How AI & Biomarkers Are Reshaping The Next Frontier In Drug Development

By Rob Maiale

Current regulatory requirements and biomarker innovations are influencing the dynamic landscape of biotech strategy, regulation, and precision medicine. Key trends include the extended retention of assets by biotechs, driven by the need to maximize value and independently manage complex clinical developments. Regulatory challenges persist, particularly with the US FDA and Europe's IVDR, while Asia presents both opportunities and challenges concerning FDA acceptance of non-US data. Precision Medicine's regional expertise is offering aid to clinical trials and biotech sponsors navigating these complexities.

Additionally, biomarker innovation is expanding beyond oncology into areas like CNS, autoimmune, inflammatory, metabolic, and rare diseases. This article highlights Precision's use of multimodal analytics in CAR-T and immunotherapy, integrating diverse data types to understand immune responses. Learn more about the importance of biomarker-driven drug development as well as Precision's integration of laboratory science, clinical expertise, and regulatory strategy to accelerate targeted therapy development across various fields.