Expanded Board Inaugural Meeting

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Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Expanded Board Inaugural Meeting April 4 th 2012

UCSF CTSI Second largest award out of 60 Renewed in 2011 for $112 million over 5 years (Year 6 now) Under new NIH institute NCATS period of transition & some uncertainty

CTSI Governance & Leadership EVC & Provost UCSF SOM, SON, SOP, SOD Deans UCSF NCATS NIH External Advisory Board Jeff Bluestone, EVC Josh Adler, CMO Mary-Anne Koda Kimble, Dean, SOP David Vlahov, Dean, SON John Featherstone, Dean, SOD Dan Lowenstein, Director SOS Paul Volberding, Director GH Mike McCune CTSI Operating Committee Clay Johnston, Director Deborah Grady, Co-Director Mini Kahlon, Deputy Director & CIO Bill Balke, Director, CRS June Lee, Director T1 Sally Mead, CAO CTSI BOARD OF DIRECTORS 1. Training & Advancement 2. Translational Phases CTSI PROGRAMS & LEADERSHIP Clinical & Translational Science Training (CTST) Deborah Grady Jeff Martin Doug Bauer Louis Reichardt Kirsten Bibbins-Domingo Tejal Desai Ralph Gonzalez Joel Palefsky Alka Kanaya Career Development (CD) Renee Navarro Early Translation Research (T1) June Lee 3. Cross-cutting Infrastructure Regulatory Knowledge & Support (RKS) Elizabeth Boyd 4. Central Management Clinical Research Services (CRS) Bill Balke Consultation Services (CS) Mark Pletcher Alka Kanaya, Mark Segal, Peter Bacchetti, Jen Creasman Community Engagement & Health Policy (CE&HP) Kevin Grumbach, Laura Schmidt Biomedical Informatics (BMI) Ida Sim, Mini Kahlon Global Health (GH) Paul Volberding Virtual Home (VH) Leslie Yuan Strategic Opportunities Support (SOS) Dan Lowenstein Finance & Ops Sally Mead Communications John Daigre Planning, Evaluation & Tracking Fabrice Beretta

CTSI Program Budget Distribution* New Initiatives 3.58% Administration 8.09% Planning, Evaluation & Tracking(PET) 2.12% Global Health (GH) 1.28% Clinical & Translational Sciences Training (CTST) 21.46% Virtual Home (VH) 6.50% Consultation Services (CS) 3.85% Community Engagement & Health Policy (CE-HP) 2.99% Biomedical Informatics (BMI) 5.54% Career Development (CD) 1.23% Strategic Opportunities Support (SOS) 4.56% Clinical Research Services (CRS) 30.86% Early Translational Research (ETR) 6.62% Regulatory Knowledge & Support (RKS) 1.31% *Percentages represent Yr07 program budget allocations from NIH and institutional support and do not include revenues, such as recharge income

CTSI Overarching Strategies Measure and improve impact of CTSI by amplifying effective interventions Plan for new areas of impact (eg. Center for Healthcare Value) Continue to clarify role of CTSI within the University Diversify and expand revenue sources Prepare for reduction in NIH budget Enable transformation of business models across programs

CTSI Overarching Strategy Initially, fix problems. Then, build based on faculty needs. Now, support faculty to identify needs and opportunities and help them address them.

CTSI Recent Areas of Progress 1. UC BRAID UC ReX 2. Early Translational Research (T1) 3. Clinical Research Services 4. San Francisco Health Improvement Partnerships 5. Online Learning 6. UCSF Profiles 7. Planning, Evaluation & Tracking Data-driven enterprise

UC BRAID

UC BRAID Major initiatives Contracting IRB coordination Drug Development Metrics Informatics?Biospecimens Proposal for core support from UCOP

Informatics: UC ReX $ 5 million for 5 years from UCOP to develop infrastructure to support cross-uc usage of clinical data Participant recruitment Research using clinical data Quality improvement? Near-term milestones Launch of cross-uc cohort discovery Fall 2012 5-year vision and technology strategy Challenges: Clarify case for greater involvement by Med Center CIOs

T1 Translational Catalyst Award Value Proposition Identify Support Enable Expert review panels Therapeutics Devices Diagnostics Health IT Customized awards Consultation awards Pilot awards Development awards Building value IP Partnerships Follow-on funding Fall 2011 Spring 2011 Fall 2010 Spring 2010 $150K $135K $125K $230K Therapeutics Devices Diagnostics Health IT 0 10 20 30 40 Applicants

Early Translational Research Funding Longterm Strategy Educational efforts Multidisciplinary research team building ETR Consultation services ADME/ PK Assay development HTS GLP toxicology Others T1 Catalyst Program Expert consultants Pilot grants Catalyst award Multiple tracks Therapeutics Diagnostics Devices Digital health Advisory Board Business development Orphan diseases Gap fund

CTSI Clinical Research Services Currently 9 research units at 7 sites o 6 university-operated o 3 affiliate relationships o Planning underway for new sites at MB o Neurosciences Building o Benioff Children s Hospital 300+ unique investigators annually 365 inpatient and outpatient protocols annually SFVA SFGH Moffitt Hospital Adult Mount Zion C o r e S e r v i c e s Sample Processing Labs Clinical Research Coordinators Bionutrition Body Composition & Exercise Labs Participant Recruitment Research Nursing Kaiser CHORI Planned: Mission Bay Benioff Children s Hospital Clinical & Translational Science Institute Clinical Research Services Planned: Mission Bay Neurosciences Building Tenderloin NICCU Moffitt Hospital Pediatrics

CRS Initiatives Develop a sustainable business model Implement cost recovery Reorganize staff Improve support to investigators to advance clinical research Participant recruitment core service Clinical research coordinator core service Scatter nursing services Clinical research HUB Mission Bay sites

SF Health Improvement Partnerships Partnership working groups formed Physical activity and healthy eating Hepatitis B High utilizers of multiple services Alcohol use Children s oral health Baseline measures gathered for two (Physical activity/healthy eating & Hep B) Additional funds raised - $1.8 million to advance physical activity/health eating

Online Learning - Approach Background: CTSI Training Programs 36 courses, Introductory Workshop, 1-year Certificate, 2-year Masters 8 level or discipline specific training programs Aims: Extend current courses to students outside UCSF Develop new courses Strategy Develop asynchronous versions of flagship course, summer workshop Develop synchronous small group experiences Make courses flexible to fit varied formats/learners Bundle courses as modules Acquire experience for development of degree program

Online Learning - Progress Asynchronous courses Designing Clinical Research (8/11) Responsible Conduct of Research (7/12) Advanced Laboratory Assays in Immunology Advanced Methods in Bioimaging Workshop Synchronous small groups Technologically challenging Plans Develop online version of Clinical Trials I, II Market current courses, implement business plan Collaborate with CA CTSI sites to develop course(s), modules on drug and device development

UCSF Profiles Key Campus Resource 30% 25% 20% 15% 10% 5% 0% %age of faculty who self-edited profiles, from launch+18 months Asst Professor Assoc Professor Professor

UCSF Profiles Efficiencies & Integration 800+ faculty profiles across campus now being automatically updated via feeds from UCSF Profiles First integration with Advance live. More to come Maturing integration & partnership with public affairs (ucsf.edu) and ITS (White Pages & mobile UCSF)

Planning, Evaluation & Tracking - Overview New senior Director from Industry/Genentech Maturing implementation of Balanced Scorecard Facilitating campus coordinated approach on research analytics Launching pilot using Lean Six Sigma to improve operations for Clinical Research Services (CRS) Launching models of collaboration within UCSF & across UCs to leverage expertise in Balanced Scorecard, performance management and Lean Six Sigma.

Planning, Evaluation & Tracking - Data Launched first version of CTSI data shoebox and automated Annual Progress reporting.

Discussion