Steven Spanhaak (MSc, BSc) 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 (PPDEG) 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 knowledge regarding regulatory requirements in general and more specifically nonclinical safety.