Launch of IHI JU VICT3R Initiative to Revolutionize Nonclinical Drug and Chemical Safety Evaluation with Virtual Controls

VICT3R is a new IHI-funded initiative aiming to revolutionize nonclinical safety testing by significantly reducing animal use in toxicology research.

Barcelona, 16th september

Today  we have announced the launch of VICT3R, a groundbreaking initiative aimed at transforming nonclinical drug and chemical safety evaluation. VICT3R is a public-private partnership supported by the Innovative Health Initiative Joint Undertaking (IHI JU), set to significantly reduce the number of animals used in experimental studies. The aim of the initiative is to replace animals in concurrent control groups (CCGs) with the power of Virtual Control Groups (VCGs) created through cutting-edge statistical and artificial intelligence (AI) techniques.

Starting September 1, 2024, and spanning 42 months, VICT3R will unite thirty-three (33) partner organizations. This alliance led by the Pompeu Fabra University (Barcelona, Spain) and Bayer AG (Berlin, Germany) includes twenty (20) industry leaders, seven (7) nimble small- and medium-sized enterprises, and six (6) top-tier academic institutions. Together, they will champion the VCG concept, harnessing decades of control animal data from pharmaceutical companies and relevant industrial and academic sectors.

Importantly, VICT3R will work towards the aims of the 3Rs—Replacement, Reduction, and Refinement—by replacing animals in control groups with virtual counterparts, reducing up to 25% the overall number of animals required for such studies, and refining the methodologies to ensure the highest standards of ethical scientific practices.

The VCG approach, initially prototyped during the eTRANSAFE IMI2 project, has shown promise in nonclinical safety assessment but requires further refinement for adoption in regulatory hazard and risk assessment. VICT3R will further develop this game-changing concept by systematically addressing key challenges such as big data sharing, collection and curation, pinpointing crucial variables for the perfect VCG-CCG match, introducing AI approaches for the generation of virtual control groups, and ensuring validation procedures aligned with Good Laboratory Practice (GLP).

At the heart of VICT3R lies an ambitious mission: to build a comprehensive, high-quality database of curated and analysed control animal data from various species. This wealth of information will be accessible to partners, regulators, and policymakers, fuelling the evolution of the VCG concept and demonstrating its validity, reproducibility, and robustness.

VICT3R isn’t just about innovation; it is a clear call for ethical scientific practices and environmental sustainability in drug and chemical safety evaluation. By wielding advanced statistical and AI techniques, VICT3R will not only enhance the scientific validity of safety assessments but also promote ethical research practices by reducing reliance on animal testing.

While VICT3R’s primary focus is on repeated dose toxicity studies, the initiative also aims to extend the VCG concept to other types of animal studies. Furthermore, VICT3R is committed to the long-term maintenance and expansion of its database and software platform, ensuring sustained accessibility and impact for years to come.

This pioneering project is backed by €28 million in funding from the Innovative Health Initiative Joint Undertaking (IHI JU) and contributing industry partners.

Stay tuned for upcoming developments from the VICT3R initiative as we embark on this exciting journey to overhaul nonclinical safety evaluation.

For more information and updates about the VICT3R initiative, please contact:

Ferran Sanz, UPF (ferran.sanz@upf.edu)

Thomas Steger-Hartmann, Bayer AG (thomas.steger-hartmann@bayer.com)

Inari Soininen, Synapse (isoininen@synapse-managers.com)

About VICT3R

The VICT3R initiative is a public-private partnership which aims to transform nonclinical drug and chemical safety evaluation by developing and implementing Virtual Control Groups (VCGs) to replace animals in concurrent control groups (CCGs). By leveraging historical control data and advanced statistical and AI techniques, VICT3R seeks to reduce animal use in experimental studies while ensuring robust and reproducible safety assessments.

This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101172693. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, Vaccines Europe, and Instem Scientific Limited.