Live Webinar: From First-in-Human to Proof-of-Concept — Quicker, Smarter, Streamlined

First-in-Human studies are make-or-break moments. A single misstep in trial design, recruitment strategy, CMC planning, or regulatory strategy can burn millions, stall timelines for months, and derail proof-of-concept — while faster competitors move ahead.

Registration for this event is closed.

Far from theory, this is a practical breakdown of how experts de-risk FIH programs and move molecules efficiently into proof-of-concept assessments. Expect clear examples of smarter SAD/MAD trial designs including multi-part and hybrid protocols, regulatory foresight, volunteer and patient recruitment considerations, and operational strategies that protect your investment and keep programs moving.

You’ll also see how to establish the kind of CMC foundation that supports a flexible and fast-tracked clinical plan—the formulation choices and flexible manufacturing approaches that determine whether you stay on track or hit costly bottlenecks. Layer in data integration, pharmacodynamic endpoints, and proactive project planning, and you’ll have a playbook for accelerating early development with confidence. 

Grounded in real-world experience, these insights provide a pragmatic playbook for leaders navigating high-stakes early development.

Expert Insights from Quotient Sciences: Here's what you'll learn

• 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

Showcasing a series of case studies including:

• Single and multiple ascending dose studies in healthy subjects and patient populations in rare diseases, obesity, CNS and inflammation
• Multi-part and hybrid protocols that are enabled by flexible CMC strategies across small molecules, peptides, and biologics\

In partnership with: