The U.S. Food and Drug Administration (FDA) has awarded $1.7 million to five universities, including The Ohio State University, 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.

Principal investigators on the project are John Gray, professor of operations at the Max M. Fisher College of Business at The Ohio State University; and George Ball, assistant professor of operations and decision technologies and Weimer Faculty Fellow at the Kelley School of Business at Indiana University.

Christian Blanco and Hyunwoo Park, assistant professors of management sciences at Fisher, will contribute as part of the team of eight researchers.

Faculty from the University of Illinois, the University of Wisconsin, and Long Island University are also engaged in the two-year research project. The total value of the contract is $1,744,985.

“Our main objective is to help the FDA understand how its actions affect quality risk, both in the short- and long-term,” Gray said. “We have two main projects. The project I am leading will study existing FDA data, using statistical models. The project George is leading will collect primary data, from experiments and surveys. This multi-method approach should be an effective way to generate new insights.”

Gray spent eight years in a FDA-regulated facility prior to getting his PhD. Much of his research has focused on pharmaceutical manufacturing compliance and drug quality.

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.

For many years, the FDA has worked with manufacturers to motivate them to consistently comply with current good manufacturing practices to ensure consistent quality in the drugs produced, Gray said.

Ball noted: “We intend to help the FDA understand not just what should be done to improve drug quality, but how, and under what conditions, it should be done. These insights will help the FDA more effectively and efficiently ensure the safety, quality and efficacy of the global supply of drugs consumed by all Americans.”

Others involved in the project include:

• Enno Siemsen, associate dean of MBA and Masters Programs and the executive director of the Erdman Center for Operations & Technology Management, and Hassam Bavafa, assistant professor of operations and information, both at the Wisconsin School of Business at the University of Wisconsin-Madison
• 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;
• Kenneth R. Morris, University Professor and director of the Lachman Institute for Pharmaceutical Analysis at Long Island University