Meriam Kabbaj
Chief Technology Officer at GENFIT- Claim this Profile
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Bio
Experience
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GENFIT
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France
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Biotechnology
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100 - 200 Employee
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Chief Technology Officer
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Jan 2023 - Present
Switzerland
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Versantis
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Switzerland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Co-founder, Chief Operations Officer, Chairman of the Board
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Mar 2015 - Nov 2023
Zürich Area, Switzerland Strategic as well as operational responsibility for all Versantis activities: • Collaborate with consultants and key opinion leaders to optimize early development strategies for advancing the company’s technology from R&D to pre-clinical stages and clinical Proof-of-Safety / Proof-of-efficacy (POC); • Provide strategic assessment of new indication opportunities for the development product. • Prepare and / or direct the preparation of early development plans, protocols… Show more Strategic as well as operational responsibility for all Versantis activities: • Collaborate with consultants and key opinion leaders to optimize early development strategies for advancing the company’s technology from R&D to pre-clinical stages and clinical Proof-of-Safety / Proof-of-efficacy (POC); • Provide strategic assessment of new indication opportunities for the development product. • Prepare and / or direct the preparation of early development plans, protocols, Investigator Brochure (IB), Clinical Study Reports (CSRs), and Standard Operating Procedures (SOPs); • Provide clinical / medical support, including CRO selection, site/investigator selection, and safety monitoring; • Manage regulatory interactions with Swiss Medic, EMA, and FDA as well as oversee Clinical Trial Application (CTA) / Investigational New Drug (IND) Application; • Give project updates at Board meetings. Mission statement: Versantis is developing a versatile antidote (VS-01), capable of rapidly removing a variety of toxic agents from the organism to save patients from metabolic intoxications and drug overdoses. Its mission is to improve and save lives of patients worldwide through innovative technologies. Show less
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Celerion
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Manager, Clinical Pharmacology Sciences
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Mar 2010 - Dec 2013
Zürich Area, Switzerland Achievements: • Strengthened the Clinical Pharmacology team in Europe; • Reviewed over 100 protocols with alternative designs for early phase clinical trials; • Was involved in the early stage development program of more than 100 molecules in various therapeutic area, provided key modelling and simulation analysis and wrote clinical study reports for submission to FDA, EMA, and TPD; • Supported generic, small biotech and large pharmaceutical companies to make final… Show more Achievements: • Strengthened the Clinical Pharmacology team in Europe; • Reviewed over 100 protocols with alternative designs for early phase clinical trials; • Was involved in the early stage development program of more than 100 molecules in various therapeutic area, provided key modelling and simulation analysis and wrote clinical study reports for submission to FDA, EMA, and TPD; • Supported generic, small biotech and large pharmaceutical companies to make final go-no-go decisions; • Last publication: Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarisation: results of a thorough QT study (TQTS) with QT-concentration analysis. B. Tyl, M. Kabbaj, S. Azzam, A. Sologuren, R. Vaiente, E. Reinbolt, K. Roupe, N. Blanco, B. Wheeler. Journal of Clinical Pharmacology, 2012; 52:893-903. Show less
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MDS Pharma Services
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United States
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Senior Manager, Clinical Pharmacology Sciences
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2009 - Mar 2010
Zurich, Switzerland Main responsibilities at Celerion included: • Leading all the operational aspects of Early Phase studies and supporting multi-disciplinary scientific teams responsible for the projects deliverables • Providing Clinical Study Reports according to timelines, with no compromises on operational and quality standards (ICH/GCP/SOPs and procedures) • Assisting in the maintenance of all supportive documentation and files and ensuring proper archiving • Participating in the development of… Show more Main responsibilities at Celerion included: • Leading all the operational aspects of Early Phase studies and supporting multi-disciplinary scientific teams responsible for the projects deliverables • Providing Clinical Study Reports according to timelines, with no compromises on operational and quality standards (ICH/GCP/SOPs and procedures) • Assisting in the maintenance of all supportive documentation and files and ensuring proper archiving • Participating in the development of material and leading scientific training • Leading development of standardized processes • Providing input into organizational improvements
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Senior PK Scientist II
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2007 - 2009
Montreal, Canada Area
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Senior PK Scientist I
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2004 - 2007
Montreal, Canada Area
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Process Development Scientist
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Oct 2003 - Oct 2004
Montreal, Canada Area Development of new processes for the manufacturing of APIs
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Education
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University of Montreal
PhD, Pharmacokinetics -
University of Montreal
MSc, Pharmaceutical Technology -
University of Geneva
DPharm, Pharmacy