2026: What will Change in Preclinical and Clinical Development?

2 minute read

Published: February 3rd, 2026

As innovation reshapes drug development, industry leaders are looking ahead to how both preclinical discovery and clinical trials will evolve in 2026, and the role regulators will play in shaping that future. Advances in structural biology, hybrid study designs, and the expanding use of real-world evidence are expected to influence decision-making earlier and more meaningfully across the R&D lifecycle.

In a new Drug Discovery World article, Billy Amzal, Head of Strategic Consulting at Phastar highlights the growing integration of real-world evidence, AI, and advanced modeling to support multi-modal data analysis and enable more precise, value-driven development strategies. The article explores why, as programs move from early to late phase, success will increasingly be defined not just by technical outcomes, but by differentiation, relative effectiveness, and unmet societal need, and how regulators are likely to respond to these shifts in 2026 and beyond.