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Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program
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Contracting within the UC Landscape: University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) Program

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Presented at the UC Braid Retreat: Imagine a statewide research engine of pooled resources, data, and expertise that accelerates the “translation” of academic research to direct patient benefit. …

Presented at the UC Braid Retreat: Imagine a statewide research engine of pooled resources, data, and expertise that accelerates the “translation” of academic research to direct patient benefit. That's the goal of the University of California Biomedical Research Acceleration, Integration, and Development (UC BRAID) program.

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  • 1. CONTRACTING Fall 2011 UC BRAID Retreat <ul><li>Clay Johnston , MD, PhD </li></ul><ul><li>Director, UCSF CTSI </li></ul><ul><li>Chair, UC BRAID </li></ul><ul><li>Chair, UC BRAID Contracting </li></ul>Gary Firestein , MD Director, UCSD CTRI Co-Chair, UC BRAID Contracting CTSI at UCSF
  • 2. Participants <ul><li>UC Davis </li></ul><ul><ul><li>Rafael Gacel-Sinclair </li></ul></ul><ul><ul><li>Ahmad Hakim-Elahi </li></ul></ul><ul><ul><li>Erick Jenkins </li></ul></ul><ul><li>UC Irvine </li></ul><ul><ul><li>Jacob Levin </li></ul></ul><ul><ul><li>Bruce Morgan </li></ul></ul><ul><ul><li>Madeline Pahl </li></ul></ul><ul><li>UCLA </li></ul><ul><ul><li>Bishoy Anastasi </li></ul></ul><ul><ul><li>Megan Brennan </li></ul></ul><ul><ul><li>Mike Bunnapradist </li></ul></ul><ul><ul><li>Helene Orescan </li></ul></ul><ul><ul><li>Brian Roe </li></ul></ul><ul><li>UCSD </li></ul><ul><li>Gary Firestein (CO-Chair) </li></ul><ul><li>Tony Perez </li></ul><ul><li>UCSF </li></ul><ul><li>Clay Johnston (Chair) </li></ul><ul><li>Melanie Funes </li></ul><ul><li>Erik Lium </li></ul><ul><li>Teri Melese </li></ul><ul><li>Susan Shih </li></ul><ul><li>Irene Shin </li></ul><ul><li>UCOP </li></ul><ul><li>Jeff Hall </li></ul><ul><li>Hillary Kalay </li></ul><ul><li>Dragana Nicolajevic </li></ul>
  • 3. UC Landscape <ul><li>UC BRAID-CONTRACTING </li></ul>
  • 4. UC BRAID-Contracting within the UC Landscape <ul><li>Why are we here? </li></ul><ul><ul><li>Forum that includes end-users </li></ul></ul><ul><ul><li>Strategic recommendations </li></ul></ul><ul><ul><li>Reinforce benefits of cooperation </li></ul></ul><ul><ul><li>Encourage new technologies/approaches </li></ul></ul><ul><ul><li>Focus on acceleration and innovation </li></ul></ul>
  • 5. Year 1 <ul><li>Goals and Objectives </li></ul>
  • 6. YR01 – Goals and Objectives <ul><li>GOAL: Accelerate Research Contracting at UC </li></ul><ul><li>Support efforts to increase Clinical Trial Master Agreements </li></ul><ul><li>Develop a Pilot Shared Database of Contract Terms </li></ul><ul><li>Support development of a Shared Clause Library </li></ul><ul><li>Plan a UC-wide Training Program for Contracting </li></ul><ul><li>Coordinate standardization of Material Transfer Agreements (MTAs) </li></ul><ul><li>Establish and Track Contracting Metrics </li></ul>
  • 7. YR01 Work and YR02 Plans <ul><li>Year 1: Accomplishments </li></ul><ul><li>Year 2: Goals </li></ul>
  • 8. Master Clinical Trials Agreements (CTAs) LEADS: Jeff Hall, Hillary Kalay, Dragana Nicolajevic (UCOP) <ul><li>Problem: Industry sponsors of clinical trials must negotiate each time they engage with a campus for a new trial </li></ul><ul><li>YR01 Goal: Increase active CTAs (5 new) </li></ul><ul><li>Accomplishment: </li></ul><ul><ul><li>5 New Master CTAs </li></ul></ul><ul><ul><li>2 in negotiation </li></ul></ul>
  • 9. Clinical Trials Agreements (CTAs) LEADS: Jeff Hall, Hillary Kalay, Dragana Nicolajevic (UCOP) <ul><li>YR02 Goals: </li></ul><ul><ul><li>Continue increasing Master CTAs (5/yr) </li></ul></ul><ul><ul><li>Resolve issues, work through clauses, develop range of options for troublesome sponsor </li></ul></ul><ul><ul><ul><li>Boehringer Ingelheim </li></ul></ul></ul><ul><ul><ul><li>Johnson & Johnson </li></ul></ul></ul><ul><ul><ul><li>Gilead </li></ul></ul></ul><ul><ul><li>Increase Master Confidentiality Agreements </li></ul></ul>
  • 10. UC-wide Contracts Database LEAD: Erik Lium(UCSF) <ul><li>Problem: Most contracts are re-worked from scratch this is inefficient </li></ul><ul><li>YR01 Goal: Develop Pilot Contracts Database </li></ul><ul><ul><li>Easy to use centralized repository of contracts </li></ul></ul><ul><ul><li>Searchable to find companies, terms, types of studies </li></ul></ul><ul><li>Accomplishment: Pilot Database Created </li></ul><ul><li>YR02 Goals: </li></ul><ul><ul><li>Establish definitions </li></ul></ul><ul><ul><li>Evaluate implementation at each campus </li></ul></ul><ul><ul><li>Encourage deployment at each campus </li></ul></ul>
  • 11. UC-wide Clause Library LEAD: Bruce Morgan (UC Irvine) <ul><li>Problem: Contracting in its current state is a handicraft as opposed to being a scalable endeavor </li></ul><ul><li>YR01 Goal: Support development of a Clause Library </li></ul><ul><li>Accomplishment: Prototype Clause Library </li></ul><ul><ul><li>Prototype expected in December 2011 </li></ul></ul><ul><li>YR02 Goals: </li></ul><ul><ul><li>Prototype testing </li></ul></ul><ul><ul><li>2 nd version created </li></ul></ul>
  • 12. Clinical Trial Negotiators Training LEAD: Hillary Kalay (UCOP) <ul><li>Problem: Staffing stability is key in contract negotiation </li></ul><ul><li>YR01 Goal: Plan a Training Program </li></ul><ul><li>Accomplishment: Online Training Program </li></ul><ul><ul><li>Interactive modules </li></ul></ul><ul><ul><li>Content includes: </li></ul></ul><ul><ul><ul><ul><li>Clinical Trials </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Definition/types </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>components </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>distinction between phases </li></ul></ul></ul></ul></ul><ul><li>YR02 Goal: Online Training Program </li></ul><ul><ul><li>Wide adoption of training program </li></ul></ul><ul><ul><ul><li>Regulating Bodies </li></ul></ul></ul><ul><ul><ul><li>Drugs and Devices </li></ul></ul></ul><ul><ul><ul><li>Contracting </li></ul></ul></ul><ul><ul><ul><ul><li>UC principles </li></ul></ul></ul></ul><ul><ul><ul><ul><li>negotiating a CTA </li></ul></ul></ul></ul>
  • 13. Standardizing MTAs LEAD: Gary Firestein (UCSD) <ul><li>Problem: MTAs can be problematic, lacking consistency from campus to campus </li></ul><ul><li>YR01 Goals: </li></ul><ul><ul><li>Establish a single MTA office at each campus </li></ul></ul><ul><ul><li>Define broader use of UBMTA </li></ul></ul><ul><ul><li>Develop MTA Standards systematizing across campuses </li></ul></ul><ul><li>Accomplishment: UC-wide agreement to use the UBMTA template as the default </li></ul><ul><li>YR02 Goals: Mission Accomplished – Effort Retired </li></ul>
  • 14. Developing Metrics LEAD: Erik Lium (UC Davis) <ul><li>Problem: Need data on contributors to delays in contract negotiations in order to improve business processes </li></ul><ul><li>YR01 Goals: Create Metrics Working Group </li></ul><ul><ul><li>Develop UC-wide process and organizational metrics </li></ul></ul><ul><ul><li>Use CTSA metrics as a model </li></ul></ul><ul><li>Accomplishment: UC BRAID Metrics Working Group </li></ul><ul><li>YR02 Goal: </li></ul><ul><ul><li>Set goal for Contracting component of Metrics </li></ul></ul>
  • 15. Year 2 <ul><li>New Efforts </li></ul>
  • 16. Faculty Research Consulting LEAD: Clay Johnston (UCSF) <ul><li>Problem: Consulting for industry can lead to: </li></ul><ul><ul><li>FACULTY: conflict of interest and compliance issues </li></ul></ul><ul><ul><li>UNIVERSITY: limits on future participation in clinical trials </li></ul></ul><ul><ul><li>INDUSTRY: complicated process </li></ul></ul><ul><li>YR02 Goals: Faculty Research Consulting Program </li></ul><ul><li>Create a Template and SOPs for implementation </li></ul><ul><ul><li>protect faculty from unknowingly conflicting themselves </li></ul></ul><ul><ul><li>maximize University’s opportunity to participate in industry-sponsored clinical trials </li></ul></ul><ul><ul><li>provide resources to the University research community and companies in support of consulting engagements </li></ul></ul>
  • 17. Thank You <ul><li>Questions? </li></ul>

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