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Clinical - Part I
Session Chair(s)
Cecil J. Nick, MS
FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom
Jian Wang, MD, PHD
Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada
This session will cover the challenging clinical safety, efficacy and practice issues faced by manufacturers, regulators and healthcare professionals in developing, authorizing and prescribing biosimilars.
Speaker(s)
PKPD
Klaus Francke, MD, PHD
PAREXEL International, Germany
Medical Affairs Consultant
Demonstrating Equivalent Efficacy
Kerry B Barker, PHD
Pfizer Inc, United States
Senior Director Leadership, Bio-Therapeutics Research
Clinical Data Extrapolation
Carlos Sattler, MD
Sandoz Inc. (a Novartis Company), United States
VP, US Clinical Development and Medical Affairs