Webinar
SPARK-BIH National GCT Webinar: Fiona Thistlethwaite
In this Webinar, Fiona Thistlethwaite will explore how clinical trial design is evolving to meet the specific challenges of cell and gene therapies (GCT).
Talk
This lecture will explore how clinical trial design is evolving to meet the specific challenges of cell and gene therapies (GCT). Unlike conventional drug development, GCT trials often involve very small and diverse patient populations, genotype-based eligibility, limited understanding of natural history, and extended safety follow-up. We will discuss how these factors influence choices around endpoints, biomarker use, and companion diagnostics to ensure that clinical signals are meaningful and reliable. The session will also cover early-phase design considerations, including dose selection, safety oversight and adaptive approaches suited to small-cohort studies. Participants will gain practical guidance on translating preclinical evidence into well-structured clinical plans while navigating emerging regulatory expectations in the GCT field.
About the Speaker
Fiona Thistlethwaite is a medical oncology consultant at The Christie NHS Foundation Trust, specializing in experimental cancer medicine and immunotherapy. She also serves as Co Director of the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility and Director of the Innovate Manchester Advanced Therapy Centre Hub (iMATCH).
Fiona works to advance innovative cancer therapies, including cell-based treatments and emerging immunotherapies, aiming to expand access to promising new options for patients. She has contributed widely to clinical research, supporting collaboration between scientists, clinicians, and industry partners Her approach emphasizes patient centered care, ethical trial design, and the translation of research into meaningful clinical outcomes. She is recognized for her leadership in the development of research networks initiatives.
Information
When
December 4, 2025 | 3:30 - 4:30 pm
Where
Online via Teams
Registration
Please register here