The U.S. Food and Drug Administration (FDA) introduced its critical path initiative in 2004 as an effort to stimulate and facilitate the scientific process for the development of new drugs, biological products, and medical devices . The initiative was grounded in the sobering reality that between 1993 and 2003, despite a doubling in research and development spending by both industry and the National Institutes of Health (NIH), the FDA observed a decrease in the number of new drug applications (NDAs) and an erratic but flat curve in the approval of new molecular entities. Of particular concern was the dramatic increase in the developmental cost of new drugs and the high rate of new drug failures occurring relatively late in the developmental life cycle (phase III or phase IV drug failures). The critical path was developed to ensure that FDA fosters a collaborative and robust scientific environment to
*The views presented in this chapter do not necessarily reflect those of the U.S. Food and Drug Administration.
Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, Edited by Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari Copyright © 2010 John Wiley & Sons, Inc.
help strengthen the assortment of tools that might be used to bring new medical products to the marketplace in an expedited manner. Since its initiation in 2004, a new office, the Critical Path Office, has been created, a comprehensive and ambitious opportunities list has been generated , and numerous collaborative projects and initiatives have been born, all with the singular goal of using good science to address the challenge of timely and cost - effective product development.
With the unveiling of the complete human genomic map in 2001-2003 [2,3] and the development of sophisticated new technologies for molecular diagnostics (including use of microarrays and bioinformatics to create integrated multiplex tests with complex molecular signals), considerable attention has been focused on biomarkers (especially those with a pharmacogenomics base) to help improve drug candidacy and to streamline drug studies.
The introduction of a diagnostic biomarker to refine drug discovery has obvious appeal. Although biomarkers in a broad sense can include both imaging technologies and in vitro diagnostic devices (IVDs), for the sake of this chapter the focus is on the latter. When used clinically, IVDs are subject to the same regulations as those applied to all other medical devices. Both the science and regulation required for proper deployment of these companion diagnostics products is quite different than the science and regulation of drugs. As a result, to bring closely linked products to the market in a timely manner, both FDA and sponsors must work collaboratively to address what may often be dual device and drug regulatory requirements.
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