Meriam Kabbaj

Chief Technology Officer at GENFIT
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Zurich, CH

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
You need to have a working account to view this content.

Experience

    • France
    • Biotechnology
    • 100 - 200 Employee
    • Chief Technology Officer
      • Jan 2023 - Present

      Switzerland

    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Co-founder, Chief Operations Officer, Chairman of the Board
      • 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

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Manager, Clinical Pharmacology Sciences
      • 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

    • United States
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Senior Manager, Clinical Pharmacology Sciences
      • 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

    • Senior PK Scientist II
      • 2007 - 2009

      Montreal, Canada Area

    • Senior PK Scientist I
      • 2004 - 2007

      Montreal, Canada Area

    • Process Development Scientist
      • Oct 2003 - Oct 2004

      Montreal, Canada Area Development of new processes for the manufacturing of APIs

Education

  • University of Montreal
    PhD, Pharmacokinetics
    2000 - 2005
  • University of Montreal
    MSc, Pharmaceutical Technology
    1998 - 2000
  • University of Geneva
    DPharm, Pharmacy
    1991 - 1997

Community

You need to have a working account to view this content. Click here to join now