Four major pharmaceutical companies have shared never-before-seen hazard data for drug substances to improve database-dependent calculation tools and help reduce animal testing.
In a pioneering program, Big Pharma companies Boehringer IngelheimF. Hoffmann-La rock, Johnson & Johnson and Merck KGaA have agreed to share unpublished drug substance data to help reduce animal testing.
Supported by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the companies have made available to the public high-quality, unpublished physicochemical, toxicological and ecotoxicological data on the hazardous properties of 19 substances from 153 tests. The data is downloadable as IUCLID datasets from the European Chemicals Agency (ECHA).
The publication of this data aims to expand the variety of high-quality chemical hazard data available to the public in order to improve the effectiveness of database-dependent property prediction tools, among other activities.
Using this data, scientists and other companies could gradually reduce or even avoid animal testing of chemicals by improving theoretical structure-activity relationship (SAR) models and through read-across capabilities, depending on the quantity, diversity and quality of the data on which these considerations or calculations are based.
Ultimately, a program in which other companies can join and make their archival data available to the public will be created. Currently, the partners (ECHA, EFPIA and the founding companies) are conducting a testing phase to flesh out the best ways to make this data contribution initiative work.
Commenting on the programme, Dr Jan Backman, Head of Chemical Legislation at F.Hoffmann-La Roche Ltd, representing EFPIA, said: “Companies provide this high quality data free of charge for the benefit of society. Our goal is to improve the effectiveness of database-dependent computational tools, such as QSARs, for testing the safety of structurally similar chemicals. Scientists can use the data to gradually reduce animal testing. This initiative is open to any company and I invite everyone to join and share their archived data.
ECHA’s Head of Prioritization and Integration, Ofelia Bercaru, added: “We see this as an example of ‘IUCLIDation’ of existing data; this facilitates the sharing, access and reuse of chemicals data, in line with the EU Chemicals Strategy for Sustainability. The promotion of harmonized formats and tools like IUCLID is essential to achieve this objective. In the long term, these data may be beneficial for developing and promoting alternative testing methods to replace animal studies.
For more information, you can access the EFPIA’s questions and answers on the publication of animal testing data here.