1. Introduction to the Institute of Translational Health Sciences Kim Folger Bruce, PhD Director of Research Partnerships July 17, 2009

2. Learning Objectives Learn about the ITHS cores and available services that support clinical and translational research teams Learn about the ITHS cores and available services that support clinical and translational research teams Learn how to navigate the new ITHS website Learn how to navigate the new ITHS website Learn how to become a member Learn how to become a member

3. ITHS Overview The ITHS is part of a national consortium, the Clinical and Translational Science Awards (CTSA), and is funded from the National Center for Research Resources, part of the National Institutes of Health. www.ctsaweb.org www.ctsaweb.org The Institute is a partnership between the University of Washington, Seattle Children’s, the Fred Hutchinson Cancer Research Center and other local/regional institutions dedicated to improving human health. Helps researchers obtain the education, resources and collaborations necessary to translate discoveries into practice.

4. ITHS Mission The ITHS mission is to create, enable, and sustain innovative translational research and collaborations across disciplines and professions which will accelerate the development of concepts and tangible products that will improve human health. Our common purpose is to: Foster innovative research and research partnerships Create and sustain research resources Ensure a translational research pipeline through robust education and career development programs

5. Definition of Translational Research Translational research involves moving knowledge and discovery gained from the basic sciences to its application in clinical and community settings. This concept is often summarized by the phrases "bench-to- bedside" and "bedside-to-community" research.

6. Phases of Translation Translational research has been described in phases of translation, or "T-phases." The ITHS has adopted a model of 5 phases (T0-T4). T0 is characterized by the identification of opportunities and approaches to health problems. T1 seeks to move basic discovery into a candidate health application. T2 assesses the value of application for health practice leading to the development of evidence-based guidelines. T3 attempts to move evidence-based guidelines into health practice, through delivery, dissemination, and diffusion research. T4 seeks to evaluate the “real world” health outcomes of population health practice. adapted from Khoury MJ. et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genomic discoveries into health care and disease prevention? Genet Med 2007:9(10):665-674.

7. Innovative Research and Research Partnerships Pre-clinical Research Development Network Biomedical Informatics Community Outreach and Research Translation CoreResearchResources Clinical Research Center Network Translational Technologies and Resources Core Center for Biomedical Statistics Regulatory Support and Bioethics Core ITHS Core and Program Structure Administration: Portal and Program Incubator Strategic Development and Evaluation Education and Career Development Short Courses TL1 Tuition Support KL2 Overarching Mentoring Programs Funding Opportunities

8. ITHS Consultations and Services

9. ITHS Portal Service The Portal evaluates project goals and provides information about: ITHS and institutional resources and services Pilot and other funding opportunities Educational programs/mentoring Collaborations ( through membership database) General questions about translational and clinical research

10. Pre-Clinical Research Development Network 1. Drug and Device Development Advisory Committee 2. ITHS/Coulter MBA summer fellowships 3. Ignition Awards 4. Academic Drug Development Symposium Highlights to date: 2 types of Ignition Awards Primate center (3) Pharmacy (3) Sponsored 7 MBA students Supported 3 IND submissions Supported 2 SBIR grant proposal submissions

11. Regulatory and Bioethics Support 1. Research bioethics consultation 2. Research bioethics collaboration and mentorship 3. Regulatory consultation visit program 4. Regulatory audit program In place and available In place and available 5. Medical Monitoring and SAE reporting In pilot phase but available In pilot phase but available 6. DSMB program In development In development Highlights to date: Cross-institutional investigator clinical research training program 8 junior investigators thru educational monitoring program Completed the first year: ITHS Clinical Research Educational Series Established a research coordinator core

12. Study and Data Management 1. Study data management tools 2. Computing and IT support for clinical and translational research 3. Accessing electronic medical record data 4. Evaluation support 5. Biomedical statistics 6. Research coordinator pool Highlights to date: Launched the Center for Biomedical Statistics Electronic tools for clinical trials management Amalga collaboration with Microsoft Toyota Lean: reduced nurse overtime by 50% (CRC), decreased wait time for appointments

13. Research Lab Services 1. 1. Lab instrumentation and techniques 2. 2. Scientific instrumentation data access 3. 3. Bionutrition and body composition consultation Working in the Community 1. Conducting practice-based research 2. Building partnerships with American Indian/Alaska Native communities 3. NWABR: Request a speaker or get speaker training Highlights to date: Created an institutional technology inventory with searchable web tool Established WWAMI Practice Based Research Network Piloted Data-Quest at key WWAMI practice sites Speaker training workshop

14. ITHS Grant Programs

15. Small Pilot Project Grants Twice yearly 10K, applications due Sept 28, 2009 Technology/Resource Access Grants Three times a year 10K, applications due November 1, 2009 Ignition/Primate Center Award Annually 100K, applications due February, 2010 ITHS Ignition/Pharmacy Award Annually 20-40K, applications due in October, 2009 Highlights to date: In first 16 months, ITHS awarded 60 grants for over $1M to investigators representing 9 institutions Funding level 20-35% depending on mechanism Training program for grant review Mentor program for those grants that miss funding

16. Education and Training Programs

17. Predoctoral Multidisciplinary Clinical Research TL1 TrainingPredoctoral Multidisciplinary Clinical Research TL1 Training - offered as both a summer and a 12-24 month certificate-degree program. Postdoctoral Clinical Research Career Development KL2Postdoctoral Clinical Research Career Development KL2 - multidisciplinary program, up to 5 years in length ITHS Tuition Support FellowshipITHS Tuition Support Fellowship - provides tuition support for MS or MPH degree in Epidemiology or Health Services from the School of Public Health and Community Medicine. Degree and Certificate Programs

18. ITHS monthly Clinical Research Education SeriesITHS monthly Clinical Research Education Series - A seminar series for investigators and research staff that features 23 clinical and translational research topics to be presented over two year cycle. ITHS monthly Career Development Series for ScholarsITHS monthly Career Development Series for Scholars - A seminar series for scholars that features topics such as grant-writing, writing for publication, presenting at scientific meetings, and more. ITHS monthly Technology Resources Seminar Series - A seminar series highlighting local research resources Other ITHS Seminars, Training, and Short Courses Other ITHS Seminars, Training, and Short Courses - A broad array of training opportunities including the ITHS annual Boot Camp, Fundamentals of Clinical Trials, and more.ITHS annual Boot Camp Educational Clearinghouse - Clinical and translational research training opportunities outside of ITHS, including certificate and degree programs, courses, training (, Good Clinical Practice, Human subject protection, etc.), workshops, and clinics offered by partners and other institutions. Seminars and Short Courses

19. Clinical and Translational Research Boot Camp The ITHS Clinical and Translational Research Boot Camp Basic training in clinical and translational research methods Topics include: biostatistical concepts, clinical epidemiology and study design, ethical issues in research on human subjects, grantsmanship, randomized clinical trials, and regulatory issues. The targeted audience is primarily incoming fellows and new faculty, other interested parties are welcome. Participants must be either an ITHS Member or Scholar to attend. Dates: September 21 through 25, 2009 Time: 9:00-11:50, 1:00-3:50 Monday-Friday (thirty 50-minute sessions) Location: University of Washington, Magnuson Health Sciences Building, Room T733 Online Registration: Pending All lectures will be streamed live on-line and archived to be made available later via the web as a benefit to ITHS members. For more information about the ITHS Clinical and Translational Research Boot Camp please send an email to shrtcrs@u.washington.edu or call (206) 616-5163. shrtcrs@u.washington.edu

20. How to Navigate – ITHS.org

21. Request a consult/Portal inquiry

22. Discover ITHS Cores/ Regulatory Support and Bioethics

23. Regulatory Support and Bioethics

24. Research Coordinator and Study Support Services

25. Research Coordinator Core Services

26. Tool Kit at https://www.iths.org/research/toolkit/coordinator

27. Tool Kit

28. Keyword Searching – ITHS.ORG

29. Search result: CRC

30. Find a Resource

31. Translational Technologies and Resources Core Resources directory http://www.iths.org/resources

32. Resources Directory: Northwest Institute of Resources Directory: Northwest Institute of Genetic Medicine

33. Links to website and contact information Northwest Institute of Genetic Medicine Links to website and contact information

34. Training for scholars

35. Online Training

36. Glossary of translational terms https://www.iths.org/glossary/term/107

37. Forms and Templates

38. ITHS Membership

39. To reach our goals of promoting translational research requires collaboration between many groups: academia, industry, non-profit agencies, government, and the community. Any researcher or individual interested in translational research from any group is invited to become a member of the ITHS.become a member Currently have 754 members from the WWAMI region

40. Become a Member of the ITHS Translational Community

41. Becoming a Member http://www.iths.org/membership

42. Questions?