Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early ...

The drug development process faces challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical ...

Preserve study integrity. Resist the temptation to bolt new exploratory endpoints midstream. If an additional endpoint is ...

Bari Kowal, Senior Vice President, Development Operations & Portfolio Management at Regeneron Clinical trial innovation is a hot topic, but it’s not a new one. The first fully virtual randomized trial ...

The adoption of AI in clinical trials holds the potential to revolutionize how therapies are discovered, but the pace of that ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors and the general public. Researchers have applied ...

Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, ...

When patient safety, regulatory approval and real-world effectiveness are on the line, AI can't act autonomously.