As neurodegenerative disease trials become increasingly complex, sponsors must balance scientific innovation with evidence strategies that meet regulatory expectations. In this white paper, Joanna Pulawska, PhD, Therapeutic Area Head, CNS, at IQVIA Biotech, examines how biotech companies can build regulatory-ready evidence through fit-for-purpose biomarkers, clinically meaningful endpoints and strategically designed clinical trials.

The paper presents four practical principles that help sponsors navigate evolving guidance, leverage emerging technologies effectively and generate clear, interpretable evidence in Alzheimer's disease, ALS and Parkinson's disease.

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