Drug, Device, Discovery, Development

1. 4
BRAI
●Drug
●Device
●Discovery
●Development
a critical new initiative…
building on success

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. D4 at UC
GOALS and
OBJECTIVES
The overall goal of
BRAID D4 is to
leverage existing
shared resources
across the UC system
with the uniquely
creative and
innovative basic and clinical research at individual
campuses in order to enable individual research and
create value in the broad field of drug and device
discovery.

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. D4 and the “Valley of Death

6. D4 and the “Valley of Death

7. Around the Nation--D4 in progress
University 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. D4 at UC
Planning began over a year ago

9. D4 at UC
ACCOMPLISHMENTS to DATE
•Identified leaders at each
campus
•Developed an action plan
with specific deliverables
•Proposed modest and
achievable costs to our recent
UCOP request

10. D4 at UC

11. IDEAS DISCUSSED TODAY IN LIGHT
OF THE UCOP BRAID INITIATIVE-1
CONSENSUS (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. IDEAS DISCUSSED TODAY IN LIGHT
OF THE UCOP BRAID INITIATIVE-2
CONSENSUS (Role of D4 in Defining Key
Themes)
• 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. IDEAS DISCUSSED TODAY IN LIGHT
OF THE UCOP BRAID INITIATIVE-3
CONSENSUS (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. IDEAS DISCUSSED TODAY IN LIGHT
OF THE UCOP BRAID INITIATIVE-4
CONSENSUS (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. IDEAS DISCUSSED TODAY IN LIGHT
OF THE UCOP BRAID INITIATIVE-5
CONSENSUS (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. Existing D4 Resources at UCSD
• Creation of Drug Discovery Institute
• High throughput screening with
Sanford-Burnham
• Pre-clinical toxicology service
• Express licensing option for start-ups
• Drug discovery consultation service
• Unique libraries (marine products)

17. Existing D4 Resources at UC Irvine
The Science of Team Science

18. Existing D4 Resources at UCSF

19. Existing D4 Resources at UCLA
Fully Automated High Throughput Screening for Drug Discovery
Expert technical staff support assay development, HTS execution, and hit
validation
• 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. Existing D4 Resources at UC Davis
Development of Injectable
Allopregnanolone for Treatment
of Traumatic Brain Injury (Dr.
Michael Rogawski)
1. SAIC : synthesis
2. UC Davis : Formulation in cGMP facility
3. UC Davis CTCS: IND filing
4. UC Davis CTCS: monitoring and QA services
5. UC Davis CTSC: REDCap database
6. ?: preclinical reproductive tox

21. Existing D4 Resources at UC Davis
Development Of Esophageal
Expansion Device For
Improvement Of Swallow (Dr.
Peter Belafsky)
1. Third Party Manufacturing and sterilization validation
2. UC Davis: large animal surgery facility (sheep)
3. UC Davis CTCS: IDE filing
4. UC Davis CTCS: monitoring and QA services
5. UC Davis CTSC: REDCap database

22. Support D4 at UC
Helping all of our campuses contribute to the
new national vision of team science and
collaboration
Speeding thru the
“Valley of Death”