Academic Public Private Partnership Program (AP4)

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Academic Public Private Partnership Program (AP4)
Dr. Edward Sausville Associate Director Developmen
tal Therapeutics Program Division of Cancer
Treatment Diagnosis National Cancer
Institute AACR Annual Meeting July 11,
2003 Washington, DC http//dtp.nci.nih.gov
Exhibit Booth 342-344
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Purpose

• To stimulate cancer intervention discovery and
  development at academic/non-profit centers in
  partnership with other academics, industry,
  non-profits and government.
• To incorporate the latest technologies to find
  novel, mechanistically targeted drugs and other
  intervention strategies for underserved diseases
• To combine the necessary expertise to reduce the
  time required to translate novel interventions to
  the clinic.

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Impetus

• The need for a new intervention discovery and
  development assistance mechanism was promoted by
  several Progress Review Groups.
• New discovery paradigm (combichem, HTS,
  genomics,) has to date not lead to an increase in
  rate of NDAs when practiced by pharma/biotech.
• Hypothesis academic/non-profit centers add
  value to this effort if appropriately partnered.

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AP4 Concept Development

• Modeled after Industrial/University Cooperative
  Research Centers (I/UCRC) at National Science
  Foundation (NSF) which stimulates
  industrial-academic partnerships
• I/UCRC created 25 years ago FY 00 - NSF funds
  of 5.2 M generated 68M budget supporting 1,750
  faculty and students at 50 centers.

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NCI Study of I/UCRC

• Could the I/UCRC concept be adapted for NCI use?
  Input from
• NCI Office of Scientific Planning and Assessment
• NIH Office of the General Counsel
• NCI Technology Transfer Branch
• NCI-CTEP
• Members of DTP Grants and Contracts Operations
  Branch
• Members of PRGs

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AP4 Primary Features

• Academic or Non-profit Director
• Each Center can have many contributing partners
  - academics, pharma, biotechs, non-profits,
  govts
• All research is carried out at the Center
• All partners agree to a membership agreement
• Steering Committee (SC) - AP4 Director, partners
  and NCI SC determines to Center projects
• Focus is preclinical discovery early
  development of interventions with access to NCI
  development and clinical resources

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AP4 Proposed Grain Size
15 Planning Grants for 50K direct costs
each 6 Partnerships of 450K to 600K direct
costs each based on 300K total partner fees
450K/yr (direct) NCI 450K total partner
fees 600K/yr (direct) NCI
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AP4 Connections

AP4 Director (College/Non-profit)
Funding
Funding
Partner 1
Voting Member Coordinator
Evaluations
Voting Members
Advice (Non- Voting)
NCI Program Director
Partner 2
Steering Committee
Review Approvals
Requests For Support/ Progress Reports
Partner 3
Project 1
Project 2
Project 3
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NCI Center Support Structure

• Year 1 450,000 (100)
• Year 2 450,000 (100)
• Year 3 450,000 (100)
• Year 4 337,500 (75 funding)
• Year 5 225,000 (50 funding)
• (To encourage increased membership)

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AP4 Director

• AP4 Director will
• Use a one year planning grant to identify
  potential partners hold a meeting and formulate
  a partnership which benefits all parties
• Administer all aspects of subsequently approved
  5-year funded partnerships.
• Organize partnership meetings and projects.
• Provide yearly partnership evaluations to NCI
  through an appointed evaluator.

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Membership Agreement

• Agreement establishes a framework for the
  relationship between all partners
• All partners must agree to terms of the agreement
  which spells out
• IP issues
• Membership fees contribution of each member
• Creation of the Steering Committee
• Publication rights
• Evaluation metrics

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Possible Center Evaluation Metrics

• of Cancer-relevant target(s) characterized
• Establishment of high throughput, target-based
  screens
• Method of analysis of data from HTS successfully
  utilized to identify true hits.
• Communication between and contribution of all
  partners to the Center
• Number of patents, INDs filed, clinical trials
  supported
• Number of licenses for new IP
• Number of NDAs.

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Intellectual Property

• IP issues should be resolved during planning
  grant period
• How IP is handled may vary from group to group
• Bayh-Dole may be modified by consent of Center
  members
• NCI should advise, but not mandate how IP will be
  handled by each Center

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Grant Mechanism

• Cooperative Agreement
• Substantial NCI scientific and/or programmatic
  involvement with the awardee.
• NCI's role is to support and/or stimulate the
  recipient's activity by working with the
  award recipient. . . , but it is not
  to assume direction, prime
  responsibility, or a dominant role in the
  activity.

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AP4 Unique Features

• Dynamic management SC will make go/no go
  decisions on projects direct authority to add
  new projects and shift funds a fundamental
  difference from traditional grant arrangements.
• Priority access to DTP development resources for
  SC approved projects (must meet DCTD Drug
  Development Group criteria).
• AP4 is a test case for NCI a partnership
  between academics, industry, non-profits and the
  govt.
• Mingling of funds from govt. and partners will
  lessen govt. financial responsibility.

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Attraction for Partners

• NCI support for high risk research of interest
  to the cancer research community
• Establishes long-term relationship between
  academia, industry, and non-profits
• Each partnership determines its own ground rules
  defines beneficial interdisciplinary membership
• Can develop students knowledgeable in drug
  discovery and development-relevant research

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AP4 Initiation Sequence

• NCI - Announcement of program
• Proposed AP4 Director may submit LOI
• Proposed AP4 Director - submits application for
  planning grant
• NCI - peer-review of planning grant
• Proposed AP4 Director uses planning grant to
  find potential partners and form partnership
• (Evidence of planning grant success is a
  submitted Center proposal)
• NCI peer review of Center proposals

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AP4 Anticipated Time Line

• 2003
• February/March - Presentation to EC and BSA
• July Present program to the AACR
• July - Appears in NIH guide
• November - Receipt of planning grant
  applications
• 2004
• February - Review of planning grant applications
• June - Planning grant awards
• 2005
• June - Receipt of Center applications
• September - Review of Center applications
• November - NCAB Funding approval
• January 06 Awards made

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AP4 Conclusion

• What is proposed AP4 Centers will be
  Cooperative Agreements based at academic or
  non-profit institutions membership will be
  comprised of academics, industry, government and
  non-profits.
• Why - to discover new interventions translatable
  into therapies, recent NDA filings tell us
  technology alone is not enough. It is essential
  that multi-disciplinary and multi-institutional
  talents be partnered in this effort.
• Uniqueness focus on partnering, new
  technologies, and underserved diseases, with
  Govt and members sharing costs SC vested with
  the power to make immediate go/no go decisions.