In this article, Matt Paterson, Chief Strategy Officer at Quotient Sciences, discusses how first-in-human is more than just safety, but a critical point that determines the future of a drug.
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. The siloed, traditional approach to early development leads to expensive delays and lost momentum between teams.
Matt discusses how an integrated model where real-time manufacturing is harmonized with clinical data, to support adaptive studies, achieve substantial shortening of timelines and leave science (not supply chain, as is currently the case) to dictate the pace.
"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." he comments.
Continue reading the full article on Clinical Leader.