Society’s biggest challenges are also its most complex. From shared economic growth to personalized medicine to global climate change, few of our most pressing problems are likely to have simple solutions. Perhaps the only way to make progress on these and other challenges is by bringing together the important stakeholders on a given issue to pursue common interests and resolve points of conflict.
However, it is not easy to assemble such groups or to keep them together. Many initiatives have stumbled and disbanded. The Biomarkers Consortium might have been one of them, but this consortium beat the odds, in large part due to the founding parties’ determination to make it work. Nine years after it was founded, this public-private partnership, which is managed by the Foundation for the National Institutes of Health and based in Bethesda, Maryland, is still working to advance the availability of biomarkers (biological indicators for disease states) as tools for drug development, including applications at the frontiers of personalized medicine.
The Biomarkers Consortium’s mandate — to bring together, in the group’s words, “the expertise and resources of various partners to rapidly identify, develop, and qualify potential high-impact biomarkers particularly to enable improvements in drug development, clinical care, and regulatory decision-making” — may look simple. However, the reality has been quite complex. The negotiations that led to the consortium’s formation in 2006 were complicated, and the subsequent balancing of common and competing interests remains challenging.
Bringing the Group Together
Many in the biomedical sector had seen the need to tackle drug discovery costs for a long time, with multiple companies concurrently spending millions, sometimes billions, of dollars only to hit common dead ends in the drug development process. In 2004 and 2005, then National Institutes of Health director Elias Zerhouni convened key people from the U.S. Food and Drug Administration, the NIH, and the Pharmaceutical Research and Manufacturers of America to create a multistakeholder forum.
Every member knew from the outset that their fellow stakeholders represented many divergent and sometimes opposing interests: large pharmaceutical companies, smaller entrepreneurial biotechnology companies, FDA regulators, NIH science and policy experts, university researchers, and nonprofit patient advocacy organizations.