Replacing concurrent control animals in toxicity studies with data collected from historical controls has the potential to significantly reduce the number of animals used in in vivo toxicity studies. Based on the large amount of preclinical safety data shared among partners of the eTRANSAFE project, five EFPIA partners (Bayer, Merck, Roche, Sanofi and Novartis) together with Fraunhofer ITEM and UPF have outlined the concept of virtual control groups (1, 2) and subsequently set-up a diligently curated VCG database comprising more than 5 mio. data points from rat studies. An extension to other species used in toxicity studies is underway. The Virtual Control Group (ViCoG) initiative has developed tools for intuitive data analysis and visualisation and as well identified priority selection criteria for an appropriate matching of the virtual control groups with the animals of the dosing groups.

The initiative has now started a qualification process for the VCG procedure and initiated approaches to interact with regulators to achieve the acceptance of the methodology.

(1) Steger-Hartmann T, Kreuchwig A, Vaas L, Wichard J, Bringezu F, Amberg A, Muster W, Pognan F, Barber C. Introducing the concept of virtual control groups into preclinical toxicology testing. ALTEX. 2020;37(3):343-349. doi: 10.14573/altex.2001311. Epub 2020 Mar 31. PMID: 32242633.

(2) Pognan F, Steger-Hartmann T, Díaz C, Blomberg N, Bringezu F, Briggs K, Callegaro G, Capella-Gutierrez S, Centeno E, Corvi J, Drew P, Drewe WC, Fernández JM, Furlong LI, Guney E, Kors JA, Mayer MA, Pastor M, Piñero J, Ramírez-Anguita JM, Ronzano F, Rowell P, Saüch-Pitarch J, Valencia A, van de Water B, van der Lei J, van Mulligen E, Sanz F. The eTRANSAFE Project on Translational Safety Assessment through Integrative Knowledge Management: Achievements and Perspectives. Pharmaceuticals (Basel). 2021 Mar 8;14(3):237. doi: 10.3390/ph14030237. PMID: 33800393; PMCID: PMC7999019.

During globally difficult times, where conflict and division seems to be the norm, it is worth emphasising the values of scientific endeavours based on mutual respect, collaboration and sharing.

eTRANSAFE is all about “sharing the unshareable” across completely different institutions and stakeholders, many times with conflicting interests. Hopefully it can be an inspiration and a reminder of profound European values, how union leads to progress, and that we are always going farther together.

The only war worth fighting is the one for the progress of science, knowledge, global harmony and human cooperation on all fronts regardless of geographical, political, social and economic considerations.

The eTRANSAFE consortium members met to discuss the project progress and next steps at the 14th Consortium Meeting held on Thursday and Friday 24-25 of February 2022.  

The latest advances in the development of the eTRANSAFE system, ToxHub, were at the centre of this virtual 2-day event.

The first day evolved around use cases for the testing and improvement of the system and for advancing its translational component, the use of preclinical data to predict human safety. The day concluded with an update from the project work packages, with an overview of recent and upcoming activities.

The second day of the meeting brought the audience a series of short sessions providing a closer look on some of the ongoing work, such as the successful virtual control groups initiative that has the aim to reduce the use of control animals in toxicology studies (link), and the collaboration with the UK-based NC3Rs for the development of a virtual dog (link).

The meeting finished with feedback from the project external Scientific Advisory Board, with appraisals and useful recommendations for next steps until the next meeting scheduled for June 2022.

We thank the consortium and SAB members for their contributions to this event and look forward to meeting soon face-to-face!

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