What does a ‘Trial Ready’ Therapeutic look like in 2026?
10 Feb 2026
Theatre 3
Clinical and translational excellence
Preparing a therapeutic for first-in-human (FIH) studies requires integrated planning across discovery, preclinical, and translational stages. This discussion highlights benchmarks, frameworks, and decision criteria that support readiness, streamline development, and mitigate early clinical risks.
Key takeaways
- Identify key attributes of a trial-ready therapeutic, including translational robustness and predictive validity
- Align preclinical and translational data to support first-in-human study design
- Define dose selection, biomarker strategy, and safety margin requirements
- Implement workflows that optimize program readiness and regulatory alignment
- Apply frameworks to anticipate early clinical risks and accelerate decision-making