Wallace is Director for Resource Development of CDE. He was Advisor for MOEA, President of SyNovate, Associate Professor in National Chao-Tune Univ. He has worked in Carnegie-Mellon Univ. and in Medical School of Univ. of Pittsburgh after earned Ph.D. from Carnegie-Mellon Univ., in Pittsburgh, PA.
Dr. Christl is the Associate Director for Biosimilars in the FDA-CDER Office of New Drugs. She has been with the FDA for 9+ years. Dr. Christl received her Ph.D. in Molecular & Cellular Biology & Pathobiology from the Medical University of South Carolina in Charleston.
Dr Richardson is a pharmacist. He worked in the pharmaceutical industry in research and development and then at UK MHRA as a pharmaceutical assessor. He was UK delegate for the Biologics Working Party of the CHMP. His current role is Head of Biologicals in Quality of Medicines Sector.
Description
This forum will explore the challenges of biosimilars in light of the recent policy developments in the US, EU, and Asia. Participants will hear from a roundtable of authorities on how to address biosimilars and the opportunities for the future.
Learning Objectives: Discuss the current status of biosimilars (focusing on US, EU, and Asia) Identify challenges and opportunities for the future.