Session Abstract – PMWC 2023 Silicon Valley

Track 2

Session Chair: Elizabeth Lamont, Elizabeth Lamont

Improving the Probability of Technical and Regulatory Success
Insights generated from patient-level historical clinical trial (HCT) data, or linking contemporaneous patient-level clinical trial data to real world data (RWD), has demonstrated meaningful improvement to sponsor's better asset strategies, optimizing trial operations, and generating evidence for regulators and payers. These insights have the potential to de-risk drug development by accelerating timelines, increasing patient centricity, lowering costs, and ultimately improving probability of regulatory success.