Agenda At-A-Glance

MAIN CONFERENCE
Day One, Monday, June 13, 2016

8:00 Registration and Continental Breakfast – Sponsored by:
9:00 Co-Chairs’ Opening Remarks 9:15 Strengthening Your Regulatory Biosimilars Strategy for Interchangeability, Naming, and More in an Uncertain Landscape 10:30 Registration and Continental Breakfast – Sponsored by:
10:45 Case Study: Amgen Inc. v. Sandoz Inc. and the Impact on the Patent Dance and the Notice of Commercial Marketing 12:15 Networking Luncheon – Sponsored by:
1:30 Charting State Regulation: Sailing Through the Murky Waters of State Laws Affecting Biosimilars 2:30 Demystifying IPRs for Effective Use in the Biosimilars Landscape 4:00 Afternoon Refreshment Break – Sponsored by:
4:15 Spotlight on the Judiciary: Lessons Learned for Biosimilars Litigation 5:15 Conference Adjourns to Day Two
Cocktail Reception – Sponsored by:

MAIN CONFERENCE
Day Two, Tuesday, June 14, 2016

8:30 Continental Breakfast – Sponsored by:
8:45 Co-Chairs’ Opening Remarks and Recap of Day 1 9:00 New Considerations for Practical Commercial Strategies and Debating the Economic Viability of Biosimilars 10:00 Registration and Continental Breakfast – Sponsored by:
10:30 Mapping Out the BPCIA Process: A Cheat Sheet on Navigating the Biosimilars Pathway 12:00 Networking Luncheon – Sponsored by:
1:15 Exploring the Strategic Implications of the Transition from NDA Approval to BLA Licensure 2:00 Section 101 and Written Description issues in Biologic Products – Prosecutor and Litigator Perspectives 3:15 Afternoon Refreshment Break – Sponsored by:
3:30 Developing Real World Strategies for Marketing and Promoting a Biosimilar: Distinguishing the Biosimilar From the Reference Product 4:30 Comparing and Contrasting the US and Global Biosimilars Experience 5:30 Conference Adjourns

POST-CONFERENCE WORKSHOP
Wednesday, June 15, 2016

9:00 – 12:00
(registration starts at 8:30)
Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space