Foley Hoag LLP partner and Intellectual Property Department Chair Donald Ware will be a featured speaker at the American Conference Institute’s 23rd FDA Boot Camp, a two-day symposium that provides basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts.
On the first day, Ware will present on "The Nature of the Approval Process," as it pertains to biological products . His discussion will examine, among other things, which “new drugs” require a biologics license application (BLA) rather than a New Drug Application (NDA); the content of the BLA; and key similarities and differences between the drug and biological product regulatory schemes.
On the second day of the symposium, Ware will teach a Master Class on Biosimilars. The class will cover an overview of the BPCIA and its applicability, an examination of FDA guidances for biosimilars, and a discussion of key issues arising under the biosimilars pathway, including proof of biosimilarity and interchangeability, naming of biosimilars, innovator and biosimilar exclusivity periods, and patent litigation procedures and strategy.
Other program sessions at the symposium include Understanding the Clinical Trial Process for Drugs and Biologics; Patents, Trademarks and Other IP Protections and Mechanisms; Adverse Events Monitoring, Pharmacovigilance and Risk Management; The Drug Supply Chain Security Act – Summarizing the Act and its Effect on FDA Practice; Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns; and Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know.
The 23rd FDA Boot Camp is being held at the Omni Parker House in Boston, MA on Sept. 18-19, 2014.