Ernst Soethout Email and Phone Number
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Managing director of Virtuvax providing essential guidance for development of vaccines and biologics from preclinical until marketing. Key strengths include:Strategy designDesign 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
Virtuvax
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- virtuvax.nl
- Employees:
- 1
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Managing DirectorVirtuvax Jan 2016 - PresentThe NetherlandsVirtuvax provides essential guidance for development of vaccines and biologics from preclinical until marketing. Virtuvax consults big pharma, biotech companies, public institutes and universities.
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Project Manager Quality Assurance A.I.Rivm National Institute For Public Health And The Environment Jan 2023 - Dec 2023Bilthoven, Utrecht, NetherlandsI was responsible for updating the Quality Management System of the Reference Laboratory for Poliovirus within the National Institute for Public Health and the Environment (RIVM), the Netherlands. Implementing a risk-based approach, this project aimed to ensure adherence to the Global Action Plan for Poliovirus Containment (GAP-IV) requirements issued by the World Health Organization in 2022. In this one-year project, my responsibilities included updating the relevant QMS procedures, preparing the organization for and hosting of an international audit, and pursuing ICC status with the WHO, for which so far only one laboratory has qualified globally. -
Head Tuberculosis Control A.I.Ggd Amsterdam Jun 2021 - Jul 2022Amsterdam, North Holland, NetherlandsResponsible for daily management and restructuring business operations of the department of tuberculosis control, the rate of absence due to illness was reduced, the department logistics were restructured leading to significant gains in working efficacy and a restructuring of finances was realized. -
General Manager A.I.Mucosis Sep 2017 - Oct 2019Groningen, NetherlandsExecuted general management of Mucosis B.V. on behalf of the Trustee, Mr. Holtz LLM (Groningen, The Netherlands) who was charged with governance of the company by the Court after declaring bankruptcy. Tasks included business development, R&D and management of intellectual property. In collaboration with Imperial College, London, the ongoing phase I clinical trial to determine safety and efficacy of the Mucosis needle-free nasal spray vaccine against respiratory syncytial virus (SynGEM) was finalized. The clinical data were published in AJRCCM showing that SynGEM is safe and immunogenic in healthy adults and capable of inducing persistent antibody responses in humans. Intellectual property protecting the RSV vaccine technology was established in patent rights, for which grantings with broad claims were obtained a.o. in USA and Japan.
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Innovation ManagerIntravacc Jan 2013 - Dec 2015Realized partnering with biotech and pharmaceutical companies. Skills: innovating new products, business development; in- and outlicensing, partnering and networkingwww.intravacc.nl -
Innovation ManagerRivm National Institute For Public Health And The Environment Jan 2011 - Dec 2012My responsibility is scientific business development, deal-making and technology transfer of our knowledge and expertise in vaccine R&D. Realizing new collaborations at the National Institute of Public Health department of Vaccines, based on a century of experience in vaccine development.
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Program ManagerNetherlands Vaccine Institute 2005 - Dec 2011Bilthoven, Utrecht, NetherlandsResearch group leader and program manager of international consortium IMECS (http://www.imecs-flu.eu/), funded by the EU under the FP7 program. Responsible for vaccine development up to clinical validation; adviser of European Medicines Agency (EMA); accountable to EU for 4M euro budget, scientific output and management of partners form EU, US and Asia -
Project ManagerNvi 2002 - 2005Bilthoven, Utrecht, NetherlandsManager and senior scientist, responsible for assay development and identification of immune responses against infectious diseases (respiratory syncytial virus, influenza). Validated, published and patented various assays applying cellular, humoral and analytical (LC-MS) technologies. Designed and executed human phase IV clinical study and developed a human preclinical model which enables the ex-vivo evaluation of cellular innate immune responses.
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PhdUtrecht University 1998 - 2002 -
VeterinarianSpoedkliniek Voor Dieren Amsterdam B.V. 1996 - 2001
Ernst Soethout Skills
Ernst Soethout Education Details
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Executive Education Strategic Negotiations -
Biobusiness Masterclass -
Advanced Course In Vaccinology -
Art 9 Certification According To The Dutch Law On Animal Experimentation
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Veterinary Medicine
Frequently Asked Questions about Ernst Soethout
What company does Ernst Soethout work for?
Ernst Soethout works for Virtuvax
What is Ernst Soethout's role at the current company?
Ernst Soethout's current role is Managing Director Virtuvax | consultant vaccine development.
What is Ernst Soethout's email address?
Ernst Soethout's email address is er****@****ail.com
What schools did Ernst Soethout attend?
Ernst Soethout attended Harvard Business School, De Baak En Niaba, University Of Geneva, Utrecht University, University Of Utrecht.
What skills is Ernst Soethout known for?
Ernst Soethout has skills like Vaccines, Biotechnology, Immunology, R&d, Life Sciences, Microbiology, Lifesciences, Infectious Diseases, Clinical Development, Molecular Biology, Business Development, Biopharmaceuticals.
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