College Part of Nonprofit That Received Up To $35 Million From The FDA for Manufacturing Sector Research Initiative

Sep. 15, 2017

The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) with up to $35M funding for a five-year period. The grant - a continuation of a multimillion-dollar FDA grant held by NIPTE since 2011 - 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. The College of Pharmacy has been a member of NIPTE since its founding in 2005.

“We are very excited about the opportunity to continue this collaboration with the U.S. FDA,” said Vadim Gurvich, NIPTE executive director and research associate professor 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.”

“NIPTE brings together the extensive experience of investigators across the 17 top schools of pharmacy and engineering who will be involved in this program. The record of accomplishments in pharmaceutical technology research and the scientific infrastructure at the NIPTE member institutions creates a national system capable of bringing together highly interdisciplinary multi-institutional scientific teams to address challenges confronting the Nation’s pharmaceutical quality assurance system,” said Ajaz Hussain, president of NIPTE. “NIPTE's academic collaboration has matured and is at the threshold to take on the additional responsibility of being a voice of the pharmaceutical technology scientific community in the interest of patients and the American public.”

NIPTE is a 501(c)(3) non-profit academic organization with the mission to improve human health through multi-university collaborative research advancing quality, safety, affordability, and speed to market of medicines. In addition to the University of Minnesota, other current members inculde Duquesne University, Illinois Institute of Technology, Long Island University, Purdue University, Rutgers University, Texas A&M University, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland, University of Michigan, University of Puerto Rico, University of Rochester Medical Center, University of Texas, and University of Wisconsin.


The College of Pharmacy,