Early Phase Clinical Trials: Key Considerations for Drug Development Pipelines
The early stages of clinical development are critical, decisions made here can determine the efficiency, cost, and ultimate success of an entire program. With the evolving landscape of early phase drug development, sponsors need flexible yet robust statistical approaches to ensure that promising compounds are evaluated effectively and efficiently. Getting this stage right not only accelerates timelines but also maximizes the chances of bringing safe, effective treatments to patients.
In this session, we’ll share practical insights into trial design, highlight important statistical considerations, and explore recent developments shaping early phase research.
Why attend?
- Gain clarity on what biotech and pharma developers should prioritize when planning early phase studies
- Understand key statistical considerations that directly influence trial design, decision-making, and downstream success
- Hear the latest updates on innovative approaches in early phase clinical trials that could strengthen your development pipeline
Meet the Experts:
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Sam Hinsley
Statistics Manager
With over 13 years’ experience in the design, conduct and analysis of phase I, II and III clinical trials, the vast majority of Sam’s expertise lies in oncology, with specialist knowledge in phase I trial design methodology.
Sam is the lead for the Early Phase Trials Working Group at Phastar and a member of the NIHR early phase clinical trials statistics group. Sam has reviewed early phase grant applications for CRUK Clinical Research Committee and NIHR Evaluation, Trials and Studies Co-ordinating Centre, as well as journal articles for numerous statistical journals such as the Lancet and Lancet Oncology.
Sam has also delivered UK-wide training on the Continual Reassessment Method and published multiple papers regarding the use of phase I trial design methodology.
Lisa Gibbons- Moderator
Senior Statistician
Lisa Gibbons is a Senior Statistician at Phastar with over 7 years’ experience in the pharmaceutical industry.
Lisa has spent more than 4 years focusing on early phase trials and is co-lead of Phastar’s Early Phase Working Group. She has worked across multiple therapeutic areas, providing statistical input into the design, analysis, and reporting of clinical trials.
Lisa holds an MSc in Statistics from Lancaster University, where she specialized in clinical trials, survival analysis, and epidemiology. Her expertise spans statistical programming, data analysis, and ensuring high-quality outputs to support decision-making in drug development.
