From First-In-Human To Proof-Of-Concept — Quicker, Smarter, Streamlined

First-in-Human (FIH) studies represent the most critical inflection point in drug development. A single misstep—in trial design, CMC planning, or operational execution—can cost millions, stall timelines for months, and derail your proof-of-concept (PoC).

This is a practical breakdown of how early-phase experts design programs to mitigate these risks and efficiently move novel molecules into PoC assessments. We move beyond theory to deliver clear, actionable strategies across the core pillars of early development.

• Smarter Trial Design & Hybrid Protocols: Detailed examples of optimized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, including the use of multi-part and hybrid protocols across small molecules, peptides, and biologics.
• Strategic CMC Foundation: Critical Chemistry, Manufacturing, and Control (CMC) decisions that determine success. Learn which formulation choices and flexible manufacturing approaches prevent costly bottlenecks and enable a fast-tracked clinical plan.
• Regulatory & Operational Foresight: Identify the hidden traps that quietly kill timelines, understand the strategic advantage of specific geographies (e.g., US and UK) for early phase trials, and spot operational blind spots before they lead to project delays.
• Maximizing Proof-of-Concept: Integrate biomarkers and pharmacodynamic (PD) endpoints effectively in healthy volunteer and patient cohorts to maximize data yield and accelerate the path to PoC validation.
• Program Acceleration: Leverage advanced data integration strategies and proactive project planning to cut months off timelines and safeguard your investment.

Grounded in real-world case studies—spanning rare diseases, obesity, CNS, and inflammation—these insights provide the pragmatic roadmap necessary for leaders navigating high-stakes early development.