The benefit-risk tolerability measure – a new way to reach insights into benefit-risk and more

Interview with Yves Schymura

Yves and I have worked together in various roles. Over time, he became more interested in becoming a statistician and I helped him to change his career path in this direction.

As part of his master thesis, he worked on an idea; I had sketched out a couple of years ago but never had the time to fully think through. I wanted to explore how we could utilize existing study data to inform the benefit-risk assessment of different therapies. In this episode, you will learn a new concept which also is related to minimal clinical meaningful differences and helps to assess the impact of various adverse events on the patient. Specifically, we dive into:

• What is the benefit-risk tolerability measure?
• How can we use the information on which patient discontinue to inform the benefit-risk assessment?
• How does the model help us rank adverse events in order of their importance?
• Which adverse events cannot be classified with the model?
• How to use the model to inform relevant difference for efficacy endpoints?

Dr. Yves Schymura

Associate Consultant Statistician at Lilly Deutschland GmbH

He studied Physiological Sciences and Pharmacology at the University of Oxford before pursuing his doctoral studies at the Max-Planck-Institute for Heart and Lung Research. For the past 7 years he worked in the German HTA context with increasing roles of responsibility, at last as HTA Team Lead / Early Pipeline Team Lead Immunology at AbbVie. During that time he discovered his passion for data and how to best use it to enable insight, effectively communicate results and generate value. 

In 2019 the finished his extra-occupational study of Medical Biometry / Biostatistics at the University of Heidelberg, his master’s thesis dealing with a novel method on how to judge the patient relevance of adverse events using data from clinical trials to inform benefit-risk assessments. Since then he is working as a statistician in the international business unit of Lilly in the areas of medical affairs and HTA. In his spare time he enjoys spending time with his family, in the outdoors and is an avid cyclist.

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