Biography

Dr. Cecil Nick is the Vice President (Biotechnology) at PAREXEL Consulting. Dr. Nick is a Biochemistry graduate and regulatory professional with over 30 years’ experience specializing in the clinical developments of biological and biotech products. He has supported 7 biosimilar marketing approvals and over 80 biosimilar Agency interactions in EU, US, Canada and RoW. De Nick offers extensive expertise to clients particularly with respect to biosimilars, comparability, clinical development, orphan drugs and training. Fellow of TOPRA and has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University MSc in Pharmaceutical Sciences courses and Biotech Module leader for the TOPRA MSc course. He was on the editorial panel of SCRIP Clinical Research. Some of over 30 publications: Nick, C., “Confronting the Challenges of Developing a Biosimilar Product,” ed. David Luscombe and Peter Stonier, Euromed Communications. Cecil Nick, Karl Ludwig Rost “Meeting the Challenges of Phase II Clinical Trials for Biopharmaceutical Products” Bioworld 2007. Nick, C. and Lassoff, P. “The Drug Device Conundrum” GCP Journal, (July 2008) Nick, C. “Biosimilars. Growing then Concept” Regulatory Affairs Journal, (Oct 2008), p671 - 6777

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Research Interest

Biosimilars, comparability, clinical development, orphan drugs.