The general public has a sense that something is amiss with the pharmaceutical industry, but few might consider it in a state of collapse. Washington University’s Michael Kinch tries to convince otherwise in “A Prescription for Change,” his history and review of the industry.
Over the past several decades, Michael Kinch of Washington University in St. Louis says, the pharmaceutical industry has managed to dismantle itself. In a provocative series of articles and interviews, Kinch, the director of the Center for Research Innovation in Businessat the university, has been describing the history of this dismantling and its implications for the future of medicine.
The U.S. Food and Drug Administration will collaborate with Assistant Professor Jeffrey T. Macher of the Robert Emmett McDonough School of Business at Georgetown University and Associate Professor Jackson A. Nickerson of the Olin School of Business at Washington University in St. Louis as part of its strategic initiative to modernize the regulation of pharmaceutical manufacturing and product quality. Under the terms of the material transfer agreement with the FDA, Macher and Nickerson will conduct research and analysis to help the FDA identify the factors that predict manufacturing performance to further refine the agency’s risk-based site selection model for inspections as well as its other efforts to target identified risks to pharmaceutical quality and strengthen its pharmaceutical compliance program.