The eTRANSAFE (Enhancing TRANslational SAFEty Assessment through Integrative Knowledge Management) project works to improve the efficiency of translational safety assessment approaches during the medicines discovery pipeline

Towards a Quantum Leap in Drug Safety Assessment – eTRANSAFE hosts its closing event with the participation of external experts

The 17th and final eTRANSAFE Consortium Meeting took place in Sitges, Barcelona on 22-24 of February 2023. The event was open to the wider scientific community, bringing together over 100 participants to celebrate the results of what has been more than five years of successful collaboration.

In addition to showcasing the final outputs of the project through short presentations, demos and use cases, the event was also attended by international keynote speakers. In the course of three days, we had the pleasure of hearing from these external experts on topics such as the use of artificial intelligence in drug and chemical safety, promotion of animal-free research, uses and challenges of data sharing and the role of public-private partnerships in promoting drug safety evaluations.

The main achievement of eTRANSAFE is the revolutionary ToxHub platform. ToxHub brings together preclinical and clinical databases in an integrative data infrastructure, combined with innovative computational and visualisation tools that aim to radically improve the predictivity, feasibility and reliability of translational safety assessment during the drug development process. 

Ensuring post-project sustainability is key for conserving and continuing project assets and often presents important challenges for consortia. eTRANSAFE has been successful in promoting continuity for ToxHub, and the plan is for it to evolve and grow in the hands of the company Instem, as the future holder of the platform. Instem representatives presented their ambitious roadmap for the platform during the meeting. To address the challenges Public-Private Partnerships often face in terms of sustainability, the meeting also featured a roundtable discussion led by sustainability experts. The roundtable highlighted experiences and learnings from eTRANSAFE and the related initiatives VHP4Safety, BigPicture, TransQST & TransBioLine, whose representatives were invited to join the event.

The meeting finalized with the 3rd Edition of the eTRANSAFE Awards, granted to consortium members who have made outstanding contributions to the project. The Award for Outstanding Individual Academic Contribution went to Javier Corvi (BSC) and the Award for Outstanding Individual Industry Contribution to Inari Soininen (Synapse). This edition also featured Special Jury Awards granted to Annika Kreuchwig (Bayer), Philip Drew (PDS), Rowan Parry (EMC), Alexander Amberg (Sanofi) and Katharine Briggs (Lhasa). We send our most heartily congratulations to all the winners and thank them for their excellent contributions to the project!

eTRANSAFE Virtual Control Group concept presented at IQ Pharma and FDA joint meeting

Despite much progress being made in recent years, one of the greatest challenges in the field of drug safety assessment is to reduce the number of animals used in in vivo toxicity studies. The eTRANSAFE project works towards this objective, pursuing the 3Rs approach to Replace, Reduce and Refine the number of animals used in drug safety evaluations.

One of the breakthroughs of the project is the revolutionary Virtual Control Groups (ViCoG) initiative, which has the potential to significantly reduce the number of animals by replacing concurrent control animals in toxicity studies with data collected from historical controls. More info about the concept here.

The ViCoG approach was recently presented in a joint meeting of IQ Pharma (BioSafe, DruSafe) and FDA on October 27th, 2022 gathering over 150 participants. The initiative was welcomed by both industry representatives and regulators and the path towards its implementation in toxicity studies was discussed. eTRANSAFE is currently planning to follow up these conversations in a workshop co-organized with the Center for Alternatives to Animal Testing (CAAT) in early Spring 2023.

eTRANSAFE announces the launch of the “eTRANSAFE ViCoG Initiative”

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.


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