讲演嘉宾
Michele Dougherty
Science Policy Analyst, Therapeutric Biologics and Biosimilars, FDA, United States
Niklas Ekman
Senior Researcher, Finnish Medicines Agency, Finland
Cecil J. Nick, MS
FTOPRA, Vice President (Technical), Parexel Consulting, United Kingdom
BSc (Hons) in Biochemistry from University of Cape Town. Working in regulatory affairs and clinical development for over 30 years with focus on biological medicines and particular expertise in biosimilars. Joined PAREXEL in 2001 prior to which was with Novo Nordisk Ltd.
Emily Shacter, PhD
Independent Consultant, ThinkFDA, LLC, United States
Dr. Shacter regulated therapeutic proteins at the FDA for 18 years, serving as Chief of the Lab of Biochemistry in CDER’s Office of Biotechnology Products until leaving FDA in 2012. She supervised the regulatory review of a wide range of protein products & contributed to FDA policies & expectations for the manufacture, control, & analytical characterization of therapeutic proteins & biosimilars. She now consults on the science & regulation of protein products through her business ThinkFDA LLC.