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 2015, Professor Raza gave a powerful and moving 13-minute TEDx Talk on the same theme, which you can view on YouTube.
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.
Abbreviated abstract: Animal toxicity studies used to assess the safety of new candidate pharmaceuticals prior to their progression into human clinical trials are unable to assess the risk of non-pharmacologically mediated idiosyncratic adverse drug reactions (ADRs), the most frequent of which are drug-induced liver injury and cardiotoxicity… The chemical insults can be detected using in vitro assays. These enable useful discrimination between drugs that cause high versus low levels of idiosyncratic ADR concern… Widespread acceptance and use of such assays has been hampered by the lack of correlation between idiosyncratic human ADR risk and toxicities observed in vivo in animals.
Sir David Amess MP hosted the launch event, which was full to capacity with senior scientists and MPs whose enthusiasm and support were palpable.
Working together, the Alliance will help to speed the transition away from animal testing, towards more efficient and predictive models based on human biology. Many breakthroughs are lost in translation from animals to humans. There is now a tremendous opportunity to make drug development faster and safer, using human relevant technologies. Some exciting technologies were highlighted at the meeting, including cutting-edge models of the liver, linked together with other organs to realistically mimic the human body.
Sir David said: “Britain is a world leader in life science research. But we had better look to our laurels if we do not want to be left behind, while others take the lead in embracing more predictive tools based on human biology. I wish the new Alliance every success with this hugely important initiative.”
We are delighted to welcome Rebecca Ram, MSc as our new Scientific Consultant. Rebecca is also a Scientific Consultant to the Lush Prize team at the Ethical Consumer Research Association. She holds an MSc in Toxicology with Bioinformatics and has worked as a Clinical Data Manager at University College London Hospital, and in pharmaceutical clinical trials for GlaxoSmithKline. She was a Project Manager of cancer clinical trials and whole genome sequencing for Genomics England, as part of the 100,000 Genomes Project. In addition to her role with Safer Medicines Trust, she is also the Communications Officer for the Alliance for Human Relevant Science.
Dods conducted an online survey of 2,512 UK health and care professionals in March 2016.
They were asked one question about their perception of pharmaceutical testing regulations on behalf of Safer Medicines Trust.
The overwhelming majority of health professionals (79 per cent) agree that pharmaceutical companies should be legally obliged to test new medicines using methods demonstrated to be the most predictive of safety for humans.
Just three per cent of health professionals disagreed that pharmaceutical companies should be legally obliged to test new medicines using methods demonstrated to be the most predictive of safety for humans.
We are delighted to welcome Dr Gerry Kenna to Safer Medicines Trust, and look forward to him continuing to innovate and forge a route to improved safety of medicines, through human-relevant methods.
Dr Gerry Kenna is a Drug Safety Consultant and a leading figure in the field of human drug induced liver injury. Following his initial scientific training in biochemistry, at the Universities of Leeds (BSc Hons) and London (PhD), Dr Kenna established and led academic research teams which, for 19 years, studied the mechanisms by which medicines and other chemicals may damage cells of the liver. He then moved to industry (at Zeneca, Syngenta and AstraZeneca), where for 14 years he used his expertise to support human safety assessment of new medicines and agrochemicals. During this time, he also led research teams which developed improved human safety testing methods. These used human tissues and did not require use of animals. Dr Kenna is committed to ensuring that such human-relevant approaches are used routinely, by scientists in industry and in regulatory agencies, to aid the invention and development of safe new medicines.