- The author of this article is Robert Hewitt, MB BS, PhD, Biosample Hub
A longstanding challenge facing many biotech companies is access to high quality patient samples to support research. The root of the problem lies with the simple fact that patient samples most often originate in a healthcare setting in the public sector. Biotechnology companies are in the private sector and therefore have reduced access.
So, what can be done to provide industry, and particularly small biotech companies, with the high-quality, reliable samples they need?
Encourage Best Practice
Biotechs should ideally obtain their samples direct from hospital biobanks. To encourage this, we need to make it easier for biotechs and hospital biobanks to find each other. One initiative that offers a solution is the online platform, Biosample Hub. This international platform is dedicated to bringing biotechs and academic/hospital biobanks together, and its use is restricted to these two groups. It includes a directory of biobank and biotech members, a directory of sample requests and social networking features. The only reason for biobanks to be on the platform is to supply industry, so the problem of false leads is minimised. One other key aspect of the platform is that it is not-for-profit, so this overcomes the ethical concerns of many biobanks.
Another way to encourage this is to make it more attractive for hospital biobanks to work with industry. Many hospital biobanks give priority to local academic researchers. Next in line are other academic researchers, leaving industry at the end of the queue.
Biobanks often operate on shoestring budgets, so funding is a way to encourage hospital biobanks to work with industry. Much has been written on the subject of biobank sustainability, especially financial sustainability. One approach is for biobanks to charge industry a cost-recovery fee for its samples and also to charge a fee from additional sample processing services, such as cutting sections and extracting DNA. This approach seems to be especially well understood by French biobanks, who use the term valorisation for the process of adding and yielding value from their samples. Almost half of the biobanks that have joined Biosample Hub are French and most offer additional sample processing services. All French hospital biobanks are certified according to the French norm NF S96-900 which must also make them more attractive to industry.
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 perhaps even having industry representatives on sample access committees. Patient representatives are well accepted, so why not industry representatives?
Discourage use of samples that lack provenance
New regulations are likely to have a major impact on how biotech companies source their clinical samples. An example is provided by the new European regulation governing manufacture of in vitro diagnostic devices, which comes into force on the 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 the sourcing of samples from biobanks that are 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. One way in which brokers may mitigate this is by using binding contracts with both the provider and the requestor of samples, to prevent them from interacting independently of the broker. Of course, not all companies or biobanks will be comfortable with such restrictions.
There are technological solutions that can be used to ensure the reliability of provenance information of samples and use of these will be beneficial. The use of blockchain is one example. 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?
As a result of the pandemic, the general public understands the importance of biotech and pharma companies more than ever. Do we want to allow biotech companies to have access to the best quality patient samples? Or do we want this access to be blocked for a variety of possibly short-sighted reasons? The time seems ripe for a major change in the way clinical samples are sourced by industry and by smaller biotech companies in particular.
ABOUT THE AUTHOR
Robert Hewitt, MB BS, PhD, is the founder of Biosample Hub, anew platform that connects Biotech companies looking for samples, with Biobanks that have ethically sourced samples available.