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Livestreamed Session
Livestreamed Session

CLIN
Session Type: Workshop

W20--Cutting-edge Clinical Trials: Insights & Updates

Friday, October 24, 2025
10:15 AM - 12:15 PM PDT
Location:Flex A

This session will explore the most recent advancements in clinical research design, implementation, and therapeutic innovation. Participants will gain insights into emerging clinical trials across various therapeutic areas, with a focus on novel trial methodologies, adaptive designs, biomarker-driven studies, and patient-centered outcomes. Experts will also share real-world challenges and strategies for integrating cutting-edge science into clinical trial execution, regulatory navigation, and data interpretation.

Learning Objectives:

  • Describe recent trends and innovations in clinical trial design and execution, including adaptive and decentralized models.
  • Summarize key findings and implications from selected high-impact trials across major therapeutic areas.
  • Apply updated knowledge to optimize clinical trial participation, data quality, real-world data, digital tools in enhancing trial precision and efficiency, and patient outcomes.

Presentations:

  • 10:15 AM - 12:15 PM PDT
    W20.1- Comparative clinical outcomes of Trikafta® versus bioequivalent ETI formulations in the management of Cystic Fibrosis in adults: a real world experience

    Speaker: Ezequiel Baran, MD – HIGA R Rossi

  • 10:15 AM - 12:15 PM PDT
    W20.2- A Phase II study (CLAIRAFLY®) evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of the DPP1 (CatC) inhibitor BI 1291583 in cystic fibrosis: Effects of CFTR modulator therapy use

    Speaker: Marcus A. Mall, MD – Charité - Universitätsmedizin Berlin

  • 10:15 AM - 12:15 PM PDT
    W20.3- Safety, tolerability, and pharmacokinetics of novel NBD1 stabilizers SION-719 and SION-451 from two phase 1 first-in-human studies

    Speaker: Jason H. Maley, MD, MS – Sionna Therapeutics

  • 10:15 AM - 12:15 PM PDT
    W20.4- Nutritional decline and glycemic variability as early clinical indicators in pediatric cystic fibrosis patients undergoing CGM: a retrospective cohort analysis

    Speaker: Meera R. Vijayan, PharmD – Stanford Medicine Children's Health

  • 10:15 AM - 12:15 PM PDT
    W20.5- Artificial intelligence integrating gut microbiome multi-omics to predict clinical outcomes in children with cystic fibrosis

    Speaker: B.L.D. Uthpala Pushpakumara, PhD – The University of New South Wales