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Drug, Device, Discovery, Development

Published in: Health & Medicine
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  1. 1. 4BRAI ●Drug ●Device ●Discovery ●Development a critical new initiative… building on success
  2. 2. “It appears that many — perhaps most — new therapeutic uses of drugs have been discovered by motivated and observant clinicians working with patients in the real world.”Scannell et al. Nature Reviews: Drug Discovery 11:191, 2012
  3. 3. D4 at UCGOALS andOBJECTIVESThe overall goal ofBRAID D4 is toleverage existingshared resourcesacross the UC systemwith the uniquelycreative andinnovative basic and clinical research at individualcampuses in order to enable individual research andcreate value in the broad field of drug and devicediscovery.
  4. 4. Why D4? Despite dramatic advances… translation of basic biomedical research into safe and effective clinical applications remains a slow, expensive, and failure-prone endeavor. …[We must] catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of diseases and conditions.
  5. 5. D4 and the “Valley of Death
  6. 6. D4 and the “Valley of Death
  7. 7. Around the Nation--D4 in progressUniversity Hospitals touts new $250M drug development model The Cleveland-area health system has launched a new $250 million project that it’s touting as something that could become a national model for developing promising drugs and bringing them to market. The aim of the new Harrington Project for Discovery & Development is to advance drug candidates through the period that runs from late animal testing to mid-clinical development in which companies find it difficult to attract funding to keep the drug development process going.
  8. 8. D4 at UC Planning began over a year ago
  9. 9. D4 at UCACCOMPLISHMENTS to DATE•Identified leaders at eachcampus•Developed an action planwith specific deliverables•Proposed modest andachievable costs to our recentUCOP request
  10. 10. D4 at UC
  11. 11. IDEAS DISCUSSED TODAY IN LIGHT OF THE UCOP BRAID INITIATIVE-1CONSENSUS (Role of D4 in BRAID)• D4 is an essential component of BRAID that complements and supports BRAID’s current mission• D4 successes will mutually benefit the contracting and IRB metrics established by UCOP in it current funding opportunity• D4 can become a key component in BRAID’s MRU application in 2 years
  12. 12. IDEAS DISCUSSED TODAY IN LIGHT OF THE UCOP BRAID INITIATIVE-2CONSENSUS (Role of D4 in Defining KeyThemes)• Role of academia in D4• Creating “value” in the process of drug and device discovery (not just $)• D4 is a major link between NCATS and BRAID!
  13. 13. IDEAS DISCUSSED TODAY IN LIGHT OF THE UCOP BRAID INITIATIVE-3CONSENSUS (Role of D4 UC-Wide)• Identify campus specific resources• Match these resources with individual investigators• Build teams in which unique drug and device discovery team requirements are addressed • PatientNursesPhysicianBasic and applied scientists
  14. 14. IDEAS DISCUSSED TODAY IN LIGHT OF THE UCOP BRAID INITIATIVE-4CONSENSUS (Role of D4 UC-Wide)• Addressing the knowledge/training gap• Configuring and growing the academia-industry interaction• Introduce industry-type “project management” paradigms into academic discovery processes
  15. 15. IDEAS DISCUSSED TODAY IN LIGHT OF THE UCOP BRAID INITIATIVE-5CONSENSUS (Next Steps)• Strategic Planning Meeting* • Solidify goals and aims • Create D4 governance and infrastructure • Identify metrics of success• U54 Center of Accelerated Innovation (NHLBI)
  16. 16. Existing D4 Resources at UCSD• Creation of Drug Discovery Institute• High throughput screening withSanford-Burnham• Pre-clinical toxicology service• Express licensing option for start-ups• Drug discovery consultation service• Unique libraries (marine products)
  17. 17. Existing D4 Resources at UC IrvineThe Science of Team Science
  18. 18. Existing D4 Resources at UCSF
  19. 19. Existing D4 Resources at UCLAFully Automated High Throughput Screening for Drug DiscoveryExpert technical staff support assay development, HTS execution, and hitvalidation• Small molecule libraries totaling 200,000 compounds, including FDA- approved drugs, natural products, and novel/diverse compounds.• Functional genomics libraries for target identification/validation • Genome-wide siRNA for mouse and human • Genome-wide shRNA for human in lentiviral vector
  20. 20. Existing D4 Resources at UC DavisDevelopment of InjectableAllopregnanolone for Treatmentof Traumatic Brain Injury (Dr.Michael Rogawski)1. SAIC : synthesis2. UC Davis : Formulation in cGMP facility3. UC Davis CTCS: IND filing4. UC Davis CTCS: monitoring and QA services5. UC Davis CTSC: REDCap database6. ?: preclinical reproductive tox
  21. 21. Existing D4 Resources at UC DavisDevelopment Of EsophagealExpansion Device ForImprovement Of Swallow (Dr.Peter Belafsky)1. Third Party Manufacturing and sterilization validation2. UC Davis: large animal surgery facility (sheep)3. UC Davis CTCS: IDE filing4. UC Davis CTCS: monitoring and QA services5. UC Davis CTSC: REDCap database
  22. 22. Support D4 at UCHelping all of our campuses contribute to thenew national vision of team science andcollaboration Speeding thru the “Valley of Death”