1. First Annual Meeting

2. Project Development Teams: Concept and Example Scott C. Denne, M.D. Professor of Pediatrics Associate Director of the Indiana CTSI

3. Barriers to Translational Research Lack of expert guidance in multidisciplinary research Lack of coordinated access to resources Insufficient protected time for experts to work with investigators Complexity of regulatory requirements Lack of coordinated access to patient populations

4. Project Development Teams Purpose Interface with basic and clinical scientists to design and implement high quality, feasible, fundable clinical/translational research projects “One stop shop” providing investigators access to multidisciplinary research expertise, biostatistics, regulatory and nursing support, and pilot funds

5. Project Development Teams Characteristics – Accessible – Facilitative – Interactive – Collaborative Not simply review groups – Will discuss ideas and concepts with investigators and fully assist in developing research projects

6. Project Development Teams Responsibilities Identify testable hypotheses Write protocols; Review proposed protocols Identify clinical collaborators Oversee IRB submission Specify resources necessary Provide pilot funds Monitor progress

7. Pediatric Project Development Team Members Clinical researchers Basic scientists Health service researcher Biostatistician Regulatory support Research Nurse coordinator Project Manager

8. Pediatric Project Development Team Members/roles 3 active experienced clinical researchers Design evaluate, write clinical protocols Specify patient populations and clinical collaborators 2 active experienced MD basic scientists Translators between basic scientists and clinicians Basic science perspective on clinical studies

9. Pediatric Project Development Team Members/roles Heath service researcher Access databases to identify patient populations Link to community research Biostatistician Provide input into study design during development Provide statistical analysis for studies

10. Pediatric Project Development Team Members/roles Regulatory Support Provides case-specific regulatory advice during design and conduct of study. Provides awareness of other protocols, resources, programs. Research Nurse/Coordinator Helps develop and write the protocol, recruitment process, budget, IRB required paperwork, and Investigational New Drug/Device applications. Performs/delegates the study procedures with subjects.

11. Pediatric Project Development Team Example Pediatric basic scientist makes an in vitro observation of the effect of glucose on endothelial progenitor cells Meets with PDT: explore extending studies to pregnant women and their babies Clinical design and protocol written by PDT, including biostatistics PDT supports IRB submission and approval

12. Pediatric Project Development Team Example (continued) Research nurse assigned to obtain pilot samples Pilot funds provided by PDT ($10K) R21 submitted and funded Manuscript published in Diabetes R01 submitted and given favorable score but not funded; additional data obtained and R01 resubmitted and currently under review.

13. Project Development Teams Preclinical PDT Pediatric PDT Adult PDT Behavioral/Population Science PDT TRIP PDT Purdue PDT

14. Project Development Teams Summary Facilitate, expand, and enhance collaborative translational research Bring expertise and resources to investigator in one setting Teams interact with overlapping membership