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Agenda: Day 2
Tuesday, November 16, 2004
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8:00 a.m. |
Welcome and Introduction to Day 2
Arjun Rajaratnam, Esq.
Vice President and Compliance Officer
Global Pharmaceuticals
GlaxoSmithKline
Research Triangle Park, NC
(Conference Co chair)
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8:05 a.m. |
A New Generation of Pharmaceutical Marketing and Sales Strategies
Christopher Viehbacher
President, US Pharmaceuticals
GlaxoSmithKline
Research Triangle Park, NC
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8:30 a.m. |
Pharmaceutical Compliance Case Study in Three Acts: Whistleblower Meets Prosecutor; The Compliance System; The Prosecutor and the Defense Counsel
Carolyn McElroy, Esq.
Member Health, Mintz Levin Cohn Ferris Glousky & Popeo
Former Director Maryland Medicaid Fraud Control Unit
Washington, DC
James Sheehan, Esq.
Associate United States Attorney
U.S. Attorney's Office for the Eastern District of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Davia B. Temin
President, Temin and Company
New York, NY
Handout Material (Acrobat)
Handout Material (Microsoft Word)
Handout Material (Acrobat)
Handout Material (Microsoft Word)
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9:15 a.m. |
FDA Regulatory Issues Update
Daniel E. Troy, Esq.
Chief Counsel, Office of the General Counsel
Food and Drug Administration
Rockville, MD
No presentation will be provided for posting
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9:45 a.m. |
Transition Break
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10:00 a.m. |
CONCURRENT SESSIONS I
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1.01 CIAs and Emerging Issues
Paul Kalb, JD, MD
Partner, Sidley, Austin, Brown and Wood
Washington, DC
Jonathon Kellerman
Director, Pharmaceutical Advisory Services Group
PricewaterhouseCoopers, LLP
Philadelphia, PA
Arjun Rajaratnam, Esq.
Vice President and Compliance Officer
Global Pharmaceuticals
GlaxoSmithKline
Research Triangle Park, NC
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1.02 Regulatory Issues in Pharmaceutical Product Development
Michael M. Breggar
Global Director, Life Sciences Practice
Life Sciences and Healthcare Regulatory
Deloitte & Touche LLP
Glen Mills, PA
For presentation material inquiries please contact:
Latraviette Smith
National Marketing Manager, Life Sciences
Deloitte
latsmith@deloitte.com
Greg Page, MD
Life Sciences Practice Head
Deloitte and Touche LLP
Jericho, NY
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1.03 Price Reporting Compliance: Best Practices in Reporting Medicaid Drug Rebate Program and Part B ASP Data
Bill Baxter
Director, Medicaid Market and Rebate Management
Johnson & Johnson
New Brunswick, NJ
Andrew Ruskin, Esq.
Vinson & Elkins
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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1.04 Top 10 Tips to Improve the Effectiveness of Your Organization's Compliance Program
Wendy C. Goldstein, Esq.
Partner, Epstein, Becker & Green, PC
New York, NY
Elizabeth A. Lewis, Esq.
Associate General Counsel
Commercial Millenium Pharmaceuticals, Inc.
Cambridge, MA
Paul J. Silver
Director, Pharmaceutical Compliance Investigative & Dispute Services
Ernst & Young LLP
Atlanta, GA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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1.05 State Law Issues: California's Antifraud Initiatives - Coming to a State Near You
Patric Hooper, Esq.
Principal, Hooper, Lundy and Bookman
Los Angeles, CA
Presentation Material (Acrobat)
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11:00 a.m. |
Transition Break
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11:15 a.m. |
CONCURRENT SESSIONS II
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2.01 The Changing Role of Medical Affairs in Pharmaceutical Enterprises
Joan M. Macaulay, Esq.
Associate, Sidley Austin Brown & Wood LLP
Washington, DC
Richard Murray, MD
Vice President, Academic Affairs Department
Merck & Company
Whitehouse Station, NJ
Brian S. Salsberg
Associate Principal, Pharmaceutical and Medical Products Practice
McKinsey & Co.
Florham Park, NJ
Marc Wilenzick, Esq.
Senior Corporate Counsel
Pfizer Inc.
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)
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2.02 Foreign Corrupt Practices Act and Other International Compliance Issues
Paul R. Berger
Associate Director, Division of Enforcement
Securities and Exchange Commission
Washington, DC
Alice S. Fisher, Esq.
Partner, Latham & Watkins
Former, Deputy Assistant Attorney General
United States Department of Justice
Washington, DC
Philip Urofsky, Esq.
Special Counsel for International Litigation, Fraud Section
United Sates Department of Justice
Washington, DC
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2.03 Clinical Compliance Programs: Investigator Payments, GCPs and More...
Teri Crouse, Esq.
Director of Compliance for Healthcare and Marketing
Eli Lilly and Company
Indianapolis, IN
Kate N. Maloney
Manager, Pharmaceutical Industry Advisory Services
PricewaterhouseCoopers, LLP
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2.04 Product Quality and Organizational Compliance
Michael Breggar, MD
Global Director, Life Sciences Regulatory Practice
Deloitte & Touche LLP
Glen Mills, PA
For presentation material inquiries please contact:
Latraviette Smith
National Marketing Manager, Life Sciences
Deloitte
latsmith@deloitte.com
Owen Richards
President, The Quantic Group
Livingston, NJ
Daniel Riganati, PMP
IM Lead, Quality Assurance
Johnson & Johnson Health Care Systems Inc.
Piscataway, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2.05 State Attorneys General Perspective on Pharmaceutical Consumer Protection and Regulatory Issues
Meredyth Andrus, Esq.
Antitrust Division, Office of the Attorney General of Maryland
Baltimore, MD
Julie Brill, Esq.
Assistant Attorney General
Office of the Attorney General of Vermont
Montpelier, VT
Handout Material (Acrobat)
Handout Material (Acrobat)
Handout Material (Acrobat)
James A. Donahue, III, Esq.
Chief Deputy Attorney General
Office of the Attorney General of Pennsylvania
Harrisburg, PA
Handout Material (Acrobat)
Shirley Stark, Esq.
Assistant Attorney General
Office of the Attorney General of New York
New York, NY
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12:15 p.m. |
Networking Luncheon in the Exhibit Hall
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1:30 p.m. |
CONCURRENT SESSIONS III
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3.01 Internal Investigations
John Bentivoglio, Esq.
Partner, King & Spalding LLP
Former Special Counsel for Health Care Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
Presentation Material (Acrobat)
Bernard J. Ford
Industry Leader
Pharmaceutical Compliance Investigative & Dispute Services
Ernst & Young LLP
Chicago, IL
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3.02 Auditing and Monitoring for Compliance
Karen Lines, Esq.
Associate General Counsel
Genentech
South San Francisco, CA
Sheryl Vacca
West Coast Life Science and Health Care Regulatory Practice Leader
Deloitte & Touche LLP
Los Angeles, CA
For presentation material inquiries please contact:
Latraviette Smith
National Marketing Manager, Life Sciences
Deloitte
latsmith@deloitte.com
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3.03 Two Perspectives on Privacy: A Customer and Industry CPO
Dean Forbes, JD
Director of Corporate Privacy
Schering-Plough Corp.
Former Senior Attorney
Federal Trade Commission
Kenilworth, NJ
Nora McCann
Privacy Manager Corporate Compliance
Fox Chase Cancer Center
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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3.04 Compliance Communications Programs for Pharmaceutical Enterprises
Richard P. Kusserow
President, Strategic Management Systems, Inc.
Former Inspector General, Department of Health & Human Services
Alexandria, VA
Nisha Shajahan
Associate Vice President
Strategic Management Systems, Inc.
Alexandria, VA
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3.05 Legal Issues in Health Information Technology Implementation for Pharmaceutical Enterprises
Gerald M. Hinkley, Esq.
Partner, Davis Wright Tremaine
San Francisco, CA
Paul T. Smith, Esq.
Partner, Davis Wright Tremaine
San Francisco, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2:30 p.m. |
Transition Break
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2:45 p.m. |
CONCURRENT SESSIONS IV
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4.01 Off-Label Promotion Compliance: Point / Counter-Point
Margaret (Peg) Hutchinson, Esq.
Assistant United States Attorney
United States Attorney's Office
Eastern District of Pennsylvania
Philadelphia, PA
T. Reed Stephens, Esq.
Partner, Sonneschein, Nath and Rosenthal
Former Trial Attorney, United States Department of Justice
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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4.02 Pharmaceutical Price Reporting Issues, Challenges, and Solutions
Ben Barrameda, CPA, MBA, Esq.
Senior Manager, Deloitte & Touche
New York, NY
Jody Ann Noon, RN, JD
Principal, National Life Science Regulatory Practice Leader
Deloitte & Touche
New York, NY
For presentation material inquiries please contact:
Latraviette Smith
National Marketing Manager, Life Sciences
Deloitte
latsmith@deloitte.com
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4.03 Department of Justice Enforcement of Intellectual Property Rights Relating to the Pharmaceutical Industry
David Israelite, Esq.
Deputy Chief of Staff and Counselor to the Attorney General
Chairman, Intellectual Property Task Force
United States Department of Justice
Washington, DC
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4.04 Crisis Management
Daniel Connolly
Managing Partner, Giuliani Partners
New York, NY
Robert Wilkerson
Senior Vice President
Crisis Consulting
Marsh, Inc.
Washington, DC
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4.05 Is CME a Continuous Challenge?
Melinda Somasekhar, PhD
Senior Manager, Professional Education Support Department
Wyeth Pharmaceuticals
Collegeville, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)
Handout Material (Microsoft Word)
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3:45 p.m. |
Transition Break
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4:00 p.m. |
CONCURRENT SESSIONS V - Pharmaceutical Compliance Knowledge Exchange and Best Practices Sessions
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5.01 Special Program for Compliance Professionals: Building a Department; Compliance Culture; Working with the Board of Directors; Staffing; and Metrics for Success
Gerry Bohm, Esq.
Senior Counsel
Hoffmann-La Roche Inc.
Nutley, NJ
Brian Riewerts
Director, Pharmaceutical Advisory Services Group
PricewaterhouseCoopers LLP
Baltimore, MD
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5.02 Special Program for International Compliance Professionals: Program Design; International Law; FCPA; and Privacy
Valli Baldassano, Esq.
Vice President, Global Compliance
Commercial Operations
Schering-Plough
Kenilworth, NJ
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5.03 Special Program for Internal/Compliance Audit Professionals: Enterprise Risk Management; Audit Cycles; Key Issues; Staffing; and Audit Reporting
Peter Claude
Partner, Pharmaceutical Advisory Services Group
PricewaterhouseCoopers, LLP
Florham Park, NJ
Gregory Crouse, CPA
Partner
Pharmaceutical Compliance Investigative & Dispute Services
Ernst & Young LLP
Tampa, FL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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5.04 Ask the Experts: Hot Issues in Pharmaceutical Regulation and Compliance
John Bentivoglio, Esq.
Partner, King & Spalding LLP
Former Special Counsel for Healthcare Fraud and Chief Privacy Officer
United States Department of Justice
Washington, DC
Presentation Material (Acrobat)
Brien T. O'Connor, Esq.
Partner, Ropes & Gray LLP
Former Chief of Public Corruption and Special Prosecutions
United States Attorney's Office
Boston, MA
Scott Willoughby
Senior Manager, Health Sciences Global Investigation and Dispute Advisory
Ernst & Young
Washington DC
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5.05 A New Focus For Pharma: Structuring and Implementing Relationships with Managed Care Companies
Dorothy DeAngelis
Director, Healthcare Payor Services
Huron Consulting Group
Charlotte, NC
Keith M. Korenchuk, JD, MPH
Partner, McGuire Woods
Charlotte, NC
Steve Young, CPA
Managing Director
Huron Consulting Group
Chicago, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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5:00 p.m. |
Transition Break
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5:15 p.m. |
Pharmaceutical Compliance Professionals Roundtable: Audience Polling of Key Regulatory and Compliance Issues; Expert Commentary
Link Bonforte
Vice President, Government Affairs
Policy and Compliance
ConvaTec
Skillman, NJ
Claudio Pincus
President, The Quantic Group
Livingston, NJ
Lori Queisser
Vice President and Chief Compliance Officer
Eli Lilly and Company
Indianapolis, IN
Michael Shaw
Deputy Compliance Officer
Novartis Pharmaceuticals Corporation
Former Senior Counsel
Office of the Inspector General
East Hanover, NJ
Jesse A. Witten, Esq.
Partner, Jones Day
Washington, DC
Arjun Rajaratnam, Esq.
Vice President and Compliance Officer
Global Pharmaceuticals
GlaxoSmithKline
Research Triangle Park, NC
(Moderator)
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6:30 p.m. |
Adjournment
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