First-In-Human Means More Than Safety: How Integrated Early Development Is Rewriting Proof-of-Concept

By Matt Paterson, Chief Strategy Officer at Quotient Sciences

In the current high-stakes drug development landscape, the traditional linear model—where formulation, manufacturing, and clinical testing happen in isolated silos—is increasingly becoming a liability. This compartmentalized approach creates "white space," or costly delays and handoffs that drain momentum and capital. Insights from industry veteran Matt Paterson suggest that the path to success lies in a continuous learning engine that treats early development as a single, integrated system rather than a series of disconnected steps.

The transition from First-in-Human (FIH) trials to Proof-of-Concept (PoC) is no longer a simple safety check; it is now a critical strategic hurdle where sponsors must demonstrate clear mechanism signals and commercial viability. Achieving this requires Translational Pharmaceutics®, a model that synchronizes real-time drug manufacturing with clinical data. By allowing for adaptive study designs, teams can shave several months off development timelines. This level of agility ensures that science, not supply chain logistics, dictates the pace of discovery. Ultimately, integrating these functions allows researchers to make better decisions faster, reducing R&D spend and increasing the likelihood that promising molecules reach the patients who need them.