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Agenda: Day Two
Tuesday, June 8, 2004
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8:00 a.m. |
Introduction to Morning of Day II
Ian Morrison, Ph.D.
Senior Fellow, Institute for the Future
Founding Partner, Harris/Harvard Strategic Health Perspectives
Author, Healthcare in the New Millennium: Vision, Values and Leadership and
The Second Curve: Managing the Velocity of Change
Menlo Park, CA
(Colloquium Co chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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8:30 a.m. |
Health Plan's Perspective on the Role of Pharma, Biotech and Device Sectors
Rob Seidman, PharmD, MPH
Chief Pharmacy Officer
WellPoint Health Networks
Thousand Oaks, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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9:00 a.m. |
The Role of Pharmacy Benefit Management (PBM) Enterprises in Transforming the Pharmaceutical Marketplace
Stephanie Kanwit, Esq.
Special Counsel, PCMA
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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9:30 a.m. |
Thoughts on Restoring Trust in the Industry
Anthony Farino
Partner and Leader
Global Pharmaceutical Advisory Services Group
PricewaterhouseCoopers LLP
Chicago, IL
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10:00 a.m. |
An Industry Under Regulatory Siege - Why It Happened and What Can Be Done to Correct Misperceptions
Bob Franks
President, Healthcare Institute of New Jersey
Former New Jersey Congressman
Hillside, NJ
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10:30 a.m. |
Break
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11:00 a.m. |
Building a Performance Culture
Michael Rennie
Director, McKinsey & Company, Inc.
Sydney, Australia
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11:30 a.m. |
Legal Trends in Corporate Governance
Daniel A. Neff, Esq.
Managing Partner, Wachtell, Lipton, Rosen & Katz
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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12:00 noon |
The Implications of the New Medicare Prescription Drug Legislation for the Pharmaceutical Sector
Pat Kelly
President, US Pharmaceuticals
Vice President, Pfizer Inc.
New York, NY
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12:30 p.m. |
Networking Luncheon
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1:45 p.m. - 6:00 p.m. |
COMPREHENSIVE COMPLIANCE, RISK MANAGEMENT AND BUSINESS STRATEGY TRACKS
(Choose One Track Only)
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Track II A: Compliance and Medical Devices: Where the Industry Is Heading
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1:45 p.m. |
Introduction to Track
Grant P. Bagley, MD, JD
Partner, Arnold & Porter
Former Director, Coverage and Analysis Group
HCFA Office of Clinical Standards and Quality
Washington, DC
(Co chair)
John Bentivoglio, Esq.
Partner, Arnold and Porter
Former Special Counsel for Healthcare Fraud and
Chief Privacy Officer
United States Department of Justice
Washington, DC
(Co chair)
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2:00 p.m. |
Medicare's Quest for Value: Coding, Coverage and Payment
Jeffrey C. Lerner, Ph.D.
President and Chief Executive Officer, ECRI
Plymouth Meeting, PA
Ron Milhorn
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Kimberly Richter (Invited)
Director, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
Gene Thirolf, Esq.
Director, Office of Consumer Litigation
U.S. Department of Justice
Washington, DC
Grant P. Bagley, MD, JD
Partner, Arnold & Porter
Former Director, Coverage and Analysis Group
HCFA Office of Clinical Standards and Quality
Washington, DC
(Moderator)
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3:30 p.m. |
Break
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4:00 p.m. |
Department of Justice Perspective on the Prosecution of Medical Device Companies
Gene Thirolf, Esq.
Director, Office of Consumer Litigation
U.S. Department of Justice
Washington, DC
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4:30 p.m. |
Risk Areas and Compliance Programs: Key Insights from In-House Compliance Professionals
Link Bonforte
Vice President, Government Affairs
Policy and Compliance, ConvaTec
Skillman, NJ
Retta Riordan, Esq.
Riordan Consulting LLC
Former Assistant General Counsel
C.R. Bard, Inc.
Former Associate General Counsel, HIMA (AdvaMed)
Mountainside, NJ
Sheva Sanders, Esq.
Principal Senior Counsel
Medtronic, Inc.
Minneapolis, MN
John Bentivoglio, Esq.
Partner, Arnold and Porter
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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6:00 p.m. |
Adjournment
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Track II B: Pharmaceutical Financial Markets and Managing Compliance Globally/Internationally
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1:45 p.m. |
Introduction
Valli Baldassano
Vice President, Global Compliance
Commercial Operations, Schering-Plough
Kenilworth, NJ
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2:00 p.m. |
Developing and Implementing an International Pharmaceutical Compliance Program
David A. Crenshaw, Esq.
Legal Director, European Operations
Schering-Plough
Lucerne, Switzerland
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Richard F. Kingham, Esq.
Partner, Covington & Burling
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Caroline H. West, Esq.
Vice President, Global Legal Compliance
Aventis
Bridgewater, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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3:30 p.m. |
Break
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4:00 p.m. |
What Wall Street Sees for Pharma, Biotech and Devices
David Moskowitz, MBA, R.Ph.
Senior Vice President and Healthcare Senior Analyst
Friedman, Billings, Ramsey Group, Inc.
Arlington, VA
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6:00 p.m. |
Adjournment
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Track II C: Applying a Risk-Based Compliance Model to Clinical and Manufacturing Operations
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1:45 p.m. |
Introduction
Patrick D. Roche
Partner, PricewaterhouseCoopers
Florham Park, NJ
(Chair)
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2:00 p.m. |
Clinical Development Compliance Issues
Felix Arellano, MD
Managing Partner, Risk Management Resources, LLC
Former Chief Safety Officer
Pharmacia Corporation
Califon, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Michael Swiatocha
Vice President of Compliance
Schering-Plough Research Institute
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Bruce Burlington, MD
Senior Vice President, Regulatory Affairs and Compliance
Wyeth-Ayerst Pharmaceuticals
Former Director, Center for Devices and Radiological Health
Food and Drug Administration
(Moderator)
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3:30 p.m. |
Break
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4:00 p.m. |
Manufacturing Compliance Issues
Gary Budney
Vice President and Compliance Officer
Global Supply Chain, Schering-Plough
Kenilworth, NJ
Bruce Burlington, MD
Senior Vice President, Regulatory Affairs and Compliance
Wyeth-Ayerst Pharmaceuticals
Former Director, Center for Devices and Radiological Health
Food and Drug Administration
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Claudio Pincus
President, Quantic
Livingston, NJ
William Vodra, Esq.
Partner, Arnold & Porter LLP
Former Associate Chief Counsel
Food and Drug Administration
Washington, DC
(Moderator)
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6:00 p.m. |
Adjournment
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