Public comments


FasterCures sends letter in support of the newly announced National Center for Advancing Translational Sciences at the NIH

Dear Dr. Collins and the NCATS planners:

First, we would like to applaud your efforts to expand NIH's investments in efforts to speed the translation of basic discoveries to clinical application through the creation of the National Center for Advancing Translational Sciences (NCATS). Such a center has the potential to cut across institutional boundaries and address fundamental scientific and biomedical challenges regardless of disease type.

The transition from basic research to clinical application requires interdisciplinary and multidisciplinary expertise. As outlined in the recently released FasterCures whitepaper "Crossing Over the Valley of Death," many new drugs drop out of the development pipeline for a variety of reasons including lack of funding for critical translational studies and insufficient investment in the technical expertise needed for technology development and transfer. These barriers inhibit both the scientists dedicated to improving health and the patients who ultimately need improved cures and care.

As you are aware, 80 to 90 percent of research projects fail before they ever get tested in humans. By industry's estimates the number may be even higher— for every 5,000 compounds tested, only 5 make it to clinical trials, and only 1 eventually receives FDA approval. Only half of all experimental drugs in Phase III trials ever become approved therapeutic agents. NIH's new proposal for the National Center for Advancing Translational Sciences is a laudable attempt to change these statistics and change the current paradigm. Creating a new center capable of working across NIH institute boundaries and transitioning such programs as the Clinical and Translational Science Awards, the Molecular Libraries Initiative, and the proposed Cures Acceleration Network is smart science. This integration of efforts will produce synergy that will benefit Americans through improved health and more efficient and effective investment of their tax dollars.

We recognize that the biotechnology and pharmaceutical industries will continue to be the primary drivers of products into the marketplace. However, we need to address the declining productivity of the R&D system in order to address the many unmet patient needs that still remain. We need to bridge the void between basic discoveries and better medicine. The steps in between discovery and application, like target validation, assay qualification, product refinement, and pre-clinical development are necessary investments to move promising new interventions to the patient. These areas of focus are often the bottleneck to moving drugs forward and exist across the drug development enterprise regardless of the disease. We believe that NIH's proposed new center will provide a significant stimulus to moving ideas out of the lab and into the clinic and fully support NIH's willingness to disrupt its own paradigm in search of better solutions. Isn't that what science is all about?

We view this as a significant development for the future of getting basic discoveries translated into much needed and long awaited treatments and cures, and we look forward to the planning efforts.

Margaret Anderson
Executive Director

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