Understanding New FDA’s Guidance on Biosimilar Product Development

Broadcast Date: Friday, July 13, 2012 from 12:00 pm to 2:00 pm (ET)
Consumer Law
Fiona Greer, PhD
Joseph A. Mahoney
Sanya Sukduang
John J. Molenda, PhD


About SGS M-Scan

SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Delivering solutions for pharmaceutical, biologics, and medical-device manufacturers, SGS provides clinical trial management (Phase I to IV) and services encompassing bioanalytical testing, data management, biostatistics, and regulatory consultancy. SGS also offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis. With the recent acquisition of Vitrology, SGS expands its service offering for biologics in the areas of cell bank and virus seeds characterization, raw material and bulk harvest testing (sterility, mycoplasma, viruses), final product testing for residual DNA, and safety consultancy services. Operating 27 facilities in 14 countries, SGS Life Science Services represents the broadest global network of contract analytical laboratories.

Website: https://www.m-scan.com/

About Mayer Brown

Mayer Brown LLP is a global law firm advising clients across the Americas, Asia and Europe. The firm’s multi-disciplinary Intellectual Property practice is uniquely positioned to provide a full range of services to its clients, including litigation and enforcement, counseling and prosecution, proceedings before the ITC and transactions. As many of the firm’s lawyers have earned technical degrees in such fields as biochemistry, chemistry, pharmacy, microbiology and chemical, mechanical and electrical engineering, they not only have a full understanding of IP law but also its practical application. Mayer Brown has extensive experience in handling issues related to the life sciences industry, including proven success in Hatch-Waxman litigation, representation of institutions in negotiating patent licenses, and successful patent, trademark and copyright litigation.

Website: https://www.mayerbrown.com/

About Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world practicing all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. Finnegan represents key innovators, including established multinational leaders as well as small, start-up companies, with IP assets that promise advancements in the life sciences field. Finnegan has delivered successful, sophisticated legal strategies to help pharmaceutical and biotech clients protect, advocate, and leverage their valuable IP assets. ]

Our clients are involved in a diverse area of biological products, such as antibodies, blood products, therapeutic proteins, and personalized medicines. From claim drafting and prosecution to developing winning litigation strategies, we provide a full range of services to our pharmaceutical and biotech clients. For more information, please visit www.finnegan.com.