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The Continuing Evolution of the FDA

November 16, 2012
View Presentations
West Lafayette - MED Institute, a Cook Group Company
Purdue Research Park
1 Geddes Way, West Lafayette, IN (Directions)
Primary Sponsors
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.  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 for the agency.


8:00 am – 9:00 amRegistration and Breakfast
9:00 am – 9:15 amWelcome and Introduction
 Matt Waninger
President, MED Institute, Inc. (a Cook Group Company)
9:15 am – 10:15 am

Keynote Presentation-

Medical Device Regulatory Reform and the FDA Safety and Innovation Act 

 Janet Trunzo
Senior Executive Vice President, Technology and Regulatory Affairs, AdvaMed
10:15 am – 10:30 amBreak
10:30 am – 12:00 pmPanel - Expected Changes From the Recent FDA Safety and Innovation Act
 Moderator: Neal Roach
Partner, Taft Stettinius & Hollister LLP
 Panel Members:
 Wendy Turner
Group Director, Regulatory Operations, Johnson & Johnson Global Surgery Group
 Dr. Robert Metcalf
Vice President Global Regulatory Affairs -US, Eli Lilly & Company
 Kelly Davis
Associate Director of Regulatory Affairs, Baxter BioPharma
 Tim Gee
Connected Health Specialist, The Anson Group
12:00 pm – 1:30 pmLuncheon Keynote- Working with the FDA from the Inside Out
 Introduction: Dan Peterson
Vice President, Industry and Government Affairs, Cook Group
 Susan Alpert
Principle, SFA Consulting LLC
Former Vice President of Regulatory Affairs and Compliance at Medtronic; former Vice President of Regulatory  Sciences at C.R. Bard, Inc.; former Director of The Office of Device Evaluation, FDA
1:30 pm – 3:00 pmAfternoon Panel – New Initiatives to Make the Agency More Effective and Efficient
 Moderator: Colleen Hittle
President and CEO, The Anson Group
 Panel Members:
 Neal Fearnot
Vice President, Cook Group Inc.
 Randy Julian
Founder & President, Indigo BioSystems, Inc.
 Joe Muldoon
CEO, FAST Biomedical
 Wade Lange, President & CEO, ImmuneWorks
3:00 pm – 3:15 pm

Wrap Up

George Telthorst, Director, Center for the Business of Life Sciences, IU Kelley School of Business