June 1, 2023

eTRANSAFE concludes with flying colours and achieves asset sustainability

01June

After close to 6 years of successful public-private collaboration, the eTRANSAFE consortium (Enhancing TRANslational SAFEty Assessment through Integrative Knowledge Management) reached the end of its funding period on the 28th of February 2023.

Over the course of the project, eTRANSAFE has produced a variety of outputs that have been made sustainable both in the short and long term. The different sustainability strategies that have been implemented by the consortium comprehend both public and private uptake of project assets.

eTRANSAFE consortium members at the project kick off meeting in Barcelona in September 2017.

eTRANSAFE ToxHub platform to be commercialized by Instem plc

The overarching goal of eTRANSAFE was to drastically improve the predictivity, feasibility and reliability of translational safety assessment during the drug development process. This was achieved through the development of the revolutionary eTRANSAFE ToxHub platform, which brings together preclinical and clinical databases in an integrative data infrastructure, combined with innovative computational and visualisation tools.

After a comprehensive process carried out to ensure the sustainability of the platform, the consortium is glad to announce the future continuation of ToxHub in the hands of the company Instem plc.

As per the recent announcement by Instem, ToxHub will be commercialised as a SaaS (software as a service) package and will continue evolving and growing under the new brand name Centrus®, following integration into the Company´s in silico suite. Centrus was first launched during the Society of Toxicology (SOT) 62nd Annual Meeting that took place in Nashville, TN, USA, in late March 2023.

The launch of the eTRANSAFE ToxHub platform rebranded as Centrus® at the Annual SOT meeting in March 2023.

eTRANSAFE hosts a legacy repository and launches a new website section for open-source results

As part of the project’s open-access principles, most of the computational tools developed in eTRANSAFE are open-source. Following this philosophy, project results have been made available through public resources as far as possible for their use by the wider scientific community. This way, the outcomes of eTRANSAFE may provide insights for future projects and serve to inspire further collaborations in the field of drug safety.

To facilitate access, a list of open-source tools and datasets with direct links to the public resources has been made available on the eTRANSAFE website: https://etransafe.eu/publicly-accessible-results/.

Additionally, with the aim to ensure the long-term preservation of project data and developments, an eTRANSAFE legacy repository has been set up by the partner Universitat Pompeu Fabra (UPF) as one of the projects´ honest brokers. Consortium partners have provided data, source code and docker images of the components developed during the project for storing at UPF, who will facilitate access to all eTRANSAFE members for research use after project completion.

eTRANSAFE consortium members at the project closing event in Sitges, Barcelona in February 2023.

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March 3, 2023

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

03March

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!

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November 18, 2022

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

18November

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.

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November 8, 2022

eTRANSAFE announces the launch of the “eTRANSAFE ViCoG Initiative”

08November

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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October 28, 2022

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

28October

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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