February 20, 2009
Institute urges Congress to boost pharmaceutical science, education fundingWEST LAFAYETTE, Ind. - Members of the National Institute for Pharmaceutical Technology and Education will meet with congressional leaders on Wednesday (Feb. 25) to stress how research and education programs can make U.S. pharmaceutical manufacturing more productive and efficient.
The institute was awarded a $1.19 million U.S. Food and Drug Administration contract last fall to develop science for helping the pharmaceutical manufacturing industry implement Quality by Design methods focused on efficiency, safety and lower cost to the consumer.
"These meetings will bring to light that we are currently lacking the fundamental science of development and manufacturing of pharmaceuticals," said Prabir Basu, NIPTE's executive director, whose offices are based in Mann Hall in Purdue University's Discovery Park.
"We hope as a result of these meetings that the FDA will be able to fund more grants to allow for basic manufacturing science research that will be available to manufacturers, academics and regulators," Basu said. "Ultimately, these advances will lead to manufacturing savings and improved quality of pharmaceuticals."
In a recent report, the FDA's Science Board concluded that the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. As a result, Basu said, there is an urgency to stem the tide of continued deterioration in the science that supports the FDA's regulatory decisions.
Investments in basic manufacturing research would increase the quality and cost effectiveness of the pharmaceutical manufacturing process. In addition, incentives are needed to preserve and grow U.S. pharmaceutical manufacturing operations, said Gintaras "Rex" Reklaitis, the Edward W. Comings Professor of Chemical Engineering at Purdue.
"Translating innovative therapies to deliverable products currently relies on outdated manufacturing methods that are failing to keep pace with the underlying progress in medical science," he said. "As a result, drug products take longer to bring to market and at higher cost."
Indiana employs 6.1 percent of the nation's drugs and pharmaceuticals workers, and Indianapolis ranks fourth nationally in employment in that sector alone, according to a 2008 report by Battelle and the Biotechnology Industry Organization.
Purdue, with its strengths in pharmacy, engineering and biological sciences, received more than $300,000 through the FDA's $1.19 million research contract awarded in October. Purdue has been a member of the consortium since it was launched in 2005. Purdue's Discovery Park, College of Engineering and School of Pharmacy and Pharmaceutical Sciences are partners in the research.
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, 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.
Writers: Phillip Fiorini, (765) 496-3133, email@example.com
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Sources: Prabir Basu, email@example.com, (765) 494-9614
Gintaras "Rex" Reklaitis, firstname.lastname@example.org, (765) 494-9662
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