Agenda
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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 |
9:45 |
Morning Networking Break |
10:00 |
Biosimilar Market RetrospectiveUnpacking the Humira and Non-Humira Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the Future |
11:30 |
Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDP |
12:30 |
Networking Lunch |
2:00 |
FDA Keynote Interchangeability and Data Requirements |
2:45 |
Adapting to Regulatory Shifts in Approval Pathways, Labelling, and Staying Ahead of Induced Infringement |
4:00 |
Afternoon Networking Break |
4:15 |
Investor’s Roundtable: Valuation, Biosimilar and Innovator Biologic Market Trends, and Strategic Insights for Portfolio Planning |
5:15 |
Conference Cocktail |
6:15 |
Conference Adjourns |
Day 2 - Friday, June 21, 2024
Day 1 - Thursday, June 20, 2024
7:00 |
Registration and Breakfast |
8:00 |
Opening Remarks from the ChairsPaki Banky Harshika Sarbajna |
8:15 |
The Politics of Innovation and Cost: The Impact of the Biden Administration’s Cadence on Manufacturer Pipelines, Product Launches and Pricing StrategiesMaureen A. Bresnahan Christine Baeder This opening session will examine how the Biden Administration’s efforts to improve access to medication are reshaping the landscape for research institutions and manufacturers, influencing their portfolios, product launch timelines, pricing strategies, and ultimately, market access. Topics of discussion will include:
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9:45 |
Morning Networking Break |
10:00 |
Biosimilar Market RetrospectiveUnpacking the Humira and Non-Humira Biosimilar Launches and Lawsuits: Lessons Learned and Insights for the FutureCraig Burton Dracey Poore Robert Cerwinski Anita Varma 14 years have passed since the Biologics Price Competition and Innovation Act
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11:30 |
Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDPJames T. Evans, Ph.D. Alicia S. Russo Matthew A. Pearson John Christopher Rozendaal Elizabeth (“Liz”) Stotland Weiswasser
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12:30 |
Networking Lunch |
2:00 |
FDA Keynote Interchangeability and Data RequirementsLaurel Goldberg |
2:45 |
Adapting to Regulatory Shifts in Approval Pathways, Labelling, and Staying Ahead of Induced InfringementJeremiah J. Kelly Adapting to a changing and dynamic regulatory landscape is paramount for success in the biosimilars and innovator biologics markets. In this comprehensive session, industry leaders will demonstrate how proactive adaptation and strategic foresight are essential for a competitive advantage. Topics of discussion include:
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4:00 |
Afternoon Networking Break |
4:15 |
Investor’s Roundtable: Valuation, Biosimilar and Innovator Biologic Market Trends, and Strategic Insights for Portfolio PlanningEdric Engert Cody Powers Moderator:Ali Ahmed In this special roundtable, life sciences investors will identify market trends, assess the impact of regulatory shifts and political cadence, and derive the strategic insights critical for informed portfolio planning and investment decisions.
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5:15 |
Conference Cocktail |
6:15 |
Conference Adjourns |
Day 2 - Friday, June 21, 2024
7:00 |
Registration and Breakfast |
8:00 |
Opening Remarks from the ChairsPaki Banky Harshika Sarbajna |
8:15 |
Reviewing Cases and Distilling Trends: The Key Federal and District Court Lawsuits Shaping the BPCIA LandscapeLarry Coury Aziz Burgy Hassen A. Sayeed Alison Hanstead
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9:15 |
Best Practices for Determining Damages and Negotiating BPCIA Settlements Without Entering the FTC’s CrosshairVishal C. Gupta Mastering the nuances of negotiating launch triggers, volume limitations, reasonable royalties and damages without entering the FTC’s crosshair is mission critical for the reference product sponsor and the biosimilar applicant. Topics of discussion include:
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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 InnovatorsKevin E. Noonan, Ph.D. The Federal Trade Commission (FTC) and, to a lesser extent, the International Trade Commission (ITC), are two agencies that life sciences companies need to be familiar with in terms of their enforcement priorities and recent investigations, outside of the BPCIA context. Topics of discussion include:
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11:30 |
Policy, Procedure and Practice Points with the PTABHonorable Jacqueline Bonilla Honorable Linda Horner Honorable Grace Obermann In this panel, PTAB judges will reflect on:
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12:30 |
Networking Lunch |
2:00 |
Reference Drug Patent Challenges: Unpacking Recent IPR Decisions and InsightsMira A. Mulvaney John J. Molenda, Ph.D. Kurt Mathas
|
3:00 |
To Dance or Not to Dance? Updated Venue Selection Matrices for a Maturing Biosimilar IndustrySteven D. Maslowski
|
4:00 |
Afternoon Networking Break |
4:15 |
Defending and Advancing Global Portfolios: Spotlight on Litigation, Regulatory, and Commercial Strategies in China and Emerging MarketsWhereas the EU biosimilar market is relatively mature, the landscape in emerging markets such as BRICS (Brazil, Russia, India, China, and South Africa) is less established. This session aims to delve into the potential opportunities and competitive implications of biosimilars in these burgeoning markets, shedding light on the attractiveness of biosimilar ventures beyond established territories like the EU and the U.S. Topics of discussion include:
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5:15 |
Diversity, Equity and Inclusion in the Research, Development, and Approval of Biologics and BiosimilarsVanessa Ford Jason Murata
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6:15 |
Conference Concludes |