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C1C - Modeling approaches in pregnancy and lactation for drug development: operational, ethical and regulatory perspectives

Monday, November 11, 2024
11:00 AM – 12:30 PM MST
Location: Sonoran Sky Ballroom 5 - 8

Disclosure(s):
Karen Rowland Yeo, PhD: No financial relationships to disclose
Priya Jayachandran, PharmD, MSE: Pfizer Inc.: Employment (Terminated), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Terminated); Regeneron Pharmaceuticals, Inc.: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)
Catriona Waitt, MBChB, PhD: Pfizer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Terminated, June 7, 2024)
Sara Quinney, PharmD, PhD: No financial relationships to disclose
Walter K. Kraft, MD: No financial relationships to disclose
Elimika Pfuma Fletcher, PharmD, PhD: No financial relationships to disclose

Presentations:

  • 11:00 AM – 11:15 AM MST
    Bridging the Gap – Clinical Studies Supported by Modeling in a Community Setting

    Speaker: Catriona Waitt, MBChB, PhD – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda

  • 11:15 AM – 11:30 AM MST
    Modeling and simulation to support therapy in pregnancy and lactation

    Speaker: Sara Quinney, PharmD, PhD (she/her/hers) – Indiana University School of Medicine

  • 11:30 AM – 11:45 AM MST
    Ethical and Operational Considerations for Clinical Study Design and Conduct in Neonatal & Pregnancy Research

    Speaker: Walter K. Kraft, MD (he/him/his) – Thomas Jefferson University

  • 11:45 AM – 11:55 AM MST
    Regulatory Experiences and Considerations for Model-Informed Approaches to Drug Development in Pregnancy and Lactation

    Speaker: Elimika Pfuma Fletcher, PharmD, PhD (she/her/hers) – U.S. Food and Drug Administration

  • 11:55 AM – 12:05 PM MST
    Large language model and active learning guided pharmacology therapy knowledge gap discovery in maternal and pediatric patients

    Speaker: Lang Li, PhD – Department of Biomedical Informatics, College of Medicine, The Ohio State University

  • 12:05 PM – 12:30 PM MST
    Panel Discussion

    Panelist: Walter K. Kraft, MD (he/him/his) – Thomas Jefferson University

    Panelist: Catriona Waitt, MBChB, PhD – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda

    Panelist: Elimika Pfuma Fletcher, PharmD, PhD (she/her/hers) – U.S. Food and Drug Administration

    Panelist: Lang Li, PhD – Department of Biomedical Informatics, College of Medicine, The Ohio State University

    Panelist: Sara Quinney, PharmD, PhD (she/her/hers) – Indiana University School of Medicine