1. UAMS CENTER FOR CLINICAL & TRANSLATIONAL RESEARCH (CCTR) CCTR Novel Methodologies UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES uams.edu/cctr Curtis L. Lowery, MD CCTR Director 501-686-5847

2. UAMS CCTR Goal The CCTR’s overarching goal is to transform the pace, effectiveness, and quality of translational research among UAMS and its partners, resulting in better health for all Arkansans.

3. Novel Methodologies & Pilot Studies  Facilitate research innovation and progress  Stimulate and solidify multidisciplinary research collaborations  Promote high-quality translational research Co-Directors S. Michael Owens, PhD Sudhir Shah, MD, FACP Overall Goals

4. Establish a critical group of experienced clinical and translational research facilitators aka Rainmakers E The Rainmakers will enhance translation research by:  Identifying upcoming scientists and clinicians who have innovative ideas  Assisting with the formation of interdisciplinary research teams  Accelerating the advancement of high-impact translational research  Evaluating progress to determine those elements that contribute to research failure or success  Participating actively in developing and administrating the different pilot programs

5. Rainmakers  S. Michael Owens, PhD, Co-chair (COM, Pharmacology & Toxicology)  Sudhir V. Shah, MD, FACP, Co-chair (COM, Nephrology)  Mary Aitken, MD, MPH (COM, Pediatrics; COPH)  Cornelia Beck, PhD, RN (CON, COPH, COM)  Warren Bickel, PhD, (COM, Psychiatry)  Marie Chow, PhD (COM, Microbiology & Physiology)  Michael Douglas, PhD (UAMS BioVentures)  Martin Hauer-Jensen, MD, PhD (COP, COM)  Katharine Stewart, PhD, MPH (COPH)

6. Rainmakers S. Michael Owens, PhD (Professor, Pharmacy and Toxicology)  Director, Center for Alcohol and Drug Abuse  Wilbur D. Mills Endowed Chair in Alcohol and Drug Abuse Prevention  Research interests: antibody-based medication for drug abuse; served on several expert panels including NIH and NSF  Founder and CSO, InterVexion Therapeutic, LLC Sudhir V. Shah, MD (Professor, Department of Internal Medicine)  Director, Division of Nephrology  Research interests: pathophysiology of renal and cardiovascular disease  NIH and VA funded since 1981; NIH training grant awardee; holder of 12 U.S. patents  Licensed technology through BioVentures to Biosite, Inc.  Assisted with obtaining FDA approval of an IND for a Phase III trial

7. Novel Methodologies & Pilot Studies Awards for Innovative Clinical and Translational Research  Investigator-initiated Pilot Award (up to $50,000/award)  Collaborative Research Award (up to $100,000/award)  High-impact Award (up to $150,000/award)

8. CCTR resources to assist with study design, proposal development, and conduction of the study itself include:  Administrative and regulatory support (IRB, protocol development, regulatory review)  Clinical laboratory and nursing services  Data safety and monitoring services  Biostatistical support, including design, analysis, and manuscript preparation  Epidemiological support and consultation  Biomedical informatics access and support  Behavioral research methods and support  Community engagement  Educational and career development Investigators are encouraged to use any of the above resources as appropriate during development of the pilot application by calling (501) 614-CCTR (2287). The CCTR Navigator will provide assistance in accessing these resources. You may visit www.uams.edu/cctr for a full description of resources available.

9. Investigator-initiated Pilot Award  The purpose is to provide seed money for obtaining preliminary data or proof-of-concept studies for extramural grant applications  The aim is to support studies focused on translating laboratory and/or clinical findings into new treatments and interventions

10. Investigator-initiated Pilot Award Applications Cover page of the grant application to include: Cover page of the grant application to include:  A brief summary of the project and the major purpose of the pilot data to be generated  Description of the innovative, translational potential of this project  Description of the major, long-term impact of this research on human health  Explanation of how data generated by this study will lead to extramural funding

11. Collaborative Research Award  Promote collaborations between investigators  Accelerate the translational and/or clinical potential of research findings through transdisciplinary teams of investigators, which may include community partners  Provide seed money to generate preliminary data for future extramural grant applications The purpose is to:

12. Collaborative Research Award Cover page of the grant application to include: Cover page of the grant application to include:  Description of the contribution of each collaborator to the project  Explanation of how this collaboration will accelerate the translational potential of the research program  Description of the major long-term impact of this research

13. High-impact Award  Provide funding to fill a critical gap for the clinical development of a discovery, a gap that cannot be filled easily by funding from NIH-type resources.  Assist investigative teams with a discovery that is ready for an initial clinical trial or a clinical development ready for expanded implementation in the community The purpose is to:

14. High-impact Award Cover page of the grant application to include: Cover page of the grant application to include:  Description of how the project will have a transformative impact on human health or healthcare delivery  Explanation of how this award will have a significant programmatic impact on the trajectory of the research  Description of how successful completion of the project fits into the long-term research goals

15. Making Connections  The CCTR Rainmakers have already connected with over 70 investigators at UAMS, ACH, and the AHECs to engage investigators in translational research, provide guidance on pilot studies, and form interdisciplinary teams  Nine potential applicants received biostatistical consultations for pilot applications  Five investigators received help with early protocol development and IRB consultation

16. Funding Information  Current deadline — November 9  Anticipated start date for pilot funding — January 1  RFAs available — http://www.uams.edu/cctr/novelcore/novelpilots.asp  FAQs — http://www.uams.edu/cctr/novelcore/novelpilots_FAQ. asp Phone or e-mail — 501-319-4513 PaulD@uams.edu