11 Universities Join FDA in "National Institute for Pharmaceutical Technology and Education"

At a Capitol Hill breakfast meeting this morning, a coalition of industry, government, and academic pharmaceutical scientists announced an 11-university research partnership with the US Food and Drug Administration “aimed at reducing the skyrocketing cost of drug development and manufacturing.”

The new National Institute for Pharmaceutical Technology and Education (NIPTE) will focus on the science needed to streamline commercial drug development, with a parallel focus on reducing production costs.

The participating institutions are:

• Duquesne University

• Illinois Institute of Technology

• Purdue University

• Rutgers University

• University of Connecticut

• University of Iowa

• University of Kansas

• University of Kentucky

• University of Maryland School of Pharmacy

• University of Minnesota

• University of Puerto Rico

Charles Rutledge, vice-president for research at Purdue University and one of the institute's founders, said in a prepared statement, "Pharmaceutical development and manufacturing processes have become so complex that it is increasingly more difficult to provide safe and effective drugs at a significantly lower cost to patients." Fundamental research is needed to make the process more efficient.

"The idea is to better understand the basic physics and chemistry to design better drug-development processes, instrumentation to monitor the processes, and create better quality control schemes-what we call having a science base for the manufacture of these products," said Stephen Byrn, head of Purdue's Department of Industrial Pharmacy. "For example, when you make a tablet, you mix granular materials and compress them all together. What's not well understood is the basic physics of how these various granular materials will stick together, how they dissolve and so on. As a result, the industry uses a trial-and-error approach to drug development."

The NIPTE is initially being supported with seed funding from its members, and the universities are seeking federal funding.

This effort is separate from, but complementary to, the Engineering Research Center for Structured Organic Composites (C-SOC) proposed last year to the National Science Foundation by researchers from Rutgers, Purdue, the New Jersey Institute of Technology, and the University of Puerto Rico at Mayagüez (see Michael T. Klein, “PAT and Process Understanding: A Call to Arms,” Pharm. Technol.29 (4), 206 (2005).

http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152005/155389/article.pdf)

According to one observer, if both proposals take root, “It will create the strongest initiative to re-invent an industry since we re-imagined microelectronics in the mid 80's.”