Bio-Sourcing, Belgium


Francois-Xavier Frapaise (Xavier) holds a MD from the University of Paris and has over 40 years’ experience in the Pharma Industry (Sanofi, Abbott, Bayer, Merck, Grünenthal as well as in several start-ups) in different roles such as Board Member, VP R&D and Medical Affairs, CMO, CSO, and CEO.He has a degree in statistics and Business (INSEAD).
He has an extensive experience of international drug development (phase I to IV), and interaction with the FDA/EMA. One major focus of his experience is on the field of biosimilars development supporting companies such as Pfenex, Boehringer-Ingelheim, Merck KGaA, MundiPharma, Prestige BIO and Bio-Sourcing.
He is the author of a landmark publication (Biodrugs,2018) challenging the biosimilars clinical development paradigm and suggesting leveraging the orthogonal analytical methods for similarity assessment and reducing the burden of phase 3 trials; his position has recently been endorsed by MHRA and is being discussed at FDA/EMA level.


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