Challenges and solutions when handling immune-mediated findings in NHP safety studies
Presenter: Stephanie Grote-Wessels, Senior Study Director and Immunotoxicology Expert at Covance Preclinical Science GmbH, Münster, Germany
Cynomolgus macaques are commonly used for the nonclinical safety assessment of medicinal products, particularly for biotechnology-derived products and oligonucleotide therapeutics. Their usage requires a science-based species justification and can be associated with numerous challenges originating from the pharmacological mode of action or anti-drug antibodies. This presentation, given by a leading expert in non-human primate toxicology, will provide assistance in determining the right species for nonclinical safety studies. Furthermore, it will assist in the diagnosis and management of morbidity associated with anti-drug antibodies. Finally, this presentation will give specific recommendations on the handling of studies with test articles that are intended to suppress the immune response.