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.
We were delighted to work alongside partners from the Alliance for Human Relevant Science, including 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.
15 minute interview with Dr Jan Turner, who explains how organoids and organs on chips are enabling new knowledge of human biology and disease. These miniature models of human systems provide human-relevant insights and can be personalised to individual diseases, allowing studies that have never been possible before. These infinitely adaptable tools overcome the insurmountable limitations of animal models, ushering in a future of better, more efficient drug development and safer medicines for patients.
Thanks to Cytiva and Dr Jan Turner, our much-missed former Director.
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.
World Patient Safety Day is grounded in the most fundamental principle of medicine – first do no harm “Medication Safety” is the theme for World Patient Safety Day 2022. Safer Medicines Trust is a patient safety charity whose mission is to improve the safety of medicines, so we very much support calls for “Medication Without Harm”. The World […]The crisis of Alzheimer’s disease research: it’s time to embrace a new approach to help patients
The problem Alzheimer’s disease (AD) is a leading cause of death in the UK and along with other dementias, is responsible for almost 11% of all deaths in England.1 More than 209,000 new cases are diagnosed each year across the UK.2 It remains a leading cause of death and disability worldwide3, affecting nearly 50 million […]