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New Approach Methodologies (NAMs) based on human biology have the potential to reduce, and ideally eliminate, toxicities that arise during drug discovery and development. Pharmaceutical companies are already using NAMs in early drug development, with considerable success. However, there are areas of unmet need where NAMs might deliver more predictive power, potentially improving and expediting drug development. At present there is no overarching consensus on how NAMs may be incorporated within regulatory guidelines and numerous hurdles are hampering action. Guidance is needed especially for academic researchers and small biotech start-ups that drive NAM development, yet may be unfamiliar with the precise needs of regulators and other end users.

NAMs need to be included within a scientifically valid, integrated human-relevant pharmaceutical safety assessment strategy that will be acceptable to industry and regulators. With this in mind, we held a series of 5 workshops with 13 international experts (regulators, preclinical scientists and NAMs developers), to identify feasible NAMs and discuss how to use them in specific safety assessment contexts.

Participants generated four decision tree ‘maps’ showing how NAMs could be used to assess safety for the liver, respiratory, cardiovascular and central nervous systems. These organ system maps provide guidance on how specific human-relevant tests may be used in each context, as well as a template that could be applied to additional organ systems, or testing in other contexts. Maps like these have potential to guide stakeholders and generate confidence in using NAMs to complement and ultimately replace in vivo animal methods.

Converting these maps into interactive decision trees would allow users to ask specific questions and select the most appropriate NAM for their purpose, so the development of a more dynamic and user-friendly version of these maps is an important project for the future. This work could lead to greater adoption of NAMs, improved pharmaceutical productivity and, most importantly, safer medicines. The findings from this workshop have potential to contribute to implementation of the recently passed FDA Modernisation Act, which enables the use of NAMs for regulatory purposes in the US. We hope others will build on this work and use it to speed the transition to greater human relevance, which is so urgently needed.

Partners from the Alliance for Human Relevant Science included Safer Medicines Trust, Animal Free Research UK and Cruelty Free International. Cruelty Free International conceived the idea for the project and we are grateful to the Cruelty Free International Trust for funding this project and to all participants for so generously giving their time and expertise.

Read the paper in ALTEX here

London recently provided the venue for the very first animal free innovation Helpathon in the UK.

Helpathons are used in the Netherlands to help researchers who might otherwise undertake animal experiments to make the shift towards animal free methods. The idea is that advances in knowledge often happen through chance encounters.  Bringing people together in a Helpathon can tip the odds of those chance encounters in our favour and help to accelerate progress.

TPI Helpathon have organised 6 successful helpathon events so far. We want the UK to join the Netherlands as an international leader in accelerating towards animal free methods. This is why Animal Free Research UK, in collaboration with the Alliance for Human Relevant Science teamed up with the Dutch Helpathon team.

On the first of the two day sprint, the problem to be solved in this Helpathon was introduced by researchers, Professor Jesmond Dalli and Dr Duco Koenis from Barts, the London School of Medicine and Dentistry and Queen Mary University. They wanted help with how to transition their research, which involves using animal models of rheumatoid arthritis, to improved human relevant animal free research methods. Their goal is to test new drug targets for reducing inflammation and bacterial infection in the disease. This will ultimately pave the way for better treatments to resolve inflammation, avoiding irreversible damage and improving patients’ lives.

Ready to capitalise on open minds, open hearts and a great diversity of views thanks to the open invitation, the Helpathon started with Jesmond and Duco presenting an overview of their work with some insightful questioning from the audience, many of whom were non-scientists.

The atmosphere was electric with engaged and inspired participants coming up with questions which were then grouped into themes.  Participants then worked together in rooms discussing and interrogating these questions and moving between rooms, encouraging new connections to be made and more ideas to be generated. Day 2 saw these ideas being released from constraints of reality with visionary thinking around an ’ideal future’ where all research is animal free. Participants worked in teams and transformed themselves into movie makers, actors, comic creators and then live-streamed their final presentations during the closing session. These creative presentations ranged from new methods to help identify drug targets through to roadmaps on how to transition to a future world where science is animal free.

This creativity was captured by a professional doodle artist and a musician who provided inspiration by observing the event and composing a unique piece entitled, ‘there’s science behind kindness’. The event concluded with these ideas being shaped into some tangible ‘takeaways’. This was in the form of letters from participants advising on ‘next steps’ for Jesmond and Duco to take back to their labs, digest and then apply new ways of working to their research.

This pioneering UK Helpathon represents the first step towards the goal of a network of international Helpathons under one umbrella. This would connect collaborators and ideas to each other, helping to create a world where human diseases are cured faster without animal suffering

Carla Owen, Chair of the Alliance for Human Relevant Science and CEO of Animal Free Research UK, said “The arrival of the project in Britain will help the country’s scientists transition away from outdated animal-based medical research methods and grasp a human-relevant future.”

On 27th October, the Royal Society of Medicine in London was the venue for an exceptionally thought-provoking and inspiring  talk by Dr Azra Raza, Professor of Medicine at Columbia University in New York, international authority on leukaemia, acclaimed author of ‘The First Cell: And the Human Costs of Pursuing Cancer to the Last’ (Amazon’s ‘best science book of the year 2019’) and Science Adviser to Safer Medicines Trust.

Dr Raza’s themes were then eloquently expanded upon by Professor Geoff Pilkington, Emeritus Professor of Neuro-oncology at the University of Portsmouth and former Head of the Brain Tumour Research Centre, Member of the Alliance for Human Relevant Science, Trustee of Animal Free Research UK and The Childhood Cancer Charity and Science Adviser to Safer Medicines Trust.

An expert audience then participated in a Q&A chaired by Dr James Le Fanu, well-known columnist and historian of science and medicine, acclaimed author of ‘The Rise and Fall of Modern Medicine’, Fellow of the Royal Society of Medicine and Patron of Safer Medicines Trust. 

Dr Raza explained why the global cancer research effort should change direction to:
1) focus on prevention and early detection, with the aim of finding the first malignant cell instead of attacking late-stage disease, to which end she has established The Oncology Think Tank and the First Cell Coalition for Cancer Survivors; and

2) focus research exclusively on humans and their tissues, rather than on mice, rats and other animal models. For this purpose, she has founded the First Cell Center, to study her tissue repository of more than 60,000 samples collected from her patients over the past 38 years.

We are so grateful to all the speakers for such an inspirational discussion. The whole event can be viewed below:

A one-of-its-kind online community aimed at improving communication among biomedical scientists has been launched by the Alliance for Human Relevant Science and Animal Free Research UK.

The Animal Free Research Community of Practice is an interactive network for members to share their work, ideas, challenges and passion among likeminded peers.

With free membership for academic and early career scientists, students, industry and other stakeholders involved in biomedical research, members can interact online 24/7 as well as attend planned events, including open houses, roundtables and Helpathons.

A user-friendly website features up to date news, resources, tools, networking and project collaboration opportunities, latest research papers, job vacancies and academic openings. The community is curated by members and hosted by Animal Free Research UK coordinators.

New members can sign up and join the community by clicking here: Join the Community of Practice

Members are invited to create and add content to the online forum, share events and resources, and to collaborate on projects such as writing reviews, articles and much more. The Animal Free Research Community of Practice will bring scientists closer. It will raise awareness, deepen knowledge, drive creativity and spark passion for a science that benefits animals as well as humans.

We urge all who want to practice modern medical research – that which truly delivers benefits for human health – to sign up and become part of this important, exciting community.

The Alliance for Human Relevant Science and Animal Free Research UK are teaming up with members of the Dutch TPI Helpathon initiative to bring the first Helpathon to the UK on 11 and 12 October.

Helpathons are used in the Netherlands to help researchers who might otherwise undertake animal experiments to make the shift towards animal free methods.

The deadline for expressions of interest is 30 June 2022.

Researchers should send a short summary of their research interests and what they would like to achieve from the Helpathon to katharine@animalfreeresearchuk.org

For more information, please visit www.animalfreeresearchuk.org/helpathon

The Alliance for Human Relevant Science and Animal Free Research UK have teamed up with Dutch partners from the Transition Programme for Innovation to launch Britain’s first Helpathon.

Helpathons are used in the Netherlands to help researchers who might otherwise undertake animal experiments to make the shift towards animal free methods.

Carla Owen, Chair of the Alliance for Human Relevant Science and CEO of Animal Free Research UK said “The arrival of the project in Britain will help the country’s scientists transition away from outdated animal-based medical research methods and grasp a human-relevant future.”

TPI Helpathon team member Pepik Henneman, said: “A Helpathon invites anyone to ask a question to help resolve a societal issue. We will invite medical researchers to ask how they can innovate their research methods in an animal free way.”

Prof Sue Gibbs of the Amsterdam University Medical Centre and TPI Helpathon team member, said: “By obtaining advice and eliciting answers from trail blazing scientists already using human-focused methods, our Helpathons are undoubtedly shifting mindsets and making it easier to transition to human relevant science.”

The first UK Helpathon will be hosted by the Alliance for Human Relevant Science on 11 and 12 October.

Owen added: “All research scientists are invited to become involved in the project. Our Helpathon is the next step in the innovation wave that is transforming medical research in the UK and beyond.”

Owen is currently chair of the Alliance for Human Relevant Science, an inclusive collaboration of like-minded companies, organisations and individuals. Working together, the Alliance aims to improve awareness of the transformative potential of human-focused research tools and increase their use to improve public health.

For more information, please contact or visit www.animalfreeresearchuk.org/helpathon

Notes to Editors: 

Animal Free Research UK CEO, and chair of The Alliance for Human Relevant Science Carla Owen, is available for interviews about the Helpathon.   Please contact Animal Free Research UK Media and PR Manager Peter Simpson – peter@animalfreeresearchuk.org : Tel (+44) 07803 051 848

Animal Free Research UK funds pioneering research that saves humans and animals and is forging a future where animals are replaced with modern, human relevant techniques. With over 92 percent of new drugs tested on animals failing to benefit human health, the charity recognises that a transition to animal-free human-relevant technology will help position the UK as a science powerhouse. For more information visit www.animalfreeresearchuk.org/

The Alliance for Human Relevant Science is an inclusive collaboration of like-minded companies, organisations and individuals. Working together, we will accelerate innovation and create positive change.  Click here to find out more Who we are – Human Relevant Science

Members of the Alliance for Human Relevant Science were devastated to hear the news of the tragic passing of Sir David Amess on Friday 15th October. Sir David was Vice Chair of the APPG for Human Relevant Science and understood the way in which human health could be improved without the need to use animals. He supported the launch of our Whitepaper in March 2020 and was keen to see change in biomedical science for the benefit of all. Above all, he was approachable, caring and genuinely interested in our cause. His compassion was clear and is reflected in the many tributes now being paid for his charitable work and steadfast dedication to the constituents he represented. He will be sorely missed and our heartfelt condolences go out to his family, friends and colleagues.

The fourth APPG on human relevant sciences will be held (virtually) on the Tuesday 14th September 2021 at 4.45 – 6.15pm UK time where we will explore how countries other than the UK have successfully addressed the transition to human relevant approaches and how EU and international animal law and ethics are important factors in this transition.

This final meeting for 2021 for this APPG will be followed by a report of our findings to be published in Nov 2021. Call back here after the meeting to hear what was discussed at the fourth meeting and our plans for the launch of the final report.

Confirmed speakers

Pepik Henneman is co-director and co-founder of Mister Lion, an Amsterdam and Ghent based lab for societal change (Meneer de Leeuw), helpathon specialist and transition management expert. Pepik lectures at the Rotterdam University Erasmus Academie on transition management and social innovation.

After having graduated at the T.U. Delft (1996) Pepik began his career as a petroleum engineer at Shell International Exploration & Production BV. Taken by the concept of sustainability he developed the basis of his vision and practice at Schumacher College (MSc Holistic Science 2001). In 2000, Pepik founds Innovaders consultancy from which he advises organizations on sustainable business. In 2006 he became affiliated to the Dutch Research Institute for Transitions (DRIFT) at Rotterdam Erasmus University where he brings the concepts of transition management into practice. At Meneer de Leeuw, Pepik leads co-creation processes between local government, institutions and citizens on a broad range of societal issues across Europe. His work includes interventions and visionary publications on regional development, urban mobility, living streets, urban climate mitigation, energy saving, sustainable agriculture, youth employment, international cooperation, refugee shelter, social divide, elderly care and citizen participation and more recently animal free innovation and sustainable transitions in the construction sector.

Pepik is the author of Frontrunners in action (Burgermeesterboek, van Gorcum 2012). Frontrunners in action describes a perspective on societal change and proposes a method for local sustainable innovation. ‘In our method we call up on officials of municipalities and departments to radically involve the frontrunners and pioneers to contribute to the development of their region. We call upon leaders of organizations and business to take on the role of regional change agents.’

Mister Lion is a social enterprise
Mister Lion is a social enterprise based in Ghent and Amsterdam, we have intervened in a wide range of societal transitions in Belgium, The Netherlands, France and various other EU countries. We have 15 years of experience in organizing coincidence. We enter into an open dialogue with people in an area, a sector or an organization. We immerse ourselves in each complex social system. Together with our stakeholders we explore new ways of doing, thinking and organizing – and try them out right away.

The way we work
Our clients see the urgency and the potential, our innovation networks explore the possibilities and we listen and look for openings. We follow the energy and discover new organizing ideas. We help our clients innovate and become more effective in accomplishing their societal mission. We ask for space and freedom to look afresh and find suitable ways to achieve results.

Animal Free Innovation
Mister Lion was asked in 2014 to lead round table discussions for the think tank on alternative financing for animal-free testing from a transition perspective, via the co-creative ‘temporary innovation network’ approach. From these conversations, the first transition sketch of the animal testing regime emerged. This sketch is included in the publication In Transitie!, together with the recommendation to continue the ‘temporary innovation networks’ approach. At the end of 2017, Mister Lion was asked by the Ministry of LNV to help set up the temporary renewal networks strategy, which forms the basis of the current TPI programme. Mister Lion was then challenged to show how the concept of temporary innovation networks can be successfully put into practice. Mister Lion organised and led the Innovative Health Research network. At the beginning of 2019, this new network presented its progress report with clarification, results and challenges. The network also introduced the Helpathon as a new innovation protocol. Since then Mister Lions co-organized five successful TPI Helpathons.

Prof. dr. Sue Gibbs is Chair in skin and mucosa regenerative medicine at both Amsterdam University Medical Center and Academic Center for Dentistry Amsterdam (ACTA). Her entire career has focused on human skin and mucosa biology, in particular in animal alternative methods to develop novel therapeutic strategies for treating and preventing human disease. In vitro models are currently implemented for risk assessment and testing mode of action of compounds and novel actives, in collaboration with industry. In 2015, she received the national ‘’Daring in the Lab’’ prize by the Dutch Animal Protection society. Recently, her research has extended into the field of hair follicles and importantly ‘’organ-on-a-chip’’, in particular immune competent ‘’skin-, melanoma-, lymph node- and gut- on-a-chip’’. These models have the potential to provide a personalized medicine approach to treating human disease. She joined the TPI network in 2018 and helped initiate the Helpathon to assist scientists willing to transition to animal free innovations. The Helpathon team won the international LUSH prize in 2020 enabling the funding of Helpathons in 2021.

David Thomas is a solicitor. He has acted for nearly all the major animal protection organisations in the UK (and beyond) and is highly experienced in EU and international animal law, including trade law. He has also acted extensively in human rights cases (which can be relevant to animal protection law), much of it again international, and public law more generally. He is a fellow of the Oxford Centre for Animal Ethics, a former chair of the RSPCA (currently a trustee) and a former director of Cruelty Free International and Compassion in World Farming. He has written extensively about animal protection law and ethics and taken part in numerous presentations, debates and media appearances. He gave oral evidence to the Burns Inquiry on hunting and has given oral testimony to several parliamentary committees and a Royal Commission as well as holding countless meetings with ministers and officials. He has been a member of European Commission and UK government panels and is an experienced teacher of law.

 

 

The Alliance for Human Relevant Science, an inclusive collaboration of like-minded companies, organisations and individuals working together to support and promote human relevant research for improved health, welcomes reports that the Government will review the use of animals in the development of medicines. Data obtained in animals is of limited relevance to humans and has not enabled development of effective treatments for many life-threatening and debilitating diseases.  There is an urgent need to transition from reliance on animal procedures to use of methods that focus directly on human biology which can provide more useful insights into human diseases and disease treatments. The opportunity provided by methods that use human organs, tissues and cells grown in the lab is a step forward in this transition and has already been highlighted in the Alliance’s series of APPG meetings this year.

Many of our members have worked with pharmaceutical companies, regulators, and academics to address issues raised in making this transition, and a wealth of data supporting the benefits of the new approach methodologies (NAMs) is available. There may be apprehension surrounding this move but we offer our expertise and advice to officials carrying out this review on how this can be done in a measured, responsible and fully informed way.