The 146th Annual Meeting of the Pharmaceutical Society of Japan (Osaka)

Organizer: Akiko Ishii-Watabe (National Inst. Health Sciences), Mutsumi Suzuki (JPMA/Kyowa Kirin)

Therapeutic monoclonal antibodies (mAbs) have established as an excellent modality due to their high target specificity and low incidence of non-specific adverse reactions. The development of mAbs is further increasing by using the innovative antibody engineering technologies. While fundamental concepts for non-clinical evaluation of mAbs have been established as shown in ICH S6 guideline, in April 2025, the US FDA announced a policy to reduce animal-based nonclinical testing by promoting the use of New Approach Methodologies (NAMs), setting mAbs as the first target. Utilizing NAMs is expected not only to reduce animal testing but also to enable in vitro or in silico evaluation of toxicity difficult to assess in animals, thereby improving predictability of pharmacokinetics, efficacy and safety in humans. The adoption of NAMs is likely to accelerate rapidly both domestically and internationally. Consequently, we should undertake necessary technological development and conduct appropriate evaluations and justification regarding the suitability of NAMs. This symposium aims to share our current position and discuss future directions about non-clinical evaluation of mAbs by using NAMs.