November 10, 2005

Purdue leading effort to help pharmaceutical industries in developing nations

WEST LAFAYETTE, Ind. – Purdue University is leading a project aimed at helping the Republic of Kazakhstan develop a successful pharmaceutical industry by teaching professionals from that country about U.S. and European regulations and procedures relating to drug manufacturing.

Purdue will team with Eli Lilly and Co. and the Parenteral Drug Association (PDA), a non-profit organization providing pharmaceutical and biopharmaceutical training based in Bethesda, Md.

"This program will provide training in good pharmaceutical manufacturing practices," said Charles Rutledge, vice president for research at Purdue and a professor of pharmacology. "But we hope it's just the beginning of an ongoing program to help developing nations become more self-sufficient in the manufacture of pharmaceuticals while improving the overall health and well-being of their citizens."

The program, which will teach about 200 Kazakhs over the next three years, began earlier this month with a four-week training of 44 students at the PDA's Training and Research Institute at the University of Maryland Technology Center in Baltimore. Those 44 students will begin a two-week series of courses on Sunday (Nov. 13) at Purdue's main campus in West Lafayette, Ind., and at Lilly headquarters in Indianapolis. Half of the students are from their nation's Ministry of Health, and the other half are from Kazakhstan's National Center for Assessment of Drugs.

"Lilly recognizes the critical importance of well-informed regulatory enforcement agencies in all parts of the world," said Michael Spink, executive director for regional manufacturing and legacy products for Lilly. "Through training sessions such as these Lilly values the opportunity to provide practical insights into the regulations for current good manufacturing practices."

Educating pharmaceutical professionals from developing nations will aid those nations as well as the United States, Rutledge said.

"There is a huge shortage of prescription drugs for diseases that are devastating the populations of developing countries," said Rutledge, who is the program's principal investigator. "If developing nations become more self-sufficient in pharmaceutical manufacturing, there will be less need for the U.S. government or U.S. pharmaceutical companies to provide these medications at a financial loss."

The training at Purdue will include sessions examining the regulatory systems and requirements necessary for the review and approval of drugs and biologic products, with an emphasis on U.S. and European regulations. Sessions also will cover the science and technologies of the pharmaceutical practice, clinical trials, manufacturing issues, labeling and advertising.

"Building on the successful training PDA provided for the Italian inspectorate in 2002 and 2003 and for Taiwanese officials in 2005, the association is well-positioned to offer comprehensive training to members of the Kazakhstan Ministry of Health and National Center for Assessment of Drugs," said PDA President Robert Myers. "We are gratefully assisted by our volunteer experts from the PDA membership, U.S. Food and Drug Administration and U.S. Pharmacopeia."

The first four-week training program is fully funded by the Republic of Kazakhstan, which also is expected to provide additional funding for the remainder of the three-year program.

Purdue will serve as the lead organization for the project and manage contractual and financial arrangements with the PDA and Lilly, Rutledge said. The project is affiliated with the Pharmaceutical Technology and Education Center in the e-Enterprise Center at Purdue's Discovery Park, the university's hub for interdisciplinary research. The Chao Center for Industrial Pharmacy & Contract Manufacturing, located in the Purdue Research Park, will be used in the training as a model for a small manufacturing facility.

Writer: Emil Venere, (765) 494-4709, venere@purdue.edu

Sources: Charles Rutledge, (765) 494-7766, chipr@purdue.edu

Matthew A. Clark, director of marketing services, Parenteral Drug Association, (301) 656-5900, clark@pda.org

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

Note to Journalists: Journalists may interview participants in the program from 6-8 p.m. on Tuesday (Nov. 15) at The Other Pub restaurant, 3000 S. Ninth St., Lafayette. The group also will attend a Purdue women's basketball game on Friday (Nov. 18), and arrangements are being made for them to meet player Natasha Bogdanova, who originally is from Russia.

Related Web site:
Purdue School of Pharmacy

To the News Service home page