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April 29, 2008 • Volume 5 / Number 9 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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Director's UpdateDirector's Update

Guest Update by Dr. Lynn Matrisian

Accelerating Translational Research at NCI: The Next Steps

Dr. Lynn Matrisian Dr. Lynn Matrisian serves as a special assistant to NCI Director John Niederhuber while maintaining her position as professor in the Department of Cancer Biology at Vanderbilt University. A former co-chair of the Translational Research Working Group, her charge is to work with the Coordinating Center for Clinical Trials to begin implementing the working group's recommendations.

On November 7-9, 2008, NCI will hold a first-of-its-kind, institute-wide translational science meeting in Washington, DC. The meeting marks a significant step toward implementing recommendations made by the Translational Research Working Group (TRWG) in its June 2007 report.

In this report, the TRWG laid out a plan to enhance the effectiveness of NCI's translational research enterprise. The recommendations focus on "early translation" - where many promising basic research discoveries can stall or derail because of a lack of tools or infrastructure.

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The TRWG further defined the early translation process with six developmental pathways - engineering diagrams that depict steps that are required to move discoveries from the laboratory, clinic, or population to the point where they can be tested in early-stage clinical trials. Basic research lies upstream from these pathways and provides a continual source of fundamental and innovative discoveries. In its June 2005 report, the Clinical Trials Working Group addressed advanced-phase trials that are downstream in the translational continuum. The TRWG's recommendations use a managed approach intended to accelerate translational progress along these six pathways.

The November meeting is the first step toward initiating a new approach to identifying and supporting promising translational research projects. Using the six pathways as a framework, the meeting's aim will be to identify projects in NCI's intramural and extramural translational portfolio that are "ripe" for translation. That is, those discoveries with sufficient promise to meet an important clinical need and those that can and should, with the appropriate links to other researchers and support tools, be efficiently moved into early-phase trials.

The meeting will provide an opportunity to assemble the components of a pathway that are focused on a single goal. There may be, for example, promising serum biomarkers or imaging approaches for early detection of a particularly devastating type of cancer that would benefit from links to an appropriate animal model, cohorts of high-risk individuals, or clinical teams poised for action. Participation from industry, foundations, and advocacy groups will be critical for traversing the translational path.

Translational teams that are pursuing projects deemed high priority could be supported through the creation of a new funding mechanism, called Special Translational Research Acceleration Project (STRAP) awards. STRAP funding will join various components required to complete the translational process and to facilitate handoff from one group to another along the six developmental pathways. As part of a requirement for receiving STRAP funding, the project would need to have a management plan for reaching early-stage human studies, specific development milestones with a timeline for achieving them, and a development/commercialization strategy; in essence, a business plan for translation.

We are in the earliest stages of implementing the TRWG's recommendations, including the prioritization process and development of the STRAP awards, and the November meeting is our testing ground. My hope is that this forum will enable NCI to identify promising projects and teams of researchers with the expertise and skills to propel research discoveries along the route to becoming effective new tools for cancer assessment and intervention.