14-15 November, 2016: The European Medicines Agency is hosting a web-casted workshop in London on identifying opportunities from "Big Data" in development and regulation of medicines. There has been such strong interest that a much larger venue is being used than available at its usual Canary Wharf centre, with perspectives from EU and USA policy makers, regulators, academia, health professionals and industry.
The EMA note: "Rapid developments in technology have led to the generation of vast
volumes of data, which have the capability to transform the way the
benefit-risk of medicinal products is
assessed over their entire life cycle. However, it is recognised there
are multiple challenges in the exploitation of these data. These range
from the fundamental need to establish methods to enable the access to,
integration and analysis of heterogeneous datasets to understanding the
limitations in its use. Importantly, robust and transparent mechanisms
to protect patient confidentiality are key to secure patient trust. It
is important for the European Medicines Agency and the European Union
medicines regulatory network to gather information on the latest
developments in big data from the perspective of all stakeholders in
order to identity how and when the multitude of data sources may
contribute to medicinal product development, authorisation and post-marketing surveillance."
Some key threads and discussion points:
- the importance of the FAIR principles (data should be Findable, Accessible, Interoperable and
- Reusable)
- access for health professionals and researchers to the European Open Science Cloud
- a major EU initiative to promote data curation
- the power of the Cloud for cross-platform data sharing
- Big Data applied to precision medicine and pharmacogenomics
- bias in datasets
- Big Data and new EU General Data Protection Regulations - from May 2018, replacing Directive 95/46
- machine-learning for chemogenomics
- challenges to implementing applications to precision medicines in 'time poor' clinical practice
- OHDSI comumity - access to international health record data sources
- twitter not designed as a health app but may provide complementary insight into unexpected adverse effects of medicines to that obtained through traditional pharmacovigilance routes
- transferable learning - e.g. from use of Big Data in transport networks
- case studies in the EU and USA
- trade-offs: methods might be rapid, unbiased and accessible/usable by the inexperienced: but not all three
- challenges in the European Region to maximise learning from Big Health Data when there are 28 independent national health care systems with barriers and challenges to data-sharing
All talks are due to be made available on the EMA website for public access.
The EMA note: "Rapid developments in technology have led to the generation of vast
volumes of data, which have the capability to transform the way the
benefit-risk of medicinal products is
assessed over their entire life cycle. However, it is recognised there
are multiple challenges in the exploitation of these data. These range
from the fundamental need to establish methods to enable the access to,
integration and analysis of heterogeneous datasets to understanding the
limitations in its use. Importantly, robust and transparent mechanisms
to protect patient confidentiality are key to secure patient trust. It
is important for the European Medicines Agency and the European Union
medicines regulatory network to gather information on the latest
developments in big data from the perspective of all stakeholders in
order to identity how and when the multitude of data sources may
contribute to medicinal product development, authorisation and post-marketing surveillance." Some key threads and discussion points:
- the importance of the FAIR principles (data should be Findable, Accessible, Interoperable and
- Reusable)
- access for health professionals and researchers to the European Open Science Cloud
- a major EU initiative to promote data curation
- the power of the Cloud for cross-platform data sharing
- Big Data applied to precision medicine and pharmacogenomics
- bias in datasets
- Big Data and new EU General Data Protection Regulations - from May 2018, replacing Directive 95/46
- machine-learning for chemogenomics
- challenges to implementing applications to precision medicines in 'time poor' clinical practice
- OHDSI comumity - access to international health record data sources
- twitter not designed as a health app but may provide complementary insight into unexpected adverse effects of medicines to that obtained through traditional pharmacovigilance routes
- transferable learning - e.g. from use of Big Data in transport networks
- case studies in the EU and USA
- trade-offs: methods might be rapid, unbiased and accessible/usable by the inexperienced: but not all three
- challenges in the European Region to maximise learning from Big Health Data when there are 28 independent national health care systems with barriers and challenges to data-sharing
All talks are due to be made available on the EMA website for public access.
