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Inside the Lab Histology, Quality assurance and quality control

Biospecimen Access For Biotechs

By Robert Hewitt

The COVID-19 pandemic has demonstrated our reliance on the biotechnology and pharmaceutical industry. Industry R&D has resulted in vaccines and diagnostics that have saved hundreds of thousands of lives. But industry can only do this work if it has access to patient samples; without clinical biospecimens, industry researchers cannot develop new and improved treatments and diagnostics. This principle applies to all human diseases – infectious diseases, cancer, heart disease, stroke, and so on, across the spectrum of human ailments.

Furthermore, these biospecimens must be carefully processed and correctly annotated to yield reliable research results. When we use biospecimens for research, the maxim “garbage in, garbage out” applies (1); samples must be of suitable quality and fit for purpose. For this reason, many hospitals have established professional biobanks or biorepositories. These facilities manage the collection, processing, storage, and distribution of patient samples in a systematic and standardized way – but, because they need significant equipment and dedicated staff, they are expensive to establish and run. And because most of their funding generally comes from allied academic centers, their primary purpose is to support local public sector researchers.

Although industry researchers also need sample access, they have limited access to hospital biobanks. This is a particular problem for biotech companies, which tend to be younger and smaller than other pharmaceutical companies and may not have had time to build networks of hospital contacts for sample supply. Furthermore, unlike pharma companies, they do not run clinical trials and therefore don’t have access to the patients and samples that clinical trials provide.

As a result, biotech companies get most of their samples from commercial brokers who work on a commercial basis and need to make a profit to pay shareholders. The main scientific disadvantage of using a broker is that sample traceability, or provenance, is often lacking (2). This is because brokers tend not to reveal their sources for business reasons – but lack of sample provenance results in uncertainty about sample quality and brings into question the reliability of the resulting research.

Biotech companies play a crucial role in the advancement of modern medicine by translating promising ideas into potential therapies, vaccines, and diagnostics. Biotechs are risk-takers and innovators and, increasingly, big pharma depends on them for new opportunities. It seems clear that biotechs should have access to the very best biobanks and biospecimens – but, instead, circumstances often force them to take “pot luck.” They may have no option but to use samples without adequate provenance information. This situation is unacceptable – so what can we do to improve it? How can biotech companies access clinical samples with adequate provenance information?

One answer is regulation. The new EU law governing the manufacture of in vitro diagnostic devices provides an example. This regulation is the IVDR, and it requires the makers of IVDs to use acceptable samples to validate their devices (3). For biosamples to be acceptable, they must come from biobanks that meet defined quality standards. Consequently, the IVDR will pressure commercial brokers to change their business practices and reveal the origin of their samples. One-way brokers sometimes do this is by including non-circumvention agreements in their contracts. 

Another answer is government funding (4). For example, the award of biobank grants could be conditional on service to industry. It could also be dependent on the availability of sample access policies and annual reports on sample distribution. Furthermore, industry representatives could be a requirement for sample access committees. Patient representatives are well accepted, so why not industry representatives? 

Another possible answer is a change in attitude. Might this be one positive consequence of the pandemic? The pandemic has demonstrated our reliance on the biotechnology and pharmaceutical industry. It has also shown that their products can be lifesaving. Will this influence the decisions of policymakers and grant agencies when it comes to determining hospital biobank access? We can only hope so.

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  1. C Compton, “Garbage In, Garbage Out,” The Pathologist (2018). Available at: https://bit.ly/3GU94zY.
  2. P Hofman et al., “Point of View: Traceability and Transparency Should be Mandatory for All Human Biospecimens” (2017). Available at: https://bit.ly/3BLMmX2.
  3. G Dagher et al., “Pre-analytical processes in medical diagnostics: New regulatory requirements and standards,” N Biotechnol, 52, 121 (2019). PMID: 31102798.
  4. “Thank you for sharing,” Nat Biotechnol, 38, 1005 (2020). PMID: 32860021.
About the Author
Robert Hewitt

Robert Hewitt is Founder of Biosample Hub, Carmarthen, UK.

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