From Biomarker Data To Proof Of Mechanism

A biomarker result can be analytically sound and still say little about mechanism. The value in the table is the final link in a chain: the decision it must support, an analytical plan built for that decision, validation matched to context of use, complementary readouts that make the number interpretable, and operations that deliver it before the dose-escalation meeting. Six steps, eight reusable tools, and two Parkinson's disease worked examples, one on lipid pathway readouts and one on GCase activity as target engagement, show how that thinking plays out.

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