Agenda At-A-Glance
Agenda At-A-Glance
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:
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
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