An emerging biopharma in Asia sought rapid approval for a novel oncology theranostic in both Japan and the US. Facing complex challenges in Phase 1 design—such as dosimetry, dose optimization, and ligand distribution—the sponsor partnered with IQVIA for regulatory and technical expertise. IQVIA conducted a detailed FDA regulatory analysis, applied physiologically based pharmacokinetic (PBPK) modeling, and introduced dose-response modeling to optimize data capture while reducing patient numbers and costs. This approach streamlined the approval pathway, reduced risk, and accelerated time to market for the innovative therapy.

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