Article | June 11, 2025

Bridging The Gap: How Strategic Resourcing Accelerates Biotech's Path From Preclinical To FIH

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Transitioning a drug candidate from preclinical research to first-in-human (FIH) trials is one of the most critical—and precarious—stages in drug development. Often referred to as the “Valley of Death,” this phase is marked by high failure rates, complex regulatory requirements, and resource limitations, particularly for emerging biotech companies. Navigating this phase successfully demands strategic planning, specialized expertise, and operational agility. TFS’s tailored Strategic Resourcing Solutions offer biotech startups access to global talent, scalable services, and proven processes to drive early-phase trial success. For companies aiming to efficiently navigate the preclinical-to-FIH transition, strategic partnerships like those offered by TFS can be the catalyst for success in the race to market.

Explore how Strategic Resourcing, particularly through Functional Service Provision (FSP) models, empowers biotech sponsors to overcome common hurdles such as regulatory complexities, trial design challenges, limited internal bandwidth, and budget constraints. By selectively outsourcing key functions—while retaining overall trial oversight—sponsors can accelerate timelines, reduce costs, and maintain quality.

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