RODEINA CHALLAND

CONSULTANT

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Rodeina, has 25 years of experience in healthcare, cancer research, and the pharmaceutical industry across a wide range of roles including clinical development strategies for biosimilars and serving as head of clinical operations globally. Experienced in all aspects of biosimilar development including global strategies, study design and regulatory agency discussions (Europe, US, Japan, Australia, Singapore, and South Korea) and has worked on 10 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, LMWH, growth hormones, FSH, Insulins, monoclonal antibodies and more recently biosimilar orphan drugs. For over 10 years directed the conduct of Phase I-IV clinical trials, including large pivotal biosimilar multi-national, multi-center trials and several post-authorization safety studies for biosimilars. In her role in PRA, she is currently working on several Biosimilar programs in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV). She has also represented PRA as a speaker in several International Biosimilar conferences across the Globe. While in the Pharmaceutical industry she was the company’s representative in several EMA consultations with regard to the development of the EMA Biosimilar Guidelines and was a member of the European Biopharmaceutical Group, which is a sector of the European Generic Association.