Translational Pharmaceutics® For First-In-Human Studies

Quotient Sciences' Translational Pharmaceutics® platform re-engineers the journey of a drug molecule into clinical development to optimize the timeline to Proof-of-Concept (POC). This novel approach is applicable to all drug molecules, routes of delivery, and formulations.

The platform integrates pharmaceutical development and clinical pharmacology, enabling rapid iterations based on real-time clinical data. Unlike conventional methods that require pre-determining multiple dose strengths and manufacturing large quantities of drug product, Translational Pharmaceutics® uses on-demand cGMP manufacturing. This allows dose strengths to be determined in real-time, drastically reducing the required drug substance (API) and shortening the time for the stability program.

By guiding decisions about dose and formulation with emerging clinical data, and testing different formulations within the same protocol, the risk of early program termination due to poor drug exposure is lowered. In some cases, combining healthy volunteer and POC phases into a single multi-part study can generate POC data in under 12 months.

Learn more about how to accelerate your drug development timeline.