The Road to First in Human Trials (Invite-Only)
This session gives biotech leaders a practical roadmap for moving a new asset from development into first-in-human readiness. Attendees will learn how to align CMC, toxicology, regulatory strategy, and early clinical planning around the target product profile so critical decisions are made earlier, risks are surfaced sooner, and resources are deployed more strategically.
The discussion will also highlight the operational and regulatory bottlenecks that most often delay IND and Phase 1 execution, what phase-appropriate development looks like in practice, and how a more integrated model can improve speed, governance, and execution across both SM and LM programs.
Attendees will take away from the program:
- How to use the target product profile to guide cross-functional decisions earlier in development.
- The three essentials of IND readiness: drug supply, the pharm/tox package, and the clinical plan .
- The bottlenecks that most often slow progress, including manufacturing lead times, formulation and dose changes, logistics, and fragmented vendor handoffs
- What “phase-appropriate” development means for speed, capital efficiency, and long-term asset value
- Why early clinical strategy should inform CMC and toxicology planning—not the other way around
- Where earlier FDA engagement and stronger regulatory planning can reduce rework and lower clinical-hold risk
- Why integrated development, clinical supply, and governance models can improve execution for lean biotech teams
Agenda Items: 8:00 AM – 10:00 AM
8:00 AM – 8:30 AM – Registration and light Breakfast
8:30 AM – 9:30 AM – Education Program
9:30 AM – 10:00 AM – Networking