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October 29, 2008

Purdue to share $1.19 million FDA pharmacy research contract

WEST LAFAYETTE, Ind. - The U.S. Food and Drug Administration has awarded a $1.19 million contract to the National Institute for Pharmaceutical Technology and Education, a consortium of 11 leading pharmaceutical engineering universities including Purdue, to develop guidance on design specifications for drug manufacturers, officials announced Wednesday (Oct. 29).

Purdue, with its strengths in pharmacy, engineering and biological sciences, will receive more than $300,000 through the FDA research contract. Purdue has been a member of the consortium since it was launched in 2005.

"With this FDA funding, Purdue will collaborate with other
Alan Rebar
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strong universities to develop this emerging area where we can focus on improving the science of drug development itself," said Alan H. Rebar, executive director of Discovery Park and senior associate vice president for research at Purdue. "This team also will study how to make the drug-manufacturing process more modern, helping improve efficiencies and the effectiveness of the pharmaceutical industry."

Ultimately, the initiative called "Quality by Design" will enhance quality control and improve manufacturing efficiency, said Prabir Basu, the consortium's executive director.

"This brings a greater degree of science into the pharmaceutical development and manufacturing process,
Prabir Basu
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providing more front-end quality and less dependence on back-end inspections,” said Basu, whose offices are in Mann Hall in Purdue's Discovery Park.

Potentially, the process will serve as the basis for developing best practices and creating science-based "guidance" documents that the FDA can use to evaluate new and generic drug applications. Basu said results of the project are expected to impact both consumers and drug makers by strengthening safety and improving processes across the industry.

About the consortium

The National Institute of Pharmaceutical Technology and Education is an independent, nonprofit organization representing 11 U.S. universities that are leaders in pharmaceutical science and engineering. In addition to Purdue, the other member universities are Duquesne University, Illinois Institute of Technology, Rutgers University, the University of Puerto Rico, the University of Connecticut, the University of Iowa, the University of Kansas, the University of Kentucky, the University of Maryland-Baltimore, and the University of Minnesota. The consortium was created specifically to work with the FDA and industry to enhance the way pharmaceutical products are being developed and manufactured by increasing the quality and education of best practices used.

About Purdue's Discovery Park

Since its 2001 launch, Purdue has invested more than $150 million in new facilities and $25 million in laboratory equipment to create what's become the nearly $400 million Discovery Park. The 40-acre hub brings together researchers from multiple disciplines to tackle the most complex challenges in the world today. The 11 centers focus on major research in areas ranging from health-care engineering, nanotechnology, life sciences and cyberinfrastructure to climate change, entrepreneurship, cancer diagnosis, homeland security and alternative energy.

About Purdue School of Pharmacy and Pharmaceutical Sciences

In addition to 648 doctorate of pharmacy students, Purdue's pharmacy program has 754 undergraduates and 117 graduate students. The school has educated more than 7,000 pharmacists and 1,000 pharmaceutical scientists and educators since its establishment in 1884. Purdue pharmacy alumni and former faculty members make up about 20 percent of the nation's deans of pharmacy.

About Purdue College of Engineering

As one of the leading colleges at Purdue, the College of Engineering makes an impact through its more than 348 faculty, 6,300 undergraduates, and 2,200 graduate students. Its more than 70,000 living alumni span the globe, focused on improving life and health. Helping lead Purdue's research efforts in the National Institute for Pharmaceutical Technology and Education are the university's schools of Chemical Engineering, ranked 13th by U.S. News & World Report, and Mechanical Engineering, ranked 7th.

Writer: Phillip Fiorini, (765) 496-3133, pfiorini@purdue.edu

Sources: Alan Rebar, (765) 496-6625, rebar@purdue.edu

Prabir Basu, (765) 494-9614, prabir1960@purdue.edu

Purdue News Service: (765) 494-2096; purduenews@purdue.edu

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