Current Approaches for ADME Characterization of Antibody-Drug Conjugates: An Industry White Paper Running Title Current Approaches for ADME Characterization of ADCs

Abstract An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a highly potent drug molecule conjugated to a monoclonal antibody (mAb). As the number of ADCs in various stages of nonclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches to understanding the disposition of ADCs. In order to identify the key ADME issues worth examining when developing an ADC and to find optimal scientifically-based approaches to evaluate ADC ADME, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an "ADC ADME working group" in early 2014. This White Paper contains observations from the working group and provides an initial framework on issues and approaches to consider when evaluating the ADME of ADCs. DMD # 68049