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George Vlahakis
IU Communications

Kelli Conder
Center for the Business of Life Sciences

Last modified: Wednesday, November 7, 2012

Next Indiana Life Sciences Collaboration event focusing on the Food and Drug Administration

Nov. 7, 2012

EDITORS: A complete program schedule, links to the participants' biographies and directions are available online at the Center for the Business of Life Sciences website.

BLOOMINGTON, Ind. -- The Indiana Life Sciences Collaboration Conference Series moves to the MED Institute, a Cook Group company based in the Purdue Research Park at West Lafayette, for a day-long discussion on Friday, Nov. 16, "The Continuing Evolution of the Food and Drug Administration."

MED Institute was established by Cook Group as a resource for its companies to identify and develop new medical product concepts, which makes it an appropriate place to discuss the FDA, said George Telthorst, director of the Center for the Business of Life Sciences in Indiana University's Kelley School of Business.

"Between changes in the politically appointed leadership and the new reauthorization law for fees and product approvals, the FDA continues to be in a state of flux," Telthorst explained. "At the same time, the agency is attempting to make itself more relevant to a variety of new products being developed and more user friendly. What will it take for the FDA to maintain its balance in the years ahead? Veterans and observers of the agency will present their opinions as to what's next."

The conference, will feature breakout sessions and presentations by top executives in regulatory matters at AdvaMed, ImmuneWorks, Indigo BioSystems, Johnson & Johnson, Eli Lilly & Co., Baxter BioPharma and Cook Group.

The luncheon keynote speaker will be Susan Alpert, principle at SFA Consulting LLC and former vice president of regulatory affairs and compliance at Medtronic, former vice president of regulatory sciences at C.R. Bard Inc. and former director of the Office of Device Evaluation at the FDA.

The conference will take place at MED Institute's headquarters at a 1 Geddes Way in the Purdue Research Park.

The registration fee for the event is $150. Students at accredited Indiana institutions of higher education may qualify for a discounted rate. Registration and additional information are available online at or by contacting Kelli Conder at the Kelley School at 812-856-0915 or

George Telthorst

George Telthorst

Print-Quality Photo

The conference series is presented by the IU Kelley School of Business, its Center for the Business of Life Sciences, the Indiana Economic Development Corp., BioCrossroads, Bacterin International Holdings, Inc., Ethicon Endo Surgery, Inc. and Zimmer.

Following registration and networking from 8 to 9 a.m., Matt Waninger, president of MED Institute, will introduce keynote presenter Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed. She will speak on the topic, "Medical Device Regulatory Reform and the FDA Safety and Innovation Act."

After a break, four veterans in regulatory affairs will participate in a panel discussion, "Expected Changes From the Recent FDA Safety and Innovation Act." Presenters will be Wendy Turner, group director for regulatory operations at Johnson & Johnson Global Surgery Group; Dr. Robert Metcalf, vice president for global regulatory affairs-U.S. at , Eli Lilly & Co.; Kelly Davis, associate director of regulatory affairs at Baxter BioPharma; and Tim Gee, connected health specialist at The Anson Group. Neal Roach, a partner at Taft Stettinius & Hollister LLP, will moderate.

At lunch, Alpert will speak on the topic, "Working with the FDA from the Inside Out." She will be introduced by Dan Peterson, vice president for industry and government affairs at Cook Group.

A second panel discussion, "New Initiatives to Make the Agency More Effective and Efficient," will follow lunch and will feature Neal Fearnot, vice president of Cook Group; Randy Julian, founder and president of Indigo BioSystems, Inc.; Joe Muldoon, chief executive officer of FAST Biomedical; and Wade Lange, president and CEO of ImmuneWorks.

The day's events will wrap up at 3 p.m.

The Nov. 16 conference is sponsored by Anson Group, Baxter BioPharma; Cook Medical and Taft, Stettinius & Hollister LLP.

Other financial sponsors are Barnes & Thornburg LLP; Biomet; Covance Laboratories; Hill-Rom; Ice Miller LLP; Indiana Clinical and Translational Sciences Institute; Indiana Health Information Exchange; IU Health; IU School of Medicine; Krieg DeVault LLP; Eli Lilly & Co.; Omnicare; Purdue University; Roche Diagnostics; and Zimmer.

Brochure sponsors are Cabello Associates; and Miles Printing on Plastics. Marketing sponsors are AIT Laboratories; Aledo Consulting, Inc.; Aptalis Pharma; Bloomington Life Sciences Partnership; CHV Capital, Inc.; Commissioning Agents, Inc.; Guerbet LLC; IU College of Arts and Sciences; IU Kelley Evening MBA Program; IU Kelley School of Business Alumni Association; IU Office for the Vice President for Engagement; IU Research & Technology Corp.; Novus Biologicals; OrthoWorx, Inc.; Pearl Pathways, LLC; Performance Validation, LLC; Regulatory Affairs Professional Society and VMS BioMarketing.