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Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.

Common early-phase pitfalls, from misaligned nonclinical strategy to gaps in CMC, bioanalysis, and species selection, can delay IND and CTA submissions. By aligning development plans with regulatory expectations from the outset and integrating cross-functional insight, sponsors can reduce rework, strengthen submissions, and maintain momentum toward first-in-human studies.