Leah Christl

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Leah Christl

Amgen, US

Executive Director, Global Regulatory and R&D Policy, JAPAC Lead and Global Biosimilars

Dr. Christl is currently an Executive Director of Global Regulatory and R&D Policy at Amgen.  She supports Global Biosimilars and serves as the JAPAC Lead. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs (OND) in the FDA's Center for Drug Evaluation and Research (CDER). In this role, she developed and led CDER’s approach to implementation of the Biologics Price Competition and Innovation Act (BPCIA) of 2009.  Dr. Christl was also the director of the Therapeutic Biologics and Biosimilars Staff (TBBS) at the US FDA and served as a scientific, regulatory, and policy expert to FDA, HHS, and external stakeholders, on biosimilar products. Dr. Christl also engaged in international activities by serving as a CDER and FDA strategist and lead for international activities related to biosimilars, including serving as FDA lead for the FDA-EMA-Health Canada-PMDA biosimilars cluster and the International Pharmaceutical Regulators Programme – Biosimilars Working Group. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston.

 

 

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