CAI Kick-Off Meeting - Center for Accelerated Innovation

Report
University of California
Center for Accelerated Innovation
STEVEN DUBINETT
MICHAEL PALAZZOLO
STEVEN GEORGE
JUNE LEE
VISH KRISHNAN
National CAI Kick-Off Meeting
October 29, 2013
Contents
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Consortium Membership & Expertise
Leadership and Governance Structure
Center Resources
Technology Solicitation to Exit
Skills Development Overview
Defining Success: Metrics & Deliverables
UC Biomedical Research Acceleration Integration and
Development (UC-BRAID)
University of California,
Los Angeles
UC Biomedical Research Acceleration Integration and
Development (UC-BRAID)
UC Biomedical Research Acceleration Integration and
Development (UC-BRAID)
• UC CAI
• UC ReX
– Enables search of 12 million de-identified patient
records from the 5 UC medical centers
– Counts of eligible patients by gender, race, ethnicity
• EngageUC
– Global consent and biobanking
– $2-million in supplemental funding from NCATS
Expertise
• Rich research base: 7% of NHLBI’s FY2012
grant funding
• Proximity to large biomedical industry clusters
in San Diego, Irvine/Orange County and San
Francisco
• More than 70 industry experts in:
– heart, lung and blood diseases
– technology platforms
– commercialization
Expertise
• History of innovation:
– breath biomarkers for asthma (D. Cooper)
– a hemodynamic system for transfusion of blood
products and administration of blood pressure
medications (J. Rinehart)
– hydrogel for cardiac tissue repair (K. Christman)
– pulmonary vein ablation catheter for atrial fibrillation
(M. Lesh)
– biologic for idiopathic pulmonary fibrosis
(D. Sheppard)
– biopolymer implant for ventricular reconstruction in
congestive heart failure patients (R. Lee)
Introduction to Leadership
Michael Palazzolo, MD, PhD - Center Director
• Director of Human Genome Center, Berkeley Lab
• Associate Director, Drosophila Genome Project,
Berkeley Lab
• Senior Director of Biosystems, Amgen
– led 270 scientists conducting high-throughput genomics
research
• Partner at Coastview Capital, a Los Angeles-based venture
capital firm
• Project manager
– international Stand Up to Cancer collaboration
– international, multiyear collaboration between academic
laboratories at U Toronto (Mak) and UCLA (Slamon)
Contents
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Consortium Membership & Expertise
Leadership and Governance Structure
Center Resources
Processes: Technology Solicitation to Exit
Skills Development Overview
Defining Success: Metrics & Deliverables
Local and National Announcements
CTSA Central
NBC Channel 4 News
Posted on Sept 30, 2013
Aired October 1, 2013
Governance
External
Selection
Committee
Executive Committee
External Advisory
Board
Business Review
Panel
Center Director
Skills Development
Program
Associate Director
Domain Areas
Therapeutics
Diagnostics
Devices
Domain/
Site Leaders
Projects
Cardiovascular
Lung & Sleep
Disorders
Blood
Diseases
Program Resources
Administrative
& Budgetary
Support
Website & Data
Management
Project
Management
Industry
Relations & IP
CTSA
Infrastructure
Evaluation
& Tracking
Site Leaders
Campuses
LauraMarcu,PhD
UC Davis
Steven George,MD,PhD
UC Irvine
SotiriosTsimikas,MD JosephWitztum,MD
UCSD
UCSD
TomasGanz,MD,PhD
UCLA
JuneLee,MD
UCSF
ShaunCoughlin,MD,PhD
UCSF
Diseases
Domain Leaders
& Skills Development Program
Sotirios Tsimikas,MD
Shaun Coughlin,MD,PhD
Cardiovascular Disease
Cardiovascular Disease
Vish Krishnan
Skills Development Program
UCSD
Tomas Ganz,MD,PhD
June Lee,MD
Blood Disorders
and Resources
Lung and Sleep Diseases
Domain Leaders
Platforms
Laura Marcu, PhD
Sotirios Tsimikas,MD
Shaun Coughlin, MD, PhD
Co-Leader,
Devices and Tools
Co-Leader,
Diagnostics
Co-Leader,
Therapeutics
StevenGeorge,MD,PhD
Joseph Witztum, MD
June Lee, MD
Co-Leader,
Devices and Tools
Co-Leader,
Diagnostics
Co-Leader,
Therapeutics
External Advisory Board
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Consists of no fewer than 5 members
Experienced business leaders
Includes NHLBI Program Officer
Advice about operations, project development
Catherine Mackey, PhD
Former Senior VP, Pfizer
Founder, MindPiece Partners
Francis Duhay, MD
VP Medical Affairs and CMD,
Edwards Lifesciences
Lawrence Souza, PhD
Former Senior VP, Amgen
Founder, Coastview Capital,
Business Review Panel
• Five members
• VCR on each campus
appoints one member
• Evaluate Center’s
progress toward sustainability
Bill Ouchi, PhD
UCLA Initial Chair
Anderson School
Progress to Date
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Campus meetings
Face-to-face meetings
Site and domain leadership meetings
Website development
Administrative meetings
100-day Implementation Plan
Progress to Date
Progress to Date
Progress to Date
http://uccai.ctsi.ucla.edu
Contents
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Consortium Membership & Expertise
Leadership and Governance Structure
Center Resources
Processes: Technology Solicitation to Exit
Skills Development Overview
Defining Success: Metrics & Deliverables
Center Resources by Development Stage
• Discovery
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Cardiovascular Research Institute (UCSF)
Lung Biology Center (UCSF)
Biomarker Laboratory (UCSD)
Drug Discovery Institute (UCSD)
Institute for Engineering in Medicine (UCSD)
Small Molecule Discovery Center (UCSF)
• Pre-clinical and Clinical
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Cardiovascular Physiology Core (UCSD)
National Primate research Center (UCD)
Large Animal Survival Science Service Facility (UCD)
Airway Clinical Research Center (UCSF)
Animal Care Program Diagnostic Laboratory Services (UCSD)
Applied Physiology-Human Performance Lab (UCI)
UC Medical System
Center Resources by Platform
• Diagnostics
– Translational Pathology Core Laboratory (UCLA)
– Tissue Array Core Facility (UCLA)
– West Coast Central Comprehensive Metabolomics Resource
Core (UCD)
– Crump Institute for Molecular Imaging (UCLA)’
• Therapeutics
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GMP Facility (UCD)
Medicinal Peptide Synthesis Core (UCLA)
Center for Molecular and Genomic Imaging (UCD)
Metabolomics Central Service Core (UCD)
Molecular Screening Shared Resource (UCLA)
• Devices
– Edwards Lifesciences Center for Advanced Cardiovascular
Technology (UCI)
Center Resources for Commercialization
• Entrepreneurial
– von Liebig Center for Entrepreneurism and Technology Advancement
(UCSD)
– Business of Science Center (UCLA)
– Harold and Pauline Price Center for Entrepreneurial Studies (UCLA)
– West Health
– CONNECT
– BIOCOM
• Incubators
– QB3 (UCSF)
– Institute for Technology Advancement (UCLA)
– Center for Innovative Therapeutics (UCSD)
• Industry Partners
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Bristol-Myers Squibb
Care Fusion
Edwards Lifesciences
Life Technologies
MedImmune Ventures
Pfizer Centers for Therapeutic Innovation
Quest Diagnostics
Edwards Lifesciences Center
Research Vision
• 6 core (22 affliated) faculty in 13,000 asf
• 40 doctoral students and postdoctoral researchers
• Research focus areas:
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Valve replacement technology
Regenerative cardiovascular medicine
Non-invasive (wireless) cardiovascular monitoring
Novel stent or catheter-based therapies
Heart valve fluid dynamics
(Professor Kheradvar)
Perfused human microtissues
(Professors George, Lee, and Hughes)
Edwards Lifesciences Center
Training Vision
Train future translational cardiovascular
researchers at all levels (undergraduate,
graduate, post-doctoral)
• Training fellowships from endowment
• Cardiology Fellow (3-yr dedicated research time)
• NIH T32 training grant (CARE Program)
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Business plan competition
6 funded slots (3 doctoral positions per year)
• E-SURP (paid summer internships – UCI ugrads)
• Summer Scientists (high school students)
Contents
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Consortium Membership & Expertise
Leadership and Governance Structure
Center Resources
Processes: Technology Solicitation to Exit
Skills Development Overview
Defining Success: Metrics & Deliverables
Technology Selection Overview
• Solicit 2-page pre-applications
• Each campus reviews and selects the best
proposals for full application
• 1st Review: Highest ranked proposals from
each campus submitted for review by panels
assembled by Domain Leaders
• 2rd Review (External Review): External
Selection Committee scores proposals and
sends to NHLBI
• 3rd Review: NHLBI makes final selection
Technology Selection Overview
RFP
Pre-application
Pre-application
Review
Full
Application
UC BRAID Review
Committee
External Selection
Committee Review
NHLBI Review
Technologies
Selected for
Entrance to Center
Technology Selection Timeline
• Annual solicitation for 3 tracks
– Therapeutics
– Devices/ digital health
– Diagnostics
• Timeline from initial solicitation to External
Selection Committee recommendation: 6
months
• Awards of up to $200K/2yrs
Solicit
PreApplication
Review
PreApplication
Develop and
Submit Full
Application
First Review
of
Full
Application
ESC Review
of
Application
1 month
1 month
2 months
1 month
1 month
Pre-application and Review
RFP
Pre-application
Pre-application
Review
Full
Application
UC BRAID Review
Committee
External Selection
Committee Review
NHLBI Review
Technologies
Selected for
Entrance to Center
Eligibility
• Faculty in all series and ranks at UC Davis,
UC Irvine, UCLA, UC San Diego, and UC San
Francisco
• Postdoctoral scholars are eligible to submit
applications as Co-PI with a faculty PI
• Projects with existing or imminent target
validation and a clear clinical indication
• Patents or patent applications are filed or
potential for obtaining defensible intellectual
property is strong
Solicitation Process
• Broad solicitation
– Focus on NHLBI priority areas (heart, lung,
blood)
• Centralized RFP for all 5 campuses
• Webinar on submission process
• Each campus is accountable for
supporting the highest potential projects
with product development related issues
Two-page Pre-application
• Centralized online submission
• Two-page pre-application contains:
– Executive summary
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Unmet Need/ Clinical impact
Research/development/ regulatory plan
Intellectual Property
Business strategy/Commercialization plan
• Local review of two page pre-applications
assess:
– Scientific merit
– Product development potential
• Highest potential projects will be requested to
submit full proposals
Technology Selection: Full Application
RFP
Pre-application
Pre-application
Review
Full
Application
UC BRAID Review
Committee
External Selection
Committee Review
NHLBI Review
Technologies
Selected for
Entrance to Center
UC BRAID Review Committee
• Selected by Domain Experts/
Platform Leads
• UC BRAID Executive Committee
• Domain Leads, Site Leads, Platform
Leads
• External experts from industry
Full Application
• Review Criteria
– Unmet medical need
– Development feasibility
– Commercial attractiveness
– Intellectual property status
– Relevance to NHLBI mission
– Metrics for success
o Evidence of target validation (therapeutic)
o Time and cost of prototyping (device)
o Combination of the above (diagnostic)
Full Application:
External Selection Committee
• Prioritize applications received from
Leadership Review
• Same review criteria as Leadership Review
• 1 month to review
• Reviewers
– Targeting total pool of 100
– Selected to review proposals based on
domain/functional expertise
– Must be external to institution(s)
– Chair/Co-Chair to finalize recommendations to be
submitted to NHLBI
Technology Development Pipeline
RFP
Pre-application
Pre-application
Review
Full
Application
Referral
UC BRAID Review
Committee
Referral
External Selection
Committee Review
Consultation
Award
NHLBI Review
Technologies
Selected for
Entrance to Center
Consultation Awards
• Eligibility
– Proposal not selected for Center but identified
as high potential
– Leadership Review or External Review
recommends Consultation Award
consideration
• Amount and duration of awards vary
– Most awards for 3-6 months
• Recipients must agree to resubmit and
target a specific RFP for resubmission
Consultation Awards
• Awards will address the following gaps:
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In vivo proof of principle
Hypothesis testing
IP assessment
Target product profile discussion
Regulatory assessment
Further development planning
• Based on results of work done during
award, awardee may be invited to submit
full proposal for subsequent cycle
Contents
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Consortium Membership & Expertise
Leadership and Governance Structure
Center Resources
Processes: Technology Solicitation to Exit
Skills Development Overview
Defining Success: Metrics & Deliverables
Key Goals and Objectives
Offer actionable cross-campus skills development
opportunities that:
• Encourage PI’s to consider commercialization
considerations when writing grant proposals
• Impart core project management and business planning
skills for life sciences projects.
• Improve awareness of market, financial, and IP issues in
the early stages of a project.
• Guide researchers on the assessment of technologies on
their readiness and risks
• Mitigate various types of risks with appropriate project
design and partnership business models.
Skills Development Canvas
Engage “Proto-innovators”
Segments
Funded
Faculty
Activities
Commercialization
Content Portal
(Readings, Videos,
Cases)
Advisory Services/
Clinics
Courses/Workshops
on Commercialization
Networking Events
and Contests
Prospective
Faculty
Post-Docs
Fellows
Grad
Students
Education and Training
• Technology Commercialization Primer
– Gateway course for Center innovators
– Teach innovators how to frame proposals for Center
– Covers technology readiness, market research, risk mitigation,
competitive analysis, company start up
– Builds on existing courses
• Lab to Market (UCSF), Idea to IPO (UCSD)
• Catalog commercialization resources across Center
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Business plan development
SBIR grant writing
IP, licensing, contract negotiation
Existing courses on campuses
• Match innovators with educational and networking events
• Annual Heart, Lung, Blood Technology Forum
– Innovators present progress and lessons learned
– Networking with industry participants
Mentoring and Advising
• Highly experienced industry professionals, venture
investors, entrepreneurs
• “Mentor the Mentor” training
– Modeled on UCD Mentoring Academy
– Recognition for superior mentoring
• Three levels of mentoring:
– Generalist -- Help innovators prepare competitive proposals
– Lead -- Guide innovators selected for the Center
– Specialist -- Available to address specialized problems during
technology development
• Online Commercialization Clinics
– Led by mentors
– Held quarterly
– Archived on Center website
Feedback
• Compile data on technology pipeline and
licensing activity
– Provide feedback to Center on investment needed
to enhance attractiveness of pipeline
Timing
• Develop and launch Technology
Commercialization Primer in year 1
• Mentoring programs and technology
commercialization clinics in years 1-2
Contents
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Consortium Membership & Expertise
Leadership and Governance Structure
Center Resources
Processes: Technology Solicitation to Exit
Skills Development Overview
Defining Success: Metrics & Deliverables
Goals
• Build an entrepreneurial ecosystem in
the NHLBI domain – skills development
• Identify the best technologies across all
5 UC campuses
• Incubate 30-40 of the most promising
technologies within the center towards
a commercially rewarding exit
• Sustainability
Why Did We Institute a
Business Review Panel?
• Each campus has the responsibility to manage
its own exits
• We agreed there isn’t a dataset that exists that
would allow the selection of an optimal exit
strategy for all five campuses
• Best approach would be to run an experiment
and use the data to guide us in the future
• The data would best be evaluated by experts
outside the Center reporting to the EC and not
the Center
Why Is Sustainability Hard?
University
Research
Tech
Transfer
Venture
Capital
Biotech
Pharma
The technological bottleneck is the mechanistic
understanding of a disease that can be used to
validate therapeutic intervention points. This happens
largely in the university.
However, the value transition point occurs at proof-ofconcept in clinical trials in phase I or phase II. This
currently takes place in Biotech and Pharma.
Sustainability May become Even Harder
• “However, although investment in pharmaceutical
research and development has increased
substantially...the lack of a corresponding
increase in terms of new drugs begin approved
indicates that therapeutic innovation has become
more challenging.”
– Nature Reviews. Drug Discovery 10, No. 6,
pp.428-438.
• “venture financing for biotech has been in
decline...Some venture capitalists have stopped
funding new biotech altogether.”
– Wall Street Journal, March 16, 2012
Bill Ouchi’s Views on Problems
That Need to Be Solved to Achieve Sustainability
• Tech transfer offices are undercapitalized
• Tech transfer offices tend to be highly
politicized
• Tech transfer offices frequently have
insufficient business expertise and
management
• Faculty need mentoring
• Universities may need to step up to incubate
technology to the point of proof of concept on
its most promising programs

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