Bioanalytics
Anna Kondic, PhD, MBA
Vice President Pharmacometrics
BMS, New Jersey
Jim Shen, PhD
Executive Director, Head of Regulated Bioanalysis and Mass Spectrometry
Bristol Myers Squibb
Princeton, New Jersey
Predictive modeling is increasingly vital for decision-making in pharmaceutical research and development, offering tools to anticipate patient outcomes, optimize treatment strategies, and support precision medicine. These models range from data-driven approaches, which use statistical and machine learning techniques to identify patterns in clinical data, to mechanistic models, which simulate biological processes based on established physiological and pharmacological principles. Mechanistic models—such as those used in pharmacokinetics/pharmacodynamics (PK/PD) and disease progression—enable scenario testing and extrapolation beyond observed data. When integrated, these approaches enhance predictive accuracy, interpretability, and clinical utility, supporting evidence-based decisions across drug development, diagnostics, and patient care. The speaker hopes to demonstrate that extra care is needed to stage the development of these models and also to benchmark their performance in various validation scenarios.