Control Strategy Expectations in Early Clinical Phase Synthetic Oncology Programs: Two Global Regulatory Case Studies

A discussion on the regulatory chemistry, manufacturing, and control (CMC) strategy and the dialogue and response from global health authorities regarding the proposed impurity/degradant control strategy for two (2) accelerated oncology programs developed under the scope of ICH S9 is presented. While the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3A/Q3B requirements are generally not considered applicable for first-in-human or early phase drug substance and drug product specifications, understanding regulatory expectations relating to CMC control strategies for accelerated oncology programs remains challenging.