Rosan Vegter
24 September 2019

Webinar Series on Quality and Reproducibility issues in drug development

Reproducibility is a foundational element of the scientific method, a benchmark upon which the reliability of an experiment can be tested. However, the field is facing alarmingly high irreproducibility rates as illustrated in various industry publications, with reports ranging from 50% to 80% of published results not being reproducible. It has been estimated that in the US alone, $28B in funding is spent on preclinical research that is not reproducible. This estimation does not even consider the impact on delaying translational research and causing high failure rates observed for the development of new treatments. 

In this context, EATRIS will run a series of webinars this fall, looking at reproducibility issues experienced during specific phases of the drug development pipeline (screening, preclinical models, biomarker development & analytical platforms, clinical validation). The aim is to bring best practices together and to discuss solutions designed to tackle the identified bottlenecks. The first one is scheduled on November 8 between 15.00 -16.00.

You will have the chance to get the latest updates from experts in the field as well as participate in a Q&A session at the end of the lecture. Please note that you will have the opportunity to watch again later as all webinars will be recorded. The first one is scheduled on November 8 between 15.00 -16.00.

 

SESSION 1: The Relevance of Reproducibility for Drug Development: An Introduction  

by Leonard Freedman (Chief Scientific Officer, Frederick National Laboratory for Cancer Research) & Andreas Scherer (Research Coordinator / Business development, Institute for Molecular Medicine Finland (FIMM)) 

Date and time
November 8 2019, 15.00-16.00 CET

Webinar Description
The drug development field is facing high irreproducibility rates. To address and discuss reproducibility issues and improvement of measures ensuring more robust data quality along the drug development pipeline, EATRIS, the European Infrastructure for Translational Medicine, is running this webinar series. During this first webinar, we will briefly introduce EATRIS, along with the EATRIS Quality Initiative, and get a thorough introduction and analysis of the current reproducibility issues by Leonard Freedman PhD, Chief Scientific Officer at Frederick National Laboratory for Cancer Research. An interactive Q&A session will conclude this 60-minute-webinar. 

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SESSION 2: Quality in Screening 

by Matthew Hall (NIH/NCATS) and Wolfgang Fecke (EU-OPENSCREEN)

Date and time
November 19 – 15:00 -16:00 CET

Webinar Description
This webinar will focus on the need to develop standards and assays guidelines for high-throughput screening (HTS). It will highlight some initiatives such as the Assay Guidance Manual (AGM) ebook and the HTS ring-testing project both led by NIH-NCATS to mitigate irreproducibility rates in HTS. The second part of the webinar will give the floor to EU-OPENSCREEN, the infrastructure providing screening capacity in Europe. Dr Fecke will explain how quality is achieved across the infrastructure. An interactive Q&A session will conclude this 60-minute-webinar. 

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SESSION 3:  Reproducibility in preclinical and animal experimentation

by Björn Gerlach (PAASP) and Michael Raess (INFRAFRONTIER)

Date and time
December 13 2019, 14:00 – 15.00 CET

Webinar Description
This webinar will address the issues of unreproducible data of in vivo experiments in preclinical research and point towards potential causes. The webinar will introduce the IMI project EQIPD (European Quality in Preclinical Data), which aims to set-up a lean and fit-for-purpose quality system for preclinical research. In the second part of the webinar INFRAFRONTIER, the European Research Infrastructure for the generation, phenotyping, archiving and distribution of model mammalian genomes, will illustrate how its partners across Europe work together to provide open access to a unique, standardised, high quality resource for basic and preclinical biomedical research.

An interactive Q&A session will conclude this 60-minute-webinar. 

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SESSION 4:  Preanalytical validation and quality systems in biobanking

by Monica Marchese (IBBL) and Andrea Wutte (BBMRI-ERIC) 

Date and time
December 17 2019, 14.00- 15.00 CET

Webinar Description
The increasing demand and use of high-quality samples and data place biobanks at the centre of basic and translational research. This webinar will give you an insight into the service portfolio of 2 renowned entities in the field, the Integrated BioBank of Luxembourg  (IBBL) and BBMRI-ERIC. It will address the importance of preanalytical quality for biomarker validation and robustness and highlight the BBMRI-ERIC Quality Management Service (BBMRI.QM), designed to help biobanks and researchers meet the highest quality standards for their research and the needs of their clients. An interactive Q&A session will conclude this 60-minute-webinar. 

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SESSION 5:  Technology Platform reproducibility 

by Weida Tong (NCTR/FDA) and Marian Hajduch (IMTM) 

Date and time
January 21 2020, 15.00 -16.00 CET

Webinar Description
High-throughput technologies are revolutionising medical research moving towards integration of multi-omic information. In this context quality and reproducibility of data generated through different technology platforms is key. 

The session will give the floor to 2 different technology platforms experts: genomic (Dr Weida Tong) and proteomic (Dr Marian Hajduch), highlighting the challenges, need and approaches in both technologies to ensure quality and robustness of the results generated.  

An interactive Q&A session will conclude this 60-minute-webinar. 

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SESSION 6:  Quality and reproducibility issues related to clinical development 

by Christine Toneatti (ECRIN)

Date and time 
February 18 2020, 14.00 -15.00 CET

Webinar Description
This webinar is dedicated to quality and reproducibility issues encountered during clinical development. Christine Toneatti from ECRIN will address how to ensure high quality of data collected during and after clinical trials. She will highlight the importance of reusing and sharing of datasets and how best to rely on existing datasets and profit from what was done earlier.

An interactive Q&A session will conclude this 60-minute-webinar. 

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