03/01/2022 | Pharma Innovation
The first such crisis, involving biosample quality, was highlighted by The Cancer Genome Atlas project, a joint initiative between the National Cancer Institute and National Human Genome Research Institute which required a large number of tumour samples for genomic sequencing analysis. The plan was to collect 1,500 samples from four to six collaborating clinical centres. Dr. Carolyn Compton, director of the Office of Biorepositories and Biospecimen Research (OBBR) at NCI co-ordinated the collection. However, she found, based in the histological quality control, that only a fraction offered were suitable. Almost 99 per cent of them were rejected as too small, not enough tumour present or lacking normal control tissue.
As a result, OBBR had to add 54 clinical centres. Then, of those that passed histological quality control, an extra 30 per cent were rejected because they failed molecular quality control. Dr. Compton went on to promote the field of biospecimen science, where preanalytical factors on specimen quality is studied as an academic discipline. This was a positive outcome from this particular crisis.
Then there was the UK’s organ retention scandal of 1999, identified when a mother investigating the death of her child at the Bristol Royal Infirmary, discovered that her child’s heart had been removed at autopsy and retained without permission.
A public inquiry established it was common practice in many hospitals for pathologists performing autopsies on infants to retain whole organs like the brain and heart for education and research purposes, without the informed consent of parents. There was a public outcry. The report of the Royal Liverpool Children’s inquiry recommended a change in the law and the Human Tissue Act of 2004 came into force. In addition, a regulatory body called the Human Tissue Authority (HTA) was set up to regulate organisations that “remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public”. In other words, yet further examples of positive changes born out of crisis.
Three years ago, a survey conducted by a UK agency Medicines Discovery Catapult showed that eight out of ten small-to-medium-sized biotechs found accessing samples from the National Health Service “unexpectedly difficult” with the result that 75 per cent of imported samples came from abroad. Given the vital role biotech companies play in translating promising ideas generated in academia, into potential therapies, such difficulty in obtaining these samples must be seen as a crisis. There are 150 hospital-associated biobanks within the UK so no shortage of samples. The problem is a failure to share them with biotech companies. This is a global issue. Around the world, biotechs rely mainly on commercial tissue brokers to obtain clinical samples. These brokers have difficulty sourcing samples in Western European countries, where ethical concerns about the sale of human tissue are prevalent. So brokers often obtain samples from Eastern Europe and parts of Asia, a practice which creates additional ethical concerns.
Commercial brokers serve a valuable purpose by providing biotech companies with clinical samples for their research. However, in general brokers have the disadvantage that for business reasons they will not reveal the source of their samples, as this risks circumvention and loss of income. This obviously means that their clients will tend to lack reliable provenance information on samples received. This is a serious problem for medical device manufacturers who must use samples with reliable provenance information to validate their devices, to be compliant with the new European IVDR regulations.
This is the NF S 96-900 “Qualité des Centres de resources biologiques” which was published as long ago as 2008. All BRCs in France are now certified according to this standard. There, public sector biobanks understand the need for “valorisation” of their services, as well as the need to support the biotechnology industry. Interestingly, over half of the biobanks on the Biosample Hub platform are French. No doubt we can all learn from the French example.
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