Ernst Soethout

Background

About Ernst Soethout

Managing director of Virtuvax providing essential guidance for development of vaccines and biologics from preclinical until marketing. Key strengths include: Strategy design Design of a development strategy with the end-point in mind: a target product profile (TPP) plus Quality-TPP (QTPP) following the principles of Quality by Design (QbD) as part of an integrated development plan (IDP) including milestones, objectives, risk assessment/alternative development options and delivery on time / budget. Pre-clinical, Chemistry, Manufacturing and Controls (CMC) and Clinical Drug Development - Non-clinical development program: pre-clinical efficacy and safety study design and execution, preclinical assay design, design of human pre-clinical studies - Biomarker development: assay design, standardization and analytical validation; test development in accordance with medical device regulations - Design of product development plan - Clinical studies:(assistance in) design and scientific writing of IMPD/IND; Pharmacovigilance: design and evaluation of phase IV clinical, CRO management Life cycle management - Technology transfer: product/technology evaluation, feasibility study design, gap assessment and risk management, design of in-licencing / out-licensing contracts and transfer package - Production process verification, analytic method life cycle management General expertises for interim assignments in life sciences requiring - Line management - Vendor management - Project management - Business development