Programs September 2014

1. ProgramsSeptember 2014

2. Connect • Learn • Get Help • The CTSI helps research teams work faster and better.

3. NCATS Transition • Leadership • Interim Director Tom Insel (Director of NIMH) • Chris Austin named as Director Sep 2012 • Divisions of Preclinical Innovation and Clinical Innovation had interim directors, Petra Kaufmann now Clinical Innovation Director • 12/23/2011: NCATS formed; NCRR disbanded • NCATS Purpose: advance translational sciences by • coordinating and developing resources that leverage basic research in support of translational science; and • developing partnerships and working cooperatively to foster synergy in ways that do not create duplication, redundancy, and competition with industry activities.

4. IOM Report – released 6/25/2013 • Suggested vision: • A “tightly integrated network that works collectively to enhance the transit of therapeutics, diagnostics, and preventive interventions along the development pipeline; disseminate innovative translational research methods and best practices; and provide leadership in informatics standards and policy development to promote shared resources.” • Recommendations • (roughly in order of prominence): • NCATS should take a more active leadership role as the principal party in cooperative agreements • Greatly streamline committee structure • The consortium should work more cohesively together and with external partners toward carefully chosen strategic goals • Establish a cross-consortium “Innovation Fund” • Tighten up the evaluation program • CTSAs should be allowed more freedom to capitalize on institutional strengths • CTSAs should concentrate efforts toward innovative education programs • CTSAs should continue to lead efforts in child health research

5. Deconstruction of CTSA Consortium

6. NCATS Response to the IOM Report • NCATS Advisory Council Working Group on the IOM Report: The CTSA Program May 2014 • Workforce Development-Goal: The translational science workforce has the skills and knowledge necessary to advance translation of discoveries. • Collaboration/Engagement-Goal: Stakeholders are engaged in collaborations to advance translation. • Integration-Goal: Translational science is integrated across its multiple phases and disciplines within complex populations and across the individual lifespan. • Methods/Processes-Goal: The scientific study of the process of conducting translational science itself enables significant advances in translation.

7. Project Development

8. Project Development

9. Targeted Outcomes-UR CTSI Goals- • Clinical and translational research education programs produce skilled multidisciplinary research team members • Local, regional and national partnerships support and enhance clinical and translational science • Researchers and research teams advance clinical and translational science • Clinical and translational research and supporting services are organized within a URMC academic home • A diverse spectrum of community members and organizations are engaged in the research process

10. Six Program Areas and Underpinnings

11. Clinical and translational research education programs produce skilled multidisciplinary research team members

12. KL2 Career Development Program • Institutional K-award program • 2 years, 75% effort • Salary support • Some support for other costs • Research project costs • Travel • Competitive application process • RFA released in July • Applications due ~ October • Awards announced ~ March • Two or three awards each year

13. TL1 Predoctoral Training Program • Institutional training grant linked to CTSA award • Three types of trainees • Academic Research Track for medical students (year-out program) • PhD students in the Translational Biomedical Sciences Program • MD/PhD students with an interest in translational science • Each trainee receives a stipend and may receive some support for other costs • 10 trainees per year • Mentors and trainees supported by CTSI Mentor Development Core

14. PhD - Translational Biomedical Science • One of the first of its kind anywhere • Goal: prepare individuals for academic and clinical careers involving the translation of basic biomedical research into clinical strategies to improve health • Required and elective coursework in diverse disciplines • Skill-building workshops and seminars • Research rotations (3 in first year) leading to selection of thesis topic

15. TL1 Predoctoral Training Program • Academic Research Track • 1 year of support • Medical students apply in December and are selected in February • Options • Pursue MPH or other research-related masters’ degree • Gain hands-on experience in a lab or research center • PhD-TBS students • Multi-year support is possible • MD/PhD students • Multi-year support is possible

16. Mentor-Protégé Curriculum • At beginning of program year, protégés develop a Research Career Development Plan with their mentors • Mentoring workshops for mentors and protégés • Mentor group meeting • Protégé group meeting • Fall – a member of the Core meets with each protégé • Spring – meeting with mentor-protégé dyad

17. Other Education Programs • Research Masters’ Degrees (provided by Dept. of Public Health Sciences) • MS – Translational Research • MS – Clinical Investigation • MPH • Non-degree programs • Academic Core Curriculum - fellows and residents – year-long program, weekly meetings • Junior Faculty Academic Core Curriculum – one-week intensive course • Skill-building training • Online training in Comparative Effectiveness Research • Online training in FDA regulatory fundamentals • eRecord for research • REDCap • i2b2 • Annual Scientific Symposium

18. Local, regional and national partnerships support and enhance clinical and translational science Researchers and research teams advance clinical and translational science

19. CTSI Research Collaboration & Services • Web-hosted information for easy reference http://www.urmc.rochester.edu/ctsi/research-help/ • Find a range of resources and services to support each stage of research development and operations • Research Help Desk • ResearchHelp@urmc.rochester.edu • Functions as an information hub, supporting research teams • Questions Answered • Resources Identified • Support for study design • Mentors, collaborators and a range of institutional services • Shared resources to include in research plan • Guidance and assistance to navigate regulations and policies

20. Voucher Program To request a voucher: http://www.urmc.rochester.edu/ctsi/funding/voucher-system.cfm

21. Voucher Funding by Beneficiary ($000s) Total = $240K since 5/2011

22. CTSI Project Funding Programs • Pilot Studies • Goal: facilitate new research and future project funding • 1 year, $50,000 • Trainee Pilots • Goal: support trainee research • 1 year, $25,000 • UNYTE Pilots • Goal: stimulate new cross-institutional collaborations • 1 year, $50,000, two or more UNYTE institutions • Novel Biostatistical and Epidemiologic Methods • Goal: stimulate new methods to improve validity, accuracy, scope or speed • 2 years, $20,000 • Incubator Program • Goal: accelerate innovative scientific discovery leading to new research programs • 2 years, $125,000, two or more linked projects

23. Pilot Funding by Department ($000s)

24. Clinical and translational research and supporting services are organized within a URMC academic home

25. Clinical Research Center • The CRC provides support for patient-oriented research: • Welcoming In- and outpatient facilities located within the Medical Center (G-5035) and in the Saunders Research Building (1.302) • Experienced assistance in Research Nursing, Bionutrition, and Clinical Research Coordination • The Center accommodates pediatric to adult research subjects. • Access to the Center requires a short application and IRB approval. • Modest fees are charged for services.

26. Expanding the reach and efficiency of clinical trials through technology • 21st century technology and methodology should expand the availability of clinical research • Clinical trials of new interventions (drugs, devices) will likely benefit the most from these new methods • Using remote access (things like Skype) will permit research participants to be seen at home • Using remote data sensing (like via smart phones) will simplify getting information • Better planning of studies will allow them to be smaller and more efficient

27. A diverse spectrum of community members and organizations are engaged in the research process

28. Improving the health of our community(s) • Healthcare delivery will change, driven by ACA and financial forces • URMC is committed to its Community mission • Healthshould improve as healthcare changes • We need to measure what is of most importance to the health of the community and target change in healthcare to the community needs • The CTSI wants to be sure that the community’s needs for healthcare change, and measuring the impacts on community health are a URMC priority • We need to organize how that input is structured so that it is consistently heard and acted upon

29. National CTSA Directions • Revamped NCATS organization- P Kaufmann • National Steering Committee setting priorities • Site supplements to lead national joint efforts • Future areas of focus uncertain still- recent RFA has substantial changes especially for CRC like structures and pilot funding • Team science essential

30. For more information… http://us6.campaign-archive1.com/home/?u=85ca914d3653b31ff7ca776b9&id=65bec3c724 Web www.urmc.rochester.edu/ctsi http://urctsi.wordpress.com/ http://www.linkedin.com/groups/University-Rochester-CTSI-4334207?trk=myg_ugrp_ovr http://www.youtube.com/user/URCTSI/featured https://twitter.com/#!/ur_ctsi http://www.flickr.com/people/urctsi