精鼎医药（Parexel）：2024新药、新洞见：推进精准肿瘤学摘要报告（英文版）（16页）.pdf

1、New Medicines,Novel Insights:Advancing Precision OncologyAn Executive Summary2|NEW MEDICINES,NOVEL INSIGHTS:ADVANCING PRECISION ONCOLOGYIn this reportAchieving the vision 3Democratizing access to data 4Expanding studies to community and regional sites 6Developing regulatory strategies for precision

2、oncology 8Planning for a co-developed companion diagnostic test 10Accelerating biomarker development 12Broadening patient access 143|NEW MEDICINES,NOVEL INSIGHTS:ADVANCING PRECISION ONCOLOGYAchieving the visionPrecision oncology,with its vision of treating each patient with the exact right medicine,

3、has been evolving for more than 20 years.Developments in precision oncology treatments for breast,lung,and blood cancers have progressed,with momentum gathering as biomarker discovery rapidly expands.Since 2012,159 novel active substances(NAS)for oncology have launched,30 in 2021 alone.1 The power o

4、f precision oncology,and to expanding patient access to clinical trials and biomarker testing,is borne out by the inspiring story of Terry Morey,a ten-year stage-four non-small cell lung cancer survivor.2Today,more than half of all cancer clinical trials are for treating patients with certain geneti

5、c characteristics.3 With increasingly more sophisticated data science and advances in technology including machine learning,deep learning,and artificial intelligence,positive patient outcomes depend on access to biomarkers.In short,advances in precision oncology hinge on the patient.Precision oncolo

6、gy has beenand will continue to bea slow unfurling.Patients are our guides and partners in this quest.Yet despite advances in trial design and the vast volume of genomic data we have accumulated,precision oncology still cannot help most cancer patients.4,5 The heterogeneity of cancer,our still-limit