Senior Director QSP - Precision Medicine, United States
Disclosure(s):
Anna Sher, MD/PhD: No relevant disclosure to display
Infectious diseases remain a critical global health challenge, with threats like Ebola, influenza, and HIV identified by the WHO as top public health concerns. Despite this, QSP applications in infectious diseases represent less than 10% of all QSP efforts, with fewer than half contributing to regulatory submissions. While modern vaccination dates to Edward Jenner’s work in the 18th century, today’s fight against infectious diseases leverages Model-Informed Drug Development (MIDD), formally recognized under PDUFA VI. As technological advancements and AI/ML integration accelerate, QSP and QST are poised for significant growth in this space. This talk will present cutting-edge case studies in HIV and Ebola, highlighting model development, calibration, validation, and their impact on decision-making and regulatory interactions to advance novel anti-infectives and vaccines.
