Why Hospital Biobanks Need To Supply Industry – and Why There Is a Blockage in the System
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The following article is an opinion piece written by Robert Hewitt. The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position of Technology Networks.
Three years ago, the annual report of a UK agency called Medicines Discovery Catapult came up with a shocking finding. A survey conducted by the organization found that 80% of SMEs (small to medium sized biotechs) found accessing samples from the National Health Service ”unexpectedly difficult with the result that 75% imported samples from abroad”.
This is surprising.
The UK has over 150 hospital-associated biobanks, whose function is to provide researchers with consented and carefully processed clinical samples.
The biotech companies requiring patient samples (biospecimens) are the risk-takers and innovators translating promising ideas generated in academia, into potential therapies, vaccines and diagnostics that can be evaluated by well-resourced pharmaceutical companies. Do these important companies receive the highest priority access to the biospecimens vital for their work? Unfortunately not.
Credit: Biosample Hub
This is not just a UK problem. Globally biotech companies have great difficulty accessing high quality patient samples to support their R&D. Paradoxically often their only solution is obtaining samples from “abroad”. So, what does this all mean?
The answer is complex, but a fundamental issue is that patient samples most often originate in public sector healthcare settings and private sector biotechnology companies have reduced access.
About hospital biobanks
Hospital biobanks exist to support research in associated universities and institutes. They require considerable resources not normally funded by grants, except in the start-up phase.
Biobanks can develop an independent income stream by charging for the provision of patient samples. However, it is illegal in many countries to profit from the sale of human tissue. So, biobanks are allowed to charge a carefully calculated cost-recovery fee.
Access to a biobank’s samples is decided by scientific and ethical committees with institutional members (e.g. scientists, clinicians, administrators, ethicists), often with a patient representative.
One issue that can reduce sample provision to industry is the concern that some patients may not want their samples to be used for profit. How patients react is very much dependent on how the issue is presented and whether the societal value of industry research is emphasized.
Biobanks of different specialties are listed in national and regional biobank directories. However, their level of interest in supplying industry is often obscure, so useful biobanks are hard to find.
Why small biotechs and big pharma are very different
Sample access problems are bigger for smaller, younger biotech companies than for established pharma companies. The pharma companies will have developed networks of hospital suppliers of samples. Also, conducting clinical trials, gives them access to hospitals, doctors and patients. Many large pharma companies have dedicated clinical sample procurement teams and in-house biobanks. Small biotechs do not have these advantages.
Obtaining samples ”from abroad”
It’s easiest for biotech companies to obtain samples from commercial brokers.
Brokers can find it difficult to obtain samples from hospitals and biobanks in western Europe, due to ethical concerns about the sale of human tissue. Some countries in eastern Europe and Asia provide a more reliable source.
The majority of brokers are based in the USA where they are better accepted, and many local hospital biobanks will supply them.
Scientifically-speaking, the main disadvantage of using brokers is that sample provenance may be lacking (brokers tend not to reveal their sources) and so there may be uncertainty about sample quality and research reliability.
So, what can be done to provide industry, and particularly small biotech companies, with the high-quality, reliable samples they need? Let’s look at two areas:
- Encouraging best practice
For best practice biotechs should ideally obtain their samples direct from hospital biobanks, meaning they can have the most confidence that samples and data have been collected professionally. To encourage this, it must become easier for biotechs and hospital biobanks to connect.
The incentive of funding is certainly the most viable option for getting hospital biobanks to work with industry. Biobanks need funding and often operate on “shoestring” budgets. To be financially sustainable one approach is for biobanks to charge industry a cost-recovery fee and also a fee from additional sample processing services like cutting sections and extracting DNA. French biobanks understand this well and use the term ”valorization” for the process of adding/yielding value from their samples.
Another approach is to make external grant funding of biobanks conditional on service to industry. This could be aided by making it mandatory for funded biobanks to make their sample access policies public, by requiring annual reports on sample distribution and even having industry representatives on sample access committees.
An example of the support needed is provided by the following statement from the UK Medical Research Council: ”The development of new drug therapies, and diagnostic and screening tests, to the point where they can be made sufficiently widely available to benefit human health, is crucially dependent on commercial involvement. Therefore access by the commercial sector to samples of human material collected in the course of MRC-funded research should be facilitated, where this is consistent with our mission.”
- Discouraging the use of samples that lack provenance
New regulations are likely to have a major impact on how biotech companies source their clinical samples; for example, the new European regulation governing manufacture of in vitro diagnostic (IVD) devices, coming into force 26th May 2022. To demonstrate conformity, makers of IVDs must show that the biospecimens used to validate their devices have undergone acceptable pre-analytic processing. This will require sourcing of samples from biobanks certified to meet specific quality management standards. As a result, diagnostics companies will need to obtain samples from known sources that provide full provenance information.
This need for provenance information will put pressure on commercial brokers to change their business practices and reveal the source of their samples. They may try to mitigate this issue by using binding contracts with both the provider and the requestor of samples, to prevent them from interacting independently of the broker.
There are technological solutions for ensuring the reliability of provenance information. For example, blockchain. This digital technology allows tracking of the transfer of biospecimens from the patient donor to the researcher in a secure, transparent and ethical manner, with all transactions documented in an incorruptible shared digital ledger.
What do patients want?
Now more than ever, as a result of the pandemic, the general public understands the importance of biotech and pharma companies.
So, the question is, do we want to allow biotech companies to have access to the best quality patient samples, in order to speed up development of new therapies, diagnostics and vaccines? Or do we want this access to be blocked? As patients (past, present and future), we need to deliberate and decide and encourage patient advocacy organizations to act on our behalf.