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About Karen L. Carroll
Karen has vast experience with biopharmaceutical and pharmaceutical companies, from obtaining patents relating to small molecules, genes, protein, antibodies, and methods of use to representing companies in federal district court patent disputes and post-grant challenges before the PTAB. Karen further counsels companies on product life cycle strategy and commercial supply chain issues. In addition to the pharmaceutical related fields, Karen has experience in other technological areas, including telecommunications, web-based applications and mechanical devices. Prior to her legal career, Karen worked in the biopharmaceutical industry for more than 10 years, first as a research scientist, and then as a patent agent. In addition to her patent prosecuting experience, Karen advised members of the scientific staff on a variety of matters relating to patent, regulatory, and Hatch-Waxman issues.
About Scott A. Cunning II
Scott Cunning is a partner with Parker Poe Law Firm in the Washington D.C. office. He assists generic, specialty, and biosimilar pharmaceutical companies by helping them bring their versions of products to market. He also counsels life sciences and technology companies and helps them to navigate patent disputes in federal district courts. He has defended hundreds of patents on behalf of clients. Scott’s experience spans a diverse variety of technological areas including semiconductor processing, digital data compression, implantable medical devices, medical imaging devices, electronic patient diaries and methods of drug delivery.
About Parker Poe Adams & Bernstein LLP
Parker Poe has more than 225 attorneys serving clients from offices in Georgia, the Carolinas, and Washington, D.C. The law firm has been serving life sciences clients for more than 35 years. Today, the firm’s Life Sciences Industry Team includes patent attorneys from Atlanta to Washington and represents some of the top pharmaceutical, biotechnology, and medical device companies in the world. It also regularly advises clinical laboratories, government and nonprofit research organizations, entrepreneurs, and scientists. www.parkerpoe.com/industries/life-sciences
As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.
Despite the uncertainties, one thing is for sure: biosimilar-related patent litigation will continue to gain momentum. Practitioners and their clients must remain in the loop of recent developments to ensure maximum compliance and improve litigation readiness.
In this Live Webcast, a seasoned panel of thought leaders and professionals brought together by The Knowledge Group will provide the audience with an in-depth analysis of the current legal issues surrounding biosimilars and the BPCIA. Speakers will also offer best compliance practices and effective litigation strategies.
· Biosimilars and the BPCIA – Recent Statistics
· Recent Regulatory and Litigation Issues
· Best Compliance Practices
· Effective Litigation Strategies
· What Lies Ahead
About The Knowledge Group
Founded in November 2006, The Knowledge Group has been at the forefront of providing quality continuing education programs for lawyers, accountants, financial executives, risk and compliance specialists, human resources professionals, technology officers, and business consultants in a wide range of industries.
The Knowledge Group strives to be the best-in-class provider of continuing education by bringing forth relevant content you can’t get anywhere else.