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SPECIAL FEDERAL DISCLOSURE POLICY PRESENTATION (Open to the public)
8:00 a.m. The Physician Payments Sunshine Act: Prospects for Federal Disclosure Law

Senator Chuck Grassley (R-IA)
Ranking Member, Senate Finance Committee, United States Senate, Washington, DC
8:30 a.m. Adjournment

DISCLOSURE TRAINING PROGRAM
NATIONAL DISCLOSURE SUMMIT AGENDA:
PRECONFERENCE SYMPOSIUM
Thursday, March 5, 2009

(Registration optional; Required for Disclosure Training Program)
Note, all times listed are Eastern Standard Time
PRECONFERENCE: DISCLOSURE SUMMIT BOOT CAMP
8:30 a.m. Welcome and Preconference Overview

Daniel A. Kracov, Esq.
Partner, Arnold & Porter, Washington, DC (Co chair)

Paul J. Silver
Managing Director, Life Sciences Advisory Services, Huron Consulting Group, LLC, Atlanta, GA (Co chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
8:45 a.m. Understanding the Forces Driving Disclosure: State Legislators, MedPAC, US Congress: The Sunshine Act, State Enforcers: Eli Lilly's Zyprexa Settlement, The HHS Office of Inspector General: and Cephalon and Other Recent CIAs

Jeffrey L. Handwerker, Esq.
Partner, Arnold & Porter, Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
9:15 a.m. Understanding the Scope of Disclosure Initiatives

William A. Sarraille, Esq.
Partner, Sidley Austin, Washington, DC
9:45 a.m. Introduction to Existing State Disclosure Laws and Regulations: Massachusetts, Minnesota, Nevada, Vermont, Washington, DC and West Virginia

Sarah K. Giesting, Esq.
Associate, Epstein Becker & Green, New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Wendy C. Goldstein, Esq.
Partner and Chair, Pharmaceutical Industry Health, Regulatory Practice Group, Epstein Becker & Green, New York, NY
10:30 a.m. Break
10:45 a.m. Facilitated Discussion of Preconference Questions

Daniel A. Kracov, Esq.
Partner, Arnold & Porter, Washington, DC (Co chair)

Paul J. Silver
Managing Director, Life Sciences Advisory Services, Huron Consulting Group, LLC, Atlanta, GA (Co chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
11:15 a.m. Aggregate Spend 101: The Nuts and Bolts of an Aggregate Spend Program

Marci Juneau
Manager, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA

Manny Tzavlakis
Director, Life Sciences Advisory Services, Huron Consulting Group, New York, NY
12:00 p.m. Preconference Adjournment


DISCLOSURE TRAINING PROGRAM
NATIONAL DISCLOSURE SUMMIT AGENDA: DAY I
Thursday, March 5, 2009

Note, all times listed are Eastern Standard Time
THE PERFECT STORM: DISCLOSURE GRIPS THE DRUG AND DEVICE INDUSTRIES
1:00 p.m. Welcome and Overview

Jonathon L. Kellerman
Partner, Pharmaceutical and Life Sciences Practice, PricewaterhouseCoopers LLP, Philadelphia, PA USA

Daniel A. Kracov, Esq.
Partner, Arnold & Porter, Washington, DC (Co chair)
1:15 p.m. How Disclosure and Transparency are Reshaping Pharmaceutical and Device Marketing and Compliance

William A. Sarraille, Esq.
Partner, Sidley Austin, Washington, DC
1:45 p.m. An Introduction to the Role of the OIG

Kathleen Meriwether, Esq.
Principal, Fraud Investigation & Dispute Services, Ernst & Young, Former Assistant United States Attorney, Eastern District of Pennsylvania, Department of Justice, Philadelphia, PA
2:00 p.m. The Role of the OIG

Mary E. Riordan, Esq.
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
2:30 p.m. Questions & Answers

Kathleen Meriwether, Esq.
Principal, Fraud Investigation & Dispute Services, Ernst & Young, Former Assistant United States Attorney, Eastern District of Pennsylvania, Department of Justice, Philadelphia, PA (Moderator)
2:45 p.m. Issues Raised by State Legislation for Pharmaceutical and Device Companies

Craig H. Smith, Esq.
Partner, Hogan & Hartson LLP, Former General Counsel, Florida Agency for Health Care Administration, Miami, FL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
3:15 p.m. The Role of State Attorneys General In Imposing Disclosure Obligations

David Hart, Esq.
Assistant Attorney General, Oregon Department of Justice, Salem, OR
3:45 p.m. Break
4:00 p.m. How Recent Settlements Have Changed the World for Pharmaceutical Marketing and Compliance

John T. Bentivoglio, Esq.
Partner, King & Spalding LLP, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, Department of Justice, Washington, DC
4:30 p.m. The Promise and Perils of Disclosure Legislation: Lessons in Transparency from the States

Susan Chimonas, PhD
Associate Research Scholar, Center on Medicine as a Profession, Columbia University, New York, NY
5:00 p.m. A Dialogue on Whether Disclosure Will Quiet the Industry's Critics

Peter Lurie, MD, MPH
Deputy Director, Public Citizen's Health Research Group, Washington, DC

Peter Pitts
Director, Center for Medicine in the Public Interest, Senior Vice President for Health Affairs, Manning, Selvage & Lee, Former Associate Commissioner for External Relations, Food and Drug Administration, Washington, DC
5:30 p.m. What to Expect From the New Congress and the New Administration
  • Key Congressional Initiatives
    Christopher J. Armstrong, Esq.
    Investigative Counsel, Committee on Finance, U.S. Senate, Senator Chuck Grassley, Ranking Member, Washington, DC
    Presentation Material (Acrobat)
    Presentation Material (Powerpoint)

    John P. Ford, Esq.
    Counsel, Sidley Austin, Former Senior Democratic Counsel, Energy and Commerce Committee, US House of Representatives, Washington, DC
    Presentation Material (Acrobat)
    Presentation Material (Powerpoint)

    Jack Mitchell
    Chief of Oversight and Investigations, Special Committee on Aging, United Sates Senate, Former CNN Reporter, Washington, DC

  • CME: Under Fire from all Directions
    Thomas Sullivan
    President and Founder, Rockpointe Corporation, Columbia, MD

  • Facilitated Discussion and Q & A
    John F. Kamp, JD, PhD
    Executive Director, Coalition for Healthcare Communication, Of Counsel, Wiley Rein LLP, Washington, DC (Moderator)
6:30 p.m. Adjournment and Networking Reception




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