The Diminishing Pipeline of New Drugs
It costs over $4B to develop and launch a new drug. This staggering amount speaks to the time and effort required to address our expanding need for new medicines. Each year hundreds of thousands of research laboratories work to further understanding of a range of disease processes and develop new techniques to thwart them. In the end most of the therapeutic approaches fail. Just a handful of new drug candidates make it to the point of clinical trials and maybe 30-40 make it through the hurdles to be approved for use as new drug treatments, for example, 35 new medicines were approved in 2011. Unfortunately, even this trickle of new treatments is slowing. Currently, more effort is required to identify new drugs, new effective drugs are more difficult and costly to develop, and the pharmaceutical industry is spending proportionally less and less on new drug development.
Governments Step Up to Drug Development
Since improving medical treatment is in everyone's interest, a large fraction of government research funding has routinely been directed toward basic biomedical research. Given the general public welfare and the enormous challenges occurring with new drug development, it may be reasonable to think that the public sector should also take a more active and focused role in the practical work of finding and testing new drugs which is typically the domain of pharmaceutical and biotech companies. This thinking has produced two major initiatives—one in the US and one in Europe—that attempt reverse the current trends and increase the number of novel and effective therapeutics introduced over the next several years.
NCATS: A New NIH Center to Translate Research into New Drugs
Last summer the NIH announced the launch a new division—the National Center for Advancing Translational Sciences (NCATS). The mission of NCATS is to, "catalyze the generation of innovative methods and technologies to enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions." This new division of the NIH consolidates some existing programs and grants with new initiatives to create an research center focused on finding and testing new drugs and diagnostics. The objective is to do more drug development work under taxpayer funds to help "derisk and streamline private development of new medicines and diagnostics." Although there is no direct link to specific commercial companies, it is an attempt to help prime the pump with the hope that the commercial sector will take the tools and technology developed to generate new therapeutic products.
The European IMI Initiative to Improve Medicine Development
Meanwhile in Europe, the Innovative Medicines Initiative has already been underway for a couple of years. A little different than the NIH/NCATS approach, the IMI is set up explicitly as a public-private joint undertaking between the European Union and the pharmaceutical industry to "speed up the development of better and safer medicines." Currently, the project has a combined research budget of EUR 430 and is funding twenty-three defined projects. While less than the budget of the NCATS, the IMI approach is also quite different in that it explicitly sets up specific collaborative research projects as consortia that involve both public laboratories from major university and government research centers with commercial laboratories in pharmaceutical and biotech companies. As with the NCATS, all findings are public and generally available to commercial parties for further development.
Is This the Way to Get Better Safer Drugs?
The objective of both of these approaches is to step up therapeutic-focused biomedical research to get more good drug targets and drug candidates into the development pipeline. The business model is somewhat novel having both a public basis but strong commercial bent. However, the biotech industry has been somewhat revolutionary from its start and always had a strong connection with academic research. Almost all biotech innovations started in academic laboratories and it was the biotech industry that really propelled the development of university technology transfer offices. Given this history, maybe these endeavors are simply a reasonable extension this unique industry. At this point, it is not clear which of these unorthodox approaches might be more successful but, with luck, maybe both will reduce the 90% rate of failure for new drugs in clinical trials.