Cecil Nick
Vice President @Parexel
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WORK HISTORY
Vice President @Parexel
EDUCATION
University of Cape Town
BSc
SKILLS
ABOUT CECIL NICK
Vice President (Biotechnology) at PAREXEL ConsultingBiochemistry graduate and regulatory professional with over 40 years\' experience specializing in the Clinical Devlopment of vaccines, monoclonals and other biological and biotech products. Supported 7 biosimilar marketing approvals and over 80 biosimilar Agency interactions in EU, US, Canada and RoW. Clinical development and regulatory support for novel anti-infectives and vaccines - COVID-19, influenza, RSV, HIV, UTI, dengue, phage therapy. Also endocrinology, rheumatology, haematology, oncology and other areasOffers extensive expertise to clients particularly with respect to vaccines, biosimilars, infectious diseases, 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. Some of over 30 publications:Nick, C.(2024). Streamlining biosimilar development based on 20 years’ experience. Expert Opinion on Biological Therapy, 24(7), 571–581. https://doi.org/10.1080/14••••••••12 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 -
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