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20/06/2024 21/06/2024 America/Toronto Biosimilars & Innovator Biologics Biosimilars & Innovator Biologics
June 20 – 21, 2024
New York City Bar Association, New York, NY
Please visit https://www.americanconference.com/biosimilars/ for more information and updates. New York City Bar Association, New York, NY true DD/MM/YYYY 1440 use-title -
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20/06/2024 21/06/2024 America/Toronto Biosimilars & Innovator Biologics Biosimilars & Innovator Biologics
June 20 – 21, 2024
New York City Bar Association, New York, NY
Please visit https://www.americanconference.com/biosimilars/ for more information and updates. New York City Bar Association, New York, NY true DD/MM/YYYY 1440 use-title -
This event is a must-attend, bringing together leaders from both biosimilar and innovator biologic industries. Attend and gain practical insights and learn the most advanced strategies to overcome hurdles in the three critical pillars of this industry: Legal, Regulatory, and Commercialization.
2024 CONFERENCE CHAIRS
Deirdre Parsons
Senior Director, Public Policy & Government Relations
Alnylam Therapeutics
Harshika Sarbajna
Vice-President Commercial and Head, Global
Alvotech
Paki Banky
Director, Senior IP Counsel, IP Lead Cell & Gene
Novartis
Government Speakers
Honorable Jacqueline Bonilla
Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office
Honorable Linda Horner
Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office
Honorable Grace Obermann
Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office
Vanessa Ford
Supervisory Patent Examiner
U.S. Patent and Trademark Office
Laurel Goldberg
Regulatory Counsel, CDER
U.S. Food and Drug Administration
Featured Speakers
Ali I. Ahmed
Senior Vice President, BioPharma
Fresenius Kabi, USA
Craig Burton
Executive Director | Senior Vice President, Policy and Strategic Alliances
Biosimilars Council | Association for Accessible Medicines
Larry Coury
Vice-President, Associate General Counsel
Regeneron Pharmaceuticals
Christine Baeder
President
Apotex Corp. US
Paul Walden, Ph.D
Vice-President, Medical Affairs
Celltrion Healthcare Co., Ltd.
Dracey Poore
Director of Biosimilars Product and Solutions Marketing
Cardinal Health
2024 is a critical year – the industry has matured since the implementation of the BPCIA, with a significant increase in lawsuits within this space and the Humira biosimilar launches in 2023, revealing unexpected deviations from anticipated trends and insights for the future.
2024 Highlights Include:
A two-part retrospective on the evolution of the biosimilars market, critically assessing the lessons learned and insights for the future, from both the Humira and non-Humira biosimilar launches
Appreciating the impact of the Biden Administration’s cadence on drug prices on manufacturer pipelines, product launches, and pricing strategies
An updated decision matrix to assist in making the critical decision of venue selection – to dance, or not to dance?
Satisfying the data requirements for biosimilarity, interchangeability and compliant labelling
Spotlight on the litigation, regulatory and commercial strategies for innovators and biosimilars operating in China and emerging markets
And more!
CLE ACCREDITATION
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
Who You Will Meet
In-house counsel from branded and biosimilars companies
Government representatives from the FDA, USPTO, and the Judiciary
Leading regulatory and patent attorneys from around the country
About this Conference
Prepare to enter the next decade of this revolutionary law.
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The incorporation of biosimilar products into the U.S. marketplace was designed to improve patient access and decrease healthcare costs. While much has evolved since the enactment of the BPCIA, the traditional barriers remain.
Now, more than ever, strategies to overcome these barriers are essential to improve the understanding of biosimilar products in the United States. The need for a solid guiding framework becomes more critical than ever before.
The next decade will see more litigation in this sphere. Further, and to an increasing extent, IPR proceedings challenging patents protecting biologic medicines, including IPRs filed before any action was taken under the BPCIA. Finally, the future will usher in considerable changes growing the scope of products that are regulated and litigated under the BPCIA.
Join the “who’s who” of the biosimilars and innovator biologics industries as they gather virtually to discuss and contemplate the impact of these critical developments.
