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

Dr. Andreas Reichl, Senior Drug Development Consultant, and Dr. Kevin Schaab, Senior Drug Development Consultant present practical breakdown of how early-phase experts design programs to mitigate these risks and efficiently move novel molecules into PoC assessments

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).

You'll learn about:

• The hidden traps in FIH trial design that quietly kill timelines — and how the pros sidestep them
• Regulatory and geographical factors to consider – reasons why the US and UK are chosen for early phase trials
• Project management and operational blind spots that most teams don’t spot until it’s too late
• Inclusion of biomarkers and PD endpoints in healthy volunteers and patient cohorts -to maximize trial efficiency and chances of demonstrating proof-of-concept)
• The CMC decisions that make-or-break early clinical outcomes — formulation, compounding and manufacturing choices that either keep you moving or grind development to a halt
• How top programs accelerate timelines with data integration and proactive planning — while others waste months and millions trying to catch up

Watch our on-demand webinar recording.