Written by its founder, Robert Hewitt. Biosample hub
As with any business, procuring biological samples for medical research is profitable. Biological samples are often obtained through brokers, intermediaries between hospital biobanks (where samples were first collected and stored) and industry clients. Since the broker charges for this service, the broker is inevitably concerned about unconditional communication between the researcher and the hospital’s biobank. Brokers do not want to be separated from the process and lose their fees. However, hiding the sample source means that the end user may lack source information for the biological sample.
This important biographical information includes: (A) Information about donors and their medical history, (b) Sample processing history. (C) Geographical origins of samples that provide information about the environment and ethnicity, and (d) former custodians that may contain one or more brokers.
To ensure this information, it is best for scientists to contact the source biobank. Then, if additional information such as treatment response or survival time is needed, the source biobank should be re-contacted. All of this becomes much more difficult if the broker refuses to reveal the source of the sample.
Knowing the geographic origin of the sample is essential because it can provide information on environmental, socio-economic, and genetic factors that can help you understand the implications of your research results. This is especially important as the international procurement of samples for industry is very widespread. A recent study by Medicines Discovery Catapult found that UK diagnostic SMEs obtain 75% of their samples from other countries. Part of the reason is that in the UK and other countries of Western Europe, there are high levels of concern about the ethics of human tissue trading, so brokers are better off sourcing samples in other parts of the world, such as the east. Because it feels much easier. Europe, Asia, America. It is important to note that some countries such as China, India and Russia have legal restrictions on the export of samples. Therefore, another reason to confirm the geographic origin is to avoid the use of illegally procured samples.
International sourcing of clinical samples can involve many commercial organizations operating in different countries, which adds additional isolation between sources and end users. It is important for the end user to be aware of this and the potential impact on the reliability of the information provided about the patient’s consent and the source of the sample.
What can the industry do to make sure that reliable biographical information is always included when it gets a sample?
One option is to allow the broker to communicate directly between the hospital sample source and the end user, but require both parties to sign a contractual agreement to the effect that they will not circumvent the broker. Such contracts are certainly used effectively by some commercial brokers.
Another possibility is for companies to build their own network of biobanks and provide the samples they need. This may be feasible in the long run, but in the short run it is often very difficult to find a suitable hospital biobank with the required samples in stock. There are publicly available biobank directories that businesses can consult with, but these are generally designed with academic researchers in mind and are actually motivating whether biobanks are willing to work with industry. It may not indicate if it is. Therefore, start-ups and companies with urgent sample needs generally have little option other than obtaining samples through a broker.
The recently established non-profit Biosample Hub offers possible solutions. It is an online platform that specializes in partnerships between industry and academic biobanks. The platform includes biobanks, enterprises, request directories, and network capabilities that allow members to communicate. So far, it has been well received by Western European academic biobanks, providing the industry with a route to previously inaccessible sources of clinical samples.
In the future, regulatory requirements for drug and diagnostic approval will increase the need for reliable sample source information, introduce new legal and regulatory requirements, and develop promising technologies to help ensure reliable sample history information. there is.
About the author
Robert Hewitt, MB BS, and PhD are the founders of Biosample Hub, a new platform that connects biotechnology companies looking for samples with biobanks that can use ethically sourced samples.
Robert Hewitt: Do Commercial Biological Sample Broker Business Practices Help Procure Reliable and Ethical Biological Samples?
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