TECHburgher :: Putting some sizzle in the Pittsburgh technology sector.

Dr. Alan W. Seadler, associate academic vice president for research at Duquesne University and treasurer of the National Institute for Pharmaceutical Technology and Education (NIPTE), will be among the representatives meeting on Capitol Hill tomorrow to encourage public backing to develop, manufacture and deliver pharmaceutical products more efficiently, more safely and at a lower cost to the consumer.

Current manufacturing methods are failing to keep pace with underlying progress in medical science and poses a risk to public health, says NIPTE, a nationwide consortium including Duquesne and 10 other cutting-edge pharmaceutical and technological institutions. Improvements are needed to better understand new pharmaceutical materials and to convert this knowledge into production.

Seadler and other NIPTE members believe that investments in basic manufacturing research are key to increasing the quality of our nation’s drugs and the cost effectiveness of the pharmaceutical manufacturing process. All of these processes are vital to keeping medication manufacturing in the United States.

The pharmaceutical industry has long been important to the economy of Pennsylvania, with a significant presence of giants such as Wyeth, GlaxoSmithKline Kline, Merck, Johnson and Johnson and Pfizer. These manufacturing giants of eastern Pennsylvania are joined by top-flight research and educational efforts in the Pittsburgh area through Duquesne and other institutions. In 2006, the drug and pharmaceutical industry sector in Pennsylvania had 111 establishments, accounting for 15.5 percent of all Pennsylvania manufacturing activities. It employed nearly 22,300, according to reports from Battelle and the Commonwealth of Pennsylvania.

Yet, the urgent need to stem continued deterioration in the science supporting regulatory decisions of the Food and Drug Administration (FDA) was recently unveiled by the FDA’s Science Board. The board concluded that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. “Our Congressional meetings will bring to light the current lack in the fundamental science of development and manufacturing of pharmaceuticals,” said Dr. Prabir Basu, executive director of NIPTE. “We hope, as a result of these meetings, that the FDA will gain the funds to be able support more basic manufacturing science research that will assist manufacturers, academics and regulators. Ultimately, these advances will lead to manufacturing savings and improved quality of pharmaceuticals.”

 In October, the FDA awarded NIPTE a $1.19 million contract to develop science to enhance how pharmaceutical products are developed and manufactured. Duquesne’s Graduate School of Pharmaceutical Sciences is among the first participants in this effort, called Quality by Design.