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DISCLOSURE SUMMIT AGENDA: DAY II
Wednesday, March 28, 2012


7:00 am Registration Commences

CLOSING PLENARY SESSION: CREATING THE PARADIGM SUNSHINE COMPLIANCE PROGRAM FOR THE FUTURE
8:00 am

Welcome and Introductions

Karen Lowney
Senior Director, Compliance, Teva Pharmaceuticals, Frazer, PA (Co chair)
Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi-Aventis, Bridgewater, NJ (Co chair)
8:15 am Where Disclosure Meets Enforcement

Virginia "Ginny" A. Gibson, Esq.
Partner, Hogan Lovells US LLP; Former Executive Assistant US Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA
8:45 am Understanding Aggregate Spend Awareness and Attitudes: Physician Survey Results and Case Study

Tim Robinson, Esq.
President, The Regulatory Law Group, PLLC; Executive Vice President & General Counsel, MMIS, Inc., New York, NY
9:15 am Educating Physicians about the Sunshine Act

Sarah K. Giesting, Esq.
Associate, Pharmaceutical Industry Health Regulatory Practice Group, Epstein Becker & Green, New York, NY
9:45 am Coordination of Compliance with Sunshine Act and Global Disclosure and Transparency Initiatives 2010 Industry Survey Key Findings

William E. Buzzeo, MS
Vice President and General Manager, Compliance, Solutions Division, Cegedim Relationship Management, Richmond, VA
10:15 am Break
10:30 am Panel on Global Transparency

Jennifer Colapietro
Partner, Transparency and Aggregate Spend Practice Lead, PricewaterhouseCoopers LLP, Florham Park, NJ

Laura O'Donnell, Esq., Chief Compliance Counsel, GE Healthcare, Wauwatosa, WI
11:15 am Case Study: Purdue Aggregate Spend Approach and Solution

Danielle Bacco
Manager, Corporate Compliance, Purdue Pharma LP, Stamford, CT

Christine N. Bradshaw, Esq.
Director, Regulatory and Compliance Services, Porzio Pharmaceutical Services, Associate, Porzio, Bromberg & Newman, Morristown, NJ
12:00 pm Networking Luncheon
12:45 pm Case Study: Sanofi-Aventis Aggregate Spend Approach and Solution

Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi-Aventis, Bridgewater, NJ
1:30 pm Advanced Implementation Best Practices Discussion Facilitated by the Following

Katherine E. Norris, MPA
Director, Corporate Compliance, The Spectranetics Corporation, Colorado Springs, CO

Jennifer Colapietro
Partner, Transparency and Aggregate Spend, Practice Lead, PricewaterhouseCoopers LLP, Florham Park, NJ

Marc Eigner, MS, MBA
Partner, Polaris Management Partners, New York, NY

Karen Lowney
Senior Director, Compliance, Teva Pharmaceuticals, Frazer, PA

Manny Tzavlakis
Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY

Jon Wilkenfeld, MBA
President, Potomac River Partners, Vienna, VA

Keith Korenchuk, Esq.
Partner, FDA and Healthcare Practice, Arnold & Porter, Washington, DC (Moderator)

Customer Master:
  • Improved linkages between HCPs and HCOs
  • Links to institutional conflicts
  • Real-time changes to data
  • Selection up-front vs. Match-merge
Healthcare Organizations:
  • Going beyond "Teaching Hospitals"
  • Address challenges
  • Incomplete government data
  • Links to Customer Master
Data Monitoring:
  • Getting beyond outlier analysis
  • Lessons learned from public disclosures (e.g. state sanction checks)
Data Certification:
  • How much data do you provide?
  • How can anyone certify millions of transactions?
Global Spend:
  • Identification of Global Customer Master
  • Capturing cross-border transactions (US affiliate spend on global HCPs, foreign affiliate spend on US HCPs)
  • Capturing ex-US transactions on ex-US HCPs
  • Gaining buy-in from ex-US counterparts
  • Impact of FCPA, foreign laws - identification of Government Officials in Global Customer Master
Clinical Spend Capture:
  • Capture of PIs and Sub-Investigators for each trial
  • Granular identification of line-item costs
  • Equipment capture
  • IIT's and post-marketing trials
Impact on Sales & Marketing and Clinical:
  • How will your business react if HCPs to refuse promotional activity tied to spend?
  • How will the media impact affect commercial operations?
  • What happens if your top-tier KOLs stop assisting in getting product message out or stop performing clinical trials?
  • Will companies risk losing clinical researchers due to disclosurerelated concerns?
3:30 pm Adjournment




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