The National Institutes of Health (NIH) is launching a new government center to help spur new drug development in an increasingly stagnant market.
Advisers to the NIH recommended in December that the agency create the new center to link discoveries made in the lab — basic or bench research — to studies of new drugs in humans.
Few drug companies are willing to put in the time or millions of dollars necessary to start developing a drug from scratch.
The early drug-development phase is known as the "Valley of Death" in the drug industry because 99.9 percent of the early work on therapeutic compounds fails to ever produce an approved drug.
NIH director Dr. Francis Collins has been pushing for such a center since he took over at the institutes in 2009. According to Collins the, “…development of therapeutics has unfortunately been a very inefficient and high failure process.”
It can cost upwards of $1 billion to bring a single new drug to market — and nearly twice as much for marketing of the drug once it wins FDA approval, Collins said.
The center — with the proposed name of the National Center for Advancing Translational Sciences — would be where NIH will does preclinical groundwork on promising compounds and then hands off the information to private companies that would refine the compounds into new drugs.
The new center won't attempt to compete with drug companies in developing medications for common diseases. Instead, it will instead focus on more neglected diseases and on drugs for diseases that "attract little commercial interest," according to the NIH website.
According to the NIH, the drug development center would:
Streamline and improve the process of therapeutic development.
Provide a central spot for access to resources, tools, and expertise in translational medicine.
Support partnerships between academia, government, industry, venture capitalists, and non-profit groups.
Provide incentives for greater sharing of scientific information and the publication of negative results.
The new $700 million center would combine two programs: the NIH's molecular library program, the Therapeutics and Rare and Neglected Diseases Program, which has been in place for about a year and its the Rapid Access to Interventional Development program, which supplies resources for projects that have the potential of moving toward human trials. The center would also encompass a number of other agency programs.
