Experience

XENOTHERA

• France
• Biotechnology Research
• 1 - 100 Employee

• Chief Scientific Officer

  • May 2023 - Present



SANIFIT Therapeutics/CSL Vifor

• Vice President Research And Development

  • Jul 2018 - Present

  Palma, Baléares, Espagne Leading pipeline expansion programs: - Identification of new therapeutic indication: PAD in CKD patients - Leading drug discovery program from hit identification to successful follow up selection - Regulatory drug development



Genoscience Pharma

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Scientific Officer

  • May 2012 - Jul 2018

  Marseille Area, France - Elaboration of phenotyping screening strategy, lead selection and candidate nomination: Discovery of two new anticancer agents with original molecular target. - Lead for interaction with regulatory authorities (SA, ODD, pIND), CRO’s, consultants and financial Partners. -Preparation of IND and CTA packages for trial approval. - Definition and coordination of regulatory and preclinical activities (CMC, Pharm-Tox-DMPK) with clinical interface (10 direct hierarchical… Show more - Elaboration of phenotyping screening strategy, lead selection and candidate nomination: Discovery of two new anticancer agents with original molecular target. - Lead for interaction with regulatory authorities (SA, ODD, pIND), CRO’s, consultants and financial Partners. -Preparation of IND and CTA packages for trial approval. - Definition and coordination of regulatory and preclinical activities (CMC, Pharm-Tox-DMPK) with clinical interface (10 direct hierarchical reports). -Establishment of scientific collaboration programs with academics and CROs. - Presentation to scientific, to potential industrial partners or venture capital funds. Show less



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Team Leader Preclinical Candidate Selection

  • Jun 2009 - May 2012

  - Drug metabolism and pharmacokinetics project and team management (11 staff) - Lead Optimization and Clinical candidates’ selection - DMPK and Toxicology representative in project teams (CNS/Fibrosis and Retinopathy) in close partnership with Bioanalysis and pharmacology project leads - Management of CROs externalized PK/TK studies, in compliance with regulatory standards - Close collaboration and interaction with other site of research of solvay legacy in Germany and… Show more - Drug metabolism and pharmacokinetics project and team management (11 staff) - Lead Optimization and Clinical candidates’ selection - DMPK and Toxicology representative in project teams (CNS/Fibrosis and Retinopathy) in close partnership with Bioanalysis and pharmacology project leads - Management of CROs externalized PK/TK studies, in compliance with regulatory standards - Close collaboration and interaction with other site of research of solvay legacy in Germany and Netherlands, performing in vivo Pk, Tox and metabolism studies for other research sites, in rodents and non-rodent species - Management, planning, implementation and follow up of in vivo pharmacokinetics and preliminary Tox studies and technologies (animal experiments) - Prediction first dose in human - Written and data synthesis related to internal and external needs (IB et IMPD) Show less



Trophos/Roches

• Head of Pharmacokinetics and Toxicology Development

  • Aug 2007 - May 2009

  - To act as Project Leader: Management, planning, implementation and follow up of non-clinical and clinical pharmacokinetics, and toxicology studies (GLP or non GLP) - Analysis, interpretation, written and oral communication of internally and externally pre-clinical and clinical pharmacokinetics data. - DMPK representative in project team in development: designing, interpreting and reporting pharmacokinetic and pharmacokinetic phase of clinical studies - Management and… Show more - To act as Project Leader: Management, planning, implementation and follow up of non-clinical and clinical pharmacokinetics, and toxicology studies (GLP or non GLP) - Analysis, interpretation, written and oral communication of internally and externally pre-clinical and clinical pharmacokinetics data. - DMPK representative in project team in development: designing, interpreting and reporting pharmacokinetic and pharmacokinetic phase of clinical studies - Management and design of clinical and pre-clinical studies closely with CRO's for preclinical and clinical studies - PK/PD modeling & simulation for selection of dose and dosing schedule for clinical studies, inculding first dose in human prediction - To participate actively in writing the regulatory documents for the non-clinical and clinical sections (IB/IMPD), Preparation and participation in meetings with regulatory authorities and due diligence. Show less



Avogadro/Eurofins

• Pharmacokinetics and Bioanalysis Project Leader

  • Apr 2006 - Jul 2007

  - Planning and implementation of R&D studies under GLP conditions in zootechny, bioanalysis, pharmacodynamics and pharmacokinetics (tolerance, residues, pharmacokinetics, ADME, bioequivalence, efficacy and analytical development and validation). - Scientific and technical advice and team management. - Participated in animal unit and bioanalysis department management - Written documents related to study (study plan, report,….) - Management of communication with sponsors… Show more - Planning and implementation of R&D studies under GLP conditions in zootechny, bioanalysis, pharmacodynamics and pharmacokinetics (tolerance, residues, pharmacokinetics, ADME, bioequivalence, efficacy and analytical development and validation). - Scientific and technical advice and team management. - Participated in animal unit and bioanalysis department management - Written documents related to study (study plan, report,….) - Management of communication with sponsors - Complex project management and results interpretation Show less



INRA French National Institute for Agricultural Research

• France
• Research
• 700 & Above Employee

• Researcher in Pharmacokinetics and Toxicology

  • Nov 2002 - Mar 2006

  Assessment of lipides effects on Macrocyclic Lactones Pharmacokintics (Ivermectin, Moxidectin, Eprinomectin and Doramectin) and their plasmatic transport by lipoproteins ( pharmacology and toxicology aspects). Mission : - Evaluation of lipids and lipoproteins role in Macrocyclic Lactones transport and bioavailability - Food effect study on bioavailability of Macrocyclic Lactones - Planning and setting up of comparative studies in bioavailability of different drugs - Development… Show more Assessment of lipides effects on Macrocyclic Lactones Pharmacokintics (Ivermectin, Moxidectin, Eprinomectin and Doramectin) and their plasmatic transport by lipoproteins ( pharmacology and toxicology aspects). Mission : - Evaluation of lipids and lipoproteins role in Macrocyclic Lactones transport and bioavailability - Food effect study on bioavailability of Macrocyclic Lactones - Planning and setting up of comparative studies in bioavailability of different drugs - Development of liposome formulations - Participate in animal unit and laboratory management (advice elected member). - Written documents related to study (study plan, report,….) Show less