Day 1 - Thursday, June 20, 2024

7:00
Registration and Breakfast
8:00
Opening Remarks from the Chairs
8:15
The Politics of Innovation and Cost: The Impact of the Biden Administration’s Cadence on Manufacturer Pipelines, Product Launches and Pricing Strategies
9:15

Biosimilar Market Retrospective Part I

Decoding the Non-Humira Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the Future
10:15
Morning Networking Break
10:30

Biosimilar Market Retrospective Part II

Decoding the Humira Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the Future
11:30
Unpacking the Lawsuits to the Price Controls of the IRA: Distilling Strategies for Pipelines, Product Launches and Pricing Strategies
12:45
Networking Lunch
1:45
Patent Term Adjustments and Obviousness Type Double Patenting: Decoding the In Re Cellect Debate and the Implications for Product Launch and Market Exclusivity
2:45
FDA Keynote Interchangeability
3:15
Afternoon Networking Break
3:30
Newest Strategies for FDA Approval: Satisfying the Data Requirements for Biosimilarity and Interchangeability and Compliant Labelling
4:30
Investor’s Roundtable: Valuating Biosimilar Market Trends and Strategic Insights for Portfolio Planning
5:30
Conference Cocktail
6:30
Conference Adjourns

Day 2 - Friday, June 21, 2024

7:00
Registration and Breakfast
8:00
Opening Remarks from the Chairs
8:15
Reviewing Cases and Distilling Trends: The Key Federal and District Court Lawsuits Shaping the Biologics and BPCIA Landscape
9:15
Best Practices for Determining Damages and Negotiating BPCIA Settlements Without Entering the FTC’s Crosshair
10:15
Morning Networking Break
10:30
Balancing Innovation and Competition: Recent Trade Secret and Anti-Trust Developments and Lawsuits Outside of the BPCIA Impacting Biosimilars and Innovators
11:30
Policy, Procedure and Practice Points with the PTAB
12:30
Networking Lunch
1:30
Reference Drug Patent Challenges: Unpacking Recent IPR Decisions and Insights
2:30
To Dance or Not to Dance?: Updated Venue Selection Matrices For a Maturing Biosimilar Industry
3:30
Afternoon Break
3:45
Defending and Advancing Global Biologics and Biosimilars Portfolios: Spotlight on the Litigation, Regulatory and Commercial Strategies for Innovators and Biosimilars Operating in China and Emerging Markets
4:45
Ethical Matters in the Approval and Use of Biologics and Biosimilars
5:45
Conference Concludes