WEST LAFAYETTE, Ind. - Purdue University's Discovery Park will sponsor a daylong symposium on Aug. 28 to help faculty and researchers navigate the complex regulations within the U.S. Food and Drug Administration to successfully commercialize their research.

A team from the Oncological Sciences Center, Burton D. Morgan Center for Entrepreneurship and the Weldon School of Biomedical Engineering will join regulatory consultants from Safis Solutions LLC to explain how the regulatory process affects strategies, procedures and ultimate translation and commercialization of innovations developed by faculty and researchers.

"The symposium will cover the basics of the regulatory process and delve into necessary preclinical safety testing and the resources available to accomplish these studies," said Julie Nagel, managing director of the Oncological Sciences Center. "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."

The symposium, "Research Translation: Planning For What Lies Ahead," will run from 8:30 a.m. to 3:45 p.m. in the Burton D. Morgan Center for Entrepreneurship, Room 121. To register, go to http://www.purdue.edu/dp/bdm/translation. For more information, contact Kris Swank at (765) 494-4674, kswank@purdue.edu.

During separate morning sessions, Gretchen Bowker, director of regulatory and compliance services at Indianapolis-based Safis Solutions, will give an overview of the FDA process and discuss the regulatory differences between filings for a device vs. a pharmaceutical drug.

"Translation of research to the clinic toward commercialization involves a long, complex regulatory pathway," Bowker said. "It is critical for translational researchers to consider the impact of regulatory expectations leading up to commercialization."

Parallel sessions beginning at 12:30 p.m. will focus on preclinical safety testing as well as protocol writing, collaborating with physicians and veterinarians, and addressing issues posed by institutional review boards.

A second set of parallel sessions at 2:15 p.m. will delve into what resources exist at Purdue to accomplish preclinical testing and how to meet FDA expectations for what the industry calls good manufacturing practices. The term is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.

The FDA is responsible for assuring the safety and security of human and veterinary drugs, biological products, medical devices, 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, as well as helping the public get the accurate, science-based information they need to use these 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 for Discovery Park and the Burton Morgan Center. "We hope this event can help clear some of the fears that researchers have about complex federal regulations."

Goonewardene holds a joint appointment between the Burton Morgan Center and the Office of Technology Commercialization to ensure the smooth and successful transfer of technology from Discovery Park to the Purdue Research Park.

Law firm Bose McKinney & Evans LLC is a sponsor of the symposium.

Discovery Park is Purdue's $350 million hub for interdisciplinary research and is home to 10 primary centers focusing on everything from biosciences and manufacturing to oncological sciences and health-care engineering.

The Oncological Sciences Center, launched in July 2005, is an interdisciplinary research center in Discovery Park designed to bolster the university's contribution in the battle against cancer. The center also is the Discovery Park arm of the Purdue Cancer Center.

The Burton D. Morgan Center is a platform to launch technology-based enterprises based on Purdue research. The Discovery Park center also helps faculty, students and Indiana entrepreneurs better understand how to bring research and technology to market.

Safis Solutions is a regulatory compliance consulting firm that works to help the life science industry bring products to market quickly by meeting regulatory demands. Areas of expertise include regulatory approval, clinical strategies, quality systems, validation, auditing and postmarket surveillance programs. Formed in 2002 by Ping Poulsen, Safis is a recent graduate of the Indiana University Emerging Technologies Center in Indianapolis.

Source: Purdue University