Alliance member CN Bio announces how a joint publication with the FDA demonstrates the advantages of their PhysioMimix™ in drug safety and metabolism applications, over standard techniques. This represents the first co-published, peer-reviewed article between a microphysiological system provider and a regulator:
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PRESS RELEASE New Parliamentary group calls for human relevant science moonshot
Tuesday 6 October, London: A new All-Party Parliamentary Group today held its first AGM with the aim of accelerating the development and uptake of human relevant life sciences in the UK.
The APPG on Human Relevant Science held its first meeting remotely on Tuesday 6 October, where the group outlined its priorities.
The APPG will be a discussion forum for politicians, the human relevant life sciences sector, third sector groups, scientists and stakeholders to promote new approach methodologies that provide unique insights into human biology, transform our ability to understand human disease and can develop effective new medicines more quickly and without the use of animals.
Its programme will cover the themes of strategic funding to incentivise the development and use of human relevant methods and technologies, and incorporation of human relevant methods into regulatory guidelines on medicines development.
The APPG’s statement of purpose is to bring together MPs and Peers of all parties to accelerate the development and uptake of human relevant life sciences in the UK.
Replacing poorly performing animal tests with innovative human relevant new approach methodologies will directly benefit the UK science base and enhance the efficiency and profitability of industries that make vital contributions to the UK economy.
Speaking at the launch, the APPG’s Chair, Labour MP Grahame Morris, said, “I am delighted to Chair the new All-Party Parliamentary Group on Human Relevant Science. The COVID-19 pandemic has demonstrated that the current approach to developing new treatments is simply not fast enough to meet humanity’s needs. We urgently need a moonshot to transition to new approach methodologies which promise to deliver safer and more effective medicines, more quickly and at less cost.”
APPG Vice Chair Conservative MP Sir David Amess said, “I am thrilled to be Vice Chair of the new All-Party Parliamentary Group on Human Relevant Science. With the cancellation of the Autumn Budget, the Government now has more time to think about what it can do to provide much-needed financial support to boost growth in the human relevant life sciences sector and enable the UK to remain an innovative science superpower.
“As the country seeks a COVID-19 vaccine, this is the perfect time for parliamentarians to take seriously the growing evidence in favour of the pioneering human relevant medical research techniques that are replacing the outdated use of animals.”
The Alliance for Human Relevant Science acts as the group’s secretariat.
ENDS
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About the Alliance for Human Relevant Science
The Alliance for Human Relevant Science is an inclusive collaboration of like-minded companies, organisations and individuals, working together to show how significant advances in science and technology can deliver new methods based on human biology, with the potential to improve the safety of medicines and other chemicals.
A CALL TO ACCELERATE HUMAN-FOCUSSED MEDICAL RESEARCH
An open letter to:
International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The International Coalition of Medicines Regulatory Authorities
European Medicines Agency
European Directorate for the Quality of Medicines and Healthcare
European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
Home Office
Department of Health and Social Care
Department for Business, Energy & Industrial Strategy
Medicines & Healthcare products Regulatory Agency
National Institute for Health and Care Excellence (NICE)
We are calling for a change of mindset and a clear timetable for regulatory change to enable accelerated development of medicines which are likely to be safer, more effective and cheaper, without the use of animals. Investment in human relevant science offers a golden opportunity to revitalise medical research, save money, create wealth and improve public health.
We find ourselves in a time of global health emergency, one that will challenge our healthcare, social fabric and economy for years to come. Hard choices today have been borne out of great and immediate need. Yet there are patterns emerging in the scientific response that will have far reaching consequences for how we progress medical science in the future.
WHITEPAPER LAUNCH
On Tuesday 10th March 2020, Grahame Morris MP hosted the launch of our new whitepaper “Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom” at Portcullis House, Westminster, London. MPs and scientists were able to discuss how significant advances in science and technology have delivered new methods based on human tissues and cells and have the potential to improve the prediction of human toxicities caused by medicines and other chemicals. Read the full whitepaper and a summary here.
Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom
The Alliance for Human Relevant Science, calls for a fresh approach to biomedical research and drug discovery.
New approach methodologies (NAMs) that are human relevant have the potential to improve the efficiency of drug research and development and to deliver safer, cheaper and more effective medicines to patients.
In the released White paper ‘Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom’, the Alliance calls for support from the Government to assist businesses in the transition to NAMs by providing supportive infrastructure, strategic funding, education, collaboration between industries and regulatory engagement.
There is an opportunity for the UK to be a world leader in developing and evaluating NAMs. Investment in human relevant methods is good for both business and public health.
Read the White Paper summary document
Read the full paper
Contributions are invited for a Special Issue in the journal ‘Animals’
The open access journal ‘Animals’ is running a Special Issue guest edited by Pandora Pound of Safer Medicines. The topic for the Special Issue is ‘Are Animal Models Needed to Discover, Develop and Test Pharmaceutical Drugs for Humans in the 21st Century?’ Original manuscripts that address this question are invited for the Special Issue. The deadline is May 15th 2020 More information can be found here.
Background to call for papers
Despite many decades of research, much of which has focused on studies in animals, humans continue to suffer from diseases and illnesses for which there are no cures or treatments. It is now clear that insights provided by animal studies do not often translate to humans, explaining the very high failure rate observed when new medicines are evaluated in human clinical trials. In addition, there is increasing evidence that animal studies are frequently conducted so poorly that no clear conclusions may be drawn from them. Some claim that if only the quality of animal studies was improved, and animal models were made to more faithfully capture the relevant human disease, then these models would begin to translate and deliver clinical benefits. Others argue that research focusing on humans is necessary to gain a better understanding of human disease and to develop safe and effective drug treatments.These scientists point to developments in human biology during the last decade that have yielded in vitro and in silico techniques capable of providing novel insights into human disease mechanisms, as well as human-relevant disease models for developing and testing drug treatments for humans. A key question is whether there is value in refining animal models, or whether these should be relinquished in favour of new, human-focused research approaches.