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