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UC CAI

University of California Center for Accelerated Innovation. UC CAI . Face-To-Face Meeting October 14, 2013. Michael Palazzolo. Local and National Announcements. CTSA Central. NBC Channel 4 News. Posted by UCLA on Sept 30, 2013 (day before the government shutdown). Aired October 1, 2013.

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UC CAI

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  1. University of California Center for Accelerated Innovation UC CAI Face-To-Face MeetingOctober 14, 2013 Michael Palazzolo

  2. Local and National Announcements CTSA Central NBC Channel 4 News • Posted by UCLA on Sept 30, 2013 (day before the government shutdown) Aired October 1, 2013

  3. Notice of Award Notice of Award: Key Points • Year 1 Budget Period 9/26/13-7/31/14 • Key Personnel • 100-day Implementation plan due 10/25/13 • Interim Progress Report in Year 1due 3/1/14 • Cost-share report due with FFR • Program Steering Committee Meeting 10/29-10/30/13

  4. Introductions

  5. Contents • Introduction to leadership • Goals • Governance • Technology Solicitation & Selection • Technology Development • Skills Development

  6. Leadership UC CAI Michael Palazzolo, MD, PhDCenter Director, UC CAIProfessor, UCLA Tomas Ganz, MD, PhD Center Associate Director Professor, UCLA

  7. Leadership Executive Committee Lars Berglund, MD, PhDDirector, UCLA Clinical and Translational Science Center Steven Dubinett, MDDirector, UCLA Clinical and Translational Science Institute Gary S. Firestein, MDExecutive Committee Chair Director, UCSD Clinical and Translational Research Institute Clay Johnston, MD, PhDDirector, UCSF Clinical and Translational Science Institute Dan Cooper, MDDirector, UCLA Institute for Clinical and Translational Science

  8. Site Leaders Campuses JuneLee,MDUCSF ShaunCoughlin,MD,PhDUCSF SotiriosTsimikas,MDUCSD JosephWitztum,MDUCSD LauraMarcu,PhDUC Davis Steven George,MD,PhDUC Irvine TomasGanz,MD,PhDUCLA

  9. Domain Leaders Diseases June Lee,MDLung and Sleep Diseases Shaun Coughlin,MD,PhDCardiovascular Disease SotiriosTsimikas,MDCardiovascular Disease Tomas Ganz,MD,PhDBlood Disorders and Resources

  10. Domain Leaders Platforms June Lee,MDCo-Leader, Therapeutics Shaun Coughlin,MD,PhDCo-Leader, Therapeutics SotiriosTsimikas,MDCo-Leader, Diagnostics Joseph Witztum,MDCo-Leader, Diagnostics Laura Marcu,PhDCo-Leader, Devices and Tools StevenGeorge,MD,PhDCo-Leader, Devices and Tools

  11. Domain/Site Leaders • At least one site leader for each campus • At least one domain leader for each platform (drugs, devices, diagnostics) and disease (heart, lung and sleep, blood) • Ensure the pool of candidate technologies is large • Oversee proposal solicitation process • Recruit study sections • Recruit and oversee project development teams on respective campuses

  12. Skills Development Program • Catalogs entrepreneurial course offerings on all five campuses • Matches innovators to mentors • Conducts webinars, symposia Vish Krishnan Leader, Skills Development Program UCSD

  13. Goals Goal 1 • Engage University of California heart lung and blood disease innovators through a comprehensive education, training and mentorship program.

  14. Goals Goal 2 • Solicit and select technologies with high commercial potential that align with NHLBI’s mission and address unmet medical needs or significant scientific opportunity.

  15. Goals Goal 3 • Incubate our most promising technologies in accordance with industry requirements to facilitate their translation to commercial products that improve patient care and enhance health.

  16. Goals Goal 4 • Create a high-performing, sustainable infrastructure that will serve as a model to academic research centers.

  17. Governance External Selection Committee Executive Committee External Advisory Board Business Review Panel Center Director Skills Development Program Associate Director Domain Areas Domain/Site Leaders Therapeutics Diagnostics Devices Projects Cardiovascular Lung & Sleep Disorders Blood Diseases Program Resources Industry Relations & IP CTSA Infrastructure Website & Data Management Administrative& Budgetary Support Project Management Evaluation & Tracking

  18. External Selection Committee • No fewer than 5 members • Size and composition depends on RFAs under review • Appointed by Executive Committee • May be present and former faculty and/or industry leaders • Must be external to institution(s)

  19. External Advisory Board • Consists of no fewer than 5 members • Experienced business leaders • Includes NHLBI Program Officer • Advice about operations, project development Catherine Mackey, PhDFormer Senior VP, PfizerFounder, MindPiecePartners Francis Duhay, MDVP Medical Affairs and CMD, Edwards Lifesciences Lawrence Souza, PhDFormer Senior VP, AmgenFounder, Coastview Capital,

  20. Business Review Panel • Five members • VCR on each campus appoints one member • Evaluate Center’s progress toward sustainability Bill Ouchi, PhDUCLA Initial Chair Anderson School

  21. CAI Administration • Administration is based at UCLA • Anne Skinner is Administrative Director • UCLA CTSI maintains CAI website • CAI information, RFP, project-tracking • Doug Bell, MD, PhD leads • UCLA CTSI conducts evaluation with UC BRAID • Pamela Davidson, PhD, MSHS leads

  22. Governance Tasks for First 100 Days • Executive Committee names at least 5 members to the External Selection Committee • VCRs at UCD, UCSD, UCI, UCSF each name 1 faculty to Business Review Panel • Name at least 2 members to External Advisory Board.

  23. Governance Tasks for First 100 Days • 1 meeting: Executive Committee, Center Director, Associate Director & External Advisory Board • 3 meetings (1 per month): Center Director, Associate Director & Executive Committee • 3 meetings (1 per month): Center Director, Domain and Skills Development Leaders

  24. Administrative Tasks for First 100 Days • Initiate intercampus sub-awards • Identify campus administrative leads • Build website • Begin coordination/communication process

  25. Discussion • Process for naming External Advisory Board members • Do we want more than 5 EAB members? • Deadlines for naming members to EAB, Business Advisory Panel, and External Selection Committee

  26. Technology Selection Overview 5-Step Process • Solicit 2-page pre-applications • 1st Review: Review Panels assembled by Domain Leaders review pre-applications and invite full applications • 2nd Review (Leadership Review): Executive Committee, Center Director, Assoc. Director, Domain Leaders and ad hoc reviewers select full proposals • 3rd Review (External Review): External Selection Committee scores proposals and sends to NHLBI • 4th Review: NHLBI makes final selection

  27. Technology Selection Overview RFP Pre-application Pre-applicationReview FullApplication Leadership Review External Selection Committee Review Technologies Selected for Entrance to Center NHLBI Review

  28. Technology Selection Timeline • Solicitations occur three times a year, one for each platform (therapeutics, devices, diagnostics) • RFPs for the platforms run concurrently • Time from solicitation to prioritization by External Selection Committee takes 7 mos. • Up to 3technologies enter Center in yr.-1 • Awards of up to $200K Review Pre-Application Solicit Pre-Application Develop and Submit Full Application First Review ofFull Application ESC Review of Application 3 months 1 month 1 month 1 month 1 month

  29. Pre-application and Review RFP Pre-application Pre-applicationReview FullApplication Leadership Review External Selection Committee Review Technologies Selected for Entrance to Center NHLBI Review

  30. Eligibility • Faculty in all series and ranks at UC Davis, UC Irvine, UCLA, UC San Diego, and UC San Francisco • Postdoctoral scholars are eligible to submit applications as Co-PI with a faculty PI • Projects with existing or imminent target validation and a clear clinical indication • Patents or patent applications are filed or potential for obtaining defensible intellectual property is strong

  31. Solicitation Process • Broad solicitation • Added focus on cardiology, pulmonary, hematology, cardiothoracic surgery, etc. • Centralized RFP • Webinar on submission process • Campuses to provide potential applicants with referrals for help with business plans, grant writing, IP, licensing, team building • Innovators may apply for Catalyst Grants from their campus CTSA to support team building

  32. 2-page Pre-application • Centralized online submission • The two-page pre-application contains: • description of the invention • its potential market and impact • description of competitive landscape • whether pre-clinical or early clinical proof of concept is achieved or imminent • what is needed to make the invention licensable • proposed budget • Review Panels (one for each platform technology) review pre-applications for scientific merit and commercial potential

  33. Review Panels • Selected by Domain Experts • Includes external experts from industry and internal or external academic experts • Domain Experts do not participate in pre-application review • At least some Review Panel members should be expert in platform under review

  34. Technology Solicitation Tasks for First 100 Days • Develop RFP for 2-page pre-application • Create Webinar about submission process • Develop online submission “package” • Each campus site develop plan for advertising RFP • Recruit Review Panel members

  35. Discussion • Review criteria for pre-application • Scoring for pre-application • Local or central pre-application review? • Size of review panel(s)? • Begin with one platform or solicit all three at once? • Are campuses prepared to provide guidance with IP, licensing, etc.? • Date for RFP release

  36. Technology Selection: Full Application RFP Pre-application Pre-applicationReview FullApplication Leadership Review External Selection Committee Review Technologies Selected for Entrance to Center NHLBI Review

  37. Full Application • By invitation • Central RFP submission • Full-proposal format: • Summary, including objectives • Background, including research strategy • Product development & commercialization • Strategic partnerships • Budget • 3 months to submit

  38. Full Application • Review Criteria • Unmet medical need • Development feasibility • Commercial attractiveness • Intellectual property status • Relevance to NHLBI mission • Metrics for success • Evidence of target validation (therapeutic) • Time and cost of prototyping (device) • Combination of the above (diagnostic)

  39. Full Application: Leadership Review • Reviewers • Executive Committee • Center Director and Assoc. Director • Domain Leaders for disease and platforms under review • As needed: Ad hoc reviewers from academia, industry, venture capital with specific expertise in the diseases and platforms under review. • 1 month to conduct Leadership Review

  40. Full Application: External Selection Committee • Prioritize applications received from Leadership Review • Same review criteria as Leadership Review • 1 month to review • Submit recommendations to NHLBI • Reviewers • No fewer than 5 members; present and former faculty and/or industry leaders • Must be external to institution(s)

  41. Full Application: Tasks for First 100 Days • Develop RFP for full applications • Develop online submission “package” for full application • Begin to identify ad hoc reviewers for Leadership Review

  42. Discussion • Limit the number of applicants who are invited to submit full proposals? • How many pages for full proposal? • Include NIH review criteria? • Scoring system?

  43. Technology Selection: Second Chances RFP Pre-application ConsultationAward Pre-applicationReview FullApplication Referral Leadership Review Referral External Selection Committee Review Technologies Selected for Entrance to Center NHLBI Review

  44. Consultation Awards • Eligibility • Proposal not selected for Center • Leadership Review or External Review recommends Consultation Award consideration • Funded by campus CTSAs • Amount and duration of awards vary • Most awards for 3-6 months • Recipients must agree to resubmit and target a specific RFP for resubmission

  45. Consultation Awards • Consultation Awards will address gaps in following areas: • In vivo proof of principle • Hypothesis testing • IP assessment • Target product profile discussion • Regulatory assessment • Further development planning • Skills Development Program will match awardees with mentors and expertise

  46. Consultation Awards: Tasks for First 100 Days • Each CTSA determines feasibility of offering Consultation Awards • Skills Development Program begins to identify expertise in the following: • In vivo proof of principle • Hypothesis testing • IP assessment • Target product profile discussion • Regulatory assessment • Further development planning

  47. Discussion • Mechanics of Consultation Award • Application process or automatic review based on referral? • Standard or local criteria? • Timeframe for review? • Who conducts review? • Size of Consultation Award • Set an upper limit or local decision? • Resubmission Process • Pre-application or directly to full review?

  48. Technology Development Process Technology EntersCenter Project Design ExitCenter Project Plan Product Development Licensing Project Design Team Project Management Team

  49. Technology Development • Two phases • Project design • Project management • Collaboration with campus IP office during entire development process is critical • Simultaneous skills development • We develop the innovation and the innovator

  50. Project Design • Center Director names Project Design Team • Platform expert(s) • Disease expert(s) • Campus Technology Transfer Officer • Project manager • Innovator • Two months to develop project plan • Must be approved by Center Director

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