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Planning Grant for Establishing
a new PI: Michael Jay, Eric Grulke Project Duration: One Year (November 1, 2004 – October 31, 2005) Organization: University of Kentucky Research Foundation ABSTRACT The aging of the U.S. population and our increasing dependence on pharmaceutical products to maintain health and reduce hospitalizations has become a major societal concern, especially as the cost of drugs has become a greater burden for many families. While governments can intervene in setting the price of drugs, this does not change the cost to produce these life-saving therapies. It is incumbent upon our society to explore all possible methods for lowering the cost of drugs for our citizens. One of the reasons for high drug costs involves the current paradigm, dictated by a strict regulatory climate, under which pharmaceutical products are manufactured. This results in high failure rates of manufactured batches and high recall rates. Not only does this drive up the cost of drug products, but it also eliminates some potentially life-saving therapies from reaching the market due to stability and manufacturability concerns. The Food and Drug Administration is beginning to address these issues with a new initiative using a “risk-based approach” that employs the principles of Process Analytical Technology. PAT involves the design of in-line, on-line or at-line sensors that operate at critical points in a pharmaceutical manufacturing operation. These sensors will markedly reduce the cost of producing pharmaceutical products by allowing manufacturing activities to become decentralized. This will, in turn, allow for the manufacture of “personalized medicines” and broaden the number of therapeutic agents and drug delivery systems available for treating human disease by reducing stability and scale-up concerns that might ordinarily prevent life-saving therapies from becoming products. The
University of Kentucky proposes to develop a center that would contribute to
sensor research as well as address critical unmet needs of the FDA initiative:
testbed facilities for integrating sensor technology with lean manufacturing and
visualization/virtual environments. The team will include faculty members from
various departments (pharmaceutical sciences, chemistry, chemical engineering,
electrical engineering, etc.) as well as several Centers and research groups
(University of Kentucky Center for Pharmaceutical Science & Technology,
Analytical Spectroscopy Research Group, University of Kentucky Center for
Computational Sciences, UK Mass Spectrometry Facility, Center for Manufacturing,
Center for Visualization and Virtual Environments). The Center will be
designed to complement existing research centers, federal funding agencies, and
industrial initiatives focused on modern manufacturing processes for the
pharmaceutical industry. Center facilities and programs will lead to the
development of new intellectual properties for Kentucky researchers, the
creating of a new pharmaceutical manufacturing industry, and educational
opportunities for citizens of the Commonwealth. |
