NIPTE is Awarded up to $35M “Manufacturing Sector Research Initiative” FDA Grant

MINNEAPOLIS--()--The US Food and Drug Administration (FDA) 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 multi-million-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.

“We are very excited about the opportunity to continue this collaboration with the US FDA. 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,” 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. “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 Dr. 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. It is comprised of 17 top schools of pharmacy, chemical and pharmaceutical engineering, and a medical school. Current members are 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 Minnesota, University of Puerto Rico, University of Rochester Medical Center, University of Texas, and University of Wisconsin.

Contacts

National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE)
Rita Stodolka
rita@nipte.org
www.nipte.org

Contacts

National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE)
Rita Stodolka
rita@nipte.org
www.nipte.org