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University of California Center for Accelerated Innovation. UC CAI . Face-To-Face Meeting October 14, 2013. Michael Palazzolo. Local and National Announcements. CTSA Central. NBC Channel 4 News. Posted by UCLA on Sept 30, 2013 (day before the government shutdown). Aired October 1, 2013.

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uc cai

University of California Center for Accelerated Innovation

UC CAI

Face-To-Face MeetingOctober 14, 2013

Michael Palazzolo

local and national announcements
Local and National Announcements

CTSA Central

NBC Channel 4 News

  • Posted by UCLA on Sept 30, 2013 (day before the government shutdown)

Aired October 1, 2013

notice of award
Notice of Award

Notice of Award: Key Points

  • Year 1 Budget Period 9/26/13-7/31/14
  • Key Personnel
  • 100-day Implementation plan due 10/25/13
  • Interim Progress Report in Year 1due 3/1/14
  • Cost-share report due with FFR
  • Program Steering Committee Meeting 10/29-10/30/13
contents
Contents
  • Introduction to leadership
  • Goals
  • Governance
  • Technology Solicitation & Selection
  • Technology Development
  • Skills Development
leadership
Leadership

UC CAI

Michael Palazzolo, MD, PhDCenter Director, UC CAIProfessor, UCLA

Tomas Ganz, MD, PhD

Center Associate Director

Professor, UCLA

leadership1
Leadership

Executive Committee

Lars Berglund, MD, PhDDirector, UCLA Clinical and Translational Science Center

Steven Dubinett, MDDirector, UCLA Clinical and Translational Science Institute

Gary S. Firestein, MDExecutive Committee Chair

Director, UCSD Clinical and Translational Research Institute

Clay Johnston, MD, PhDDirector, UCSF Clinical and Translational Science Institute

Dan Cooper, MDDirector, UCLA Institute for Clinical and Translational Science

site leaders
Site Leaders

Campuses

JuneLee,MDUCSF

ShaunCoughlin,MD,PhDUCSF

SotiriosTsimikas,MDUCSD

JosephWitztum,MDUCSD

LauraMarcu,PhDUC Davis

Steven George,MD,PhDUC Irvine

TomasGanz,MD,PhDUCLA

domain leaders
Domain Leaders

Diseases

June Lee,MDLung and Sleep Diseases

Shaun Coughlin,MD,PhDCardiovascular Disease

SotiriosTsimikas,MDCardiovascular Disease

Tomas Ganz,MD,PhDBlood Disorders and Resources

domain leaders1
Domain Leaders

Platforms

June Lee,MDCo-Leader, Therapeutics

Shaun Coughlin,MD,PhDCo-Leader, Therapeutics

SotiriosTsimikas,MDCo-Leader, Diagnostics

Joseph Witztum,MDCo-Leader, Diagnostics

Laura Marcu,PhDCo-Leader, Devices and Tools

StevenGeorge,MD,PhDCo-Leader, Devices and Tools

domain site leaders
Domain/Site Leaders
  • At least one site leader for each campus
  • At least one domain leader for each platform (drugs, devices, diagnostics) and disease (heart, lung and sleep, blood)
  • Ensure the pool of candidate technologies is large
  • Oversee proposal solicitation process
  • Recruit study sections
  • Recruit and oversee project development teams on respective campuses
skills development program
Skills Development Program
  • Catalogs entrepreneurial course offerings on all five campuses
  • Matches innovators to mentors
  • Conducts webinars, symposia

Vish Krishnan

Leader, Skills Development Program

UCSD

goals
Goals

Goal 1

  • Engage University of California heart lung and blood disease innovators through a comprehensive education, training and mentorship program.
goals1
Goals

Goal 2

  • Solicit and select technologies with high commercial potential that align with NHLBI’s mission and address unmet medical needs or significant scientific opportunity.
goals2
Goals

Goal 3

  • Incubate our most promising technologies in accordance with industry requirements to facilitate their translation to commercial products that improve patient care and enhance health.
goals3
Goals

Goal 4

  • Create a high-performing, sustainable infrastructure that will serve as a model to academic research centers.
governance
Governance

External Selection Committee

Executive Committee

External Advisory Board

Business Review Panel

Center Director

Skills Development Program

Associate Director

Domain Areas

Domain/Site Leaders

Therapeutics

Diagnostics

Devices

Projects

Cardiovascular

Lung & Sleep Disorders

Blood

Diseases

Program Resources

Industry Relations & IP

CTSA Infrastructure

Website & Data Management

Administrative& Budgetary Support

Project Management

Evaluation & Tracking

external selection committee
External Selection Committee
  • No fewer than 5 members
  • Size and composition depends on RFAs under review
  • Appointed by Executive Committee
  • May be present and former faculty and/or industry leaders
  • Must be external to institution(s)
external advisory board
External Advisory Board
  • Consists of no fewer than 5 members
  • Experienced business leaders
  • Includes NHLBI Program Officer
  • Advice about operations, project development

Catherine Mackey, PhDFormer Senior VP, PfizerFounder, MindPiecePartners

Francis Duhay, MDVP Medical Affairs and CMD, Edwards Lifesciences

Lawrence Souza, PhDFormer Senior VP, AmgenFounder, Coastview Capital,

business review panel
Business Review Panel
  • Five members
  • VCR on each campus appoints one member
  • Evaluate Center’s progress toward sustainability

Bill Ouchi, PhDUCLA Initial Chair

Anderson School

cai administration
CAI Administration
  • Administration is based at UCLA
    • Anne Skinner is Administrative Director
  • UCLA CTSI maintains CAI website
    • CAI information, RFP, project-tracking
    • Doug Bell, MD, PhD leads
  • UCLA CTSI conducts evaluation with UC BRAID
    • Pamela Davidson, PhD, MSHS leads
governance tasks for first 100 days
Governance Tasks for First 100 Days
  • Executive Committee names at least 5 members to the External Selection Committee
  • VCRs at UCD, UCSD, UCI, UCSF each name 1 faculty to Business Review Panel
  • Name at least 2 members to External Advisory Board.
governance tasks for first 100 days1
Governance Tasks for First 100 Days
  • 1 meeting: Executive Committee, Center Director, Associate Director & External Advisory Board
  • 3 meetings (1 per month): Center Director, Associate Director & Executive Committee
  • 3 meetings (1 per month): Center Director, Domain and Skills Development Leaders
administrative tasks for first 100 days
Administrative Tasks for First 100 Days
  • Initiate intercampus sub-awards
  • Identify campus administrative leads
  • Build website
  • Begin coordination/communication process
discussion
Discussion
  • Process for naming External Advisory Board members
  • Do we want more than 5 EAB members?
  • Deadlines for naming members to EAB, Business Advisory Panel, and External Selection Committee
technology selection overview
Technology Selection Overview

5-Step Process

  • Solicit 2-page pre-applications
  • 1st Review: Review Panels assembled by Domain Leaders review pre-applications and invite full applications
  • 2nd Review (Leadership Review): Executive Committee, Center Director, Assoc. Director, Domain Leaders and ad hoc reviewers select full proposals
  • 3rd Review (External Review): External Selection Committee scores proposals and sends to NHLBI
  • 4th Review: NHLBI makes final selection
technology selection overview1
Technology Selection Overview

RFP Pre-application

Pre-applicationReview

FullApplication

Leadership Review

External Selection Committee Review

Technologies Selected for Entrance to Center

NHLBI Review

technology selection timeline
Technology Selection Timeline
  • Solicitations occur three times a year, one for each platform (therapeutics, devices, diagnostics)
  • RFPs for the platforms run concurrently
  • Time from solicitation to prioritization by External Selection Committee takes 7 mos.
  • Up to 3technologies enter Center in yr.-1
  • Awards of up to $200K

Review Pre-Application

Solicit Pre-Application

Develop and Submit Full Application

First Review ofFull Application

ESC Review of Application

3 months

1 month

1 month

1 month

1 month

pre application and review
Pre-application and Review

RFP Pre-application

Pre-applicationReview

FullApplication

Leadership Review

External Selection Committee Review

Technologies Selected for Entrance to Center

NHLBI Review

eligibility
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
Solicitation Process
  • Broad solicitation
  • Added focus on cardiology, pulmonary, hematology, cardiothoracic surgery, etc.
  • Centralized RFP
  • Webinar on submission process
  • Campuses to provide potential applicants with referrals for help with business plans, grant writing, IP, licensing, team building
  • Innovators may apply for Catalyst Grants from their campus CTSA to support team building
2 page pre application
2-page Pre-application
  • Centralized online submission
  • The two-page pre-application contains:
    • description of the invention
    • its potential market and impact
    • description of competitive landscape
    • whether pre-clinical or early clinical proof of concept is achieved or imminent
    • what is needed to make the invention licensable
    • proposed budget
  • Review Panels (one for each platform technology) review pre-applications for scientific merit and commercial potential
review panels
Review Panels
  • Selected by Domain Experts
  • Includes external experts from industry and internal or external academic experts
  • Domain Experts do not participate in pre-application review
  • At least some Review Panel members should be expert in platform under review
technology solicitation tasks for first 100 days
Technology Solicitation Tasks for First 100 Days
  • Develop RFP for 2-page pre-application
  • Create Webinar about submission process
  • Develop online submission “package”
  • Each campus site develop plan for advertising RFP
  • Recruit Review Panel members
discussion1
Discussion
  • Review criteria for pre-application
  • Scoring for pre-application
  • Local or central pre-application review?
  • Size of review panel(s)?
  • Begin with one platform or solicit all three at once?
  • Are campuses prepared to provide guidance with IP, licensing, etc.?
  • Date for RFP release
technology selection full application
Technology Selection: Full Application

RFP Pre-application

Pre-applicationReview

FullApplication

Leadership Review

External Selection Committee Review

Technologies Selected for Entrance to Center

NHLBI Review

full application
Full Application
  • By invitation
  • Central RFP submission
  • Full-proposal format:
    • Summary, including objectives
    • Background, including research strategy
    • Product development & commercialization
    • Strategic partnerships
    • Budget
  • 3 months to submit
full application1
Full Application
  • Review Criteria
    • Unmet medical need
    • Development feasibility
    • Commercial attractiveness
    • Intellectual property status
    • Relevance to NHLBI mission
    • Metrics for success
      • Evidence of target validation (therapeutic)
      • Time and cost of prototyping (device)
      • Combination of the above (diagnostic)
full application leadership review
Full Application: Leadership Review
  • Reviewers
    • Executive Committee
    • Center Director and Assoc. Director
    • Domain Leaders for disease and platforms under review
    • As needed: Ad hoc reviewers from academia, industry, venture capital with specific expertise in the diseases and platforms under review.
  • 1 month to conduct Leadership Review
full application external selection committee
Full Application: External Selection Committee
  • Prioritize applications received from Leadership Review
  • Same review criteria as Leadership Review
  • 1 month to review
  • Submit recommendations to NHLBI
  • Reviewers
    • No fewer than 5 members; present and former faculty and/or industry leaders
    • Must be external to institution(s)
full application tasks for first 100 days
Full Application: Tasks for First 100 Days
  • Develop RFP for full applications
  • Develop online submission “package” for full application
  • Begin to identify ad hoc reviewers for Leadership Review
discussion2
Discussion
  • Limit the number of applicants who are invited to submit full proposals?
  • How many pages for full proposal?
  • Include NIH review criteria?
  • Scoring system?
technology selection second chances
Technology Selection: Second Chances

RFP Pre-application

ConsultationAward

Pre-applicationReview

FullApplication

Referral

Leadership Review

Referral

External Selection Committee Review

Technologies Selected for Entrance to Center

NHLBI Review

consultation awards
Consultation Awards
  • Eligibility
    • Proposal not selected for Center
    • Leadership Review or External Review recommends Consultation Award consideration
  • Funded by campus CTSAs
  • 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 awards1
Consultation Awards
  • Consultation Awards will address gaps in following areas:
    • In vivo proof of principle
    • Hypothesis testing
    • IP assessment
    • Target product profile discussion
    • Regulatory assessment
    • Further development planning
  • Skills Development Program will match awardees with mentors and expertise
consultation awards tasks for first 100 days
Consultation Awards: Tasks for First 100 Days
  • Each CTSA determines feasibility of offering Consultation Awards
  • Skills Development Program begins to identify expertise in the following:
    • In vivo proof of principle
    • Hypothesis testing
    • IP assessment
    • Target product profile discussion
    • Regulatory assessment
    • Further development planning
discussion3
Discussion
  • Mechanics of Consultation Award
    • Application process or automatic review based on referral?
    • Standard or local criteria?
    • Timeframe for review?
    • Who conducts review?
  • Size of Consultation Award
    • Set an upper limit or local decision?
  • Resubmission Process
    • Pre-application or directly to full review?
technology development process
Technology Development Process

Technology EntersCenter

Project Design

ExitCenter

Project Plan

Product Development

Licensing

Project Design Team

Project Management Team

technology development
Technology Development
  • Two phases
    • Project design
    • Project management
  • Collaboration with campus IP office during entire development process is critical
  • Simultaneous skills development
    • We develop the innovation and the innovator
project design
Project Design
  • Center Director names Project Design Team
    • Platform expert(s)
    • Disease expert(s)
    • Campus Technology Transfer Officer
    • Project manager
    • Innovator
  • Two months to develop project plan
  • Must be approved by Center Director
elements of project plan
Elements of Project Plan
  • Product profile and exit strategy
  • Task definition
  • Resource identification
  • Identification of critical path and milestones
  • Gantt charts for
    • task responsibility and ordering
    • time to task completion
    • activity-based budgets
    • process for tracking project against milestones
    • process for periodic review
product profile example
Product Profile Example

Device Development Profile

Unmet Clinical Needs

Testing / Validation

IP/FDA

Technology / Components

Hardware / Software Validation

Intellectual Property

Cost Breakout

Animal Model

FDA Device ClassApproval Path

Good Laboratory Practices

Pilot Human Study

Commercial Partner /FDA

project management
Project Management
  • Site leader assembles team to manage product development
  • Team includes at a minimum:
    • Site leader
    • Project manager
    • Innovator
    • Campus Technology Transfer Officer
    • Mentors assigned to innovator by Skills Development Program
  • Team may also include ad hoc disease, platform or business experts assigned by Site leader
  • Project managers report to Site leaders
monitoring progress
Monitoring Progress
  • Continually assess progress against milestones
  • Terminate projects that do not make adequate progress
  • Use risk-mitigation strategies to permit multiple paths to success
  • Center Director is final authority for go/ no-go decisions
go no go decisions
Go/No-Go Decisions

Potent, Selective Compounds

Test PK Properties

All Compounds

Sufficient t ½ and oral bioavailability

IntraperitonealIn Vivo Assays

Oral In Vivo Assays

Sufficient Therapeutic Index

Insufficient Therapeutic Index

Sufficient Therapeutic Index

Insufficient Therapeutic Index

Go

No

Go

No

exit strategies
Exit Strategies

Exit Processes

Development Outside the Center

Low future interest

Return IP

Licensing not achieved

Project aborted by PI

Further management by Technology Transfer Office

Development at the Center

Continued evaluation by Center leadership

Licensing

Review by Technology Transfer Office

High future interest

Further incubation or marketing

technology development tasks for first100 days
Technology Development: Tasks for First100 Days
  • UCLA and UCSF identify possible project managers
  • Each campus begins to identify internal and external disease, platform and business experts for project design and project management teams
  • Site leaders liaise with campus Technology Transfer Office
  • Establish committee of Technology Transfer Officers from each campus to advise the Center.
  • Campuses identify cores that will be available to CAI innovators
technology development discussion
Technology Development Discussion
  • How do we make unique cores on each of our campuses visible to innovators at all campuses?
    • Can CTSA Translational Technologies and Resources Programs coordinate this effort?
  • What must be done to make cores available to all innovators with minimal red tape?
  • Process for organizing committee of Technology Transfer Officers from each campus