A new paper by Safer Medicines scientific consultant Rebecca Ram, Dr. Domenico Gadaleta of the Mario Negri Institute, Italy and Dr. Tim Allen of the MRC Toxicology Unit, Cambridge discusses the progress of in-silico methods in New Approach Methodologies (NAMs) as well as the increasing need for use of ‘big data’ and artificial intelligence (AI) approaches in safety testing and biomedical research.
In silico, or computer-based research methods continue to emerge as part of a robust 21st century public health strategy, vital to improving the efficiency of preclinical drug discovery, as well as safety testing in the chemicals industry. They can be used alongside other methods e.g., human-based in vitro (cell or tissue derived) models as components of human-relevant New Approach Methodologies (NAMs).
Despite resisting scientific scrutiny for decades, animal studies have, over the last twenty years, been revealed by systematic reviews to be poorly conducted and unreliable, with the result that humans have, on occasion, been seriously harmed. Such troubling exposures have prompted several initiatives to improve the quality of animal studies and their reporting, but these have had little impact so far on improving their translation to humans. Could it be that fundamental differences between species constitute an insurmountable problem for biomedical research? Given that transformative human relevant technologies such as organ-chips and organoids are now available, could now be the time for a new paradigm?
March 22: The All Party Parliamentary Group for Human Relevant Science launches their report in Parliament, entitled: BRINGING BACK THE HUMAN: TRANSITIONING FROM ANIMAL RESEARCH TO HUMAN RELEVANT SCIENCE IN THE UK. MPs say human relevant science is essential to medical progress, and make recommendations including the creation of a dedicated ministerial-level post to ‘lead an ambitious and detailed programme of work’ cutting across Government to drive the UK’s transition to human relevant science.
Evidence given to the APPG stressed that now is the time for government leadership to put the human first and modernise medical research.
It emerged during the inquiry that ‘funding for human relevant technologies represents just 0.02% of the total public expenditure on research and development.’ The group is therefore urging the Government to increase the funding of human relevant approaches by strategically diverting resources away from traditional animal-based approaches which have a high failure rate and directing funding to transformative human relevant technologies.
Read the report and/or a separate brief summary here:
Our Pharmaceutical Director, Dr Gerry Kenna, recently presented a virtual seminar on “In vitro models for assessment of drug-induced liver injury (DILI): a personal perspective” to the Liver Toxicity Working Group of the US regulator, the FDA. The illustrated talk is 45 minutes long and gives a valuable insight, from an expert with decades of experience, into the state of the art of drug safety testing to avoid the risk of DILI. DILI is an important cause of drug-related ill health, which can be serious and even fatal, and is a leading reason for failed development and use of many otherwise promising new drugs.
The talk is technical, so you may wish to focus just on the Summary in the final 7 minutes. Here, Gerry explains that numerous methods which use human-derived cells are available, and provide data that are much more useful than animal safety studies. Because DILI is complicated, no single method can be used and multiple endpoints need to be analysed. Gerry highlights that there is an urgent need for scientists to reach consensus on which assays to use and how best to analyse and interpret the data that they provide. There is also a need for strong regulatory guidance that requires in vitro methods be used to assess the risk of DILI, thus reducing the incidence of this serious but often avoidable adverse drug reaction.
A new paper by Safer Medicines scientific consultant Rebecca Ram, Dr. Domenico Gadaleta of the Mario Negri Institute, Italy and Dr. Tim Allen of the MRC Toxicology Unit, Cambridge discusses the progress of in-silico methods in New Approach Methodologies (NAMs) as well as the increasing need for use of ‘big data’ and artificial intelligence (AI) […]World Animal Free Research Day
One of our partner charities in the Alliance for Human Relevant Science is Animal Free Research UK. They have initiated an annual World Animal Free Research Day on the anniversary of their founding, 27th May. Our goals are very complementary: Animal Free Research UK’s vision is “To create a world where human diseases are cured faster without animal suffering”, while […]