Novel modalities and therapeutics have changed the landscape of biopharma in recent years. This surge in complex, engineered therapeutics appears set to continue. Bi-, tri- and multi-specifics are showing potential to improve ORR, while CAR-T therapies move us towards personalized cancer treatment. Cell and Gene therapies promise life saving treatments for rare diseases that cannot be treated by conventional modes of treatment.

Each therapy class has its own unique challenges – but some are common to them all. They all have complex MoA and yet only limited data is available to understand PK-PD relationship. Further, each has unique and multi factorial interactions with physiology. Take ADCs for example, factors in consideration include payload potency, bystander effect, Drug-antibody ratio, linker stability, and the effects of all of these aspects on efficacy and safety.

The twin challenge of low data & physiological complexity is precisely what QSP can handle. We have steadily developed our base of experience to address questions of interest in all of the above area.