Safis in the News

Symposium to explore FDA regulatory process

By Max Showalter
Journal and Courier
August 23, 2007

Dealing with the complex regulations of the U.S. Food and Drug Administration may soon be easier for some Purdue University faculty members and researchers hoping to find a commercial market for their work.

Purdue's Discovery Park will hold a symposium on Aug. 28 that will provide information on the basics of the regulatory process, necessary preclinical safety testing and resources available for that work.

"By understanding the experiments and data necessary to ready a device, diagnostic or drug for future FDA approval, researchers will be better equipped to guide and plan their research initiatives toward eventual translation," said Julie Nagel, managing director of the Oncological Sciences Center, a component of Discovery Park.

Consultants from Safis Solutions LLC will join representatives from the Oncological Sciences Center, Burton D. Morgan Center for Entrepreneurship and the Weldon School of Biomedical Engineering in presenting the symposium.

"Translation of research to the clinic toward commercialization involves a long, complex regulatory pathway," said Gretchen Bowker, director of regulatory and compliance services with Safis Solutions. "It is critical for translational researchers to consider the impact of regulatory expectations leading up to commercialization."

The FDA is responsible for assuring the safety and security of human and veterinary drugs, biological products, medical devices and procedures, the nation's food supply, cosmetics and products that emit radiation.

The agency also works to speed innovations that make products more effective, safer and affordable, and helps the public get accurate, science-based information they need to use the products to improve their health.

"Past Discovery Park workshops have exposed our entrepreneurially minded faculty, researchers and students to experts in developing business plans and making pitches to venture capitalists," said Julie Goonewardene, associate director of technology commercialization at Discovery Park. "We hope this event can help clear some of the fears that researchers have about complex federal regulations."