De-Risking FIH: Integrated Strategies For Rapid Proof-Of-Concept

By Andreas Reichl, M.D., and Kevin Schaab, Ph.D., Quotient Sciences

The transition from preclinical to clinical testing, particularly first-in-human (FIH) studies, is a pivotal yet challenging phase of drug development due to inherent risks and regulatory hurdles. Proper planning, as well as incorporating innovative SAD/MAD design and a sound CMC strategy, is crucial to avoid costly delays and to fast-track proof-of-concept (PoC) validation.

Current industry trends, including funding challenges and increased competition resulting from AI-driven discovery, necessitate speedy, de-risked early development. High attrition rates, particularly in Phase 2, emphasize the need for earlier PoC assessments to enable quicker wins and faster fails. Consequently, it is imperative to streamline Phase 1 activities, secure conclusive data for fundraising, and design FIH protocols that deliver multi-faceted data.

Reducing the time between drug product manufacture (CDMO) and clinical dosing (CRO) is also vital. Integrated approaches, such as Quotient’s Translational Pharmaceutics , offer a proven method to accelerate development programs, simplify design, enhance decision-making, and reduce R&D costs.