Events
2 minute read

Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space

Kevin E. Noonan, Ph.D.June 3, 20159:00 am - 12:00 pm

American Conference Institute (“ACI”) together with McDonnell Boehnen Hulbert & Berghoff LLP is pleased to announce that Dr. Kevin E. Noonan, a leading life sciences attorney and MBHB partner, will speak at ACI’s 6th Annual Biosimilars Conference at the Affinia Manhattan in New York City on June 3, 2015 from 9:00 a.m. to 12:00 p.m. ET. The 6th annual event will bring together more than 100 industry leaders and experts, a “who’s who” of the regulatory and intellectual property bars, including the inaugural Biosimilars In-House Advisory Board.


Dr. Noonan is speaking on a presentation entitled, “Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space.” Dr. Noonan will be joining an all-star faculty including in-house counsel and executives from leading companies such as Boehringer Ingelheim, Fresenius, Genentech, Momenta, Novartis and more. They will provide attendees with the critical information that they need including:



  • Insights into the FDA biosimilars approval process including making an interchangeability determination, demonstrating safety and efficacy, and designating a name for the biosimilar
  • Reviewing the biosimilars litigation cases to date including Sandoz v. Amgen and Celltrion v. Janssen
  • Detailing strategies for declaratory judgment actions, preliminary injunctions, and using new USPTO inter partes review procedures
  • US Federal Trade Commission and state law updates: understanding the controversy surrounding competition, substitution, and naming in the biosimilars arena
  • Cost-benefit analysis: determining the potential value of biosimilars revenue based on relevant pricing, IP, regulatory, and commercial factors

 


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