# Presentation: 711017

## Academic Public Private Partnership Program (AP4)

- Dr. Edward Sausville
- Associate Director
- Developmental Therapeutics Program
- Division of Cancer Treatment & Diagnosis
- National Cancer Institute
- AACR Annual Meeting
- July 11, 2003
- Washington, DC
- _[http://dtp.nci.nih.gov](http://dtp.nci.nih.gov/)_                        Exhibit Booth #342-344

## 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.

## 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.

## 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.

## 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

## AP4 Primary Features

- Academic or Non-profit Director
- Each Center can have many contributing “partners” - academics, pharma, biotechs, non-profits, gov’ts
- 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

## 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 **

## AP4  – Connections

**  ****(College/Non-profit)**
**  **

**NCI Program**
**Director**

-   **Partner 1**

**Project 1**

**Project 2**

**Project 3**

**Partner 2**

**Partner 3**

- Steering Committee

**Advice**
**(Non-**
**Voting)**

-  **Voting**
**Members**

**Review &**
**Approvals**

**Voting Member &**
**Coordinator**

**Requests**
**For Support/**
**Progress Reports**

**Funding**

**Funding**

**Evaluations**

## 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)

## 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.

## 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

## 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.

## 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

## 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.

## 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 gov’t.
- Mingling of funds from gov’t. and partners will lessen gov’t. financial responsibility.

## 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

## 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

## 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**

## 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 Gov’t and members sharing costs; SC vested with the power to make immediate go/no go decisions.