governance

Jean-Pierre Fonta

PhD CMC expert

Jean-Pierre graduated as an engineer from Centrale Lille (France) and completed his biotechnology education with a MS and a PhD in Chemical and Biochemical Engineering from SUNY Buffalo (USA) and Business education with an MBA from Babson College (USA) followed by business trainings from IMD (Switzerland) and INSEAD (France).
He has more than 30 years of international experience in multiple operational and
strategic leadership positions within several leading international biotech companies.

Dr. Brigitte Happ

PhD Regulatory expert

With more than 25 years of experience in the biotechnology and pharmaceutical industry, Brigitte Happ has held various positions at Serono and Merck Serono. Expert in regulation with strategic and operational expertise for small and medium-sized enterprises, Brigitte’s strong scientific background allows her to bridge the gap between research and development.

Dr Jasna Knezevic

MD, MSc, Medical Safety Expert

Jasna is a pharmaceutical physician (Dipl. Pharm. Med), and an Assistant Professor in Pediatrics. Over more than 20 years, Jasna has served as an expert in pharmacovigilance as Medical Director at GSK Global Clinical Safety and Pharmacovigilance.
Jasna is experienced in proactive safety assessment, including the detection and evaluation of safety signals, and risk management activities for developing compounds and marketed products.

Dr. Mario Pellegatti

Non-clinical
Pharmacokinetics expert

Mario has spent more than 30 years in pharmaceutical industry, at GSK, where he managed the DMPK department and oversaw the project portfolio including multiple projects/programs, some of which succesfully reached registration and marketing authorization.
Mario is the author of more than 60 publications, and currently provides his expertise in pharmacokinetics and drug development to small and medium-sized biotechnology companies.  He is also the co-founder of a start-up company, developing  a drug with a new mechanism of action in diseases in CNS (Central Nervous System).

Nigel Roome

MSc, PhD
Non clinical toxicology expert

Nigel Roome is expert in Toxicology and Toxicologic Pathology with more than 35 years experience. He worked with Sanofi for 30 years across several roles: toxicologic pathologist, study direction, project management, regulatory dossier preparation, submission and interactions with regulatory authorities.
Nigel has served as an expert consultant on all aspects of preclinical development for both small molecule and biological pharmaceuticals, with several biotech and pharmaceutical companies in addition to NGOs and is involved in teaching at university and scientific society training courses.

Kuste Biopharma

2 bis rue Tête d’Or
69006 Lyon

5 rue de Castiglione
75001 Paris

+33 (0) 481 133 530
contact@kustebiopharma.com

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