Help on the way? Lugar introduces bill for pharma education

Indiana senator Dick Lugar has introduced a bill to provide significant funding for pharmaceutical education, which would directly benefit Purdue, DuQuesne, Rutgers, University of Puerto Rico-Mayaguez and the other academic participants in the NIPTE consortium. FDA and industry would play a major role as well. The following is courtesy of the Purdue News Service on May 17: -- PWT

WEST LAFAYETTE, Ind. ” Sen. Richard Lugar, R-Ind., has introduced a bill in the Senate that would give a boost to a Purdue University-led consortium created to develop pharmaceutical products faster, more safely and at a lower cost to consumers.The Pharmaceutical Technology and Education Act would establish a partnership among the Food and Drug Administration and other federal agencies, the pharmaceutical and medical industries and the Purdue-led 11-member National Institute for Pharmaceutical Technology and Education.

"This legislation is significant because it establishes funding that will go a long way toward developing this emerging area," said Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education. "This effort strives to bring together a group of many of the country's leading academic institutions to develop safer and more efficient means of delivering pharmaceutical products to patients.

"Engaging the academic community in this process is vital, and we commend Senator Lugar for his leadership in this area."

The legislation would invest $25 million annually to enhance the FDA's research and education programs in the science and engineering of pharmaceuticals and biotechnology. Ten percent would go toward administration; 45 percent would go toward centers of excellence at the member institutions; and 45 percent would be used to benefit specific projects to improve drug-manufacturing processes.

Under Lugar's proposal, the FDA's research and education programs would be expanded to focus on the physical design, characterization, manufacturing, scale-up and quality control of pharmaceutical products through a partnership with the National Institute for Pharmaceutical Technology and Education, referred to as NIPTE, which represents a number of schools of pharmacy and pharmacy education.

Purdue President Martin C. Jischke said he was pleased that Lugar introduced the legislation.

"I commend Senator Lugar for his foresight and his leadership on an issue that is extremely important to the health of all Americans and that has implications for people throughout the world," he said. "By creating a partnership among the FDA, and the university and corporate members of NIPTE, we have the opportunity to use engineering and science principles to streamline the development of new drugs and reduce the costs of manufacturing pharmaceutical products that are sorely needed in underdeveloped regions of the world. Purdue looks forward to playing a key role in developing the full potential of this exciting initiative."

Basu said the pharmaceutical industry currently spends a great deal of money on the discovery and development of new drugs, but there is not much focus on improving the science of drug development itself.

"Once a new therapy is discovered, product development and manufacturing remain the same as they have for decades," he said. "The science is very primitive. Our institute will spend its time doing research in an effort to make the drug-manufacturing process more modern, resulting in more efficient and predictable drug performance."

Charles O. Rutledge, Purdue's vice president for research and the chairman of the institute's board of directors, said this legislation positions the institute to become a leader in drug-manufacturing science.

"This partnership provides an unusual opportunity to improve the science of manufacturing pharmaceuticals," Rutledge said. "The consortium will bring together experts from across the country to improve the way we make drugs.

"Until now, funding was limited in this area of pharmaceutical research, so this legislation is a huge shot in the arm to our institute effort."

Rutledge said one example of how this collaboration will benefit the pharmaceutical industry can be found at Purdue.

The Chao Center, based in the Purdue Research Park, is working with drugs that initially were developed as long ago as the 1950s. While they still have value in treatment, he said, they aren't very profitable. Part of the reason is because manufacturing processes remain the same as they were then, and due to regulatory restrictions, cannot be changed without extensive cost and approvals.

"Senator Lugar's bill opens up the possibility to create new, innovative ways to make these pharmaceuticals without prohibitive costs," Rutledge said.

He said improving the science behind drug manufacturing could also have a direct effect on patient care.

"It would be greatly beneficial, for instance, to have a drug that you can take once a day instead of four times a day," he said. "By updating and improving the way drugs are made, innovations like this will be possible."

The National Institute for Pharmaceutical Technology and Education was created in 2005. Its goal is to bring together scientists, researchers, engineers and the FDA to develop state-of-the-art science and technology to enable the pharmaceutical industry to develop products faster and at a significantly lower cost with less product variability and higher predictability of performance.

The other member universities of the institute are Duquesne University, Illinois Institute of Technology, Rutgers University, the University of Puerto Rico San Juan/Mayaguez, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland-Baltimore and University of Minnesota.

Writer: Kim Medaris, (765) 494-6998, kmedaris@purdue.edu

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

Charles O. Rutledge, (765) 494-6209, chipr@purdue.edu

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