A Deep Dive into the FDA NAMs Road Map with Former Senior Management of the FDA
Translational risk remains a major challenge in oncology and immunology drug discovery. In oncology, the complexity of the tumor microenvironment and the growing diversity of therapeutic modalities—including antibody-drug conjugates (ADCs) and protein degraders—make it difficult to evaluate efficacy and predict clinical outcomes using conventional preclinical models. In immunology, disease heterogeneity and fundamental differences between rodent and human immune systems often limit confidence in target validation and candidate selection.
