Purdue
University is part of a
national institute that received a grant of up to $35 million over the next
five years from the U.S. Food and Drug Administration (FDA).
The FDA awarded the grant to the National Institute for
Pharmaceutical Technology and Education, or NIPTE, to improve manufacturing
standards and ultimately cut health care costs, create jobs, and improve drug
safety.
Purdue was instrumental in the formation of NIPTE six
years ago, and the university’s combined strength in pharmacy and engineering
bring important expertise to the problems faced in the production of today’s
medicines, says Craig Svensson, dean of Purdue’s College of Pharmacy
and member of NIPTE’s board of directors.
Ten universities now comprise NIPTE, which focuses on
collaborative research in pharmaceutical product development and manufacturing
and is the only partnership of its kind.
Prabir Basu, executive director of NIPTE, says the grant
comes at a time when the current cost of bringing a drug to market in the United States
exceeds $1 billion and an increasing number of drugs and drug ingredients are
being imported from abroad.
“Outsourcing of drugs and drug intermediates are
increasing at an alarming rate, potentially threatening the overall quality of
our drugs and leading to huge job losses in this country,” he says.
“Development and manufacturing costs can be reduced, quality of our drugs can
be improved, and outsourcing trends can be reversed by developing science-based
standards for drug development and manufacturing.”
The FDA grant will support programs to address these drug
development and manufacturing problems by creating ways to reduce time to
market, enabling new performance attributes, improving small-batch production,
promoting continuous manufacturing, saving money or energy, and reducing
environmental impact from the manufacturing of products, he says.
Svensson says this work could also alleviate medication
shortages.
“At present we face serious shortages of critical
medicines used in the treatment of a variety of diseases—especially
cancer,” he says. “Most of these shortages are the result of quality
problems in the production of medicines. Current manufacturing processes are
often inefficient, resulting in increased costs and delays in getting medicines
to the market. It all comes down to providing patients with the best care and
treatments possible.”
Helen N. Winkle, director of the FDA office of
pharmaceutical sciences, says she is looking forward to NIPTE’s findings.
“Over the last several years, NIPTE has contributed a
great deal of research toward our understanding of quality pharmaceutical
manufacturing,” she says. “Progress in this area will mean safer, more
efficient and less costly drug production here in the U.S.”
Filed Under: Drug Discovery
