The landscape of biomedical research is evolving, driven by a pressing need to refine, reduce, and replace the use of animals in non-clinical safety assessment. In this transformative era, the EU-funded NHPig project stands at the forefront of innovation, offering a visionary approach to non-clinical safety testing by leveraging mini- and micropig models as viable alternatives to non-human primates (NHPs). With a substantial €17.5 million backing from the Innovative Health Initiative Joint Undertaking and industry partners, this five-year endeavor signals a paradigm shift in the way we approach drug development and regulatory science.
A Unified Effort for Ethical and Effective Research
NHPig is not just a research project; it is a collaborative powerhouse uniting 27 leading international organizations under the leadership of Ludwig-Maximilians-Universität München (Germany) and Novo Nordisk A/S (Denmark). By bringing together expertise across academia, industry, and regulatory bodies, the project is poised to generate robust scientific insights that will enhance the translational relevance of mini- and micropig models.
At the heart of NHPig’s mission is the commitment to the 3R principles: Replacement, Reduction, and Refinement. These guiding tenets underpin every initiative within the project, ensuring that the use of animals in research is not only minimized but also optimized to yield the highest scientific and ethical standards. Ellegaard Göttingen Minipigs A/S is one of the 27 organisations in the project, and about their role CSO, Lars Siim Madsen, says: "The Göttingen Minipig has long been recognized for its translational relevance in biomedical research. Through NHPig, we now have the opportunity to further refine its application, ensuring that it serves as a scientifically robust and ethically sound alternative to non-human primates in non-clinical safety assessments."
Building a Comprehensive Knowledge Base
A cornerstone of NHPig’s work is the development of a database and IT platform that facilitates cross-species comparison of mini- and micropig biological data. This initiative will bridge the translational gap between pigs, NHPs, and humans, equipping researchers with an invaluable tool for data-driven decision-making in preclinical safety testing. “By participating in NHPig we wish to contribute to the development of cutting-edge models and data-driven insights. Ellegaard Göttingen Minipigs A/S has always invested ressources in knowledge-sharing, and in this forum we get the opportunity to join in the discussion about minipigs in contemporary and future research” Lars Siim Madsen explains.
The project is also characterizing humanized IgG1/4 minipigs and micropigs to evaluate their suitability for testing human therapeutic antibodies. By delving into the immunological responses of these models, NHPig aims to establish pigs as reliable and ethical alternatives for assessing drug safety and efficacy.
Harnessing Technology and AI for Advanced Safety Testing
A defining feature of NHPig’s approach is its embrace of cutting-edge technology. The project is establishing biobanks of wildtype and genetically modified minipigs and micropigs, enabling researchers to collect and analyze multi-omics data. These comprehensive datasets will fuel biomarker discovery and improve the predictive accuracy of preclinical models.
Artificial intelligence (AI) is also playing a crucial role in NHPig’s objectives. The project is developing AI-integrated digital solutions that enhance preclinical toxicity studies by objectively measuring clinically relevant biomarkers. These innovations will not only improve data accuracy and reliability but also ensure compliance with stringent regulatory requirements.
Regulatory and Ethical Excellence
Ensuring the highest standards of ethical research and regulatory alignment is paramount for NHPig. To this end, the project has established both a Regulatory Advisory Board and an Ethics and Animal Welfare Advisory Board. These bodies will guide the scientific community toward best practices in the responsible use of animals in biomedical research while fostering transparent regulatory interactions.
Shaping the Future of Preclinical Research
The initiation of the NHPig project marks a significant milestone for biomedical research in the EU. Lars Siim Madsen elaborates: “NHPig is a game-changer for preclinical research. By deepening our understanding of mini- and micropig models, we are creating new opportunities for safer and more ethical drug development. This project will provide researchers and regulators with the knowledge needed to make informed decisions that benefit both science and animal welfare.”
By expanding understanding of mini- and micropig models, NHPig has set out to find a reliable and translationally relevant alternative to NHPs in non-clinical safety testing. With continued collaboration and innovation, the project is set to leave a lasting impact on biomedical research, helping to shape future regulatory frameworks and improve drug development processes.
Learn more about NHPig
...at the official website nhpig.eu
