders”, “More Efficient Submission Process”, “Tips for eIRB Submission”, and “Recruitment, Retention, and Enrollment.”

During 2012, OHRP also hosted eIRB training on a monthly basis to assist researchers with navigating the electronic IRB submission system. As a result of the successful sessions, the eIRB Researcher User Manual was revised to be a detailed step-by-step guide for navigating and accurately submitting all research. The manual was published on the Office of Human Research Protection website in October 2012.

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Future Education and Training for first quarter of 2013: In 2012, we had the opportu-

nity to work closely with Augusta State University in the consolidation process. With the positive results, we are pleased to announce more individualized training and networking opportunities that will be available at GRU Augusta to encourage the growth of biomedical and social/behavioral research. We look forward to continued success and growth that will better serve you in 2013.

Office of Laboratory Animal Services Facility-wide treatment plan activated: A

facility-wide treatment plan utilizing Ivermectin was implemented on Nov. 15, 2012 in response to the widespread pinworm and fur mite outbreaks in the rodent population on campus. This plan included a pre-treatment phase to determine sensitivity and was followed up by a 45-day treatment of all rodents on campus, irrespective of their parasite or infection status, with Ivermectin (15 Âľg/ml) delivered through the drinking water.

During the treatment phase, housing decontamination and transfer procedures and surveillance methods will be initiated. In response, LAS has concluded the first phase of a large-scale facility reorganization to reduce traffic between facilities, reduce the risk of cross-contamination and streamline operations for LAS, PIs and research staff.

A major component in the first phase was relocating all barrier-housed animals out of CB to maintain CB as an all-conventional facility. This also allowed for the designation of additional procedure spaces in each facility, providing space to perform procedures within the vivarium and limit movement to PI labs.

Congratulations to Sophia Jones: We are proud to announce that Training Coordinator Sophia Jones was recently chosen as one of three recipients for the 2013 SEAALAS (Southeastern American Association for Laboratory Animal Science) Travel Award. This award pays for meeting registration, hotel and a stipend to the 2013 Annual Meeting in Decatur, Ga. We are also proud to announce that Animal Operations Specialist Levi Trusty has received his Laboratory Animal Technician (LAT) certification.

Welcome new LAS veterinary staff: LAS has

Patricia Johnson

recently seen some personnel changes and have welcomed Dr. Patricia Charlton back as Associate Director and contracted Dr. J. Paul Spurlock as Clinical Veterinarian. Dr. Alvin Terry, Jr. has stepped in as the LAS Interim Director while a search committee actively advertises and recruits for the Director vacancy.

Division of Sponsored Programs Administration Let the NIH ASSIST : NIH has announced that

they are piloting a new fully electronic submission process for Multi-Project Application (program projects). The first funding opportunity to use the new ASSIST (Application submission System and Interface Submission) software. ASSIST is web based, has the ability to pre-populate applications with data in the NIG Commons and is fully electronic and identifies NIH and Grants.gov error checking capability diagnostic to be run prior to submission. Applicants are able to prepare multi-project applications, submit them to Grants.gov and view the assembled application from within a single system. The timeline for full implementation is forthcoming.

Mandatory Training Requirement for all PHS funded Researchers: All PHS funded re-

searchers are, in accordance with federal requirements and GHSU’s new Conflict of Interest Policy all Investigators need to receive training on conflicts of interest in research. PHS funded Investigators will receive an e-mail on n Dec. 1, 2012 requesting that they take this mandatory training. There are two ways to accomplish the mandatory training: 1) Investigators may take the 2011 WebBased Tutorial and send their certificates of training to Sarah White or Sheree Wright or they may use the module GHSU worked with CITI to design. The later includes training on GHSU policy and is strongly recommended.

The CITI Conflict of Interest module will automatically provide DSPA with certificates indication that the training has been completed. Either method takes approximately 45 minutes to one-hour to complete. Researchers are required to retake this training once every four years or as regulations or institutional Conflict of Interest Policy changes or is updated https://www.citiprogram.org/.

Reporting Sponsored Travel: All research Inves-

tigators must disclose, within thirty days of receipt, any sponsored travel or travel reimbursements for themselves of their immediate family which is reasonably related to their institutional responsibilities.

Disclosure information includes the: 1) sponsor, 2) duration, 3) destination, 4) duration and 5) purpose of the trip.  

Covered Individuals must disclose any Sponsored Travel which in aggregate exceeds $5,000 (received over the calendar year). Travel sponsored by: domestic or foreign for profit entities (e.g. industry), or nonprofit entities (e.g. foundations) as well as any funding received from foreign governments must be disclosed.   Covered Individuals do not need to disclose: direct reimbursement or income from seminars, lectures or teaching engagements sponsored by a federal, state, or local government, nor do they need to report travel sponsored by a U.S. higher education institution, an academic teaching hospital, a medical center, or a research institute affiliated with an higher education institution. Covered individuals do not need to report income from service on an advisory committee or review panel for a federal, state or local government agency; or from a U.S, higher education institution. If upon evaluation of the disclosure the Research Integrity Officer feels that additional information is needed to determine if the sponsored travel indicates a significant financial interest, then additional information such as the estimated or actual cost of the travel may be requested.

Division of Sponsored Programs Administration ary all members of the GHSU research community will receive notification that they need to complete their Annual Disclosure Form. Researchers will be asked to provide general information about their outside interest and activities to determine if a potential or actual conflict of interest which could affect their ability to do unbiased research is present. The form requests information about five categories of outside interests most likely to create a conflict of interest these include: income, ownership/ business relationships, consulting, and travel sponsored by certain types of outside entities (i.e. from foreign entities or industry). Annual disclosure is based on the previous calendar year (2012). Investigators report on outside interests for themselves and their immediate family members which are or could be seen to be related to their institutional responsibilities at GHSU. More information on conflict of interest see: http://policy.georgiahealth. edu/2010/09/23/individual-conflicts-of-interest-policy/

Announcing the Availability of Grants.

Select: The GSHURI has purchased a subscription to

Grants.Select. This funding search engine has a clean user interface and is intuitive. The system provides access to funding opportunities including everything from bioscience and medicine to arts and sciences as well as education and each record includes contact information, sponsor name and address, subject terms for related searches, and type of sponsor (Federal agency, foundation, research institute, etc.) The program can be configured to provide researchers with automatic updates on opportunities based on the criteria they set. For more information contact SPA.

SPA Holiday Week Closing: The Division of Sponsored Programs will officially be closed for the Holiday Week (Dec. 24, 2012 through Dec. 28, 2012). Please let us know as soon as possible if you will have a proposal due at this so that we can make arrangements to assist you with the review and submission of it. If there are other business matters that require DSPA assistance during that time please feel free to contact Sarah White at (sarwhite@gerogiahealth.edu) or on her cell at (713)408-2997. We do anticipate that a few individuals will be in the office that week so if you need help during that week please call X3087. We wish you all a wonderful holiday season and a happy, healthy 2013.

Patricia Johnson

Sample Annual Disclosure Form: In early Janu-

Division of Sponsored Programs Administration Sponsored Programs Fiscal Year 13 First Quarter: The Division of Sponsored Programs pro-

cessed 226 submissions valued at $43.23 million and received 235 awards valued at $43.08 million in the first quarter of Fiscal Year 2013. These numbers are up slightly from the same period in Fiscal Year 2012. Of the 226 submissions, 202/$38.49 million were research related with 69/$24.44 million submitted to the National Institutes of Health. An analysis of the awards received to date revealed that of the 235 overall sponsored awards, 204/$36.17 million were research related with 76/$23.70 million from the National Institutes of Health.

Thanks to all of our research faculty who have been so productive this year.

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Congratulations Linda Ashe:

Linda Ashe is retiring after 25 years of dedicated service to the institution. During her tenure she has held positions in the School of Medical (now known as the Medical College of Georgia), The Georgia Prevention Institute, and since April of 2003, the Division of Sponsored Programs. Linda has been a faithful and devoted Grant and Contract Officer. She is he is loved by the faculty and staff that she serves as well as her co-workers. In addition to her excellent customer service and keen knowledge of the sponsored activity, Linda always has a kind and uplifting word to offer all that she encounters. While we wish Linda all the best in her retirement, she will be sorely missed. A reception in Linda’s honor will be held on Thursday, Nov. 29, 2012 from 2 p.m. until 4 p.m. in the GHSU Student Center Conference Room, DA 2021. Thank you Linda, we appreciate you!

Office of Technology Transfer & Economic Development GRA Grant to Dr. Daron Ferris: Congratulations Clinical Research in Georgia Meeting: Into Dr. Daron Ferris, a faculty member in the Department novation & Opportunities for Success: GHSU of Obstetrics and Gynecology, who received a Phase 1A grant from the Georgia Research Alliance (GRA). The GRA grant will advance the development of Dr. Ferris’s device for more effectively and comfortably collecting samples for HPV testing. The GRA funds will be used for prototype design and small-scale production for testing purposes of the device which is projected to be of use with at least 4 million patients per year worldwide.

was well-represented at the first Clinical Research in Georgia meeting recently held in Atlanta. At this conference, attendees from the region discussed best practices in attracting and conducting clinical trials. GHSU was a sponsor of the meeting and presented a video highlighting its expertise and capacity for conducting clinical trials.

We’re looking forward to being a very visible once again at this meeting next year.

Welcome, Sisene Oncology: A spinout of French

More Incubator Tenants, More Products: The

biotech SISENE, Sisene Oncology has located in the Life Science Business Development Center, GHSU’s bio-business incubator. The company, which was recently awarded a $100,000 Georgia Research Alliance VentureLab Phase II grant, is developing a new class of innovative cancer therapies under the scientific direction of Dr. Olivier Rixe, head of the GHSU Cancer Center’s Experimental Therapeutics Program and leader of its Neuro-Oncology Multi-Disciplinary Clinic.

Faculty Absorb American Invents Act: Charles

Vorndran, J.D., Ph.D., of the Pabst Patent Group, addressed 30 faculty and staff concerning the America Invents Act (“AIA”) during a recent “Lunch and Learn” session sponsored by OTTED. The AIA was enacted into law on Sept. 16, 2011 and is the most sweeping change in U.S. patent law in many decades. A major change under the AIA is the movement from a “first to invent” approach to determining who may obtain a patent to a “first to file” system as used throughout the rest of the world.

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Georgia Health Sciences University incubator, located in the Life Sciences Business Development Center, is currently home to four companies: Camellix, Jinfiniti Biosciences, Luminomics, and Sisene Oncology. At present, these companies have created 25 jobs in the Augusta area. Earlier this year, Camellix introduced MighTeaFlow Green Tea with Xylitol gum, a new generation product for dry mouth, as well as ReviTealize Natural Hair Care with Green Tea and Botanic Extracts for Hair Thickening Shampoo and Anti-Dandruff Shampoo. Watch soon for Green Tea with Xylitol lozenges for dry mouth and AverTeaX, a new generation of natural treatment for cold sores/fever blisters in a daily lip protector and topical ointment.