For commercial organisations, sourcing reliable biosamples is not an easy task. With highly specific needs, biotech companies may have to trawl through a list of hundreds of biobanks before finding one that can provide the sample they need.
In the world of research, most biobanks are linked with an academic centre and are set up with the academic researcher in mind. It means for-profit organisations are rarely a priority and can often lose out on the high-quality samples they need to carry out research.
Robert Hewitt, PhD, has worked in biobanking for over thirty years and is considered a pioneer in his field having served as President of the ISBER International Biobanking Association and established biobanks in London, Riyadh and Singapore.
Hewitt believes the system for sourcing samples is broken and needs to be changed in order to make high-quality samples more accessible to commercial researchers.
In 2010, Hewitt founded a European association for biobanking called ESBB. Through the organisation he began to focus on improving industry access to samples. He discovered that commercial organisations were having difficulty in accessing high-quality patient samples and sourcing provenance information.
Provenance information is vital for determining the quality of a biosample. It contains details about how the sample was handled from the point at which it was removed to when it was frozen. Without this information, researchers are unable to factor in these variabilities or trust that the sample is usable.
“[Companies] need to get samples of high quality that they can trust and in order to trust the samples they’ve got to know where the samples come from. They have to know the provenance information about the samples, they have to know where they were collected and how they were collected.
“That has an enormous impact on their quality and therefore on the reliability and the reproducibility of the work that can be done with them. So it’s really vitally important that these companies have that information.”
Researchers in industry tend to rely on commercial brokers to find samples on their behalf. But, with business interests to think about, commercial brokers rarely make introductions between the end-user and the original source of the sample.
With the middleman often reluctant to divulge too much information, biotech companies can find themselves with less reliable provenance information.
“I think the main reason for the lack of provenance information is that it’s difficult for the company to be in direct contact with the source,” Hewitt said.
“The firm may facilitate the exchange of information without actually making an introduction, so the information may go from the hospital to the broker to the company but that’s not ideal.
“Of course brokers understand the need to provide the provenance information but at the same time, they’ve got to protect their business interests so it is a problem.”
Hewitt believes that academic biobanks need to be more discoverable for industry researchers which is why he launched a not for profit organisation, Biosample Hub, to help address the issue.
Biosample Hub is an online platform that connects academic biobanks with companies, acting as a non-commercial alternative to commercial brokers. An important pillar of the organisation and the reason why Hewitt chose to launch it as a not-for-profit is the ethics of biosampling.
The Oviedo Convention, an international treaty that lays out a set of standards for the European biomedical industry, states that human tissue must not be sold for profit. Although not all European countries signed the treaty, it is generally accepted that the fee charged for biosamples should only recover costs. Therefore in western Europe, hospitals and biobanks can often be wary of supplying commercial brokers due to the fact that they need to make a profit.
Hewitt added: “In order to make this platform acceptable to academic biobanks and hospitals, it has to be ethically above-board and trustworthy, so I think it was very important for Biosample Hub to be not for profit and to be completely financially transparent.
“That has meant that we’ve been much more accepted by academic biobanks and we’ve had a large number of biobanks in western Europe joining the platform. If we’d been for-profit that never would have happened.”
Biosample Hub allows direct contact between the academic biobank and the commercial company, which means that researchers have access to the provenance information that they need.
This feature is especially important as new regulations are due to come into force next May that will make it compulsory for makers of in vitro diagnostic devices to provide evidence about the provenance of samples.
Biosample Hub contains directories of biobanks, commercial companies and specific biosample requests. The platform also includes a communication tool allowing companies and biobanks to make connections with each other, in a similar way to LinkedIn.
In the next five to 10 years, Hewitt said that blockchain is a key technological development that could improve the biosampling process by enabling end-users to find out exactly where the samples originated from and allowing biobanks to know where the sample is used.