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Agenda

Agenda at a Glance

Policy Updates
Pharma Business
Regulatory

Day One: Wednesday, December 2, 2009
8:15Chairperson’s Welcome and Opening Remarks
8:30Keynote Address
Access Expansion, Payment Reforms, Policy Overhaul – What it Means for the Industry
  • Dr. Mark B. McClellan, Senior Fellow, Director of Engelberg Center for Healthcare Reform
9:15Biopharm Rehash – What Happened in 2009 and A Look Forward to 2010
  • Carolyn Clancy, MD, Director, Agency for Healthcare Research and Quality (AHRQ)
  • Jim Greenwood, CEO, Biotechnology Industry Organization (BIO)
10:1530 Minute Morning Networking Break
10:45Healthcare Reform – Impact on Patients
  • Myrl Weinberg, President, National Health Council
11:15Impact of Health Reform – Emerging Biopharm Strategies
  • Ian D. Spatz, Principal, ROCK CREEK POLICY GROUP and Senior Advisor, MANNATT HEALTH SOLUTIONS, formerly, Vice President, Global Health Policy, MERCK
11:45Panel Discussion - Business Impact of Current Legislation on Biopharma
  • Julie K. Letwat, JD, MPH, Government and External Affairs, Takeda Pharmaceuticals America
  • D. Bruce Burlington, MD, Pharmaceutical Product Development and Regulatory Affairs, Independent Consultant, former Executive Vice President Business Practices and Compliance, Wyeth
12:30Interactive Networking Luncheon Table Discussions
Enjoy lunch while interacting with regulatory leaders, industry experts, and colleagues on key issues affecting your company and daily responsibilities. Take advantage of the opportunity to share your expertise, opinions, concerns, and suggestions.
Table 1: Medicaid at Federal and State Levels – expansions, cuts, reform, pricing
Table 2: Sales and Marketing Practices - Aggregate spending, state reporting , Sunshine Act
Table 3: State Government Price Reporting - Tricare, PHS reform, Medicaid reform, Medicare reform, Implications for the provider
Table 4: OIG Compliance – status of compliance initiatives, ramification of increasing scope, possible changes from increased state liability
1:40Meet and Greet the New FDA Leadership – 20 Minute Q&A Session
  • Joshua Sharfstein, MD, Principal Deputy Commissioner, FDA (Invited)
2:00Meet and Greet CMS Leadership - 20 Minute Q&A Session
  • Jacquelyn White, Director, OFFICE OF ST RATEGIC OPERATIONS AND REGULATORY AFFAIRS, (CMS)
  • Noemi Rudolph, Director, Division of Research on Health Plans & Drugs, OFFICE OF RESEARCH, DEVELOPMENT AND INFORMATION (CMS) (Invited)
2:20Medicare Part D - 2009 Trends
  • Jane Galvin, Managing Director, Regulatory Affairs, BLUE CROSS BLUE SHIELD (BCBS)
3:0030 Minute Afternoon Network Break
3:30Medicare Part D Reform Updates and A Strategic Look at Price Controls
  • Joseph Antos, Health Adviser to the Congressional Budget Office, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH
4:15Sales and Marketing Practices
5:15Day One Concludes
Day Two: Thursday, December 3, 2009
8:30Chairperson’s Recap of Day One
8:45Assessing the Impact of Healthcare Reform on Regulatory Expectations and Future Directions for Comparative Effectiveness Research and Biosimilars
  • Steven Kozlowski, Director, Office of Biotechnology Products, FDA
9:30Evaluating the Future of Comparative Effectiveness and Ramifications for Industry
  • Jennifer Graff, Research Director, Methods, Evidence & Coverage, NATIONAL PHARMACEUTICAL COUNCIL
  • Amy Miller, PhD, Director, Public Policy, PERSONALIZED MEDICINE COALITION
10:3030 Minute Morning Networking Break
11:00GRACE Principles – Observational Studies of Comparative Effectiveness
  • Nancy Dreyer, MPH, PhD, Chief of Scientific Affairs and Senior Vice President, OUTCOME SCIENCES
11:30Panel Discussion - Effects of Pending Legislation on Innovation
  • Dan Todd, Executive Director, Health Policy, EMD SERONO
  • Amy Miller, PhD, Director, Public Policy, PERSONALIZED MEDICINE COALITION
12:30Conference Concludes
Biopharm Regulatory Reform