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News Release

Last modified: Friday, February 11, 2011

Feb. 25 conference will focus on impact of regulatory compliance on Indiana's life science firms

FOR IMMEDIATE RELEASE
Feb. 11, 2011

EDITORS: A complete program schedule, links to the participants' biographies and directions are available at https://kelley.iu.edu/CBLS/conferences/page19191.html.

BLOOMINGTON, Ind. -- A relatively new administration, leadership and legislation all contribute to the recent changes in how the U.S. Food and Drug Administration (FDA) performs its role.

At the same time, manufacturers of pharmaceutical products, nutritionals, medical devices and diagnostic equipment, and other medical technologies are constantly looking for new ways to distribute, market and sell their products.

Many would say that the effects of this combination are putting businesses under more regulatory scrutiny, subjecting companies to more liability and delaying the availability of new products and therapies to health care providers and ultimately, the public.

The next event in the Indiana Life Sciences Collaboration Conference Series, on Friday, Feb. 25 in Indianapolis, will bring experts from industry and the regulatory environment together to discuss whether this is indeed the case and review strategies for the future.

The day-long conference, "An Update on Regulatory Compliance," will take place 8 a.m. to 3:15 p.m., at the offices of Barnes & Thornburg LLP, 11 S. Meridian St.

"When administrations change, interpretations of laws and regulations and areas of focus at FDA change as well. Additionally, due to several laws recently passed, the FDA's span of responsibility has increased," said George Telthorst, director of the Center for the Business of Life Sciences in IU's Kelley School of Business. "This conference points out what industry members and observers are seeing in response to both these forces."

Among the presenters will be Steve Usdin, senior editor of BioCentury, an internationally recognized provider of information, analysis and data for biotechnology and pharmaceutical companies, investors, academia and government on the strategic issues essential to the formation, development and sustainability of life science ventures.

Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and former associate FDA commissioner for external relations, will speak at lunch.

The Feb. 25 event is the third in a series of four conferences. The cost is $90. The final event in the series will take place on May 13 at the IU School of Medicine, also in Indianapolis, and is titled "Health Information Technology: Indiana's Role in the Development of a National Model."

Registration and additional information is available online at https://www.kelley.iu.edu/CBLS/conferences/registration/page16551.html or by contacting Kelli Conder at the Kelley School at 812-856-0915 or kconder@indiana.edu.

The conference series is presented by the IU Kelley School of Business and its Center for the Business of Life Sciences, BioCrossroads and Duke Energy. Primary sponsors of the Feb. 25 event are Anson Group, Barnes & Thornburg LLP and Mead Johnson, the supporting sponsor is Beckman Coulter, Inc., and the conference marketing partner is BioCentury.

Following registration and networking from 8-9 a.m., Kep Carmichael, partner and co-chair of the Life Science Practice Group at Barnes & Thornburg, will introduce the opening keynote speaker Usdin, who will discuss the topic, "The FDA in the 21st Century: Reflections of a Veteran FDA Observer."

Usdin will be followed by the first panel, which will focus on new product reviews and approval policies and procedures. The panel, moderated by Todd Vare, partner and co-chair of the Nanotechnology Practice Group at Barnes & Thornburg, will consist of Tom Bolton, manager of regulatory affairs at Eurand; Hugh Tucker, a Distinguished Research Fellow, Global Research & Development, at Mead Johnson Nutrition; Chris Kilander, regulatory affairs manager and corporate compliance administrator at Cook Urological Inc.; and Donna Zimmerman, vice president of Elona Biotechnologies Inc.

At lunch, Pitts will offer the presentation "The FDA Perspective." He will be introduced by Craig Hadley, associate director of North America Regulatory Science at Mead Johnson Nutrition.

After lunch, a second panel discussion will look at the regulatory environment as it relates to current business operations. Panelists will include David Ceryak, senior director and assistant general counsel on the Regulatory Legal Team at Eli Lilly and Co.; Lynn Gagel, assistant general counsel at Roche Diagnostics Corp.; Richard E. Kruger, principal at Kruger Consulting Inc.; and Joe Levitt, former director of the Center for Food Safety & Applied Nutrition at the FDA. Colleen Hittle, managing partner at Anson Group, will moderate.

Financial sponsors for the entire series include AIT Laboratories; Aledo Consulting; Anson Group; Baker & Daniels LLP; Barnes & Thornburg LLP; Beckman Coulter Inc.; BSA Life Structures; Clarian Health Ventures; Cook Medical; Commissioning Agents Inc.; Eli Lilly and Co.; Indiana Health Information Exchange; Ice Miller LLP; the Indiana Clinical and Translational Sciences Institute; the IU School of Medicine; Mead Johnson Nutrition; Meyer Najem; NoMoreClipboard.com; Purdue University; Symmetry Medical; Taft Stettinius and Zimmer.

Brochure sponsors are Cabello Associates Inc. and Miles Printing on Plastics. Marketing sponsors are BioCentury; BioConvergence LLC; Bloomington Life Sciences Partnership; Covidien; Deloitte Center for Health Solutions; Harlan Laboratories; Indiana Healthcare Businesswoman's Association; Indiana Health Industry Forum; IU College of Arts and Sciences; IU Research and Technology Corp.; the Kelley School's Evening MBA Program; the Kelley School of Business Alumni Association; IU Maurer School of Law, Center for Intellectual Property; IU Office for the Vice President for Engagement; IU School of Informatics; OrthoWorx; Prolifiq Software Inc.; Purdue University Regulatory & Quality Compliance Graduate Program; and the University of Notre Dame.

More information about the Center for the Business of Life Sciences is available online at https://kelley.iu.edu/cbls/.

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