15/06/2026
Did you miss our webinar, 'Improve Oncology Clinical Trial Readiness for Faster Proof-of-Concept,' presented by Luke Gill, Vice President and Global Head of Oncology and Medical Affairs, and Yong Wang, Head of Biometrics?
Its now available on demand – https://bit.ly/3S4oSdS
• Bayesian Designs: Replaces rigid 3+3 rules with flexible models (like BOIN) to find optimal benefit-risk doses instead of just maximum tolerated doses.
• Master Protocols: Uses basket, umbrella, and platform structures to run multiple biomarker-driven sub-studies under one overarching infrastructure.
• Real-World Evidence (RWE): Employs external control arms and hybrid models to supplement trial data for rare diseases and fast-track approvals.
• Global Regulatory Agility: Accelerates early ex*****on in Australia, builds FDA credibility, and integrates China into early Phase I/II proof-of-concept.
Regulatory Agility