ポスター：前臨床／臨床研究におけるバイオアッセイのためのEnd-to-endデータ統合プラットフォーム

第16回JBFシンポジウム
3月 3, 2025

本ポスター発表では、抗体薬物複合体（ADC）を例に、免疫原性モニタリングやバイオマーカーの評価などの前臨床・臨床における研究解析を簡素化し、意思決定をサポートするプラットフォームを紹介します。薬物動態・有効性・安全性試験などのデータを一元管理し、組み合わせて解析・可視化することで、至適用量の決定に役立てることができます。

Here we present how Genedata Profiler software provides decision support across a range of preclinical and clinical areas, using an antibody-drug conjugate (ADC) as example. Preclinical experiments and results build on each other and interconnect, allowing scientists to determine a therapeutic window (TW). For example, pharmacokinetic studies inform early stage preclinical work (in vivo efficacy experimental design), as well as support late stage analysis (cross-species comparisons of safety limits). PK and efficacy results in turn combine with safety data to help determine the TW. Despite the need to connect these different data, they are usually located in different places, and appropriate visualization tools are often lacking for the late-stage and most important analyses. Genedata Profiler provides a central place to store, combine and easily analyze these data. The value of this integrative approach extends to clinical trials, where PK and efficacy results can be assessed in the context of biomarker and immunogenicity data for example, or phase III exposures can be compared back to preclinical safety limits.