NIH launches collaborative program to spur therapeutic development
The National Institutes of Health (NIH) has unveiled a collaborative program, Discovering New Therapeutic Uses for Existing Molecules, that will match researchers with a selection of pharmaceutical industry compounds to help scientists explore new treatments for patients.
NIH's new National Center for Advancing Translational Sciences (NCATS) has partnered initially with Pfizer, AstraZeneca and Eli Lilly, which have agreed to make dozens of their compounds available for this initiative's pilot phase.
"Americans are eagerly awaiting the next generation of cures and treatments to help them live longer and healthier lives. To accelerate our nation's therapeutic development process, it is essential that we forge strong, innovative and strategic partnerships across government, academia and industry," said Kathleen Sebelius, health and human services secretary.
In recent years, researchers have succeeded in identifying the causes of more than 4,500 diseases. But it has proven difficult to turn such knowledge into new therapies; effective treatments exist for only about 250 of these conditions. NCATS was established in 2011 to help address this gap. It supports rigorous scientific research designed to re-engineer elements of the development pipeline to move basic research findings into new treatments for patients.
Some compounds do not prove effective for the specific use for which they were developed; however, if additional research is conducted, they may succeed for a different therapeutic use. A prime example is azidothymidine (AZT), which failed to show efficacy against cancer, but was later found to be the first medicine effective against HIV.
"Clearly, we need to speed the pace at which we are turning discoveries into better health outcomes," said NIH director Francis S. Collins, M.D., Ph.D. "NIH looks forward to working with our partners in industry and academia to tackle an urgent need that is beyond the scope of any one organization or sector."
The initiative will direct researchers' attention to a part of the therapeutic pipeline that traditionally has been difficult for them to access: compounds that already have cleared several key steps in the development process, including safety testing in humans. The president's fiscal year 2013 budget proposed $575 million for NCATS, $20 million of which will be provided to support research grants of up to three years duration for pre-clinical and clinical feasibility studies. These studies will test more than 20 compounds from industry partners for their effectiveness against a variety of diseases and conditions. The companies will provide the researchers with access to the compounds and related data.
The pilot program incorporates innovative template agreements designed to streamline the legal and administrative process for participation by multiple organizations. These template agreements reduce time, cost and effort, as well as allow greater participation than traditional partnerships. The templates also provide a roadmap for handling intellectual property used in or developed through the program. Participating industry partners will retain ownership of their compounds, while academic research partners will own any intellectual property they discover through the research project with the right to publish the results of their work.