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    Preconference Symposia - Monday, November 7, 2005





    7:00 a.m.



Congress Registration



    8:30 a.m.



Preconference Symposia; Choose one only



    Preconference I





Compliance Primer - How to Establish a Compliance Program for a Pharmaceutical Enterprise

Robert A. Freeman
US Compliance Officer and Compliance Counsel
Serono, Inc.
Rockland, MA

Robert G. Homchick, Esq.
Partner and Chair, Health Law Group
Davis Wright Tremaine
Seattle, WA

Sheryl Vacca
CHC, West Coast Life Science and Health Care Regulatory Practice Leader
Deloitte & Touche LLP
Immediate Past President, Health Care Compliance Association
Costa Mesa, CA
(Moderator)




    Preconference II





Best Practices for Getting Cooperation for Risk Management and Corporate Compliance

John T. Bentivoglio, Esq.
Partner, King & Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC

Ron Geigle
President, Polidais
Arlington, VA

Charlie Lucas, Esq.
Vice President, General Counsel
Biotechnology Industry Association
Washington, DC

Nan Matthews
President, The Matthews Group
Littleton, CO

Marie Marlow
President, M Squared Associates, Inc.
Formerly with Pfizer Hospital Products Group
Washington, DC

Steve Ojala, Ph.D.
Global Director, Eli Lilly
Indianapolis, IN

Nancy Singer, Esq.
President, Compliance-Alliance
Former Special Counsel, AdvaMed
Founder, AdvaMed Medical Technology Learning Institute
Arlington, VA
(Moderator)




    Preconference III





Government Price Reporting - Staying Ahead of the Curve on Problems and Solutions

Peter J. Claude
Pharmaceutical and Life Sciences Advisory Services
Partner, PricewaterhouseCoopers LLP
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Timothy Nugent
Director, Pharmaceutical and Life Sciences Advisory Services
PricewaterhouseCoopers LLP
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

John D. Shakow, Esq.
Counsel, King & Spalding LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

David Weiss
Solutions Architect
Model N
Clarendon Hills, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Jonathon L. Kellerman
Director, Pharmaceutical and Medical Products Advisory Services
PricewaterhouseCoopers LLP
Philadelphia, PA
(Moderator)




    Noon



Adjournment






    Pharma Congress Day One - Monday, November 7, 2005





1:00 p.m.





Welcome and Introduction

Bert Weinstein, Esq.
Vice President, Corporate Compliance
Purdue Pharma LP
Stamford, CT
(Co chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1:15 p.m.





OIG Oversight of the Pharmaceutical Industry

Daniel R. Levinson
Inspector General
Department of Health and Human Services
Washington, DC




1:45 p.m.





The New Medicare Prescription Drug Law - What's Next?

Thomas Scully
Senior Counsel, Alston & Bird
Senior Adviser, Welsh, Carson, Anderson and Stowe
Former Administrator, Centers for Medicare and Medicaid Services
Department of Health & Human Services
Washington, DC




2:15 p.m.





Compliance Lessons from the Trenches

Alan Yuspeh, JD, MBA
Senior Vice President, Ethics
Compliance and Corporate Responsibility, HCA, Inc.
Former Coordinator, Defense Industry Initiative on Business Ethics and Conduct
Nashville, TN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2:45 p.m.





Compliance Perspectives from The Ethicist

Randy Cohen
Author, "The Ethicist" column
The New York Times Magazine
New York, NY




3:15 p.m.



Break




3:45 p.m.





Socratic Dialogue: The Top Five Pharmaceutical Compliance Issues in 2006

John T. Bentivoglio, Esq.
Partner, King & Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC

Lori Queisser
Vice President and Chief Compliance Officer
Eli Lilly and Company
Indianapolis, IN

Janet L. "Lucy" Rose, MBA
President, Lucy Rose and Associates
Former Director, Division of Drug Marketing, Advertising, and Communications (DDMAC)
Former Director, Office of Training and Communications
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
Washington, DC

Brian Salsberg, JD
Associate Principal, Pharmaceutical and Medical Products Practice
McKinsey & Company
Florham Park, NJ

Brenton L. Saunders, JD, MBA
Senior Vice President, Global Compliance and Business Practices
Schering-Plough Corporation
Past President, Health Care Compliance Association
Founder, International Association of Privacy Professionals
Kenilworth, NJ

Jonathan K. Sprole
Vice President and Deputy General Counsel and Chief Compliance Officer
Bristol-Myers Squibb Company
New York, NY

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




5:00 p.m.






























Pharma Congress Interactive Hypothetical (click here for full details)

This year the Pharma Congress will feature a complex hypothetical in which a pharmaceutical company is faced with a series of regulatory and compliance challenges. The hypothetical will be presented on Monday afternoon. On Tuesday part of concurrent session time will be dedicated to hypothetical resolution. The hypothetical will conclude on Wednesday morning. Throughout the Congress intervening events will create new challenges.

Cast of Characters:
Valli Baldassano
Vice President, Global Compliance
Commercial Operations, Schering-Plough
Kenilworth, NJ

William T. Fitzgerald
Director, Global Compliance
Alcon Laboratories
Fort Worth, TX

Linda Heitzman
Director, Life Sciences & Healthcare
Deloitte & Touche LLP
Cincinnati, OH

Lori Queisser
Vice President and Chief Compliance Officer
Eli Lilly and Company
Indianapolis, IN

Arjun Rajaratnam, JD
Vice President and Compliance Officer
Global Pharmaceuticals, GlaxoSmithKline
Research Triangle Park, NC

Brian Riewerts
Senior Manager, Global Pharmaceutical Advisory Services Group
PricewaterhouseCoopers LLP
Baltimore, MD

Sue Seferian, Esq.
Senior Counsel
Corporate Law Department
Johnson & Johnson
New Brunswick, NJ

Michael Shaw
Deputy Compliance Officer
Novartis Pharmaceuticals Corporation
East Hanover, NJ

James Sheehan, Esq.
Associate United States Attorney
U.S. Attorney's Office for the Eastern District of Pennsylvania
Philadelphia, PA

Eric Siegel
Vice President, Associate General Counsel &
Chief Compliance Officer
Cephalon, Inc.
Frazer, PA

Paul J. Silver
National Leader, Health Sciences
Investigative and Dispute Services
Ernst & Young LLP
Atlanta, GA

Kelly M. Talley
Director Global Medical Affairs Compliance
Bristol-Myers Squibb Company
New York, NY

Bert Weinstein, Esq.
Vice President, Corporate Compliance
Purdue Pharma LP
Stamford, CT

Keith M. Korenchuk, JD, MPH
Partner, McGuire Woods
Charlotte, NC
(Co chair)




6:30 p.m.




Adjournment and Code of Conduct Poster Board and Exchange Reception

The Pharma Congress Monday Networking Reception will feature the exchange and presentation of company Codes of Conduct at poster boards throughout the Pharma Congress Exhibi Hall.

Participating Companies to Date:
  • Abbott Laboratories
  • AstraZeneca
  • Boehringer Ingelheim
  • Bristol-Myers Squibb Company
  • Cephalon
  • Eli Lilly and Company
  • GlaxoSmithKline
  • Merck & Company
  • Novartis Pharmaceuticals
  • Purdue Pharma LP
  • Roche
  • Schering-Plough Corporation
  • Serono
  • TAP Pharmaceuticals
  • Wyeth




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