Connecting Biobanks With Biotech and Pharma Successfully
Connecting Biobanks With Biotech and Pharma Successfully
Many biotech and pharmaceutical companies depend on commercial intermediaries to source clinical samples; however, this can be a disconnected process, inhibiting the transfer of biosample provenance information. As a result, scientists have an incomplete picture in terms of the samples they are working with – raising questions as to whether they are likely to be suitable for their intended purpose.
Technology Networks recently had the pleasure of speaking with Robert Hewitt, founder and manager of Biosample Hub, a unique platform designed to connect biotech and pharmaceutical companies with biobanks. Biosample Hub aims to help scientists obtain the samples they need to support the testing and development of novel therapeutics, diagnostics and vaccines, while establishing and maintaining biospecimen provenance information. We interviewed Robert to find out more.
Laura Lansdowne (LL): What are biosamples, how are they used and who are they used by?
Robert Hewitt (RH): Biosamples are biological samples that may come from any human, animal, plant or another living thing. In this context, we are talking about human samples. They may be blood, solid tissue, saliva, urine or any other secretion or excretion. They may be used for diagnosis or if surplus to requirements, they may be used for research.
LL: What is the standard process for getting biosamples to the researchers who need them?
RH: The standard process is for a hospital unit called a biobank to take responsibility for the collection, processing and storage of biosamples. These units have staff working to professional standards, who ensure that samples are collected with informed patient consent and are processed and stored according to strict standard operating procedures in order to maintain sample quality and reliability. They release samples to researchers who have obtained ethical approval for the work they want to use the samples for.
LL: What are some of the key challenges related to this process and what role do commercial brokers play?
RH: There are many challenges relating to the management of biobanks. One major challenge is obtaining the necessary funds to enable them to operate efficiently with adequate staff and equipment. Biobanks are essential infrastructure for research, but they require continued maintenance funding, and in general, much of this must come from the host institution where there are many other competing needs for funding.
Another major challenge is to connect researchers in need of samples with the appropriate biobank. Researchers have very specific needs, and often finding the right biobank to meet these needs is like searching for a needle in a haystack! It is often not easy to do for researchers associated with the academic medical centres and hospitals (public institutions) where samples are typically collected. It is much more difficult to do for researchers working in biotechnology and pharmaceutical companies (private institutions) and these researchers need patient samples to test and develop the drugs, diagnostics and vaccines that we all depend on.
Commercial brokers play an important role in providing industry scientists with samples. Their role is to be an intermediary between the hospitals and biobanks where samples are collected initially, and the industry client. While they perform a necessary service, there are some ways in which this may not be ideal. In general, brokers avoid placing the sample requester in direct contact with the biobank source, because to do so would risk being circumvented for future requests and therefore loss of income. This lack of direct communication between the biobanks and the end-user tends to inhibit the transfer of biosample provenance information.
LL: What is provenance in this context and why is it so important?
RH: The word “provenance” means the origin or source of something. In the medical and scientific world when applied to biospecimens, it covers the following categories of information:
- Sample processing history
- Information about the donor and their medical history
- The samples’ geographic origin which gives information on ethnicity and environment
- Previous organizations that have had custody of the samples
Sample processing history allows the researcher to determine whether the sample is likely to be reliable for its intended research. There are many variables that affect sample quality – for example, in the case of blood samples that require centrifugation to separate out different components, the quality of the sample can be affected by the type of primary container used, the pre-centrifugation delay, centrifugation conditions (e.g., temperature, time and g-force) and more. All of these details need to be tracked with meticulous attention if the researcher is going to know for sure that the sample is reliable.
LL: What issues can arise from a lack of provenance?
RH: One example comes from a major program in the USA called The Cancer Genome Atlas (TGCA), for which samples were requested from biobanks around the country for molecular analysis. A very high percentage of samples received were found to be of such poor quality they were unusable, so obviously provenance information was either lacking or unreliable. In 2018, renowned pathologist Carolyn Compton authored an article in The Pathologist called “Garbage In, Garbage Out: The hidden reason laboratory test results may not be as reliable as they seem” and in this article she stressed the importance of controlling pre-analytical variables that affect sample quality.
Over the past 10 years there have been major improvements in biobanking standards with many biobanks in the USA, Europe and around the world striving for improvement. Some have introduced quality assurance programs and obtained accreditation and certification to various quality standards. Of course, standards vary from one biobank to another and that is why it is so important for researchers to know the identity and reputation of the biobank that their samples are coming from.
Our genes and our environment affect our health, the diseases we get and also our response to different treatments. So, it is important for researchers who using biosamples in their studies to have information about demographic factors like age, sex, ethnicity and geographic origin.
LL: What needs to be done to ensure that biosamples always have reliable provenance information delivered with them?
RH: The first step is to allow direct communication between the industry researcher and the source biobank. Only then can the researcher begin to gain confidence in terms of the provenance information provided. To gain full confidence, the researcher will want to find out more about the biobank, whether they have some form of licensing, certification or accreditation and the standard operating procedures they use.
In the future, regulatory authorities will undoubtedly have a key role. For example, to access the European market, the manufacturers of medical devices including in vitro diagnostics must now demonstrate that the biospecimens used in validating their devices have undergone acceptable pre-analytic processing. This is required under the new European IVD Regulation (IVDR) coming into force in May 2022.
LL: What are the alternatives? For example, could researchers build their own networks of suppliers? Or could an exchange or clearing house (as used in financial markets) solve the problem i.e., the clearing house knows the details of the providers and the users and can give users relevant information on a need-to-know basis without revealing source details? Or could researchers be linked directly with sample providers through a central database?
RH: One alternative is for industry researchers to obtain samples through a broker that does allow direct communication with the source. A few such brokers do exist, and they avoid circumvention by contractual agreements with their clients/partners. The problem here is that not all companies and biobanks are comfortable with agreements that restrict their ability to enter into different partnerships in the future.
To get the samples they need companies can develop their own networks of biobanks independently, but this is not a short-term project. They can also approach publicly available biobank directories, but these are primarily designed for academic researchers.
A recently established not-for-profit company called Biosample Hub provides a further solution, through an online platform dedicated to partnering industry with academic biobanks. The platform presents companies with a ready-made network of biobanks all of which want to work with industry. The platform also includes a directory of companies, a directory of requests and networking features to allow members to communicate. This is being received positively in western Europe by academic biobanks.
Robert Hewitt was speaking with Laura Elizabeth Lansdowne, Managing Editor for Technology Networks.