early translational research

Download Early Translational Research

Post on 20-Aug-2015

379 views

Category:

Health & Medicine

1 download

Embed Size (px)

TRANSCRIPT

  1. 1. CTSI SLG November 7, 2011 Early Translational Research June Lee, MD
  2. 2. Translational research Early (T1) Late( T2) Bench Bedside Community Outcomes/ Impact Better Health Academia Start up company/ biotech Large pharma/company Academia Start up company/ biotech Large pharma/company
  3. 3. T1 Translational Catalyst Award
    • Identify the best projects
      • Diagnostics, devices,or therapeutics
    • Bring in missing pieces
      • Panels include people from industry and academics
      • Panels review and provide individualized feedback
    • Leverage limited resources
      • Identify partnerships if appropriate
    • Feedback
      • Pilot grants helped advance programs
      • Customized consulting service very useful
  4. 4. T1 Catalyst Award program assessment
    • Status
      • In our 4 thcycle of funding
      • Number of proposals submitted increased substantially
      • Changed the review process to include multiple specialized tracks
        • Therapeutics (13 proposals)
        • Diagnostics (8 proposals)
        • Devices (4 proposals)
        • mHealth (8 proposals)
        • Orphan/ rare diseases (TBA)
  5. 5. T1 Catalyst Panels/ Consultations
    • Consultation panel comprised of:
      • Faculty
      • Industry experts (Approximately 80% volunteers)
        • Drug/Device/Diagnostics development experts
        • IP attorneys
        • Venture capitalists
        • Experienced bioentrepreneurs
      • OTM representative
      • QB3 representative
  6. 6. Consultation awards
    • Offered to approximately 50% of applicants
    • Average award value $2K-$5K
    • Pilot award and 100K award recipients will be determined in February
  7. 7. Other key activities in T1 Catalyst Program
    • Deploying the consultation service to UCSF investigators beyond the T1 Catalyst Award participants
      • In collaboration with OTM
    • Enhance the consultant panel
    • Identifying additional sources of funding
      • Pharma partners
      • Entrepreneurs/VCs
  8. 8. T1 translational catalyst program Identify & Enable Science Invention Invention Product Gap:Science to Invention, Invention to Product
  9. 9. Translational research in drug development
    • Unmet medical
    • need/potential clinical indication(s)
    • ~18 months
    • DISCOVERY
    • ESR
    • LSR
    • ED
    • ECD (Ph I/II)
    • IND submission and clearance
  10. 10. Early phase drug development activities
    • Discovery/Early stage research/ Late stage research
      • Target selection/validation
      • Proof of activity
      • Lead molecule optimization
      • Evaluation of unmet need
      • Define target candidate profile (TCP )
    • Late stage research/ Pre-early development
      • Select lead molecule
      • Indication (s) selection
      • Define target product profile (TPP)
    • Early Development
      • Clinical manufacturing
      • IND enabling toxicology study
      • Regulatory filing strategy
      • Overall clinical development strategy
  11. 12. Innovative partnerships
    • Critical to extending the T1 translational capacity in academia
    • Non-traditional models and re-defining the boundaries of private/public partnerships
      • Pharma/academia
      • Early stage investors (e.g. Venture capital)
      • Foundations and venture philanthropy
      • Others

Recommended

View more >