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Jerome THEVENON

MARCY L'ETOILE

En résumé

Phatophy is a Contract Research Organisation established in Lyon since 1981. Phatophy offers to sponsors and clients from human and veterinary pharmaceutical/biological companies, biotechs and academic laboratories comprehensive services from proof of concept to regulatory studies throughout the whole development of your candidates, projects, products, medical devices and feed additives.
Phatophy has developed expertise and excellence in different activities:
• Pharmaceutical development (analytical development, quality control, stability studies)
• InLife studies (preclinical studies)
• BioAnalysis
• Regulatory Affairs and Project Management
Phatophy is GLP (BPL) accredited by ANSES French National Agency. Phatophy has Research Tax Credit (“Crédit Impôt Recherche / CIR”) agreement for the coming years. This agreement, obtained from the French authorities, permits to the clients working with Phatophy to refund R&D expenses to their corporate taxes. Phatophy is a member ofArray network.
Phatophy is a Phatobio Company and operates from facilities based in Rhone Alpes region (France).
www.phatophy.com - contact@phatophy.com


Mes compétences :
Gestion de projet
Management
Affaires réglementaires
Recherche clinique
Biologie
R&D vaccins
Etudes pré-cliniques
Analyses biologiques
Industrie pharmaceutique

Entreprises

  • Phatophy / Phatobio SAS - Directeur Général / CEO

    2014 - maintenant Fondateur et Président de Phatobio SAS, Société ayant rachetée en octobre 2014 la Société Phatophy, désormais EURL à associé unique Phatobio SAS.
    Phatophy est une CRO proposant 4 types de services : - des études pré-cliniques pour tester des candidats, produits médicamenteux, produits diététiques ainsi que des dispositifs médicaux. - le développement et la validation de méthodes analytiques pour le dosage de molécules (analyses pharmaceutiques) dans des produits pharmaceutiques (principes actifs, produits finis) ou dans des matrices biologiques (bioanalyses) à des fins d’études de pharmacocinétique, d’efficacité, de résidus, … - des contrôles de qualité sur les produits finis (aliments médicamenteux, médicaments ou autres), avec développement et validation de méthodes analytiques et études de stabilité, - l’expertise et la rédaction de dossiers réglementaires, le conseil en développement de vaccins vétérinaires.

  • Ceva santé animale - Bacteriological & Immunological Development Director

    2011 - 2014 - Identifies and champions innovative approaches to applicable vaccines research and development that will benefit and create value to Ceva’s customers and Ceva
    - Assesses and validates internal and external recommendations on new vaccine candidates and ensure that new vaccine candidates are aligned with the applicable franchise strategy
    - Creates and develops a complete range of differentiated and recombinant vaccines for the global vaccine market, both new bacterial products and product extensions
    - Determines priorities and areas of focus for Bio R&D programs and projects
    - Ensures that BioR&D activities are linked to market needs and meet Ceva’s strategic and commercial criteria.
    - Ensures that vaccines under development can be successfully transferred to full-scale production
    - Leads developers in the platforms of Bact. R&D to develop Swine/poultry/cattle bacterial and subunit vaccines
    - Manages all aspects of bacteriological development projects
    - Collaborates with RA for registration strategy and timelines for the dossier submissions
    - Provides post-license support
    - Builds up and follows the budget of the Directorate
    - Improves and manages the intra and inter-departmental HR collaboration

    COGLAPIX, HYOGEN, COXEVAC, TRANSMUNE, LANDAVAX...

  • Ceva Sante Animale - Global Biological Project Management and R&D QA Director

    2004 - 2011 • Head of Biological Project Group.
    • Head of Clinical Development Group, GLP and GCP compliance.
    • Biological Project Portfolio Management; Responsible of Bio R&D Budget & Expenses; ~16.5 M€ in 2011, preparation, consolidation and monitoring, ~105 employees in R&D at Budapest + US, Japan R&D centres.
    • Set-up of Project Management Tools and Methodology (Specifications, development plan, planning, costing, project cost reporting…).
    • Head of Biological R&D Quality Assurance Unit (GLP certified).
    • Member of Ceva-Phylaxia Board of Directors, of the Biological Management Team, Offer Conception & Research Committees (Corporate Level).
    • Scientific coordinator for NEOTOK Project (Pôle de compétitivité)

  • MERIAL - Chef de Projet Vaccin

    Lyon 1995 - 2004 HYORESP, HYACTIN, PASTOBOV, HAEMOVAX, PARVORUVAX, LEPTORABISIN,...
    ZACTRAN

  • Rhône Merieux - Responsable du Laboratoire R&D Bactériologie

    1992 - 1995 Culture, caractérisation et production d'Antigènes bactériens, Laboratoire de Biochimie, développement analytique des méthodes de contrôles en cours de process et sur produits finis ; PASTOBOV, MERILYM, HAEMOVAC, TRIVACTON, NEOCOLIPOR, MILOXAN...

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