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Modeling approaches in pregnancy and lactation for drug development: operational, ethical and regulatory perspectives

Ethical and Operational Considerations for Clinical Study Design and Conduct in Neonatal & Pregnancy Research

Monday, November 11, 2024
11:30 AM – 11:45 AM MST
Location: Sonoran Sky Ballroom 5 - 8

    Speaker(s)

  • Walter K. Kraft, MD (he/him/his)

    Professor of Pharmacology, Surgery and Medicine
    Thomas Jefferson University
    Philadelphia, Pennsylvania, United States

    Disclosure(s): No financial relationships to disclose

Disclosure(s):
Walter K. Kraft, MD: No financial relationships to disclose
This presentation will provide a clinician’s perspective on neonatal considerations and how it may intersect with pregnant individuals. Walter will discuss ethical considerations in running the IRB/research ethics oversight for his university and hospital system. He will also provide insights into challenges related to PD endpoints and covariates in this population, which are key modeling considerations.