FDA-Approved New Molecular EntitiesThe flagship CRIB project originated from efforts to create a census of all active ingredients from FDA-approved medicines. At project initiation, this information was not readily available and in the course of gathering this information, additional efforts identified scientific basis and clinical application of these medicines as well as the organizations that contributed to their research and development. Altogether these findings detailed the history of the modern drug discovery enterprise, which started in earnest in the 1940s. Changes in the clinical application and mechanistic action of new medicines were amongst the findings from this initial study. Whereas infectious diseases (and anti-bacterials) dominated the early decades of the modern pharmaceutical era, these have now largely fallen out of favor, and have been replaced with emphasis upon oncology and drugs targeting orphan indications. Our studies also demonstrated that the mechanistic basis of FDA-approved medicines has favored a surprisingly narrow range of target types. For example, a mere three families (GPCRs, ion channels and nuclear receptors) encompass more than half of all approved medicines. Trends within different disease categories revealed less innovation in terms of target choices that might have been anticipated given our ever-widening knowledge of the molecular basis of disease.
Origin and Fate of BiotechnologyThe survey of FDA-approved medicines unintentionally provided an overview of the history of the biotechnology industry. Ongoing studies are identifying the innovators and their inventions that contributed to the approval of new medicines. A major finding of our ongoing studies is that biotechnology companies are being acquired and dismantled at a faster rate than their creation. As biotechnology now is the primary source of biomedical innovation for FDA-approved products (particularly early-stage research), this raises questions about the sustainability of the entire drug development enterprise.
VaccinesBeyond medicines, CRIB is launching a project to survey all vaccines ever approved by the FDA, including an analysis of the innovating organizations that have contributed to their discovery and development.
Medical DevicesCRIB is also surveying medical devices, which encompasses a large number of different types of instruments and assays. The Center intends to emphasize the sources of innovation and their fate over time, much as has been done with medicines.
Biotechnology Entrepreneurship: St Louis as an ExemplarMany converging lines of investigation reveal that the St Louis region is the fastest growing technology hub in the world. Given the wealth of human and agricultural research clustered in the region, it is unsurprising that biotechnology is a major contributor to the rapid rise of St Louis. Given Washington University’s location and role in promoting innovation and entrepreneurship, CRIB is utilizing the region as a microcosm to study the local and regional factors leading to biotechnology success.