December 18, 2017 Faculty working to improve pharmaceutical safety through research

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Three faculty members from Fisher’s Department of Management Sciences are a part of a team of U.S. researchers that recently received key funding to continue to explore pharmaceutical science and technology.

Fisher’s Christian Blanco, John Gray and Hyunwoo Park join approximately a dozen faculty members from universities across the U.S. as part of the Manufacturing Sector Research Initiative. The initiative was made possible by a five-year grant totaling up to $35 million that was awarded in September 2017 to the National Institute for Pharmaceutical Technology and Education (NIPTE) from the Food and Drug Administration (FDA).

Gray will lead two sub-teams — one focused on developing a better measure of quality risk at the plant level, and the other that will study the drivers of quality risk, including consideration of plant location, whether the plants are contract manufacturers, and/or produce generic or branded drugs. Blanco is one of three members of the first team, while Park and another colleague constitute the second team. Both Blanco and Park will also contribute to a team that will utilize analytics to examine data available on the internet to detect risk.

“This grant provides the opportunity to address even more thoroughly questions important to the safety and efficacy of our drugs,” Gray said. “We’re honored to be a part of such a prestigious team of researchers from both business and pharmacy schools. Opportunities to collaborate with other thought leaders in the exploration of critical issues underscore Fisher’s mission of conducting research that is both relevant and has impact.”

The NIPTE grant is a continuation of a multi-million-dollar FDA grant NIPTE has held since 2011. It supports scientific projects in various areas of pharmaceutical science and technology, such as improving manufacturing practices, quality of pharmaceutical products and the knowledge base of the scientific community.

“We are very excited about the opportunity to continue this collaboration with the U.S. FDA,” said Dr. Vadim J. Gurvich, executive director of NIPTE and research associate professor at the University of Minnesota who serves as principal investigator on the grant. “The funding allows NIPTE faculty to contribute their research expertise, helping the FDA create policies in critical areas such as quality by design of complex pharmaceutical products, characterization of pharmaceutical materials, and formulation strategies like abuse deterrent products to combat opioid abuse.

“In addition, NIPTE will also address topics such as Quality Metrics and Quality Score Card as tools to improve surveillance and risk-based decisions. This brings our decade-long collaboration with the FDA to the next level, allowing us to make a bigger impact on quality, safety, and affordability of pharmaceutical products.”

Christian Blanco Management Sciences
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Hyunwoo Park Management Sciences
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John Gray Management Sciences
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