ABSTRACT
It has been more than 10 years since the FDA released its initial report on the “Challenge and Opportunity on the Critical Path to New Medical Products” (2004). In 2014, the FDA published a guidance document that described the process for qualifying these drug development tools in order to accelerate drug approvals. They also directly encouraged the formation of collaborative groups that could share the burden of biomarker development and stated that several consortia had previously shown the usefulness of this approach.
Since 2004, the number of consortia carrying out biomarker development has indeed grown, but there have been only a few attempts to assess their impact, and these have been mostly limited to analysis of individual efforts. Although these publications focus on a single consortium at a time, a more general indication of biomarker consortia activity can be found in the high percentage of consortia-based projects currently in the FDA qualification pipeline. This seems to provide the strongest evidence that consortia-based efforts have had clear benefits for drug development in terms of actual drug approvals and related regulatory decision making.
In addition to providing specific decision-making tools, consortia have in fact begun to address critical issues in the overall biomarker development process. These partnerships have been able to provide a unique mechanism to gather data and build consensus to support inquiry into areas of biomarker development that have been difficult for any single scientific entity to address on its own. As the regulatory use of biomarkers has matured, the unique characteristics of consortia have proved increasingly useful in addressing the fundamental processes FDA uses to evaluate and qualify biomarkers. This section describes and categorizes specific biomarker development activities of US-based consortia and provides some examples of semiquantitative metrics of their impact on the field as well as highlighting efforts to clarify the qualification process and providing more efficient approaches to future biomarker development.
