“Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products”

This chapter describes common "pitfalls" in biologics drug development at the pre-Investigational New Drug (pre-IND) and Investigational New Drug (IND) stages to help biologics drug developers avoid potential issues. A pre-IND and subsequent IND submission for a biologic drug require multiple complex elements to come together in a timely fashion. For nonclinical deliverables, the key is to provide sufficient in vitro and in vivo datasets and conduct high-quality Good Laboratory Practices (GLP)-compliant toxicology studies that support the rationale for first-in-human (FIH) dosing. These studies should carefully consider the target, expected mechanism(s) of action (MOA), as well as potential on- and off-target effects that may translate to humans. Through case studies of biologic products with different modalities and indications, key considerations are provided to navigate common drug development issues and help ensure a high-quality nonclinical package that supports FIH clinical trials and beyond.