FDA awards US$35m grant to NIPTE
Partnership of US universities aims to improve drug manufacturing standards
The US Food and Drug Administration (FDA) has awarded US$35m over the next five years to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug manufacturing standards and ultimately cut healthcare costs, create jobs in the US, improve drug safety and bring medicines to market faster.
NIPTE is an academic not-for-profit organisation focused on research and education in pharmaceutical product development and manufacturing.
Prabir Basu, executive director of NIPTE, said the grant comes at a time when the current cost of bringing a drug to market in the US exceeds $1bn and an increasing number of drugs and drug ingredients are being imported from abroad.
‘Outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs accompanied by huge job losses in this country,’ he said.
‘Development and manufacturing costs can be reduced, quality of our drugs can be improved, and outsourcing trends can be reversed by developing science-based standards for drug development and manufacturing.’
The FDA grant will support projects to rectify these drug development and manufacturing problems by creating ways to reduce time to market, enabling new performance attributes, improving small-batch production, promote continuous manufacturing, saving money or energy, or reducing environmental impact from the manufacturing of products, he said.
NIPTE partners 10 US universities that specialise in pharmaceutical science and engineering. These are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kentucky, University of Maryland – Baltimore, and the University of Minnesota. It is said to be the only partnership of universities of its kind.
