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# Advanced Technology Partnerships Initiative

# Program Narrative

**November 2008**

###  Executive Summary: 

The number of candidate drug targets and products aimed at prediction,
prevention, diagnosis, and treatment of cancer has increased
dramatically during the past decade. This is a direct outgrowth of
increased support for biomedical research and advances across the entire
research spectrum. The sequencing of the human genome alone has brought
science to the threshold of unparalleled opportunity. However, the
promise of these basic research discoveries will not be realized without
a translational research enterprise that can rapidly and
cost-effectively transition them into products for cancer patients.

The National Cancer Institute\'s (NCI) Advanced Technology Partnerships
Initiative (ATPI) will address this need through development of
partnerships involving advanced technologies and translational science
in collaboration with other government and nongovernmental research and
development organizations. Procedures will be in place to ensure
protection of intellectual property and appropriate management of
potential conflicts of interest.

NCI will draw upon its wide array of cutting-edge technologies at its
national laboratory in Frederick, Md. NCI-Frederick is a Federally
Funded Research and Development Center (FFRDC), a government-owned,
contractor-operated national laboratory, one of only 38 in the nation
designed to accomplish special long-term research or development needs
that cannot be met as effectively by existing in-house or contractor
resources. NCI-Frederick is currently home to many state-of-the-art and
cost-effective advanced technology programs for the rapid translation of
basic discoveries into interventions for cancer patients. NCI will build
on this capability to capitalize on existing expertise and to avoid
redundancy of infrastructure.

### Strategic Objective: The Basis for Measuring Progress Against Cancer

NCI's mission is to reduce the burden of cancer. The report, "*National
Cancer Institute Response to Congressional Report Language on Strategic
Plan Implementation (Response*)," notes that to achieve this strategic
objective, NCI must integrate all of its activities across a seamless
research continuum. This will require partnerships and the ability to
transition new research discoveries to the clinic in order to preempt
cancer and to expedite the delivery of effective interventions to cancer
patients.

This strategic goal is not unique to NCI. In fact, the objective of
delivering high-quality, safe, and effective medical products to
patients faster and more cost efficiently is embodied in the Department
of Health and Human Services' (HHS) *Priorities for America's Health
Care*, as well as the National Institutes of Health's (NIH) *Roadmap for
Medical Research.*

The basis for measuring how well NCI is meeting its strategic objective
is its ability to deliver effective interventions to cancer patients.

### Barriers to Achieving NCI's Strategic Objective:

Several independent studies have noted that barriers exist to the
translation of new discoveries into effective clinical products. In
2006, the Government Accountability Office (GAO) cited two major
barriers:

-   the inability of drug developers to effectively harness new
    technologies

-   and the shortage of researchers with expertise in translating basic
    discoveries into new drugs.

In its November 2006 report to Congress entitled *New Drug Development:
Science, Business, Regulatory, and Intellectual Property Issues Cited as
Hampering Drug Development Efforts,* the GAO said the number of new
molecular entities submitted to FDA for approval from 1993 to 2004
increased by only 7 percent despite an increase in private-sector R&D
expenditures of 147 percent. The report cites an FDA study
acknowledging, "There is an urgent need to improve the drug development
process and to enhance collaboration among the Government, Industry, and
Academia."

NCI addressed these issues by convening a roundtable of cancer research
community leaders representing cancer centers, industry, academia,
philanthropic and advocacy groups, and the financial markets to examine,
among other things, the key barriers that stand in the way of
accelerating progress against cancer and strategies for speeding the
development and delivery of new diagnostics, preventives, and treatments
for cancer. The roundtable recommended four approaches for eliminating
major barriers to translational research:

-   Building cross-disciplinary collaborations and teams

-   Bridging the gap between late discovery and early development of
    diagnostics and therapeutics

-   Developing data standards

-   Developing cross-cutting technology platforms

In February 2006, the NCI sponsored the first of two Translational
Research Working Group Roundtables for advice on how to create and
sustain a 21^st^ century translational research model using
multidisciplinary collaborations with coordinated, complex
infrastructures and streamlined, efficient procedures. The working group
is now focusing on early translation involving partnerships and
collaborations, intervention development, and phase I and II clinical
trials.

### ATPI: An Approach for Achieving NCI's Strategic Objective

The ATPI seeks to accelerate the delivery of effective products to
cancer patients. This will be achieved by utilizing advanced technology
platforms and collaborative research agreements to identify the most
promising candidates and then move them efficiently through the
translational continuum.

NCI-Frederick has a proven track record in managing research and
development agreements with other organizations, both inside and outside
of the government. This expertise combined with a broad array of
advanced technologies will support ATPI objectives.

The FFRDC contractor is required by Federal Acquisition Regulation to be
an autonomous organization that operates in the public interest with
full disclosure of its activities to the government. The FFRDC also
enjoys access to government and supplier data, employees, and facilities
beyond that which is found in other contractual relationships. The FFRDC
environment will provide a wealth of resources to accelerate the
development of new, more effective ways to diagnose, treat, and
ultimately prevent, cancer.

Congress has rightfully expressed concerns about ensuring that
interactions among the government and other research and development
organizations avoid conflicts of interest. The ATPI is well-suited to
provide an environment in which these interactions between the
government and other organizations may occur transparently, thus
mitigating conflict-of-interest concerns.

The use of the FFRDC is also consistent with the NCI FY 08 Bypass Budget
(Budget), known formally as *The Nation's Investment in Cancer
Research.* The FY 08 Budget lists five key forces as critical to the
realization of NCI's strategic objective. One of these five key forces,
"Leveraging Resources and Knowledge -- *where collaborative efforts and
entities meet,*" acknowledges that research and development partnerships
are changing the way NCI works to reduce the burden of cancer. It goes
on to state that NCI's FFRDC comprises an effective resource of
world-class biomedical research and technology capabilities that can
support a collaborative approach to the translation of basic research
results into new prototype cancer diagnostics and therapies for
patients.

NCI-Frederick technologies to which the Budget refers include
translational research programs in:

-   Genomics

-   Proteomics

-   Imaging

-   Nanotechnology

-   Mouse Models

-   High-throughput screening

-   Biospecimen repositories

-   High-Performance Computing and Bioinformatics

-   Biopharmaceutical Development

-   cGMP manufacturing

-   Associated Quality Assurance Capabilities

-   Regulatory affairs programs that can support development of
    Investigational New Drug (IND) applications

### Benefits of the ATPI to the Public Health

The ATPI is designed to reduce the time and cost associated with the
translation of candidate drug products into effective interventions that
would be available to cancer patients more rapidly and at lower cost.

The ATPI will take advantage of technology platforms that help identify
the candidates most likely to be efficacious and have low toxicity when
they enter clinical trials. This will enable the partners to allocate
their finite resources to high-probability candidates and to move them
more rapidly through development and clinical testing.

For example: the development of mouse models that mimic human disease
would be valuable in determining whether a drug or biologic candidate is
likely to be successful in human clinical trials; development of
standardized biomarkers would facilitate evaluating a products
effectiveness in treating a disease; and standardized genomic profiling
techniques would enable clinicians to prescribe drugs and biologics that
are most likely to be effective against an individual patient's specific
disease.

The ATPI will also enable studies that partners may otherwise be unable
to accomplish. An example is the conduct of phase I, II, or III clinical
trials using multiple-combination drugs from multiple organizations.
This type of clinical trial can be difficult to undertake for companies
that are normally competitors; it may, however, be possible by
partnering with other organizations in such a way that does not
compromise proprietary rights.

The ATPI will offer:

-   access to a diverse and integrated portfolio of cost-effective,
    state-of-the-art advanced technology platforms, thus avoiding the
    cost to establish and sustain a redundant technology infrastructure

-   access to translational and clinical drug development expertise that
    is distinct from the drug discovery paradigm

-   expanded access to cGMP development and manufacturing capabilities
    and regulatory affairs support

The NIH has a number of partnerships, including the NIH Biomarkers
Consortium, which began in 2006 to identify and validate biomarkers for
disease. The ATPI shares features and benefits of the biomarkers
consortium, but will address a more diverse set of challenges.