Highlights of CTSI Program Reviews June 2012

1. Highlights of CTSI Program ReviewsJune 2012 Prepared for the CTSI Board Meeting July11th2012.

2. CTSI Program Reviews: Overview • Key objective: approve Y07 program strategy and budget • Guiding principles for the reviews: • Enable transparency and accountability • Support program planning and management of initiatives • Data driven • Ensure alignment and facilitate collaborations between programs

3. CTSI Program Reviews: Process • Assess Y06 performance by analyzing actual metrics vs targets in program scorecards • Evaluate Y07 planning and budget by reviewing: • Portfolio of initiatives with associated resources, key milestones and expected benefits. • Projected non-NIH revenues • Approve total budget and allocation to initiatives based on alignment with CTSI’s objectives, expected benefits and feasibility of implementation.

4. CTSI Program Reviews: Highlights Community Engagement & Health Policy • Outstanding work convening the right partners and building momentum for SFHIP • Need to develop specific health improvement targets and detailed program plan to capture progress and minimize risks.

5. CTSI Program Reviews: Highlights Consultation Services • Very strong and efficient program that provides a broad spectrum of expertise to UCSF investigators. Has expanded the expertise provided under its umbrella. • Need to address challenges in biostatistics consulting capacity

6. CTSI Program Reviews: Highlights Strategic Opportunities Support • Highly efficient program. • Are there models for SOS to bring in revenue, perhaps through philanthropy or partnerships?

7. CTSI Program Reviews: Highlights Virtual Home • Flexible partner and successful developer of products; demonstrated ability to encourage use of new tools such as Profiles • Need to identify resources to help develop business models – “What business is VH in?”

8. CTSI Program Reviews: Highlights Early Translational Research (T1) • Successful launch of new program and expansion of flagship T1 Catalyst program • Need to define business model and plan for sustainability. Need to continue to coordinate CTSI efforts with broader UCSF efforts.

9. CTSI Program Reviews: Highlights Clinical Research Services • Major strides in transforming the CRCs into an efficient program that delivers valuable services to all researchers engaged in human subjects research; instituted new leadership, organization, administrative efficiencies, and recharge for services • Need to work quickly to address rising labor costs and to evolving investigator needs.

10. CTSI Program Reviews: Highlights Clinical & Translational Sciences Training (CTST) • Robust education & training for all levels of trainees from a wide variety of disciplines. Highly successful scholars. Innovative new Online program. • Need to establish business plans to best manage the opportunities in online learning.

11. CTSI Program Reviews: Highlights Regulatory Knowledge & Support • Transitioned to strong new leadership (AVC Ethics & Compliance) Progress towards reducing IRB requirements through reciprocal agreements & Western IRB. • Need to develop a strategy in collaboration with the appropriate groups to integrate disparate systems such as iMedRIS, the consent builder, RedCap, Oncore, C&G

12. CTSI Program Reviews: Highlights Communications • Substantial progress in raising awareness of CTSI on campus. Very successful partnership with University Relations. Growing acknowledgement of expertise in Social Media • Need to assess and report on impact of social media and other innovative strategies in advancing CTSI goals.

13. CTSI Program Reviews: Highlights Planning, Evaluation & Tracking • Transitioned to new leadership. Rapid early progress towards building a center of excellence in performance management. Piloting Lean Six Sigma to improve clinical research services. • Need to improve CTSI program review process and tools.

14. CTSI Program Reviews: Highlights Global Health • Created and successfully convened global health stakeholder group from across campus and maintained valued international projects database • Need to move international database to more automated solution in partnership with Virtual Home

15. CTSI Program Reviews: Highlights Career Advancement • Continues strong leadership and close collaboration with campus resources to support robust mentor development activities, career development activities, and focus on diversity.  • Need to finalize a database that will provide reliable statistics on recruitment and retention of women and minorities, and develop a sustainability plan.

16. Highlighted Topics for Discussion • Virtual Home (+ Communications + PET) • Precision email platform for UCSF • Early Translational Research • Promoting early translational research on campus

17. Precision Email Platform Maninder Kahlon, PhD CTSI Board Meeting July 11th 2012

18. Need What if you could target investigators with information on available resources and upcoming opportunities based on knowledge of their interests and plans?

19. A precision email platform …will allow for the generation of emails to subsets of researchers based on - • Their research history • Recent grant submission history • Industry partnerships • Participation in infrastructure/center activities/grants • Official affiliation at UCSF (department, school, etc) • Etc. + • Network information on coauthorship, co-dept, school, etc.

20. The first pilot from CTSI

21. Open for Business! 2012-13 • Basic platform and CTSI pilot 2013-14 • Non-CTSI pilot at UCSF • Governance and principles of usage.

22. Early Translational Research ProgramJune Lee, MD, FACCP (Director)Ruben Rathnasingham, PhD (Senior Program Manager)Irina Gitlin, PhD (Senior Program Manager)

23. CTSI: Accelerating Research To Improve Health Early Translational Research Clinical Research Late-Stage Translational Research In Vitro/ In Vivo Health Policy Clinical Trials Therapeutic Target ID Global Health Candidate Optimization First in Human Observational Studies Community Health Promotion Toxicology Outcomes Research

24. Early Translational Research: Program Overview • T1 Catalyst Award Program • Infrastructure and resource development • Expert advice and education • Public/Private partnerships

25. Points for discussion • How should these programs be better promoted to be utilized across the campus and the four schools? • Where can we better coordinate with the ongoing efforts on campus?

26. T1 Translational Catalyst Award Expert review panels • Therapeutics • Devices • Diagnostics • Digital Health Customized awards • Consultation awards • Pilot awards • Development awards Building value • IP • Partnerships • Follow-on funding

27. Unique Multi-Disciplinary Consultant Panel Large company Small company Academia VC Legal Accelerators Diagnostics Therapeutics Digital Health Devices

28. T1 Catalyst Program • Utilization • Mostly from school of medicine • Coordination with campus • Ongoing coordination with ITA and Licensing office (OTM) • dHealth efforts • Gap fund • Leveraging the T1 Catalyst consultant panel

29. Areas requiring coordination with campus • T1 catalyst program • Access to consultants • Gap fund • Early development expert consultation • Access to CROs • Educational efforts in ETR • Coordination of collaborative projects