News

Open Access (free) E-book, also available to buy in hard copy from scholarly publisher Brill

In this important new book, 51 authors critically review current animal use in science, present new and innovative non-animal approaches to address urgent scientific questions, and offer a roadmap towards an animal-free world of science.

Edited by Drs Kathrin Herrmann and Kimberley Jayne

Featuring a chapter by Kathy Archibald, Tamara Drake and Dr Robert Coleman, entitled: Replacing Animal Tests to Improve Safety for Humans

Watch a 30 minute presentation of the chapter, from the recent London Book Launch Conference, by Dr Jan Turner

Researchers, academics and representatives from the pharmaceutical industry and advocacy groups have joined together to call for a significant and urgent shift to prioritise predictive, human-based nonclinical tests.

Drug Discovery Today has published the call from participants of the Nonclinical Innovation and Patient Safety Initiative, including Dr Gerry Kenna of Safer Medicines Trust.

Read the Open Access paper

We are deeply saddened by the death of Paul Flynn MP. It was a great honour for us to have his support as a Patron. He was a politician of courage and conviction and a fearsomely talented communicator, which made him a powerful advocate for causes he cared passionately about, including social justice and improving the safety of medicines. He was a towering figure in the House of Commons and in his beloved Welsh homeland and will be greatly missed.

Dr Gerry Kenna, our Pharmaceutical Director, spoke at the second WIST Congress in Germany on October 27th 2018

•  View 30 minute talk
• View slides
• View programme
• Read all abstracts and view all talks in English and German

We are delighted to announce the appointment of Dr Jan Turner as our new Director. She brings with her a wealth of experience in developing and promoting human-relevant in vitro technologies, including directing validation studies and influencing organisations such as the FDA to introduce such technologies into the early safety testing of drugs.

After completing her BSc in Biochemistry & Pharmacology, followed by a PhD and postdoctoral research in Genetic Toxicology, Dr Turner worked for Amersham Biosciences, subsequently GE Healthcare Life Sciences. Her roles included Development Scientist, Project Leader, Global Product Manager and Product Management Operations Leader. For the past 18 months she has been Senior Product Manager at BBI Solutions, directing global cross-functional teams and driving adoption of innovative technologies.

Jan is passionate about human-focused biomedical research and we look forward to her leadership in making medicines safer by accelerating the transition from animal-based to human-relevant drug development and testing. She says:

“I am thrilled to join Safer Medicines Trust and to work with so many talented and inspirational people towards our shared vision of a future where safe and effective treatments for patients will be delivered by scientifically valid, human-focused research.”

Kathy Archibald, our founder and Director for the past 14 years, remains the Chair of Trustees and will continue to manage Supporter Communications as the charity moves from strength to strength. She says:

“We are excited to welcome Jan to lead our team at this important time. I believe our expert team and the many visionary scientists and others with whom we collaborate will help to realise a future where better science will improve our health and save lives.”

Our 2018 newsletter contains brief summaries of our latest publications and examples of several exciting advances in human relevant technologies. Read it here and if you would like free hard copies, just let us know how many: email info@safermedicines.org or call 0300 302 0521

Commentary by Kathy Archibald, Katya Tsaioun, Gerry Kenna and Pandora Pound published in the Journal of the Royal Society of Medicine

Our commentary warns that the UK must not fall behind in the race to ‘humanise’ drug discovery. Current research models and regulation are blocking the development of human-relevant approaches to drug discovery and perpetuating animal-based approaches. The UK has world-leading research in this area but significant investment in non-animal technologies is taking place in the US and Europe. The UK should seize the initiative to revolutionise medicine through more intelligent, human-relevant research.

Read the full paper here

New article by Dr Pandora Pound and Professor Merel Ritskes-Hoitinga published in Journal of Translational Medicine

The authors make a compelling argument that preclinical animal models can never be fully valid due to the uncertainties introduced by species differences. They suggest that to improve clinical translation and ultimately benefit patients, research should focus instead on human-relevant research methods and technologies.

Read the full paper here

New review article coauthored by Dr Gerry Kenna published in the journal Clinical Pharmacology & Therapeutics:

Can BSEP Inhibition Testing In Drug Discovery And Development Reduce Liver Injury Risk? An International Transporter Consortium Perspective

Medicines can cause serious unwanted side effects in some patients. These include drug-induced liver injury (DILI), which is poorly predicted by the currently used safety test methods. Assays that focus on human-relevant mechanisms can provide more useful data. One important mechanism is inhibition of a liver cell membrane transport protein called the Bile Salt Export Pump (BSEP). This article reviews the evidence linking BSEP inhibition with DILI and describes methods to evaluate and interpret BSEP inhibition. It also recommends how these data can be used to aid the design and selection of safer medicines. The authors from Safer Medicines Trust, major pharmaceutical companies, universities and biotechnology companies were brought together by the International Transporter Consortium.

New paper published in the journal Drug Metabolism and Disposition: Do In Vitro Assays Predict Drug Candidate Idiosyncratic Drug-Induced Liver Injury Risk?

Our Pharmaceutical Director, Dr Gerry Kenna co-authored the paper with Dr Jack Uetrecht, Professor of Pharmacy and Medicine at the University of Toronto and the Canada Research Chair in Adverse Drug Reactions

Many new medicines cause undesired side effects in humans that are not predicted by the drug safety studies performed currently. This review focuses on liver injury, which is an especially important human adverse drug effect. It highlights both the promising progress made in developing human-relevant in vitro methods that can anticipate and reduce drug induced liver injury risk, and outstanding challenges which remain to be addressed.

The harm-benefit analysis is a cornerstone of animal research regulation in the EU and elsewhere. When applications for research projects involving animals are submitted for licensing the regulators weigh up the harms that animals are expected to suffer against the anticipated benefits of that research to humans.

Researchers at the University of Bristol reviewed a sample of animal research studies from 1967 to 2005. All the studies were judged to be of poor quality and most involved severe harms to animals. When the harms to animals were weighed against the benefits to humans less than 7% of the studies were judged to be permissible in terms of minimising harms to animals whilst being associated with benefits for humans.

Dr Pandora Pound, who led the research, says, “The regulatory systems in place when these studies were conducted failed to safeguard animals from severe suffering or to ensure that only beneficial, scientifically rigorous research was conducted.” The research is published in PLOS ONE

New paper by Kathy Archibald published in the Journal of Animal Ethics

Excerpt: Animals are used in biomedical research to study disease, develop new medicines, and test them for safety… A revolution in science and technology has produced a new generation of more relevant and predictive tools, which could be used to create safer medicines more quickly and at less cost: a win-win situation that should be supported by everyone. The obstacle preventing this from happening is governments’ continued insistence on animal testing. Yet the evidence is clear that reliance on animals as surrogate humans puts patients at risk, can delay medical progress, and can cause effective treatments to be wrongly discarded. There is a compelling case to be made that animal research is an ethical issue for humans as well as for animals.

A report was published in January by the Medicines Discovery Catapult and the BioIndustry Association, entitled: State of the Discovery Nation 2018. Based on surveys and in-depth interviews with more than 100 senior executives of drug discovery companies, the report offers a blueprint for successful pharmaceutical research, where patients and human data are placed at the heart of drug discovery. The current research process depends on animal models of disease and toxicology that are “poor approximations of humans”; consequently 40 per cent of new drugs fail when first tried in real patients. The rate at which new drugs are launched per $1bn spent on pharma R&D is one-30th of the level 40 years ago but “humanising” the early stages of research would ease the “productivity crisis” in pharmaceutical research.

“Discovery must start with biological targets derived from patient data and samples, which create candidate drugs that are highly selective for proven human disease targets in well-defined patient subgroups, not animal models,” said Chris Molloy, chief executive of the Medicines Discovery Catapult, quoted in the Financial Times.

Dr Azra Raza, Professor of Medicine at Columbia University in New York, and Science Adviser to Safer Medicines Trust, gives a fascinating one-hour interview on the human imperative in cancer research in this highly informative podcast. In 2014, Professor Raza gave a powerful and moving 13-minute TEDx Talk on the same theme, which you can view on YouTube.

Read our latest newsletter here 

Also, read article about the launch event, published here