Business schools collaborate with FDA on drug manufacturing performance study

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.

“This collaboration underscores the positive impact of academic inquiry brought to bear on industrial and regulatory practices,” said John W. Mayo, dean of the McDonough School and executive director of the Center for Business and Public Policy, which provided partial funding for the research.

Olin School of Business Dean Stuart I. Greenbaum said that the collaborative study is a milestone toward rationalizing the manufacture of pharmaceuticals for the benefit of mankind. “McDonough and Olin are joining forces to develop practices and processes that will reduce the costs and expand the availability of life-saving medicines,” he said.

Funding for Macher and Nickerson’s research comes from the Center for Business and Public Policy, the Boeing Center for Technology, Information, and Manufacturing and the Center for Research in Economics and Strategy in the Olin School of Business at Washington University in St. Louis, and the National Bureau of Economic Research/Sloan Foundation.

Macher teaches undergraduate, full-time MBA, executive MBA and executive education courses in microeconomics, strategy and the management of technology and innovation at the McDonough School of Business. He is also a fellow in the McDonough School’s Center for Business and Public Policy.

Nickerson teaches undergraduate, MBA, executive MBA, and Ph.D. courses in management, strategic management in healthcare, strategic management in life sciences, and competitive strategy at the Olin School of Business. His research focuses on business strategy and public policy, organizational economics, new institutional economics, intellectual capital management, technology licensing, and organizational theory.

The FDA announced the collaboration Sept. 3 in a report on the first anniversary of its Good Manufacturing Practices Initiative for the 21st Century. Macher and Nickerson will present the results of their study in the next year.