Steven Spanhaak Email and Phone Number
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Apart from his specific background in the area of Immunotoxicology and significant expertise in preclinical compound development, over the years Steven developed the following additional occupations/passions:1)regulatory toxicology, i.e. especially supporting the improvement of the regulatory environment, and 2)preclinical safety data management, an essential link in support of safety assessment and innovation of preclinical safety testing. During his period at Janssen/J&J (2003-2021) he has been leading several activities related to: (1) improvement of the regulatory environment, (2) global impurity management, (3) nonclinical safety data management. He held several project management positions during his 13 years (1988-2000) at TNO, where he directed research in the area of Immunotoxicology/pharmacology and headed the immunotoxicity laboratory. Thereafter, expanding his toxicological expertise in the more general direction of drug development, he held a position as Safety Assessor and Global Preclinical Project Leader in the CNS and Immunology therapeutic areas at Organon.Steven joined J&J PRD, in 2003 as a Principal Scientist in the global preclinical development organization. During the years he gradually took on and substantially expanded a leadership role in the area of regulatory toxicology. From 2004 to 2018 he has been chairing the European Federation of Pharmaceutical Industries and Associations (EFPIA) Preclinical Development Expert Group. Under his leadership this group of senior preclinical safety experts, representing the various Pharma companies in Europe, was quite successful in their interactions with Regulatory Authorities resulting in the improvement of many guidelines. Steven was the EFPIA topic leader in the ICH expert working groups that drafted the recent ICH S8 (immunotoxicity), ICH M3 (timing of required nonclinical safety studies for the conduct of clinical trials), ICH S5 (developmental toxicity testing and the ICH M7 (genotoxic impurities) guidelines.Specialties: Immunotoxicology, Safety Assessment Pharmaceuticals, Regulatory Toxicology, Impurity Management, EFPIA, ICH
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Director And Founder - Senior Consultant - Spanhaak Consultancy ServicesSpanhaak Consultancy ServicesApeldoorn, Ge, Nl
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Director/Founder - Senior Consultant - Spanhaak Consultancy ServicesSpanhaak Consultancy Services Dec 2021 - PresentNetherlandsSteven Spanhaak has more than 30 years’ experience in non-clinical drug development.He is knowledgeable, pragmatic, and skilled in problem-solving. He graduated as a biologist and became a trained immunotoxicologist/study director. In his further carrier he subsequently participated in many early and late drug development programs as the nonclinical safety leader. During the past 15 years he has developed a unique expertise regarding impurity management and excipient safety.In the same period, Steven chaired the European Federation of Pharmaceutical Industries and Associations (EFPIA) Preclinical Development Expert Group (PDEG) from 2004 till the end of 2018.Under his leadership this group of senior preclinical safety experts, representing the variouspharmaceutical companies in Europe, interacted with several Regulatory Authorities resulting in theimprovement/optimization of many guidelines. Furthermore, Steven was the EFPIA topic leader inseveral ICH expert working groups which drafted or revised the following guidelines: ICH S8- immunotoxicity, ICH M3(R1)-timing of nonclinical safety studies required for the conduct of clinicaltrials, ICH S5(R3)-reproductive and developmental toxicity and the ICH M7 and ICH M7(R1)-genotoxic impurities.Next to building an extensive professional network, Steven has developed an in-depth knowledgeregarding regulatory requirements in general and more specifically nonclinical safety.
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Senior ConsultantD2Team Jan 2022 - PresentNetherlandsSteven Spanhaak has more than 30 years’ experience in non-clinical drug development. He is knowledgeable, pragmatic, and skilled in problem-solving. He graduated as a biologist and became a trained immunotoxicologist/study director. In his further carrier he subsequently participated in many early and late drug development programs as the nonclinical safety leader. During the past 15 years he has developed a unique expertise regarding impurity management and excipient safety. In the same period, Steven chaired the European Federation of Pharmaceutical Industries and Associations (EFPIA) Preclinical Development Expert Group (PDEG) from 2004 till the end of 2018. Under his leadership this group of senior preclinical safety experts, representing the various pharmaceutical companies in Europe, interacted with several Regulatory Authorities resulting in the improvement/optimization of many guidelines. Furthermore, Steven was the EFPIA topic leader in several ICH expert working groups which drafted or revised the following guidelines: ICH S8- immunotoxicity, ICH M3(R1)-timing of nonclinical safety studies required for the conduct of clinical trials, ICH S5(R3)-reproductive and developmental toxicity and the ICH M7 and ICH M7(R1)- genotoxic impurities.Next to building an extensive professional network, Steven has developed an in-depth knowledgeregarding regulatory requirements in general and more specifically nonclinical safety. -
Scientific Director Ncs - Global Head Regulatory Policy & Impurity ManagementJohnson & Johnson Jun 2015 - Nov 2021Beerse, Belgium -
Director, Senior Scientific AdvisorJohnson & Johnson 2003 - Jun 2015
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Chair Of The Preclinical Development Committee (Former Safety Ad Hoc Group)Efpia May 2004 - Oct 2018 -
Compound Coordinator/ Safety Assessor, Department Toxicology And Drug DispositionNv Organon 2000 - 2003 -
Project Manager/ Laboratory Head Immunotoxicology, Division ToxicologyTno Quality Of Life 1988 - 1999 -
Group Leader / Research Technician, Cytology Dept Clinical Chemistry Laboratory, Sophia HospitalIsala Klinieken 1977 - 1987
Steven Spanhaak Skills
Steven Spanhaak Education Details
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Biology -
Laboratoriumschool Hengelo(O)Clinical Chemistry -
Military Service
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Clinical Chemistry
Frequently Asked Questions about Steven Spanhaak
What company does Steven Spanhaak work for?
Steven Spanhaak works for Spanhaak Consultancy Services
What is Steven Spanhaak's role at the current company?
Steven Spanhaak's current role is Director and Founder - Senior Consultant - Spanhaak Consultancy Services.
What is Steven Spanhaak's email address?
Steven Spanhaak's email address is de****@****live.be
What schools did Steven Spanhaak attend?
Steven Spanhaak attended Utrecht University, Laboratoriumschool Hengelo(O), Military Service, Saxion University Of Applied Sciences.
What skills is Steven Spanhaak known for?
Steven Spanhaak has skills like Toxicology, Immunology, Pharmaceuticals, Regulatory Affairs, Pharmacology, In Vitro, Research, R&d, In Vivo, Glp, Risk Assessment, Regulatory Submissions.
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