Safer Medicines - putting patient safety first

Putting patient safety first

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Advancing nonclinical innovation and safety in pharmaceutical testing

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


Paul Flynn 1935 – 2019

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.



Safer Medicines Trust welcomes new Director

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.

Dr Jan Turner

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.”



Better science for safer medicines: the human imperative

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


Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail

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

 


Human cell-based assays vital to assess risk of drug-induced liver injury

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.


Predicting drug-induced liver injury risk


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.


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