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U.S. Food and Drug Administration Awards $1.7 Million to WSB and Other Universities for Quality Management Research

By Wisconsin School of Business

November 14, 2019

The U.S. Food and Drug Administration has awarded $1.7 million to five schools, including the Wisconsin School of Business, at the University of Wisconsin–Madison, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.

Wisconsin School of Business faculty Enno Siemsen, associate dean of MBA and Masters Programs and professor of operations and information management, and Hessam Bavafa, assistant professor of operations and information management, are participating in this two-year research project. The total value of the federal contract is $1,744,985.

Principle investigators are George Ball, assistant professor of operations and decision technologies and Weimer Faculty Fellow at the IU Kelley School of Business; and John Gray, professor of operations at the Fisher College of Business at Ohio State University. Faculty from the University of Illinois and Long Island University are also engaged.

Adverse drug events cause nearly one million emergency room visits each year while serious drug product recalls have increased each year over the last decade.

“Problems with drug quality and efficacy persist in the industry. Drug shortages also occur as manufacturers abandon unprofitable segments,” says Siemsen. “The FDA has many ways in which it can interact with companies to increase the availability of effective and safe products on the market. Our research intends to help the FDA understand how to tailor its approach to achieve that objective,” adds Siemsen, who in addition to his position in the Wisconsin School of Business holds an affiliated appointment in the UW School of Pharmacy, and has focused his research on quality inspections in pharmaceuticals and medical devices for the past ten years.

“There is so much data available now that can shed light on these issues,” notes Bavafa. “Patients are sharing their experiences, and the firms that manufacture pharmaceuticals leave a footprint on the web. Modern data analytics techniques can really help us develop a deeper insight.”

There are two aspects to the project. Initial efforts will be directed towards developing a statistical model that will provide insights into the effectiveness of FDA efforts. Researchers will draw upon data from public sources as well as FDA-provided information to predict which inspection activities lead to higher drug product quality.

Given the challenges of inferring cause with observational studies, the second project will be comprised of behavioral experiments to develop a better understanding of the trade-offs between, and conditions under which, collaborative or adversarial approaches are more effective.

Others involved in the project include:

  • Gopesh Anand, associate professor of business administration and academic director, operations management, at the Gies College of Business at the University of Illinois Urbana-Champaign;
  • Hyunwoo Park and Christian Blanco, assistant professors of management science at the Fisher College of Business at Ohio State University
  • Kenneth R. Morris, University Professor and director of the Lachman Institute for Pharmaceutical Analysis at Long Island University

About the Wisconsin School of Business

The Wisconsin School of Business at the University of Wisconsin–Madison is a world-renowned institution that prides itself on academic excellence, a commitment to ethics, and real-world experiences for its students. Established in 1900, the School was one of the first five business programs in the nation. Today, it proudly educates students from all walks of life with its nationally recognized undergraduate, MBA, MS, PhD, and professional development programs. Web: Social: Facebook | Twitter | LinkedIn