A new White Paper published by the Alliance for Human Relevant Science is calling for a fresh approach to biomedical research and drug discovery to deliver safer medicines more quickly and at less cost.

Launched at a parliamentary reception hosted by Grahame Morris MP during British Science Week, ‘Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom’ champions the development of innovative, human relevant research models.

Known as new approach methodologies (NAMs)*, these focus on human biology and allow a more sophisticated understanding of human disease processes. They also avoid the problem of animal-human species differences that can make translation to humans unreliable.

Grahame Morris MP, who hosted the White Paper launch event “Accelerating human relevant life sciences in the UK” said: “I very much welcome the publication of this timely report and, in collaboration with the Alliance, will be urging the Government to support NAM development for the benefit of public health.” A new Early Day Motion 256 has been tabled alongside the launch of the White Paper.

Many major diseases such as cancer, stroke, heart disease and Alzheimer’s remain poorly understood and lack adequate treatments. New treatments are needed urgently but the discovery and development of new medicines is complex, time-consuming, risky and very expensive. The development of a new drug typically takes 10 years or more and costs around £2 billion, but 86 – 90% of new medicines fail when trialled in humans, most commonly due to lack of benefit or safety.

This low success rate arises despite extensive ‘preclinical’ studies that typically use animals. Animal studies are often unable to accurately predict whether a new medicine will be effective or safe in humans. The current dependence on animal data is proving to be costly, both in terms of research resources and public health.

NAMs are already providing valuable new insights into human biology and disease processes. They have the potential to improve our understanding of human disease, deliver more effective medicines and improve the prediction of adverse drug reactions (ADRs). It is estimated that ADRs kill more than 10,000 people in the UK each year, account for 6.5% of hospital admissions and in England alone, cost the NHS up to £1.6 billion annually. NAMs have clear potential then, to deliver safer medicines, more quickly and at less cost, with clear benefits for public health.

The UK is regarded as one of the world’s best locations for developing new medicines. The Alliance states that, with government backing – to provide infrastructure, strategic funding and education, and to encourage collaboration between industries and regulators – the UK has a golden opportunity to take a lead in the transition to human relevant approaches and become a “global powerhouse” in NAM development.

Dr Rob Riley, Alliance member and Executive VP at Cyprotex said: “Increased investment in human-based systems coupled with emerging technologies should address the sub-optimal translation from pre-clinical animal models and enhance our probability of success in the clinic”.

Dr Jan Turner, Director of Safer Medicines Trust, a founding member of the Alliance said: “If there is to be progress, the UK Government needs to take a lead in supporting the transition to human relevant science”.

Jan Creamer, President of Alliance Member Lord Dowding Fund for Humane Research said “Advanced non-animal research methods are increasingly delivering more effective medicines and efficiencies in drug development – good for people and animals”.  NAMs and their potential:

· *NAMs include: genomics, the study of DNA; the use of human stem cells; 3D cell models including ‘organs-on-a-chip’; cell lines grown for toxicity testing; human tissues from patient surgeries; in silico (i.e. computer simulation) models.

· A number of countries, including the UK, US and Netherlands have produced roadmaps to progress the transition to NAMs. UK roadmaps are optimistic about the benefits of NAMs and highlight their potential to attract business investment and drive economic growth, but they lack the ambitious programmes that other countries have launched for their implementation.

· The US government provides funding and incentives to test chemicals using NAMs. The US Environmental Protection Agency has recently provided $4.25 million for NAMs and aims to eliminate all requests and funding for studies using mammals by 2035.

· The business opportunity for NAMs is potentially huge. Global market forecasts include cell-based assays reaching $18.9 billion by 2024, stem cell technologies and applications reaching $28 billion by 2029 and organ-on-a-chip technologies reaching $60-176 million by 2022.