Bio: Dr. Bianca Feyen is an Associate Scientific Director in Toxicology at Johnson & Johnson Innovative Medicine. She holds a Doctor of Veterinary Medicine (DVM) degree from the University of Ghent. Her career began in 2003 at the Faculty of Veterinary Medicine at the University of Ghent, where she worked in the Department of Reproduction, Obstetrics and Herd Health. During this period, she honed her expertise in veterinary medicine and animal science, which she would later apply to the field of toxicology. In 2005, she joined Johnson & Johnson Innovative Medicine as a study toxicologist, where she was entrusted with the responsibility of designing and overseeing in vivo general toxicology studies for both small molecules and biologics. She was engaged in multi-disciplinary teams within preclinical safety to provide scientific and technical expertise on drug development programs. Throughout her career at Johnson & Johnson, Bianca gained extensive experience conducting toxicology studies in minipigs. Her hands-on involvement and experience in this area led to her recognition as a subject matter expert in the field. Since 2001, she is serving as the EU head of the study toxicology group at Johnson and Johnson.

Abstract: Non-human primates (NHPs) are being utilized in drug development for assessing drug safety and efficacy due to their physiological and genetic similarities to humans. However, in recent years, ethical concerns, regulatory pressures, shortage and significant advancements in alternative testing methods have led to an increasing focus on minimizing NHP use in the pharmaceutical industry. Although NHP’s are not the default choice for non-rodent toxicology studies in small molecule programs, they are still regularly used, and they remain essential for biologics. This abstract explores the opportunities to reduce NHP use through a variety of innovative strategies, including advancements in study design, alternative recovery group strategies, minimizing in control group sizes/use of virtual controls/no controls, and the elimination of the need for two-species testing, alongside the continued development of alternative methodologies and the incorporation of alternative animal models such as the minipig, which has gained prominence as a replacement for NHPs in certain applications. Furthermore, the development of humanized animal models is another strategy aimed at reducing NHP use. These models, which involve genetically modified animals with human-like immune systems or organs, provide a closer approximation of human responses than traditional non-human models.