2006 FDA Symposium

The Second Annual FDA Regulatory and Compliance Symposium
Managing Risks — From Pipeline to Patient

August 22 - 25, 2006

Classes Held in Harvard University's Annenberg Hall and Sanders Theatre, Cambridge, MA

Annenberg Hall

Sanders Theatre

Symposium Hotels: The Charles Hotel
Cambridge, MA

SPONSORED BY

MEDIA SPONSORS

BRONZE GRANTORS

NOW AVAILABLE!

The 2005 FDA Regulatory and Compliance Symposium on CD-ROM

The FDA Regulatory and Compliance Symposium CD-ROM set will include video of all faculty presentations, synchronized with the PowerPoint presentations, which can easily be viewed using your computer. You can instantly navigate to the presenter and the exact content you wish to view.

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Discounts available for purchase of multiple copies.

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SYMPOSIUM CD-ROM AND iPOD NOW AVAILABLE!

CD-ROM Interactive Video and and Video iPOD
from the 2006 FDA Symposium.

FDA Symposium content available either on CD-ROM or conference podcast via Video iPOD. Both offer plenary session video with synchronized PowerPoint slides and concurrent sessions audio. Purchase both for deep discount.

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Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

"It is my pleasure to welcome attendees of the FDA Symposium to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Food and Drug Administration regulatory and compliance issues in this extraordinary academic environment."

GOVERNMENT KEYNOTE SPEAKERS:

Thomas W. Abrams, RPh, MBA Director, Division of Drug Marketing, Advertising, and Communications, CDER, FDA, Washington, DC
Peter B. Bach, MD, MAPP Senior Advisor, Office of the Administrator, Centers for Medicare & Medicaid Services, Washington, DC
Sheldon T. Bradshaw, Esq. Chief Counsel, FDA, Washington, DC
Igor Cerny, Pharm.D. Director, CDER Advisors and Consultants Staff, Office of Executive Programs, FDA, Washington, DC
David J. Cummings Office of Pharmaceutical Science (OPS) Quality System Manager, FDA, Silver Spring, MD
Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, FDA, Washington, DC
David J. Horowitz, Esq. Deputy Associate Commissioner for Compliance Policy, Office of Regulatory Affairs, FDA, Washington, DC
Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group, Office of Clinical Standards & Quality, Centers for Medicare & Medicaid Services, Baltimore, MD
CAPT Paul J. Seligman, MD, MPH Associate Director for Safety Policy and Communication, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
James Sheehan, Esq. Associate United States Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA
David W. Waterbury, Esq. Senior Counsel and Director, Washington State Medicaid Fraud Control Unit, Tacoma, WA

KEYNOTE SPEAKERS:

Jane E. Henney, MD Senior Vice President and Provost for Health Affairs, University of Cincinnati Academic Health Center; Former Commissioner, FDA, Cincinnati, OH
Philip J. Hilts Former Science Reporter, The New York Times and The Washington Post; Lecturer, Department of Journalism, Boston University; Author, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation and RX for Survival: Why We Must Rise to the Global Health Challenge; Winner, 2004 Los Angeles Times Book Prize for Science and Technology and The New York Times Notable Book of the Year distinction, Brookline, MA
John F. Kamp, J.D., Ph.D. Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein & Fielding LLP, Washington, DC
Wayne L. Pines President, Regulatory Services and Healthcare, APCO Worldwide; Former Associate Commissioner for Public Affairs, FDA, Washington, DC
Peter J. Pitts President, Center for Medicines in the Public Interest; Senior Vice President for Global Health Affairs, Manning, Selvage & Lee; Former Associate Commissioner for External Relations, FDA, New York, NY
Eric J. Topol, MD Professor, Department of Genetics, Case Western Reserve University, Cleveland, OH
Daniel E. Troy, Esq. Partner, Sidley Austin Brown & Wood; Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC

CO CHAIRS:

Robert Barton Editorial Director, FDAnews, Falls Church, VA
George M. Burditt, Esq. Of Counsel, Drug and Device Law Group, Bell Boyd and Lloyd, Former General Counsel, Food and Drug Law Institute, Former Illinois State Representative, Chicago, IL
David Ceryak, Esq. Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Linda Horton, Esq. Partner, Hogan & Hartson; Former Director of International Policy, FDA, Brussels, Belgium
Keith M. Korenchuk, JD, MPH Partner, Covington & Burling LLP, Charlotte, NC
Geoffrey Levitt, Esq. Vice President and Chief Counsel, Regulatory and Research, Wyeth Pharmaceuticals, Collegeville, PA
Nancy Singer, Esq. President, Compliance-Alliance, LLC; Former Special Counsel, AdvaMed; Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
Marc Wilenzick, Esq. Senior Corporate Counsel, Pfizer, New York, NY

FEATURED FACULTY:

Ann Bacon, Esq.
Compliance Counsel, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

David Balto, Esq.
Partner, Robins, Kaplan, Miller & Ciresi; Former Policy Director of the Bureau of Competition of the Federal Trade Commission, Washington, DC

Martin Browning
President and Co-Founder, EduQuest; Former Special Assistant to the Associate Commissioner for Regulatory Affairs, FDA, Hyattstown, MD

Daniel Carpenter, Ph.D.
Professor and Director of Graduate Studies, Department of Government, Harvard University, Cambridge, MA

Jeffrey Chasnow, Esq.
Senior Corporate Counsel, Pfizer, New York, NY

Richard Cooper, JD
Partner, Williams & Connolly, LLP; Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC

James Czaban, Esq.
Shareholder, Heller Ehrman, LLP, Washington, DC

Kirk Dobbins, JD
Of Counsel, Hyman, Phelps & McNamara, P.C.; Former Senior Staff Attorney and Acting Supervisory Attorney for Litigation, Office of the General Counsel, HHS, CMS, Washington, DC

Kelly Freeman, Ph.D.
Director, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN

Gary Giampetruzzi, Esq.
Senior Corporate Counsel, Government Investigation Section, Pfizer, Legal Division, New York, NY

Thomas Greene, Esq.
Partner, Greene and Hoffman, Boston, MA

Margaret Hurley, MD
President and CEO, Hurley Consulting Associates Ltd., Chatham, NJ

Ann Leopold Kaplan, Esq.
Assistant General Counsel, PhRMA, Washington, DC

Anjali R. Kataria
Founder, and Vice President, Marketing and Business Development, FDA-Conformia CRADA, Principal Investigator, Conformia, Sunnyvale, CA

Robert M. Kirsch, RAC
Vice President - Regulatory Affairs, TolerRx, Inc., TolerRx, Inc., Cambridge, MA

Greg Koski, Ph.D., MD
CPI Associate Professor of Anesthesia, Senior Scientist, Institute for Health Policy, Massachusetts General Hospital, Partners Health Care System, Harvard Medical School; Former Director, Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, HHS, Boston, MA

Daniel Kracov, Esq.
Partner, Co-Head, Pharmaceutical and Medical Device Practice, Arnold & Porter, Washington, DC

Jeffrey Lenow, MD, JD, FAAFP
Associate Professor, Department of Family and Community Medicine, Jefferson Medical College of Thomas Jefferson University; EVP, Chief Medical Officer, CardinalHealth, Medford, NJ

Stephen Paul Mahinka, Esq.
Partner, Chair, Life Sciences Interdisciplinary Practice, Morgan, Lewis & Bockius LLP, Washington, DC

John McGrory
President and CEO, Edge Dynamics, Redwood City, CA

Arthur Miller, Esq.
Bruce Bromley Professor of Law, Harvard Law School, Cambridge, MA

Susan M. Mondabaugh, Ph.D.
Vice President - Regulatory Affairs, Hurley Consulting Associates Ltd., Chatham, NJ

Gregory Page, Ph.D.
FDA Life Sciences Practice Leader, Life Science and Healthcare Regulatory Practice, Deloitte & Touche, Jericho, NY

Gregory T. Parks
Partner, Morgan, Lewis & Bockius, LLP, Philadelphia, PA

Claudio Pincus
President, The Quantic Group, Livingston, NJ

Heather Powell, Esq.
Compliance Counsel, Cephalon, Inc., West Chester, PA

R. Owen Richards
President, Quantic Regulatory Services, Livingston, NJ

Linda Rivero
Founder and President, Voice of Persuasion; Former Adjunct Professor of Language, State University of New York and Iona College, Alexandria, VA

George Serafin
Senior Manager, Life Science and Healthcare Regulatory Practice, Deloitte & Touche, Parsippany, NJ

Peter Slone, MBA
Vice President, Government Affairs, Medtronic, Inc., Washington, DC

Adam Turteltaub
Corporate Relations Executive, LRN, Los Angeles, CA

Matthew Van Hook, Esq.
Partner, Engel & Novitt, Washington, DC

Joseph Vinhais, RAC
Vice President of Regulatory Compliance, Brooks Software, Chelmsford, MA

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