Everything You Wanted to Know about Trademarks and Branding
(Grand Ballroom South)

The Trademarks and Branding panel will discuss the importance of trademarks and branding in the pharmaceutical and dietary supplement arenas.

Branding Agencies

Moderator:
James L. Dettore, President and CEO, The Brand Institute

Panelists:
Dennis H. Cavanaugh, Trademark Counsel, Ullman, Shapiro & Ullman
Schuyla M. Goodson, Trademark Counsel, The Coca-Cola Company
Robert E. Lee, Jr., Assistant General Patent Counsel, Eli Lilly & Company
Branding Agencies

45th Annual FDLI EDUCATIONAL CONFERENCE
April 15-17, 2002
Renaissance Washington D.C. Hotel
Washington, D.C.

Monday, April 15th
1:00pm - 3:00pm Drugs and Biologics Committee Meeting (Meeting Room 2)
2:00pm - 4:00pm Membership Committee Meeting (Meeting Room 3)
3:00pm - 5:00pm Devices Committee Meeting (Meeting Room 4)

3:00pm - 7:00pm Registration (Grand Foyer)
FDLI Resources Center (Grand Foyer)

6:30pm FDLI Journal Advisory Board Working Dinner (Meeting Room 16)

Tuesday, April 16th
7:30am - 5:30pm Registration and Coffee (Grand Foyer)
Cyber Café (Grand Foyer)
FDLI Resources Center (Grand Foyer)

8:30am Morning Welcome (Grand Ballroom North / Central)
Jerome A. Halperin, President and CEO, FDLI

Keynote Addresses:
Introductions and Moderator:
Mark Novitch, M.D., Chairman, FDLI Board of Directors

Speakers:
The Honorable Orrin Hatch, (R-UT) United States Senate
Lester M. Crawford, Jr., D.V.M., Ph.D., Deputy Commissioner,
Food and Drug Administration

"Dan Troy… Speaking Freely"

FDA's Chief Counsel discusses the principal legal challenges he sees facing
the FDA, focusing on some of the issues which have most occupied him
during his first 8 months as the Agency's top lawyer.

speaker:
Daniel E. Troy, Chief Counsel, Food and Drug Administration

Moderator:
Bruce N. Kuhlik, Partner, Covington & Burling
Panelists:
John W. Bode, Principal, Olsson, Frank and Weeda, P.C.
Michael A. Hacker, Vice President & Assistant General Counsel,
Merck & Co., Inc.
Marlene K. Tandy, M.D., J.D., General Attorney, Johnson & Johnson

Networking Break (Grand Foyer)

Is the Current Enforcement Climate a Sign of Things to Come?
(Grand Ballroom North / Central)
Moderator:
Arthur N. Levine, Partner, Arnold & Porter
Panelists:
Robert J. Klepinski, Senior Legal Counsel, Medtronic, Inc.
Patrick M. McLain, Vice President, Federal Government Affairs,
GlaxoSmithKline Inc.
Larry R. Pilot, Partner, McKenna & Cuneo
John M. Taylor, Director, Office of Enforcement, Office of Regulatory
Affairs, Food and Drug Administration

12:00pm FDLI Luncheon (Renaissance Ballroom)
· Presentation of 2002 FDLI Distinguished Service and Leadership Awards
· Announcement of New Emeriti Members
· Introduction of Author/Editor Contributors
Mark Novitch, M.D., Chairman, FDLI Board of Directors
Jerome A. Halperin, President & CEO, FDLI

"Combating Deception in Dietary Supplements - The FTC Approach "

Sheila F. Anthony, Commissioner, Federal Trade Commission

2:00pm Concurrent Sessions

The FD&C Act + Healthcare Fraud = ??? (Grand Ballroom North)

Participation by drug, device and biologic manufacturers and suppliers in
federal healthcare programs carries with it obligations to supply products
that comply with federal laws and regulations, including the Federal Food,
Drug, and Cosmetic Act. Learn what the federal government has done
when such manufacturers or suppliers have committed health care fraud.

Moderator:
Eugene M. Thirolf, Jr., Director, Office of Consumer Litigation,
U.S. Department of Justice
Panelists:
Raymond A. Bonner, Partner, Sidley Austin Brown & Wood
Michael Loucks, Health Care Fraud Chief, District of Massachusetts,
United States Attorney's Office
William McConagha, Associate Chief Counsel for Drugs, Office of the
Chief Counsel, Food and Drug Administration
Laurence J. Freedman, Assistant Director, Commercial Litigation Branch,
Fraud Section, Civil Division, U.S. Department of Justice
Robert Nicholson, Healthcare Fraud Coordinator, Executive Office for
United States Attorneys
Alan Slobodin, Senior Oversight Counsel, House Oversight Committee,
U.S. House of Representatives

Point/CounterPoint: Is FDA Enforcing the FD&C Act Effectively?
(Auditorium)

The session will explore the use of the various enforcement authorities under the FD&C Act and whether the use of those authorities helps to maintain a level playing field for the regulated industries. Particular attention will be paid to the enforcement of the food-related provisions of the FD&C Act, including food labeling, dietary supplements, food ingredients, and GMPs. The session will also address whether the enforcement authorities in the bioterrorism legislation are needed and how those authorities, assuming that the legislation becomes law, will affect FDA and food processors.

Moderator:
Stuart M. Pape, Managing Partner, Patton Boggs LLP
Panelists:
Robert M. Spiller, Jr., Associate Chief Counsel, Enforcement, Office of the Chief Counsel, Food and Drug Administration
Marsha C. Wertzberger, Partner, Arent Fox Kintner Plotkin & Kahn, PLLC

The Direction and Future of Product Liability Litigation (Meeting Room 4)
The panelists will identify and discuss developing procedural and substantive trends in products litigation. Among the procedural issues to be discussed will be the relative decline of class actions, the rise in the use of electronic media in the defense of nationwide litigation and the negative side effects of judicial management tools in drug and device litigation. Implications of the Perez decision on direct to consumer marketing, and the evolution of clinical trial liability claims against sponsor-manufacturers are included in the substantive topics to be considered during the session.

Moderator:
Philip W. Crawford, Director, Products Liability, Gibbons, Del Deo, Dolan, Griffinger & Vecchione
Panelists:
James M. Beck, Partner, Pepper Hamilton LLP
Diane E. Lifton, Partner, Gibbons, Del Deo, Dolan, Griffinger & Vecchione
Gregory D. Winfree, Corporate Counsel, Wyeth Pharmaceuticals
James M. Wood, Attorney, Crosby Heafey

In an Era of Refocused GMPs, What's the Industry to Do? (Grand Ballroom Central)

The Who's Who of the pharmaceutical and medical device industries have
recently become the target of FDA enforcement action. Why are industry and FDA so far apart on what constitutes GMP compliance? Learn about some of the causes for this disconnect and hear some ways industry can respond.

Moderator:
Ron Johnson, Executive Vice President, Quintiles Consulting
Panelists:
Frederick H. Branding, Member, Bell, Boyd & Lloyd LLC
Cathy L. Burgess, President, Law Offices of Cathy L. Burgess
Kevin M. Fain, Associate Chief Counsel for Enforcement, Office of the Chief Counsel, Food and Drug Administration
Martin J. Levitas, Vice President, Legal, Campbell Soup Company
Centers for Medicare and Medicaid Services (CMS) in Today's Environment
Branding Agencies

Centers for Medicare and Medicaid Services (CMS) in Today's Environment (Grand Ballroom South)

CMS in Today's Environment" will address issues and actions of the federal Medicare and Medicaid regulatory agency that have impact on FDLI members. The panel represents viewpoints from industry, legal advisors, and government representatives.

Moderator:
Kendra L. Dimond, Partner, Epstein Becker & Green, P.C.
Panelists:
Grant P. Bagley, M.D., J.D., Partner, Arnold & Porter
Thomas A. Gustafson, M.D., Director, Purchasing Policy Group, CMS, U.S. Department of Health and Human Services
John B. Reiss, Ph.D., J.D., Partner & Chair of Health Law Dept., Saul Ewing LLP
Randel Richner, Vice President, Reimbursement & Outcomes Planning, Boston Scientific Corporation, Inc.

Networking Break (Grand Foyer)

Concurrent Sessions

The FD&C Act + Healthcare Fraud = ??? (Grand Ballroom North)

Participation by drug, device and biologic manufacturers and suppliers in federal healthcare programs carries with it obligations to supply products that comply with federal laws and regulations, including the Federal Food, Drug, and Cosmetic Act. Learn what the federal government has done when such manufacturers or suppliers have committed health care fraud.

Moderator:
Eugene M. Thirolf, Jr., Director, Office of Consumer Litigation, U.S. Department of Justice
Panelists:
Raymond A. Bonner, Partner, Sidley Austin Brown & Wood
Michael Loucks, Health Care Fraud Chief, District of Massachusetts, United States Attorney's Office
William McConagha, Associate Chief Counsel for Drugs, Office of the Chief Counsel, Food and Drug Administration
Laurence J. Freedman, Assistant Director, Commercial Litigation Branch, Fraud Section, Civil Division, U.S. Department of Justice
Robert Nicholson, Healthcare Fraud Coordinator, Executive Office for United States Attorneys
Alan Slobodin, Senior Oversight Counsel, House Oversight Committee, U.S. House of Representatives

Point/Counterpoint: Is FDA Enforcing the FD&C Act Effectively? (Auditorium)

This session will address FDA's application of the FD&C Act to drug
approvals and withdrawals. Topics will include: whether FDA has become
too risk-averse; whether the Agency should leave more risk-benefit
decisions to individual patients and physicians; whether
special-distribution systems are desirable; whether PDUFA focuses on the
proper milestones; and whether improvement is needed in FDA's means for
resolving internal disagreements affecting drug approvals.

Moderator:
Richard M. Cooper, Partner, Williams & Connolly LLP
Panelists:
Peter Barton Hutt, Partner, Covington & Burling
Robert J. Temple, M.D., Director, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration
Branding Agencies

The Direction and Future of Product Liability Litigation (Meeting Room 4)
The panelists will identify and discuss developing procedural and substantive trends in products litigation. Among the procedural issues to be discussed will be the relative decline of class actions, the rise in the use of electronic media in the defense of nationwide litigation and the negative side effects of judicial management tools in drug and device litigation. Implications of the Perez decision on direct to consumer marketing, and the evolution of clinical trial liability claims against sponsor-manufacturers are included in the substantive topics to be considered during the session.

Moderator:
Philip W. Crawford, Director, Products Liability, Gibbons, Del Deo, Dolan, Griffinger & Vecchione
Panelists:
James M. Beck, Partner, Pepper Hamilton LLP
Diane E. Filton, Partner, Gibbons, Del Deo, Dolan, Griffinger & Vecchione
Gregory D. Winfree, Corporate Counsel, Wyeth Pharmaceuticals
James M. Wood, Attorney, Crosby Heafey

In an Era of Refocused GMPs, What's the Industry to Do? (Grand Ballroom Central)

The Who's Who of the pharmaceutical and medical device industries have
recently become the target of FDA enforcement action. Why are industry and FDA so far apart on what constitutes GMP compliance? Learn about some of the causes for this disconnect and hear some ways industry can respond.

Moderator:
Ron Johnson, Executive Vice President, Quintiles Consulting
Panelists:
Kevin M. Fain, Associate Chief Counsel for Enforcement, Office of the Chief Counsel, Food and Drug Administration
David J. Miner, Ph.D., Compliance Leader, Corporate GMP Compliance, Eli Lilly and Company
Daniel F. Shaw, Assistant General Counsel, H.J. Heinz Company
Paul Vogel, Lachman Consulting Services, Inc.

Centers for Medicare and Medicaid Services (CMS) in Today's Environment (Grand Ballroom South)

CMS in Today's Environment" will address issues and actions of the federal Medicare and Medicaid regulatory agency that have impact on FDLI members. The panel represents viewpoints from industry, legal advisors, and government representatives.

Moderator:
Kendra L. Dimond, Partner, Epstein Becker & Green, P.C.
Panelists:
Grant P. Bagley, M.D., J.D., Partner, Arnold & Porter
Thomas A. Gustafson, M.D., Director, Purchasing Policy Group, CMS, U.S. Department of Health and Human Services
John B. Reiss, Ph.D.,J.D., Partner & Chair of Health Law Dept., Saul Ewing LLP
Randel Richner, Vice President, Reimbursement & Outcomes Planning, Boston Scientific Corporation, Inc.

5:30pm - 7:00pm Reception: FDLI = Food, Drink, Lively Interaction
(Renaissance Ballroom)

7:00pm - 9:00pm Chairman's Dessert Reception (By Invitation Only) (Suite 1128)

Wednesday, April 17th

7:00am - 8:00am Law Professors Breakfast (By Invitation Only) (Tavern Restaurant)

7:30am - 4:00pm Registration & Coffee (Grand Foyer)
Cyber Café (Grand Foyer)
FDLI Resources Center (Grand Foyer)

8:00am "Hot Topics" from FDA's Center Directors

Center for Biologics Evaluation and Research (CBER) (Auditorium)
Moderator:
James Kenimer, Ph.D., President, Biologics Consulting Group, LLC
speaker:
Kathryn C. Zoon, Ph.D., Director, Center for Biologics Evaluation and Research, Food and Drug Administration
Panelists:
Kate C. Beardsley, Partner, Buc & Beardsley
Christopher P. Healey, Executive Director - North America, Plasma Protein Therapeutics Association
Geoffrey M. Levitt, Vice President & Chief Regulatory Counsel, Wyeth Pharmaceuticals

Center for Drug Evaluation and Research (CDER) (Grand Ballroom North)
Branding Agencies

The session will focus on bringing about change through regulation. It will include discussion of the considerations involved in seeking to resolve issues such as: generic vs. innovator drug concerns, pharmacy compounding limitations, and adoption of new manufacturing technologies while meeting cGMP

Moderator:
Donald R. Stone, Partner, Kilpatrick & Lockhart LLP
speaker:
Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research, Food and Drug Administration
Panelists:
Arnold I. Friede, Senior Corporate Counsel, Pfizer, Inc.
Stephen Paul Mahinka, Partner, Morgan Lewis

Center for Devices and Radiological Health (CDRH) (Grand Ballroom Central)

Following a presentation on regulatory topics currently being addressed by
CDRH, the panel will discuss those and other areas of interest to the
industry and legal communities. Questions from the floor will be
encouraged.

Moderator:
Edward M. Basile, Senior Partner, King & Spalding
speaker:
David W. Feigal, Jr., M.D., M.P.H., Director, Center for Devices and Radiological Health, Food and Drug Administration
Panelists:
John D. Goetz, Partner, Jones, Day, Reavis & Pogue
Barry Sall, Senior Regulatory Consultant, PAREXEL International Corporation

Center for Food Safety and Applied Nutrition (CFSAN) & Food Safety and Inspection Service (FSIS) (Grand Ballroom South)

This session will feature top officials from CFSAN and FSIS discussing the most pressing regulatory issues facing their agencies today. Expect to hear about biosecurity, BSE, single food agency, performance standards, and other hot topics.

Moderator:
Kinsey S. Reagan, Partner, Kleinfeld, Kaplan & Becker
Speakers:
Janice F. Oliver, Deputy Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration
Ronald Hicks, Acting Associate Administrator, Food Safety and Inspection Service, USDA
Panelists:
Kenneth C. Mercurio, Director, Regulatory and Nutrition, Nestle USA
Alice L. Johnson, D.V.M., Vice President, Food Safety Programs, National Food Processors Association
Michael R. Taylor, Senior Fellow and Director, Resources for the Future

Center for Veterinary Medicine (CVM) & USDA Veterinary Biologics (Meeting Room 4)

The CVM and USDA Veterinary Biologics session will address current, significant issues related to the approval of new animal drugs and veterinary biologics by those agencies, respectively. The session will also address significant issues relating to other products for animal use regulated by CVM.

Moderator:
Arthur Y. Tsien, Principal, Olsson, Frank and Weeda, P.C.
Speakers:
Albert P. Morgan, Veterinary Medical Officer, Animal & Plant Health Inspection Service, United States Department of Agriculture
Stephen F. Sundlof, D.V.M., Ph.D., Director, Center for Veterinary Medicine, Food and Drug
Administration
Branding Agencies

Panelists:
Kenneth R. Johannes, Director, Regulatory & Governmental Affairs, Hill's Pet Nutrition
Kent D. McClure, D.V.M., Director, Scientific Affairs, Animal Health Institute
Robert B. Nicholas, Capital Partner, McDermott, Will & Emery
Michael C. Tucker, General Counsel, Intervet, Inc.

Networking Break (Grand Foyer)

Concurrent Sessions

Functional Food Claims: How Far Can You Go? (Grand Ballroom North)

Whether it is bread, snack foods, cereals, beverages or dietary supplements, whether on labels, television, or the Internet, we are seeing an increasing amount and variety of health-related promotional claims for foods. This experienced panel of government and nongovernment representatives will discuss the current rules, current enforcement, and where we are going with the regulation of "functional" foods that are represented to offer special health-related benefits.

Moderator:
Stephen H. McNamara, Partner, Hyman, Phelps & McNamara, P.C.
Panelists:
George A. Burdock, Ph.D., President, Burdock Group
Elizabeth J. Campbell, Senior Consultant, AAC Consulting Group, Inc.
Melvin S. Drozen, Partner, Keller and Heckman LLP
Lesley A. Fair, Attorney, Federal Trade Commission
Cate A. McGinn, Senior Attorney, Kellogg Company

BSE Sourcing (Meeting Room 4)

Moderator:
Murray M. Lumpkin, M.D., Senior Associate Commissioner for International Activities and Strategic Initiatives, Office of the Commissioner, Food and Drug Administration
Panelists:
Edward J. Allera, Executive Director, Animal Drug Alliance
Caroline Smith DeWaal, Director of Food Safety, Center for Science in the Public Interest
Thad Lively, Manager, Regulatory Affairs, The Iams Company
Daniel G. McChesney, Deputy Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration
Richard Sellers, Vice President, Feed Control and Nutrition, American Feed Industry Association

Of Mice and Men: Use of Cloning, Transgenics and Genomics to Create New Drugs (Grand Ballroom Central)

This session will address various scientific, patent-related, bioethical and FDA regulatory topics pertaining to the use of newer technological areas, such as cloning, transgenics and genomics, to develop human biological and other drugs.

Moderator:
Edward L. Korwek, Ph.D., Partner, Hogan & Hartson, L.L.P.
Panelists:
James N. Czaban, Shareholder, Heller Ehrman White & McAuliffe LLP
Timothy Maines, Director of Quality, Genzyme Transgenics
Philip D. Noguchi, M.D., Director, Division of Cellular and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration

International Issues: The WORLD of Food and Drug Law (Auditorium)

New paradigms in the areas of food and drug regulation are developing outside of the U.S. that will have profound effects on both industries. Regulatory affairs management and legal counsel for multinational food and
pharmaceutical companies need to be attuned to developments outside of the
U.S. Attendees of this session will learn how registering drug products in third world countries can affect new product development strategies; how Codex and WTO process-based labeling requirements currently under
debate may affect the import and export of food; and what the impact of harmonization efforts will be on drug imports and exports.

Moderator:
Kristine A. Rapp, Associate General Counsel, Baxter International Inc.
Panelists:
Walter M. Batts, Acting Director, Office of International Programs, Office of the Commissioner, Food and Drug Administration
Karen M. Becker, Ph.D., President, Becker and Associates Consulting, Inc.
Nicole Coutrelis, Partner, Coutrelis & Associates (Paris and Brussels)
Sarah Fogarty, Director, International Trade, Grocery Manufacturers of America
Eric Sheinin, Ph.D., Vice President, Information and Standards Development, U.S. Pharmacopeia

Branding Agencies

Everything You Wanted to Know about Trademarks and Branding (Grand Ballroom South)

The Trademarks and Branding panel will discuss the importance of trademarks and branding in the pharmaceutical and dietary supplement arenas. The panel will also address recent food and drug law trends and the issues created by the

Moderator:
James L. Dettore, President and CEO, The Brand Institute
Panelists:
Dennis H. Cavanaugh, Trademark Counsel, Ullman, Shapiro & Ullman
Schuyla M. Goodson, Trademark Counsel, The Coca-Cola Company
Robert E. Lee, Jr., Assistant General Patent Counsel, Eli Lilly & Company
Branding Agencies

12:00pm Lunch Options:
§ Lawyers Networking Lunch (Separate registration required; space is limited) (Renaissance Ballroom)
"A General Counsel's Perspective on the Regulation of Health Care"
Alex Azar, III, General Counsel, U.S. Department of Health & Human Services
or
§ FDLI Writing Award Committee Meeting (By Invitation Only) (Meeting Room 10/11)
or
· Lunch "On Your Own" (Grand Foyer - Cash and Carry Buffet)

1:30pm Closing Plenary Session

Emergency Preparedness and the Threat of Bioterrorism (Grand Ballroom North/Central)

Join the closing plenary discussion on this vitally important topic. We will hear from Senator Kennedy about the status of the bioterrorism legislation, with its many features of interest to FDA and the regulated industry. Then experts in the Agency, the industry and the private bar will lead the discussion of what we have learned and where we re on this topic. We need YOUR perspective too, so come with your questions and comments!

Keynote Speaker:
D.A. Henderson, Director, Office of Public Health Preparedness, U.S. Department of Health and Human Services (invited)
The Honorable Edward M. Kennedy (D-MA), United States Senate (invited)
Tom Ridge, Director, Homeland Security (invited)
Moderator:
Linda R. Horton, Partner, Hogan & Hartson, L.L.P.
Panelists:
Andrea N. Meyerhoff, M.D., Director, Anti-Terrorism Programs, Office of the Commissioner, Food and Drug Administration
Robert G. Pinco, Head, Biomedical/FDA Group, Buchanan Ingersoll, P.C.
William Radvak, President and CEO, Response Biomedical Corporation
Marc J. Scheineson, Partner, Reed Smith LLP
Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest
Branding Agencies

Closing Remarks: Jerome A. Halperin
5:00pm Adjournment

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