Bio: Linhai Qu is a globally certified toxicologist (DABT, ERT, DCST) and safety pharmacologist (DSP), with over 18 years of experiences in academia, CRO, and pharmaceutical industry. He is experienced in nonclinical development of various of modalities with various indications.

Abstract: Evaluation of developmental and reproductive toxicity (DART) is normally conducted in rodents and rabbits. However, it is often very challenging for biotherapeutics when nonhuman primates (NHPs) are the only relevant species. Currently, the cynomolgus monkey (Macaca Fascicularis) is the predominant NHP species used for general toxicology and DART evaluation of biotherapeutics, especially for monoclonal antibodies. In addition, the pattern of immunoglobulin G (IgG) placenta transfer during gestation is comparable between human and cynomolgus monkeys. Under these circumstances, an ePPND study in cynomolgus monkey is recommended for evaluation of embryofetal, pre- and postnatal developmental toxicity of biotherapeutics. In light to the progresses in scientific and regulatory background as revised in ICH M3(R2), ICH S6(R1) and ICH S5(R3) guidelines, the ePPND study has evolved over the decade. This abstract focuses on the special considerations when conducting an ePPND study, including animal selection and husbandry, study design, special endpoints, etc. Due to the inherent expense and time commitment of an ePPND study, especially when considering the special considerations required for animal welfare and data integrity, meticulous planning and rigorous execution are paramount to ensure a successful outcome.