early translational research
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Clinical and TranslationalScience Institute / CTSIat the University of California, San Francisco
CTSI SLGNovember 7, 2011Early Translational Research
June Lee, MD
Translational research
Academia
Start up company/ biotech
Large pharma/company
Academia
Start up company/
biotechLarge
pharma/company
Early (T1) Late (T2)
Bench Bedside Community
Outcomes/ ImpactOutcomes/ Impact BetterHealth
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
T1 Catalyst Award program assessment
• Status– In our 4th cycle 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)
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
Consultation awards
• Offered to approximately 50% of applicants
• Average award value $2K-$5K
• Pilot award and 100K award recipients will be determined in February
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
•
T1 translational catalyst program
Identify & Enable
ScienceInvention
InventionProduct
Gap: Science to Invention, Invention to Product
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
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
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