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Pharma Congress Day Two - Thursday, November 9, 2006 |
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8:00 a.m.  |
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Welcome and Introduction to Day Two 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 (Co chair) |
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8:15 a.m.   |
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PCF Panel on Compliance Survey Results: Medical Affairs and Marketing Nancy Coddington, PhD Senior Director, Compliance Operations and External Scientific Affairs AstraZeneca Pharmaceuticals Wilmington, DE Stuart Kurlander. Esq. Partner, Latham & Watkins Washington, DC Robert G. Sikora, MS, R.Ph. Retired Vice President of Clinical Education Pfizer, Inc. New York, NY Anthony Farino Partner, Life Sciences Advisory Leader PricewaterhouseCoopers LLP Chicago, IL (Moderator) |
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9:15 a.m. |
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Break |
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9:30 a.m. |
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Concurrent Sessions I |
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1.01. The Special Concerns of Small Cap Companies: Building a Compliance Program with Limited Resources (Both Head Count and Money) Colleen M. Craven Vice President, Ethics and Corporate Compliance Endo Pharmaceuticals Chadds Ford, PA Janice Toran Vice President, Corporate Compliance Astellas US LLC Deerfield, IL Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1.02. Death by a Thousand Paper Cuts: State Laws and Pharmaceutical Companies Julie Brill, Esq. Assistant Attorney General Office of the Attorney General of Vermont Montpelier, VT Brien O'Connor, Esq. Partner, Ropes and Grey Former Chief of Public Corruption and Special Prosecutions for the US Attorney's Office Boston, MA Carlton E. Wessel, Esq. (Invited) Senior Corporate Counsel Pfizer, Inc. New York, NY Scott R. Willoughby Managing Director, Huron Consulting Group Former Associate General Counsel Pharmaceutical Research and Manufacturers Association (PhRMA) Washington, DC |
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1.03. Qui Tam Suits: The Barometer of Future Enforcement Actions Peter Chatfield, Esq. Partner, Phillips & Cohen LLP Washington, DC Thomas M. Greene, Esq. Partner, Greene and Hoffman Boston, MA Presentation Material (Acrobat) Presentation Material (Powerpoint) Mark Allen Kleiman, Esq. Partner, Law Offices of Mark Allen Kleiman Los Angeles, CA Presentation Material (Acrobat) Presentation Material (Powerpoint) David V. Marshall, Esq. Partner, Davis Wright Tremaine Seattle, WA (Moderator) |
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1.04. Best Practices in Compliance Program Auditing: A Panel Discussion of Evolving Compliance Strategies Michael Dusseau Senior Director, Compliance USA Schering-Plough Corporation Kenilworth, NJ Kelly Freeman, PhD Director, Compliance and Ethics Eli Lilly and Company Indianapolis, IN A. Monica Jonhart Director, Auditing Bristol-Myers Squibb Plainsboro, NJ Ann E. Lewis Vice President and Senior Counsel, US Healthcare Law Compliance Bristol-Myers Squibb Company Plainsboro, NJ (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1.05. Managing Compliance through Technology William F. Hills Partner, VantagePoint Consulting Group Flemington, NJ Bill Van Nostrand President and Chief Executive Officer Medical Marketing Solutions Flemington, NJ Presentation Material (Powerpoint) Adobe Acrobat Version too large to post |
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1.06. Integrating Compliance with Business: Developing a Business-Facing Compliance Program David Davidovic Senior Director, Business Practices Genentech South San Francisco, CA Ty Howton Chief Healthcare Compliance Officer Genentech South San Francisco, CA Jody Ann Noon, JD, RN National Practice Leader, Life Sciences & Health Care Regulatory Practice Deloitte & Touche LLP New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:30 a.m. |
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Transition Break |
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10:45 a.m. |
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Plenary Session: PCF Panel on Compliance Survey Results: Managing your Compliance Program John P. Hansen Director of Member Services & Government Affairs Ethics & Compliance Officer Association Waltham, MA Robert A. Freeman US Compliance Officer and Compliance Counsel Serono, Inc. Boston, MA Jonathan K. Sprole Vice President and Deputy General Counsel and Chief Compliance Officer Bristol Myers Squibb New York, NY Win Swenson, Esq. Partner, Compliance Systems Legal Group Washington, DC Brian Riewerts Partner, Life Sciences Governance Risk and Compliance Advisory Leader PricewaterhouseCoopers LLP Washington, DC (Moderator) |
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11:45 a.m. |
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Networking Luncheon in the Exhibit Hall |
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12:45 p.m. |
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Concurrent Sessions II |
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2.01. Approaches to Operating a Compliance Program with a Small Compliance Department A. Demarest (Demi) Allen Associate General Counsel, Corporate Compliance ZymoGenetics, Inc. Seattle, WA Eric Siegel Vice President Associate General Counsel & Chief Compliance Officer Cephalon, Inc. Fraser, PA Caroline H. West Senior Vice President, Chief Compliance and Risk Officer Shire Pharmaceuticals Wayne, PA Retta M. Riordan Business Ethics and Compliance Officer Organon USA Inc., an Akzo Nobel Company Roseland, NJ (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2.02. Compliance Branding L. Stephan Vincze, Esq. Vice President, Ethics & Compliance Officer TAP Pharmaceutical Products, Inc. Lake Forest, IL Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2.03. Off Label Controls and Monitoring John T. Bentivoglio, Esq. Partner, King & Spalding Former Special Counsel for Healthcare, Fraud and Chief Privacy Officer United States Department of Justice Washington, DC Lori Queisser Vice President and Chief Compliance Officer Eli Lilly and Company Indianapolis, IN |
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2.04. Fair Market Value: Where, When and How to Use It Wendy C. Goldstein, Esq. Partner, Epstein Becker & Green New York, NY Tom Gregory Partner, Ernst & Young LLP Atlanta, GA |
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2.05. How to Develop Internal Monitoring Programs Keith M. Korenchuk, JD, MPH Covington & Burling LLC Washington, DC Steve Mohr, Esq. Chief Compliance Officer AstraZeneca Pharmaceuticals Wilmington, DE |
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2.06. Integrating Compliance with Business: Developing and Implementing the Tysabri Risk Map - Reintroduction of a Breakthrough Medical Product Erika Cawthron Associate Director TYSABRI Services Biogen Idec Cambridge, MA Gregory V. Page, Ph.D. FDA Practice Leader Life Sciences & Health Care Regulatory Practice Deloitte & Touche LLP Jericho, NY Melissa Seymour Director of Corporate Compliance Biogen Idec Research Triangle Park, NC Juan L. Torres, PhD Vice President, Global Quality Biogen Idec Research Triangle Park, NC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1:45 p.m. |
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Transition Break |
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2:00 p.m. |
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Concurrent Sessions III |
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3.01. Monitoring and Tracking in Companies with Small Compliance Departments Thomas M. Glavin Vice President and Deputy Compliance Officer Shire Pharmaceuticals Inc. Wayne, PA Scot Steinheiser Senior Manager, Corporate Compliance Astellas US LLC Deerfield, IL Retta M. Riordan Business Ethics and Compliance Officer Organon USA Inc., an Akzo Nobel Company Roseland, NJ (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3.02. Grants, CME and Compliance Sujata Dayal Deputy Ethics and Compliance Officer, Abbott Labs Pharmaceutical Products Division Abbott Park, IL Sue Seferian, Esq. Senior Counsel, Corporate Law Department Johnson & Johnson New Brunswick, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3.03. FCPA and Other International Compliance Issues Jonathon Kellerman Senior Manager, PricewaterhouseCoopers Philadelphia, PA Rita Gail Johnson Director, Corporate Business Development Eurasia Group New York, NY |
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3.04. Compliance vs. the Law Department: How to Work Together Michael Dusseau Senior Director, Compliance USA Schering-Plough Corporation Kenilworth, NJ David Ralston, Esq. Assistant General Counsel Schering-Plough Corporation Kenilworth, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3.05. Self Assessments: Adding Value to Your Compliance Program Gregory A. Crouse, CPA Partner, Investigative & Dispute Services, Health Sciences Ernst & Young LLP Washington, DC Kip Ebel Manager, Fraud Investigation & Dispute Services Ernst & Young, LLP Chicago, IL |
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3.06. Integrating Compliance with Business: Integrating Compliance Auditing and Monitoring with Internal Audit David Chandler, Ph.D., DABT Associate Director of Outcomes and Analysis, Corporate Compliance Amgen Thousand Oaks, CA Wayne Davey, MBA Director, Corporate Audit Amgen Thousand Oaks, CA 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 Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3:00 p.m. |
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Transition Break |
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3:15 p.m. |
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Introduction to Afternoon Plenary Session Lori Queisser Vice President and Chief Compliance Officer Eli Lilly and Company Indianapolis, IN (Co chair) |
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3:30 p.m. |
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PCF Panel on Compliance Survey Results: Drug Safety and Pharmacovigilence Maria C. Koster, Ph.D. Chief Executive Officer, Vigilex B.V. Rotterdam, The Netherlands Joanna Haas, MD Vice President, Pharmacovigilance Genzyme Corporation Cambridge, MA Dan Kracov, Esq. Partner and Co-Head, Pharmaceutical and Medical Device Practice Arnold & Porter Washington, DC Carol Krueger Consumer Safety Officer FDA CDER Office of Compliance Rockville, MD Peter Claude Partner, Life Sciences Advisory Group PricewaterhouseCoopers LLP Florham Park, NJ (Moderator) |
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4:30 p.m. |
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An Overview of OIG Pharma Investigative Initiatives Lewis Morris, Esq. Chief Counsel, Office of Inspector General Department of Health and Human Services Washington, DC |
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5:00 p.m. |
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An Overview of DOJ Pharma Prosecution Initiatives Michael K. Loucks, Esq. First Assistant United States Attorney United States Attorney's Office for the District of Massachusetts Boston, MA |
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5:30 p.m. |
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Regulators Roundtable Eric M. Blumberg, Esq. Deputy Chief Counsel, Litigation Office of Chief Counsel Office of the Commissioner Food and Drug Administration Washington, DC Michael K. Loucks, Esq. First Assistant United States Attorney United States Attorney's Office for the District of Massachusetts Boston, MA Lewis Morris, Esq. Chief Counsel, Office of Inspector General Department of Health and Human Services Washington, DC Patrick J. O'Connell, Esq. Section Chief, Civil Medicaid Fraud Texas Office of the Attorney General Austin, TX James Sheehan, Esq. Associate United States Attorney United States Attorney's Office for the Eastern District of Pennsylvania Philadelphia, PA John T. Bentivoglio, Esq. Partner, King & Spalding Former Special Counsel for Healthcare Fraud and Chief Privacy Officer United States Department of Justice Washington, DC (Co chair) |
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6:45 p.m. |
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Adjournment and Meet the Regulator Networking Reception The Pharma Congress Thursday network reception will feature an opportunity to meet a number of key Federal and State regulators and Capitol Hill staff specializing in pharmaceutical policy. |
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