Building translational infrastructure for emerging biotech

Early-stage biotech companies often face gaps in translational capabilities that slow advancement into human studies. This fireside discussion outlines approaches to align discovery outputs with clinical needs, establish fit-for-purpose workflows, and build systems that improve translational fidelity and predictive validity.

Key takeaways

• Define core translational functions that bridge discovery, preclinical assessment, and FIH readiness
• Structure decision criteria for dose selection, biomarker strategy, and safety margin evaluation
• Integrate PK and PD data flows to strengthen program planning and portfolio governance
• Implement scalable processes that maintain quality while supporting rapid iteration
• Prioritize analytical frameworks that improve predictive validity for human subjects