- PhD in Agricultural Sciences.
- R&D experience in: drug metabolism and pharmacokinetics (DMPK); preclinical drug development; enzyme kinetics and bioanalysis; protein purification; biological receptor assays; cell culture; modelling and simulation of biological/biochemical phenomena; .
- Author or co-author of 16 publications in peer reviewed journals and of 23 conference posters.
- Project management; capable of handling multiple priorities.
- People management.
- Analytical, organizational and problem solving skills; result-oriented.
Scientific Advisor Regulatory Affairs Brussels, Belgium
Since December 2015
- Monitor of studies (physicochemistry, analytical method validation, residues, metabolism, operator exposure) for registration of plant protection products; scientific advise
- Writing of scientific summaries and making risk assessments according to EU guidelines
- Project management
Principal Scientist (latest job title - DMPK (drug metabolism and pharmacokinetics) Department Beerse, België
December 1992 --- September 2010
Ended due to a global reorganisation
- Study director or principal investigator for in vitro/in vivo preclinical ADME (absorption, distribution, metabolism, excretion) and mechanistic toxicology studies; study monitor for outsourced studies; familiar with OECD Guidelines of GLP.
- Membership/leadership in drug project and cross-functional teams (centre of expertise on drug-drug interactions, in vitro–in vivo extrapolation and enzyme reaction phenotyping; study outsourcing).
- Project management: DMPK representative of allocated projects.
- Scientific input: optimization of existing procedures and implementation of novel assays (including automation of enzyme assays); scientific lectures; consultation on technical/scientific issues to colleague study directors and team members; scientific support of dossiers at the occasion of questions from regulatory
- Scientific writing: author and reviewer of preclinical protocols, study reports and technical notes.
- People management: coaching/ leadership of new study directors, students and lab technicians.
- Liaise with external collaborators (J&J US) and researchers at CROs and academic institutions.
- Supervision of about 270 preclinical DMPK studies.
- Appropriate contributions for registration of new human (CNS, HIV, oncology, infection, Hep C, GI, Alzheimer) and veterinary (obesity in dog) drugs and for re-registration of a postharvest fungicide.
- Johnson & Johnson Standards of Leadership Award for partnership on the submission of a new oncology drug.
- Peer-reviewed publications; poster presentations at scientific symposia.
Research Assistant (Department of Veterinary Physiology) Ghent, België
August 1990 --- December 1991
- Development and validation of a radio-ligand beta2-adrenoceptor binding assay with low aspecific binding, suitable to assess the milk-ability of dairy cows.
- Peer-reviewed publication
Research Assistant (Department of Agro-Engineering) Leuven, België
June 1989 --- July 1990
- Supervision of a research project aimed at the development of an on-line system in the milking machine to detect subclinical mastitis in dairy cows.
- Inventory of subclinical mastitis indicators in milk. Evaluation of the predictive value of selected physiological and biochemical parameters.
Research Assistant (Department of Medical Research) Leuven, België
October 1981 --- July 1988
- Development and validation of a radio-assay to study hepatic bilirubin metabolism.
- Evaluation of mathematical models for kinetic and binding equilibria of lipophilic substrates and ligands with membrane-bound enzymes and acceptors, in which linear solute partition in the membrane is taken into account.
- PhD thesis.
- Peer-reviewed publications.
Trainee (Rega Institute for Medical Research) Leuven, België
March 1981 --- June 1981
- Hybridoma culture and screening for anti-interferon-gamma monoclonal antibodies.
Analytical thinkingOptimismProblem solvingInterest in knowledgeInnovative thinkingEfficiencyCuriosityCritical thinkingCollaborationAttention to detailProactivity
R&D Scientific writingData AnalysisDrug development processDrug InteractionDrug metabolismEarly development stageEnglishGenetic polymorphismGood Laboratory Practice (GLP)HPLCIn VitroIn VivoIt skillsKnowledge of the drug development processLaboratoryLaboratory study designPharmacokineticsPowerPointPre-clinical researchProcess improvementProblem-solving methods and troubleshootingPreclinical regulations and practicesPosition PaperProtocolR&DRate of drug eliminationSDS-PAGEScientific methodologySOPTeam LeadershipToxicology
Skills and Expertise
Present data at congressPublication of articlesReview study protocolsShipment of biological specimenSolve problems Analyze data Create SOPs Develop protocols Control data Guide students Interpret data Report data Write papersAttend seminarsAdjust methodsAnalyze dataCoachCollaborate with project teamConduct literature searchesConduct research at universitiesDesign studyDirect co-workersEvaluate protocolsExecute scientific projectsInteract with CROsInteract with pre-clinical scientistsManuscript preparation and reviewNegotiate protocol details Oral presentationOrganise meetingsPrepare final report
Ph.D. in Agricultural Sciences from Catholic University of Leuven in 1992
Agricultural Engineer in Agricultural Sciences from Catholic University of Leuven in 1980
Training and Certification
Hands-on Toxicology in 2011 Certification
Population-based in vitro-in vivo extrapolation of ADME properties in 2008 Certification
Design of experiments in chemical and related industries in 2007 Certification
Interpretation of MS/MS spectra in 2004 Certification
Molecular Biological Techniques in 2002 Certification
Pharmacokinetics in 2001 Certification
Expert has 16 publications (Will be avalible with full profile)