The premier event is back—
in the heart of Boston!
This event, now in year 16, unites legal, regulatory, and market leaders to tackle challenges from FDA approvals and patent cliffs to global litigation trends.
Join top industry leaders, policymakers, and innovators to tackle challenges, uncover strategies, and drive innovation, accessibility, and success in the evolving biosimilars market.
Conference Co-Chairs
Mary Jo Carden
Head, Policy
Sandoz
Tara Rahemba
Vice President, Intellectual Property
Apogee Therapeutics
Julia C. Weisberg
Vice President, Drug Development | Regulatory Law
Bristol Myers Squibb
Patent Trial and Appeal Board, USPTO
Honorable Susan Mitchell
Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office
Honorable Grace Obermann
Administrative Patent Judge
Patent Trial and Appeal Board
U.S. Patent and Trademark Office
Advisory Board
ACI’s Biosimilars & Innovator Biologics Advisory Board ensures our programs deliver cutting-edge insights with a world-class faculty. Composed of senior IP, market access, regulatory, and policy leaders from both biosimilar and innovator biologics companies, the board provides strategic guidance on litigation, competition, and evolving market dynamics. Balancing perspectives across the industry, this inner circle helps shape critical discussions on innovation, access, and the future of biologics.
Key Conference Takeaways
Regulatory Insights
Explore the impact of 2024’s record biosimilar approvals and FDA’s evolving interchangeability standards.
Patent Litigation
Gain strategies to address BPCIA lawsuits, inter partes review (IPR) proceedings, Section 1782 actions, and the 2025 patent cliff.
Market Access
Discover lessons from Humira launches, PBM decisions, and collaboration to enhance biosimilar adoption.
Global Developments
Learn from EU and Canadian frameworks and how they shape U.S. market strategies.
Political Shifts
Assess the impact of the Trump administration’s policies on pricing, Medicare, and deregulation.
Innovation
Understand advancements in biosimilar development, including AI and lifecycle management techniques.
Future Trends
Prepare for an expanded BPCIA scope, intensified competition post-patent cliff, and the implications of Supreme Court rulings like Loper Bright Enterprises v. Raimondo.
Earn CLE/Ethics Credits
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as non-transitional for the purposes of CLE accreditation.
Learn more
Join our companion event!
Biosecurity isn’t optional—it’s urgent. With mounting scrutiny from regulators, life sciences companies face a perfect storm of challenges: geopolitical instability, evolving mandates, and vulnerable supply chains. Explore our co-located event!
Learn moreSponsor Opportunities
With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, the Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.
For more information please contact:
Aaron Goldstein
Senior Business Development Manager
Email: [email protected]
