Harpreet Singh, Chief Medical Officer of Precision for Medicine, shared a post on LinkedIn:
“Last week, I was honored to serve as the opening keynote at the 2026 Biostatistics Symposium of Southern California. Over the course of my career, first at the FDA and now at Precision For Medicine, I’ve worked closely with esteemed colleagues in biostatistics.
In my remarks, I shared an inside perspective on two pivotal advisory committees, CodeBreaK 200 and STARGLO, both of which highlighted how statistical analysis and trial conduct shape how data are ultimately interpreted. In each case, questions around PFS, OS, subgroup effects, and trial robustness could not be answered without deep engagement between clinicians and biostatisticians.
These lessons highlighted how issues like incremental treatment effects, early dropout, crossover, and regional heterogeneity can introduce uncertainty, and why rigorous statistical methods and transparent interpretation are essential to regulatory decision-making.
I’m grateful to continue this collaboration at Precision, working hand in hand with biostatistics colleagues to support biotech sponsors navigating increasingly complex development and regulatory landscapes.”
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