Jie J. Li, PhD (she/her/hers)

Associate Director RWE
Office of Surveillance and Epidemiology, CDER, US FDA
Silver Spring, United States

Dr. Jie (Jenni) Li is Associate Director for Real World Evidence (RWE) at the Office of Surveillance and Epidemiology in CDER FDA, leading office activities relating to RWE matters. She oversees OSE’s scientific input into guidance and policy development for RWE. Dr. Li has more than 15 years research experiences in pharmacoepidemiology and clinical studies, designing and conducting observational studies using large electronic healthcare databases, national surveys and patient registries.

Disclosure information not submitted.

Presentation(s):

• Real-World Evidence (RWE) Generation for Rare Disease Drug Development and Orphan Drug Approvals

  Sunday, August 25, 2024
  2:30 PM – 6:00 PM CEST

• High-Dimensional Multiple Imputation (HDMI) For Partially Observed Confounders Including Natural Language Processing-Derived Auxiliary Covariates

  Tuesday, August 27, 2024
  8:45 AM – 9:00 AM CEST

• Novel Individualized Therapeutics: Challenges and Opportunities for the Use of Real-World Evidence in Rare Diseases

  Tuesday, August 27, 2024
  4:15 PM – 5:45 PM CEST