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 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

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!

The 15th Consortium Meeting was held in Barcelona with the novelty of the 1st eTRANSAFE Awards

The 15CM took place on 9-10 of June 2022 at the H10 Marina Hotel in Barcelona, with the novelty of the first edition of the eTRANSAFE Awards.

Adrián Rodrigo, Enric Bousoño, Fabián Avilés, Antonio Pérez, Miguel Ferreira (GMV), Nicolas Bosc (EMBL-EBI), Frank Bringezu (Merck) – Winners of the 1st eTRANSAFE Awards.

After several virtual editions, the eTRANSAFE consortium members gathered again in Barcelona in June for the first face-to-face event since 2020.

The main aim of the meeting was to showcase the latest advances of the eTRANSAFE ToxHub platform and foster interaction between the developing team and the end-users. This was accomplished through a series of interactive use cases and workshops, which the meeting participants joined from their laptops.

With this philosophy, the meeting kicked-off with a pre-meeting session targeted at skilled programmers, followed by registration and a networking lunch, witnessing many long-awaited reunions of colleagues after the pandemic.

After welcome words from the project Executive Committee, the participants split into two use case groups focused on retrieval & visualisation of SEND data and preclinical-clinical translation. To maximize the learnings of these sessions, the outcomes and findings of each use case where afterwards discussed in a plenary session with all participants.

The meeting continued with simultaneous workshops, where project experts led hands-on exercises on text-mining, model building & retraining and on tools to foster preclinical data donation. The day concluded with an informal booth session, during which participants were able to move around the meeting room and visit the different booths to exchange opinions and extract learnings on compound access in ToxHub, project modeling tools, data visualization and preclinical-clinical predictions.

Booth sessions

Day 2 of the meeting offered plenary talks on a variety of topics. A clinical use case session raised interesting discussions among the audience on the so called rosetta stone concept, leveraging the translational nature of the project. Opportunities for collaboration were studied with the neighbouring BigPicture IMI2 project and a progress update was given on the Open Innovation Modelling Challenge and the Virtual Control Groups initiative, which has the potential of reducing the number of animals used in research up to 25%.  

The meeting culminated in the 1st eTRANSAFE Awards ceremony. The awards were granted in three categories to partners who had made important contributions to the project. After nominations cast by consortium members, the final awardees were Nicolas Bosc (EMBL-EBI) for Outstanding Individual Academic Contribution, Frank Bringezu (Merck) for Outstanding Individual Industry Contribution and GMV as a group for Outstanding Team Contribution. We send our congratulations to all the winners!  

The 15th CM concluded with an overview on project management & sustainability perspectives, followed by recommendations from the project external Scientific Advisory Board, whose members actively participated in the sessions and discussions throughout the meeting.

We thank all the participants for this extremely productive event, and we are very much looking forward to meeting again for the next edition in October!


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