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Drug Development & IND Strategy

Guiding companies through regulatory submissions, optimizing IND packages, and streamlining approval pathways.

Exploratory IND: Rethinking the Clinical Drug Development Strategy

Biomarker Plan Development

Designing biomarker-driven clinical trials to enhance patient selection, improve efficacy, and increase trial success rates.

Use of ctDNA for Early-Stage Solid Tumor Drug Development

Plasma ctDNA Response Is an Early Marker of Treatment Effect

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