Safety Considerations for the Development of Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) are a novel modality leveraging monoclonal antibody (mAb)-mediated delivery of a cytotoxic payload molecule to its target. Since the drug conjugated to mAb, typically a highly cytotoxic small molecule, can be released unconjugated in plasma and contribute to drug-drug interaction (DDI) potential, both the antibody and small molecule drug component are considered from the perspective of ADC safety. Numerous chemotherapies utilizing ADCs are being developed for treatment of advanced cancers, however, the regulatory guidance for evaluation of ADC DDI potential is not well established. This webinar will: Introduce the novel therapeutic modality of antibody-drug conjugates Summarize the mechanism of action and safety considerations for FDA-approved ADCs Describe drug interaction potential of ADC payloads currently in the clinic Outline experimental strategies for identification of drug interaction potential for novel small molecule ADC payloads Download a copy of the slides: https://info.bioivt.com/adc-wbr-mat About the Presenter Dr. Maciej Czerwinski has extensive experience in a broad range of ADME model systems including methods to drug-drug interactions between biologics and small-molecule drugs. Maciej received his PhD from the University of Maryland at Baltimore Medical School in the Department of Pathology. He conducted his doctoral thesis research in the Laboratory of Metabolism at the National Cancer Institute in Bethesda, followed by a postdoctoral fellowship at the Department of Pharmaceutics, University of Washington in Seattle. Dr. Czerwinski joined XenoTech in 1999 and was instrumental in developing the innovative products that were brought to the market as well as building out the research services. He also invented the CryostaX® single-freeze pooled hepatocyte product and currently serves on the XenoTech Consulting Services team at BioIVT.