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3-part ONLINE Series

Shaping the Future of Clinical Trials
with Expert Insights

Join us for an insightful, 3-part online series to explore the latest innovations in early phase clinical trials, the impact of Real-World Evidence (RWE) in modern healthcare, and the significance of Bayesian methodologies for rare diseases.

Key Topics:

Webinar One: Visit our Knowledge Center to watch on-demand
Leveraging Real-World Evidence: Data Sources, Challenges, and Applications in Modern Clinical Trials

Real World Evidence (RWE) plays a critical role across multiple pharma processes, including drug development, regulatory decision-making, precision medicine and health economics, providing valuable insights from actual clinical practice. In order to leverage these data effectively and make informed decisions, sponsors need to be aware of the types of data that are available and the challenges faced within as well as the differences between RWE and clinical trial data and how they can complement each other. In this seminar, we will introduce RWE and discuss the challenges and strengths one might encounter in this space.

We will showcase a real-life example of using Real World Evidence to develop a precision medicine tool highlighting how RWE enables valuable insights and informed clinical decision-making.

Key learning points:

  • Harnessing Real World Data (RWD) to generate RWE for regulatory studies
  • Leveraging RWE alongside Clinical Trial Data
  • Deploying RWE to make data driven decisions - a real application 

This webinar took place on Tuesday 29th April. To watch the session on-demand, please visit our webinar library via the Knowledge Centre.

Webinar Two: Tuesday 27th May, 4pm - 5pm BST
Harnessing Bayesian Methods: Tackling Challenges in Rare Disease and Small Population Trials

Sponsors working in rare diseases/running small population studies often have difficulties in demonstrating efficacy due to the small number of patients available for analyses. Bayesian methodologies offer promising solutions for small population and rare disease trials where leveraging available data can provide important insights and evidence. Discover the importance of Bayesian methodologies and the different ways and situations that they can be utilized.  

Key learning points: 

  • Understand Bayesian methods – key differentiators from standard methodologies usually seen by regulators  
  • How to use Bayesian methodologies in rare diseases and small population trials to provide valuable insights 
  • Explore a case study where Bayesian methods were implemented in a rare disease setting 
Webinar Three: Tuesday 24th June, 4pm - 5pm BST
Early Phase Clinical Trials: Key Considerations for Drug Development Pipelines

Early phase trials play a crucial role in drug development, determining the dose to test in later phases. With the rise of combination treatments, there is a growing need for innovative and efficient trial designs to navigate this complex landscape. Discover how new research is paving the way for more efficient and flexible strategies in early phase combination trials, increasing our chances of identifying safe and efficacious dose levels.  

Key learning points: 

  • Understand key statistical considerations that impact trial design and outcomes 
  • Discover emerging methods in early-phase clinical trial development 
  • Consider the most important strategies for developers when planning early-phase trials 

Meet the Speakers

Tasos Mangelis
Principal Data Scientist

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Leveraging Real-World Evidence: Data Sources, Challenges, and Applications in Modern Clinical Trials

Tasos Mangelis is a Principal Data Scientist at Phastar with extensive experience in RWE and clinical trial data. Following his PhD in computational biology, his career spans both academia and industry (consulting and Pharma), where he has led high-impact projects—from developing statistical analysis plans and advanced predictive models for large-scale observational studies to driving research and projects involving thousands of patients. Tasos has worked for many research and health organizations such as the NHS and King's College London with ongoing collaborations as an affiliate researcher and has contributed to multiple publications.

Giles Partington
Consultant Statistician

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Harnessing Bayesian Methods: Tackling Challenges in Rare Disease and Small Population Trials

Giles Partington is a Consultant Statistician at Phastar working with multiple clients on trial design, especially in early phase studies, he also works as part of the Bayesian elicitation research team within the company. Previously he did a pre-doctoral fellowship with Imperial Clinical Trials Unit focusing on the usage of Bayesian statistics for rare disease/small population trials.

Samantha Hinsley
Statistics Manager

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Early Phase Clinical Trials – Key Considerations for Drug Development Pipelines

Sam Hinsley is a Statistics Manager with over 12 years’ experience in the design, conduct and analysis of phase I, II and III clinical trials. Sam’s expertise lies in oncology, with specialist knowledge in phase I trial design methodology. Sam is a member of the NIHR early phase clinical trials statistics group and has reviewed 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 delivered UK-wide training on the Continual Reassessment Method and published multiple papers regarding the use of phase I trial design methodology.

 Moderators:

Alice Wang
Associate Director of Data Science

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Christina Geyer
Principal Statistician

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Lisa Gibbons
Senior Statistician

LG

Sign up today

By registering, you are signing up for all sessions in the series. For those that have already taken place, you can access the recording via the Knowledge Center.

Visit the Knowledge Centre

Access our library of webinar recordings including:

  • FSP Strategic Partnerships & Fuel Efficient Drug Development
  • Study Design Considerations for Biotechs
  • Use of Expert Prior Elicitation for Clinical Research
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