FDA Symposium: Agenda: Day 2

Pre-Conference

Day One

Day Two

Day Three

Agenda: Day 2 Thursday, Aug. 24, 2006
MORNING
Morning Track 1 - Drug Safety and Risk Management
8:00 a.m.	Welcome and Introduction Linda Horton, Esq. Partner, Hogan & Hartson Former Director of International Policy, FDA Brussels, Belgium (Co-Chair) Geoffrey Levitt, Esq. Vice President and Chief Counsel Regulatory and Research, Wyeth Pharmaceuticals Collegeville, PA (Co-Chair) Presentation Material (Acrobat) Presentation Material (Powerpoint)
8:15 a.m.	Postmarket Assessment of Drug Safety at the FDA CAPT Paul J. Seligman, MD, MPH Associate Director for Safety Policy and Communication Center for Drug Evaluation and Research, FDA Silver Spring, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
9:00 a.m.	Where is EU Drug Safety Law Headed: Are Controls Tightening? Linda Horton, Esq. Partner, Hogan & Hartson Former Director of International Policy, FDA Brussels, Belgium
9:45 a.m.	Innovator Drug Development in a Pharmacovigilant Environment Gregory Page, Ph.D. FDA Life Sciences Practice Leader Life Science and Healthcare Regulatory Practice Deloitte & Touche Jericho, NY George Serafin Senior Manager, Life Science and Healthcare Regulatory Practice Deloitte & Touche Parsippany, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint)
10:30 a.m.	Break
11:00 a.m.	FDA Oversight of Drug Safety: What Works, What Doesn't Geoffrey Levitt, Esq. Vice President and Chief Counsel Regulatory and Research Wyeth Pharmaceuticals Collegeville, PA Presentation Material (Acrobat) Presentation Material (Powerpoint)
11:45 a.m.	Risk Management Strategy Through the Life Cycle of Pharma and Biotech Products Stephen Paul Mahinka, Esq. Partner, Chair, Life Sciences Interdisciplinary Practice Morgan, Lewis & Bockius LLP Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Gregory T. Parks Partner, Morgan, Lewis & Bockius, LLP Philadelphia, PA Presentation Material (Acrobat) Presentation Material (Powerpoint)
12:30 p.m.	Networking Luncheon in Annenberg Hall

Morning Track 2: Advertising, Promotion and Compliance
8:00 a.m.	Welcome and Introduction John Kamp, JD, Ph.D. Executive Director, Coalition for Healthcare Communication Of Counsel, Wiley Rein & Fielding LLP Washington, DC (Co-chair) No Presentation Provided Wayne Pines President, Regulatory Services and Healthcare, APCO Worldwide Former Associate Commissioner for Public Affairs, FDA Washington, DC (Co-chair) Presentation Material (Acrobat) Presentation Material (Powerpoint)
8:15 a.m.	Moving from DTC to DTC Squared: Direct-to-Patient Communications in the 21st Century Peter Pitts President, Center for Medicines in the Public Interest Senior Vice President for Global Health Affairs, Manning, Selvage & Lee Former Associate Commissioner for External Relations, FDA New York, NY Presentation Material (Acrobat)
9:00 a.m.	Meeting the Latest FDA and OIG/DOJ Marketing Rules Wayne Pines President, Regulatory Services and Healthcare, APCO Worldwide Former Associate Commissioner for Public Affairs, FDA Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
9:45 a.m.	Pharma Funding, Fraud and the First Amendment: A Critical View of Recent Federal Enforcement Actions John Kamp, JD, Ph.D. Executive Director, Coalition for Healthcare Communication Of Counsel, Wiley Rein & Fielding LLP Washington, DC No Presentation Provided
10:30 a.m.	Break
11:00 a.m.	Innovative Models of Compliance Education: The 'Intellinex' Case Study Jeffrey Lenow, MD, JD, FAAFP Associate Professor, Department of Family and Community Medicine Jefferson Medical College of Thomas Jefferson University EVP, Chief Medical Officer, CardinalHealth Medford, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint)
11:45 a.m.	The Most Important Element to Assure That Your Sales and Marketing Compliance Program Is Working Effectively Kelly Freeman, Ph.D. Director, Compliance and Ethics Eli Lilly and Company Indianapolis, IN Presentation Material (Acrobat) Presentation Material (Powerpoint)
12:30 p.m.	Networking Luncheon in Annenberg Hall

Morning Track 3: Where the FDA and CMS Meet
8:00 a.m.	Welcome and Introduction Robert Barton Editorial Director, FDAnews Falls Church, VA (Co-chair)
8:15 a.m.	The Role of Medicare National Coverage in the Regulatory Process Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group Office of Clinical Standards & Quality Centers for Medicare & Medicaid Services Baltimore, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
9:00 a.m.	Coordination Between FDA and CMS: Strategic Considerations for Medicare Coverage AND Payment, and the Growing Impact of CMS in the Marketplace Kirk Dobbins, JD Of Counsel, Hyman, Phelps & McNamara, P.C. Former Senior Staff Attorney and Acting Supervisory Attorney for Litigation Office of the General Counsel, HHS, CMS Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
9:45 a.m.	CMS Data and Price Information Collection: What Are the Implications? Ann Leopold Kaplan, Esq. Assistant General Counsel, PhRMA Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
10:30 a.m.	Break
11:00 a.m.	Reckoning with the Growing Impact of CMS on Product Development and Life Cycle Management for the Research-Based Biopharmaceutical Industry Matthew Van Hook, Esq. Partner, Engel & Novitt Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
11:45 a.m.	Policy Implications of Greater FDA/CMS Collaboration Peter Slone, MBA Vice President, Government Affairs Medtronic, Inc. Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
12:30 p.m.	Networking Luncheon in Annenberg Hall

Afternoon Track 4: Drug and Device Development and Clinical Trials
2:00 p.m.	Welcome and Introduction David Ceryak, Esq. Assistant General Counsel Eli Lilly and Company Indianapolis, IN (Co-chair)
2:15 p.m.	A Cross-functional Perspective of Key Issues Facing New Product Introductions Claudio Pincus President, The Quantic Group Livingston, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) R. Owen Richards President, Quantic Regulatory Services Livingston, NJ
3:00 p.m.	Climbing the Ivory Tower: Special Challenges for Sponsors of Clinical Trials at Academic Sites Greg Koski, Ph.D., MD CPI Associate Professor of Anesthesia Senior Scientist, Institute for Health Policy, Massachusetts General Hospital Partners Health Care System, Harvard Medical School Former Director, Office for Human Research Protections Office of Public Health and Science, Office of the Secretary, HHS Boston, MA No Presentation Provided
3:45 p.m.	Break
4:15 p.m.	Risk Management Through Electronic Enforcement Joseph Vinhais, RAC Vice President of Regulatory Compliance, Brooks Software Chelmsford, MA Presentation Material (Acrobat) Presentation Material (Powerpoint)
5:00 p.m.	Deciphering Section 505(b)(2) and Its Implications for Product Life Cycles and Regulatory Strategies David Ceryak, Esq. Associate General Counsel, Eli Lilly and Company Indianapolis, IN Jeffrey Chasnow, Esq. Senior Corporate Counsel, Pfizer New York, NY James Czaban, Esq. Shareholder, Heller Ehrman, LLP Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
5:45 p.m.	Adjournment

Afternoon Track 5: Compliance and FDA Enforcement
2:00 p.m.	Welcome and Introduction Marc Wilenzick, Esq. Senior Corporate Counsel, Pfizer New York, NY (Co-chair)
2:15 p.m.	Beginning the Next 100 Years of FDA Regulation - There Have Been a Few Changes Since 1906 Martin Browning President and Co-Founder, EduQuest Former Special Assistant to the Associate Commissioner for Regulatory Affairs, FDA Hyattstown, MD Presentation Material (Acrobat) Presentation Material (Powerpoint)
3:00 p.m.	The Policy and Regulatory Challenges of Authorized Generics David Balto, Esq. Partner, Robins, Kaplan, Miller & Ciresi Former Policy Director of the Bureau of Competition of the Federal Trade Commission Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint)
3:45 p.m.	Break
4:00 p.m.	Regulation, Compliance, Culture or All of the Above Ann Bacon, Esq. Compliance Counsel Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT Gary Giampetruzzi, Esq. Senior Corporate Counsel, Government Investigation Section Pfizer, Legal Division New York, NY Heather Powell, Esq. Compliance Counsel Cephalon, Inc. West Chester, PA Adam Turteltaub Corporate Relations Executive, LRN Los Angeles, CA Presentation Material (Acrobat) Presentation Material (Powerpoint)
4:45 p.m.	Compliance Panel Discussion: PDUFA and FDA Reform Daniel Carpenter, Ph.D. Professor and Director of Graduate Studies Department of Government, Harvard University Cambridge, MA Presentation Material (Acrobat) Daniel Kracov, Esq. Partner, Co-Head, Pharmaceutical and Medical Device Practice Arnold & Porter Washington, DC Marc Wilenzick, Esq. Senior Corporate Counsel, Pfizer New York, NY (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint)
5:45 p.m.	Role of Technology in Commercial Risk Management and Compliance John McGrory President and CEO, Edge Dynamics Redwood City, CA Presentation Material (Acrobat) Presentation Material (Powerpoint)
6:15 p.m.	Adjournment

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