Twan Ederveen
Assessor at College Ter Beoordeling Van Geneesmiddelen
Based in Wijchen, Netherlands
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Seniority
Staff
Department
Manufacturing & Production
Location
Wijchen
Industry
Pharmaceutical Manufacturing
Company size
502
Contact information
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t•••••••@cbg-meb.nl
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Background
About Twan Ederveen
A pharmacology / pharmacokinetics professional having 25 years experience in pharmaceutical R&D with both line management (> 20p) and multidisciplinary project management expertise. My experience extends from preclinical discovery research to clinical development and includes capability to establish new research concepts, to provide translational scientific and strategic support for selecting new preclinical drug candidates for further clinical development and to bring these into early clinical development (from First in Man up to clinical Proof of Concept) providing pharmacology and pharmacokinetic expertise input. My multidisciplinary cross-cultural team members see me as a committed, reliable, communicative and quick learning person with a high problem solving capacity. I enjoy finding creative solutions and find it challenging to formulate and execute follow-up steps to enhance development. Therapeutic area pharmacology expertise: Osteoporosis, Menopausal Complaints, Oncology (Breast, Prostate, Colon), Diabetes, Hypertension, BPH, contraception. Achievements: 24 Early Development Compounds, 2 patent applications and 57 peer reviewed publications. Specialties: Pharmaceutical R&D, translational pharmacology, designing in vitro and in vivo preclinical studies, biomarkers, toxicology, Clinical PKPD, First in Man, clinical study design (single, multiple dose, drug-drug interactions, bioequivalence, formulation, IND), initiate, monitor & evaluate PharmacoKinetics, PK modeling, Fixed Dose Combination, authoring CTD modules, Emerging Markets, interactions with regulatory authorities, ao FDA type C advisory, CRO’s, expert meetings. Line / people management (coaching, review, budget, resource and portfolio planning) Project management of multidisciplinary, cross-cultural teams as leader and member (Lead Optimisation, Early Development, inlicencing & task force teams).
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