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Pharma Colloquium Day II
Tuesday, June 7, 2005
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Track I A: Reinventing the Pharma Go To Market Model
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8:00 a.m. |
Welcome and Introduction
Brian Salsberg, JD
Associate Principal
Pharmaceutical and Medical Products Practice
McKinsey & Company
Florham Park, NJ
(Co chair)
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8:15 a.m. |
Preparing for Productivity Transformation in Pharma
Aamir Malik
Principal, Pharmaceutical and Medical Products Practice
McKinsey & Company
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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8:45 a.m. |
Reinventing Medical Marketing: CME and MSL Effectiveness
Ronald Piervincenzi
Associate Principal, Pharmaceuticals and Medical Products Practice
McKinsey & Company
Florham Park, NJ
Marissa Seligman
Vice President
M/C Communications (Pri-Med Institute)
Boston, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Julie K. Taitsman, MD, JD
Senior Counsel, Industry Guidance Branch
Office of Counsel to the Inspector General
Department of Health and Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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9:45 a.m. |
Break
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10:00 a.m. |
Rethinking the Strategic Importance of OTC Medicines
Nancy Miller-Rich
Vice President, Business Development
Schering-Plough Consumer Health
Berkeley Heights, NJ
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10:30 a.m. |
Deriving Value from Integrated Operations and Business Planning within the R&D Pipeline
Mike Ferrante
Director, PricewaterhouseCoopers LLP
Florham Park, NJ
Presentation Material (Acrobat)
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11:15 a.m. |
MMA: Why Part D and Other Changes on the Horizon Will Require Pharma to Re-invent Approaches to Managed Markets
John T. Bentivoglio, Esq.
Partner, King & Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
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11:45 a.m. |
Linking Medicare Coverage to Research Participation
Grant P. Bagley, MD, JD
Partner, Arnold & Porter
Former Director, Coverage and Analysis Group
HCFA Office of Clinical Standards and Quality
Washington, DC
Presentation Material (Acrobat)
Clifford Goodman, Ph.D.
Vice President, The Lewin Group
Falls Church, VA
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12:15 p.m. |
Track Adjournment
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Track II A: The Brave New Regulatory Environment: Drug Safety for Pharmaceutical and Medical Products
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8:00 a.m. |
Welcome and Introduction
Daniel E. Troy, Esq.
Partner, Sidley Austin Brown & Wood
Former Chief Counsel, Office of the General Counsel
Food and Drug Administration
Washington, DC
(Co chair)
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8:15 a.m. |
The United States Drug Safety Paradigm
Stephen A. Goldman, MD, FAPM, FAPA
Managing Member, Stephen A. Goldman Consulting Services, L.L.C.
Former Medical Director, MedWatch
Food and Drug Administration
Morris Plains, NJ
Presentation Material (Acrobat)
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9:00 a.m. |
The International Drug Safety Paradigm
Angus McCulloch
Principal, Life Sciences Practice
WCI Group
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Shinya Yamauchi
Director, Global Pharmacovigilance
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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10:00 a.m. |
Break
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10:30 a.m. |
Drug Safety: What Should Companies Do Now?
Janice K. Bush, MD
Vice President, Quality
Education and Business Support
Benefit Risk Management
Johnson & Johnson Pharmaceuticals
Immediate Past Chair, PhRMA Pharmacovigilance and Epidemiology Technical Committee
Titusville, NJ
Janet Steiner
Senior Director, Compliance & Ethics
Clinical Development, AstraZeneca
Wilmington, DE
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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11:15 a.m. |
Drug Safety, Product Liability and Litigation
Jay P. Mayesh, Esq.
Partner, Litigation
Co-Chair, Product Liability
Kaye Scholer, LLP
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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Noon |
Track Adjournment
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Noon |
Networking Luncheon
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Track I B: Integrity Driven Performance - Managing Compliance Productivity, Risk and Reputation
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1:00 p.m. |
Welcome and Introduction
Anthony L. Farino
Leader, Global Pharmaceutical Advisory Services Group
PricewaterhouseCoopers LLP
Chicago, IL
(Co chair)
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1:15 p.m. |
Keys to Restoring the Financial Strength of the Pharma Industry
David Moskowitz, MBA, R.Ph.
Senior Vice President and Healthcare Senior Analyst
Friedman, Billings, Ramsey Group, Inc.
Arlington, VA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2:00 p.m. |
Managing Performance: Making and Keeping Promises
Brian Kelly
Executive Director, Development Operations Group
Merck and Company
Bedminster, NJ
Presentation Material (Acrobat)
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2:45 p.m. |
Three Key Areas to Jump Start Commercial Business Performance
Jonathon Kellerman
Senior Manager
PricewaterhouseCoopers
Philadelphia, PA
Dalton Smart
Director, Global Compliance and Business Practices
Schering-Plough
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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3:45 p.m. |
Break
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4:15 p.m. |
Interplay Between Emerging Compliance and Risk Management Standards
Carlo di Florio, JD
Director, Advisory Services
PricewaterhouseCoopers, LLP
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Scott L. Mitchell
President and Chief Executive Officer
Open Compliance and Ethics Group
Phoenix, AZ
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5:15 p.m. |
Adjournment
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Track II B: Manufacturing: the Critical Partner at Risk
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1:00 p.m. |
Welcome and Introduction
Claudio Pincus
President, The Quantic Group
Livingston, NJ
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1:15 p.m. |
Company Expectations and Strategic Approaches for Reliable Supply and Compliance
Claudio Pincus
President, The Quantic Group
Livingston, NJ
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1:45 p.m. |
The Biotech Perspective on Reliable Manufacturing
Markus Gemuend
Vice President, Manaufacturing, Collaboration and Contracts Manufacturing
Genentech
South San Francisco, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2:15 p.m. |
The Device Perspective on Quality in Manufacturing
Matthew Robin, M.Eng.
Chief Executive Officer, Ypsomed
Advisor, BVGroup Private Equity
Switzerland
Presentation Material (Acrobat)
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2:45 p.m. |
Similarities and Differences between Pharma, Biotech and Device Manufacturing Concerns
Terry Dwyer
Vice President Quality and Compliance
PSGA, A Division of Ortho McNeil
Bridgewater, NJ
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3:15 p.m. |
Break
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3:45 p.m. |
Sustaining Quality: Why is Quality Good for Business
Diane Bergeron
Vice President, Consent Decree Management
Schering-Plough Corporation
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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4:15 p.m. |
Risk Management Beyond GMPs
Ray Bonner, Esq.
Partner, Sidley Austin Brown & Wood
Washington, DC
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4:45 p.m. |
Quality, Risk Management and Compliance: Making it Work
Claudio Pincus
President, The Quantic Group
Livingston, NJ
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5:30 p.m. |
Adjournment
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Track III B: An Interactive Case-Study Workshop Focusing on Clinical Affairs, Clinical Trials and CME: Response to FCA Whistleblowers and Internal Investigations, Compliance Assessment and Planning, and Auditing, Monitoring and Continuous Improvement
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1:00 p.m. |
Hypothetical Case Study
Valli Baldassano
Vice President, Global Compliance
Commercial Operations, Schering-Plough
Kenilworth, NJ
Douglas S. Strang
Partner, PricewaterhouseCoopers
Philadelphia, PA
L. Stephan Vincze, Esq.
Ethics & Compliance Officer
TAP Pharmaceuticals
Lake Forest, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Keith M. Korenchuk, JD, MPH
Partner, McGuire Woods
Charlotte, NC
(Co chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)
Handout Material (Microsoft Word)
Handout Material (Acrobat)
Handout Material (Microsoft Word)
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5:00 p.m. |
Adjournment
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