The UCSF Clinical and Translational Science Institute and Campus Core Resources

1. The UCSF Clinical and Translational Science Institute and Campus Core Resources Fred Waldman CTSI Translational Technology and Resources ProgramCore Leadership RetreatNovember 6, 2007

2. NIH Clinical and Translational Science Awards • Accelerate clinical and translational research - moving new discoveries into the community • Encourage innovative approaches • Lower barriers between disciplines • Catalyze change: break silos, break barriers, and break conventions • Train next generation of clinical scientists RFA issued October, 2005

3. Meeting the Translational Research Challenge at UCSF • Four professional schools • Multiple clinical and translational research units • Little cross-cutting organization • Multiple redundancies • Insufficient infrastructure to support C&T research LH Cancer Center VAMC MB MCB Parnassus SFGH

4. The UCSF Response The Clinical and Translational Science Institute

5. UCSF Clinical and Translational Science Institute Clinic Bench Community • Aimed at providing infrastructure and support for clinical and translational research

6. UCSF Clinical and Translational Science Institute Clinic Bench Community • Aimed at providing infrastructure and support for clinical and translational research • Involves more than 200 senior faculty members across all schools, and clinical and translational units

7. UCSF Clinical and Translational Science Institute Clinic Bench Community • Aimed at providing infrastructure and support for clinical and translational research • Involves more than 200 senior faculty members across all schools, and clinical and translational units • Designed to accommodate and to facilitate needs of all individuals/units engaged in clinical and translational research

8. Enhance and Expand Our Training Programs Training • Clinical and translational science training • Training in other program functions

9. Build the Infrastructure to Facilitate Translational Science Training Research Design Research Implementation • Clinical and translational science training • Training in other program functions • Design, biostatistics, & ethics • Translational methodologies • Participant interactions • Translational technologies • Regulatory • Informatics • Community • Global health • Health policy

10. Provide Pathways to Successful Careers in Clinical and Translational Research Training Research Design Research Implementation Career Advancement • Clinical and translational science training • Training in other program functions • Design, biostatistics, & ethics • Translational methodologies • Participant interactions • Translational technologies • Regulatory • Informatics • Community • Global health • Health policy • Pilot studies • Career advancement

11. Tying It All Together Training Research Design Research Implementation Career Advancement • Research education & training • Training in other program functions • Design, biostatistics, & ethics • Translational methodologies • Participant interactions • Translational technologies • Regulatory • Informatics • Community • Global health • Health policy • Pilot studies • Career advancement CREATION OF A “VIRTUAL HOME” Central Administration Web-based home Collaborative Environments

12. CTSI Leadership • Overall Integrated Approach McCune/Autry • Tracking & Evaluation Breyer/Brindis Program Directors Team Susan Autry • Informatics Segal/Showstack/Kamerick • Design, Biostat, & Ethics Johnston/Bacchetti/Lo • Translational Methods Johnston/Rosenthal/Santi • Research Training Hulley/Martin/Yamamoto • Global Health McKerrow/Padian • Career Advancement Damsky/Brown Mike McCune Deborah Grady – Joel Palefsky – Dan Lowenstein • Pilot Studies Giacomini/Volberding/ Waldman • Community Engagement Grumbach/Selby • Virtual Home Kahlon/Cameron • Health Policy Luft/Kahn • Regulatory Support Lee/Wiener-Kronish • Participant Interaction Schambelan/Wara • Translational Tech Waldman/Nelson/ Derynck/Sinclair

13. Translational Technology and Resources • Mandate to facilitate availability of campus cores to basic, translational, and clinical scientists, and to support campus core functions. Fund development of new technologies for campus Cores Developed UCSF Cores questionnaire, database, and Core Managers group. Hosting Core Leadership Retreat. Academic Services Coordinator (Robert Smith) available to develop technology training programs and to assist UCSF investigators in utilization of existing technology cores. Initial activities are being focused on campus imaging cores and tissue/histology cores

14. 2006 Translational Technology Awards Christopher Barker, PhD; Gladstone Institute of Cardiovascular DiseaseDNA Microarray Analysis of Formalin Fixed Paraffin Embedded Samples Charles Chiu, MD; School of Medicine, Infectious DiseasesEstablishing a Microarray Test for Pan-Viral Identification (Virochip) as a Core Laboratory Resource Lawrence Fong, MD; School of Medicine, Hematology/OncologyFlow Cytometry-Based Immune Markers of Clinical Disease Steven Hall, PhD; School of Dentistry, Cell and Tissue BiologyTowards Development of Software Infrastructure to Enable Translation of Mass Spectrometry Data into Clinical Solutions Steven Hamilton, MD, PhD; School of Medicine, PsychiatryNanoscale Sample Manipulation for Clinical Genomic Applications Yong Huang, PhDl; School of Pharmacy, BiopharmacyBioanalytical core for clinical and translational research Nola Hylton, PhD; School of Medicine, RadiologySmall Animal MRI Techniques for Treatment Response Assessment in Solid Tumors Matthew Krummel, PhD; School of Medicine, PathologyHigh-Resolution Quantitative Micro-Endoscopy

15. Tissue Banking at UCSF • Clinical and translational scientists can’t easily find services and tissues for studies • Campus biospecimen service cores and repositories are not well publicized • Need system for tracking specimens and data from the patient to the bank and from the bank to translational scientists • Tissue inventory database (Freezerworks), surveys of tissue bank services and biospecimens, web based database to allow matching between scientists and specimen collections

16. BREAD (Biostats, Research Ethics, and Design) Make available a consultation service to the clinical and translational research community -- especially important for junior investigators and early study phases (on a recharge basis) Biostatistics Study Design and Implementation Research Ethics Data Management (Data Center and Database design and management)

17. Biomedical Informatics • Developed database design and management service Developed bioinformatics analysis service for high-level structured data Will soon beta-test the secure research environment (secure data servers with controlled access) Planning for research data environment, which will allow access to administrative and clinical data for research

18. Data Management Unit Consult on choice of database platform/vendor Design/develop/maintain/support study databases Modular system of design Host study databases Assist with querying or existing research databases

19. Clinical and Translational Science Training • Developed a clinical and translational research training program for clinical residents that began in January • Developed a track in T1 and T2 translational research for clinical researchers to be offered in Y2 • Courses in T1 translational research for lab-based researchers are being developed

20. Regulatory Knowledge and Support Established a new business research unit to facilitate contracts and grants services Established new services to facilitate CHR and Conflict of Interest review and FDA submissions Established a seminar series focused on drug development

21. Clinical Research Centers CTSIClinical Research Center • Consolidated three separate GCRCs into one new unit • Added three new units at Kaiser Permanente, the VAMC, and Children’s Hospital of Oakland. A fourth new unit in the Tenderloin is being established

22. Community Engagement Hired navigators at UCSF (Paula Fleisher) and at Kaiser (Maureen Fitzpatrick) to facilitate collaborative research • Four active groups working on: Community Clinician Relations, Community Academic Research Engagement, Communication of Research Relevance, UCSF/Kaiser partnerships

24. Strategic Opportunities Support Center Cycle 1 (Spring, 2007) Reviewed 260 LOIs followed by 98 full applications • Awarded 23 grants for a total of $1.06M Cycle 2 (December 15, 2007) Created campus-wide application submission and review group in collaboration with REAC, CFAR, and Cancer Center (Resources Allocation Program -- RAP)

25. Resources Allocation Program –RAPhttp://rap.ucsf.edu Pilot Projects Pilot Research Awards for Junior Investigators in Basic and Clinical/Translational Sciences ($30k) REAC and SOS/CTSI General Pilot Award Program in HIV/AIDS Basic Science Award Program In HIV/AIDS Technologies and Methods Shared Instrument Awards ($75k/$30k) – must be placed into cores Translational Technology Development Awards ($75k) – into cores Novel Clinical/Translational Methods Catalyst Awards ($30k) Technology Mini-Symposium Awards ($2500) Multidisciplinary Awards Multidisciplinary Research Project Planning Awards Multicenter Start-Up Planning Awards

26. Resources Allocation Program –RAPhttp://rap.ucsf.edu Career Development Hardship Awards New Direction Awards Under-Represented Faculty & Senior Fellows in Clinical and Translational Research Awards Flexible Mini-Sabbatical/Leave Awards Mentored Scientist Award Program in HIV/AIDS International Global Health Awards Fogarty International Training Awards in HIV/AIDS International Mentored Scientist Award Program in HIV/AIDS

28. Tying It All Together Virtual Home • Launched our initial website and coordinated content development and program representation across CTSI • Collaborated with programs on the development of web-based tools for specific information systems and service of CTSI programs, e.g., SOS, TTR, CA • Conducted internal researcher & administration needs assessment

29. Additional Campus-wide Activities • Coordination of programs shared between the CTSI and the office of the Executive Vice Chancellor • Integration of SOS with other pilot funding sources on campus (e.g., REAC) - to form “RAP” • Coordination of efforts across campus to prioritize and integrate clinical and translational core services • Coordination of CTSI programs with existing campus programs aimed at industrial alliances, e.g., the Industry Alliance Coordinating Committee, the Research Administration Board, and QB3

30. The National CTSA ConsortiumFY2006 and 2007 CTSA Awards CTSA Awards - 2006: 12 CTSA Awards - 2007: 12 UW WA ME MT ND Oregon HSU VT MN OR U Rochester NH Mayo-Rochester Columbia ID WI NY MA SD UM RI WY UWisc MI Yale UC UC Davis U Penn CT NJ UIowa OH Rockefeller IA PA U Pittsburgh NE NV JHU Cornell DE CWRU IN IL UC San Francisco Wash U UT MD CO WV VA KS MO CA KY Vanderbilt Duke TN AZ Emory OK AR SC NM GA AL UTSW MS TX UTHSC,Houston LA AK FL HI

31. TheNational CTSA Consortium • Zerhouni/NIH: • Create a national consortium that will cooperatively address impediments to clinical and translational science

32. Contact Us CTSI Website http://ctsi.ucsf.edu TTR – Robert Smith (502-2129) SOS – Emy Volpe (514-0301) http://rap.ucsf.edu

33. QUESTIONS Bringing better health to more people more quickly!

34. What is a Core? • A laboratory which offers services and/or equipment for use by the campus community