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Early Translational Research


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June Lee, MD, Director of CTSI's Early Translational Research program, presents the goals and vision for the program. Learn more about June Lee at UCSF Profiles

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Early Translational Research

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