Access to National Consortium of Academic Health Centers – 60 now

1. Indiana Clinical and Translational Sciences Institute A statewide Laboratory for accelerating Clinical and Translational Research

2. Access to National Consortium of Academic Health Centers – 60 now

3. Indiana CTSI Partners – Providing Leveraging Opportunities Throughout the State IU Health Eli Lilly and Company Regenstrief Institute Richard M. Fairbanks Foundation Indiana University Notre Dame Purdue University Cook Group, Inc BioCrossroads Roudebush VA Medical Center Roche Diagnostics Wishard Health Services Indiana State Government

5. Journal of Immunology • 293 Transformative Change #3: Creating the CTSI HUB HUB Online Grant System Indiana CTSI Service Cores CITE Education

6. $12.5 million in awards distributed 2008-2011

8. Project Development Teams • You should call for PDT assistance if youneed to: • Generate preliminary data for a new or revised submission of a grant • Demonstrate feasibility of a new collaboration • Find a clinical collaborator to translate your successful basic science program • Refocus your research program • Find core services or novel technologies to move your research forward • For questions or assistance, please contact the Translational Research Sciences Officer: Tammy Sajdyk, PhD; 317-278-7488; tsajdyk@iupui.edu

9. Indiana CTSI Project Development Teams • Purpose: To provide investigators with access to multidisciplinary teams that will assist and guide in the development of translational projects Pediatric Sciences Imaging Sciences Behavioral/ Population Sciences Clinical Sciences Preclinical Sciences • Chair: Vickie Champion • Co-Chair: Greg Zimet • Project Manager: Liza Sumpter • Chair: Scott Denne • Project Manager: Lucy Miller • Chair: Gary Hutchins • Project Manager: • Paul Territo • Chair: Sharon Moe • Co-Chair: Mike Sturek • Project Manager: Tammy Sajdyk • Chair: Mark Kelley • Project Manager: Crystal Banks Community and Urban Health Purdue (Bioengineering and Nutrition) Notre Dame (Preclinical) IUB (Social Networking) Program Project Planning • Chair: TBN • Project Manager: Andy Bullock • Chair: Bernice Pescosolido • Project Manager: Alex Capshew • Chair: Sarah Wiehe • Project Manager: Julie Driscol • Chair: Siu Hui • Project Manager: Julie Driscol • Chair: Connie Weaver • Project Manager: • Tommy Sors

10. Predoctoral (TL1) 18-20 positions Must have completed  1 yr of PhD program Dual mentorship of clinician and non-clinician (PhD) scientist ~ $24,000 stipend/yr + health insurance + partial tuition if needed Young Investigator (KL2) 12-16 positions Clinician-scientist (MD, DDS, DVM, PharmD, PhD nurse, dietician, psychologist, others) A few campuses have basic science K awards Assistant professors Dual mentorship 75% salary support up to $90,000/yr Pilot funds (~ $10,000) Indiana CTSI Training Awards • For questions or assistance, please contact Suzanne Galbraith; sgalbraith@regenstrief.org

11. Masters’ Degrees in Clinical or Translational Research

12. Enhanced Access to Design & Biostatistics Program • Free Service: Design and analysis plan for animal, laboratory, clinical, behavioral, and health services research • Free Service: Database development (e.g. REDCap, custom) • Free Service: Education (e.g. short courses, lectures) • Hourly Charge: Data Management and Analysis • Requests for assistance: https://redcap.uits.iu.edu/surveys/?s=nBEjN8

13. Indiana CTSI Regulatory Knowledge and Support (RKS) Program • Our mission:Provide comprehensive content expertise regarding relevant federal, institutional, and local regulations that is accessible to all CTSI researchers and translational centers throughout the state • Our services: • Consultation – provide case-specific regulatory advice for researchers/research teams regarding projects which involve human subjects research • Institutional Review Board (IRB) expertise • Other regulatory obligations (e.g., Food and Drug Administration (FDA), etc.) for drug and device research • Project Development Team (PDT) participation • Education– conduct educational presentations related to human subjects regulatory issues for investigators, their research staff, research groups, and/or academic departments • Monthly IU Research Coordinator Educational Programming • IU Research Coordinator Certification Program (RCCP) • Other presentations as needed • For questions or assistance, please contact the RKS Program Manager: Jody Harland, MS, CIP; (317) 274-2115; harlandj@iupui.edu

14. Translational Technologies Resources Improve research by encouraging investigators to utilize novel technologies • Facilitate access to 60+ technology core resources https://www.indianactsi.org/servicecores • Core Pilot Funds • Technology education through symposia • Support for shared software and clinical trial material development • For questions or assistance, please contact Director: Ken Cornetta, MD; Lilith Reeves; 317-278-6930; lreeves@iupui.edu

15. Bioethics and Subject Advocacy Consultation: Translational Research Ethics Consult Service (T-REX) - free help to clarify and address issues in the planning and conduct of human subjects research. Policy: supports development and reviews policy. Education: Classroom and small group instruction, mentoring, presentations, Web-based modules (CITI) Outreach: works with internal and external groups to engage communities in the discussion of ethical issues in translational research. Information: in-depth reference support; custom literature reviews; digital, ethics news and literature - https://www.indianactsi.org/programs/bsap/big. Subject Advocacy: advocates serve on Protocol Development Teams and assist with Data Safety Monitoring. • For questions or assistance, please contact: Director: Eric M. Meslin, PhD; Jere Odell, MLS; 317-278-4034; bsap@iupui.edu

16. Community Health Engagement Program (CHEP) • Help initiate and foster community-academic partnerships throughout Indiana (Currently Engaging over 300 community groups) • Stimulates and supports high quality community-based and community participatory research • Provides pilot grants • Runs a Community Newsletter • Created a New on-line Tool for best practices for all CTSAs

17. Integrated CTSI Clinical Research Facilities • For questions or assistance, please contact Administrative Manager: • Sharon Cromer; scromer2@iupui.edu; Operations Director: Laurie Trevino; lhackwar@iupui.edu

18. Subject Recruitment Office For more information or assistance from our recruitment office, please contact: Brenda Hudson, MA, CCRP, brlhudso@iupui.edu; (317) 278-0913

19. Mission: To develop a statewide collection of biospecimen as a research tool to enhance translational research and to promote personalized therapy. • Established in July 2010 • Funded by the: • Lilly Endowment • NCRR Clinical and Translational Sciences Award • Future, unspecified use of biological samples – linked to EMR in perpetuity • Prospective informed consent will be obtained For more information or assistance, please contact: Anne Nguyen, annnguye@iupui.edu; 317-656-4167; Website: www.indianabiobank.org

20. QUESTIONS