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

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.

eTRANSAFE celebrated its 16th Consortium Meeting in October 2022 featuring the 2nd edition of the eTRANSAFE Awards

The eTRANSAFE consortium members got together on 20-21 October for the second face-to-face meeting of the year.

The multistakeholder project consisting of 16 public partners and 13 pharma partners recently celebrated its fifth anniversary at the end of August, and the project end-date of February 2023 is rapidly approaching on the horizon. With this in mind, the aim of the 16th CM was to overview the state of activities and agree upon the prioritization of pending task.

eTRANSAFE has come a long way in these past five years. The consortium has been successful in developing “ToxHub”, a revolutionary platform to improve drug safety predictions. The system brings together several preclinical and clinical databases in an integrative data infrastructure and innovative computational tools that aim to drastically improve the feasibility and reliability of translational safety assessment during the drug development process. The platform was first launched as a prototype in Summer 2021 and is currently being tested by the project pharma partners. Several use cases were demonstrated during the meeting. The post-project sustainability of the system was at the centre of the 16CM and plans are progressing towards ensuring its future maintenance and development.  

The event also featured the 2nd Edition of the eTRANSAFE Awards, acknowledging the work of consortium members who have made outstanding contributions to the project. Manuel Pastor (UPF) was awarded for Outstanding Individual Academic Contribution, Gavin Nicholson (Optibrium) for Outstanding Individual Industry Contribution and the EMC crew, comprised of Johan Van Der Lei, Jan Kors, Rowan Parry and Erik van Mulligen, for Outstanding Team Contribution. Congratulations to all the winners!

We thank all the participants for this extremely productive event, and we are very much looking forward to meeting everyone again for the 17th and final eTRANSAFE Consortium Meeting in February 2023!

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