American Conference Institute (ACI) will be holding an International Summit on Biosimilars and Originator Biologics on December 1-2, 2022 at the Hilton Munich Park, Munich Germany, and as a livestreaming event. Co-chairs Sharada F. Devarsetty from Sandoz and Christine Berndt from STADA Arzneimittel AG will host, wherein ACI faculty will offer presentations on the following topics:
• The Unitary Patent and Patent Court and strategies for biosimilars and originator biologics
• The impact of anticipated EU regulatory change on Life Sciences companies
• A comparison of global biosimilar regulation before the EMA and FDA
• European Supplementary Protection Certificates and the evolving SPC framework
• Medical uses of known biological products and drug repurposing
• Plausibility, sufficiency, and inventive step for formulation and combination patents
• Proportionality in injunctions and damage calculations
• Alternative dispute resolution
• The balance between competition and innovation regarding patent thickets, litigation, and economic considerations for settlement
• Biosimilar economics, improved market access and sustainability
• Global strategies in the U.S., the EU, and Asia
• Business considerations for developing forward-thinking portfolio strategies
• Artificial intelligence in drug development and accelerating biopharmaceutical discovery and development
Other talks include a special interview with Judge Margot Kokke from the Court of the Hague, Netherlands, and government insight from Steffen Thirstrup from the European Medicines Agency.
The conference includes two pre-conference workshops on November 30th. The first, "Patenting mRNA, CRISPR, and Emerging Biotechnological Inventions" will be presented from 9:00 am until noon; and a "Working Group on Innovator Biologics and Biosimilars in the U.S.: The BPCIA, aBLAs, the Patent Dance, and the Purple Book” from 1:00 pm until 4:00 pm.
An agenda for the conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee is €1,399 for in-house counsel and €2,099 otherwise if registered and paid by 28 October; thereafter the costs are €1,599 and €2,299 respectively. The in-person workshops are €450 apiece. There is also a livestream option, costing €1,099 for in-house counsel and €1,799 for others if registered and paid by 28 October; thereafter the costs are €1,299 and €1,999 respectively. Patent Docs readers are entitled to a 10% discount off registration using discount code D10-999-PATENTDOCS. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's International Summit on Biosimilars and Originator Biologics.
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