When it comes to using biospecimens for research, the saying “garbage in, garbage out” applies (Compton, 2018). This maxim has been a driving force in biospecimen science: a field in which the focus is pre-analytical factors affecting biospecimen quality. It has also been a driving force in the professionalization of biobanking. As a result, the biobanking domain emphasizes best practices, quality standards, education, certification, accreditation, improved equipment, equipment monitoring and automation.
There is a consensus that biospecimen collection for research requires specialized units. These units, called biobanks or biorepositories, are important for ethical and scientific reasons. They are important for protecting patient interests through data protection and informed consent. They are also important for providing researchers with high-quality, reliable biospecimens and associated data (Hewitt, 2010).
Access problems — especially for biotechs
The good news is that many professional biobanks now exist around the world. However, such biobanks are expensive to set up and run. So not all hospitals have the necessary funds available. Furthermore, access to professional biobanks may be difficult. This fact is especially true for some groups of researchers.
Hospital patients generally donate biospecimens. So biospecimens originate in the public sector. Here, public sector biobanks collect, process and store the samples for research. Public institutions like hospitals and universities establish and maintain biobanks. They do so for the primary purpose of supporting research in their own institution. Institutional committees decide on access requests. Their general rule is that local academic researchers are first priority. Other academic researchers are second priority. Then researchers from for-profit ‘commercial’ companies are third priority. Unfortunately, these third-priority researchers include scientists in biotech and pharmaceutical companies. These are the people we depend on to make new treatments available to patients.
Large, well-established pharmaceutical companies have ways to cope with this situation. They can afford large teams of sample procurement staff. Over the years, these staff can develop extensive hospital supply networks. Pharma companies also have access to patients and clinicians through their clinical trials.
The situation for small, young biotech companies is completely different, however. These companies are fresh on the scene. They have small teams and have no clinical trials to provide access to samples. So how do they cope at all?
How biotechs access biospecimens
The answer is that, in general, biotechs depend on commercial biospecimen brokers. These exist in many countries around the world, especially in the U.S. They get their samples from various sources. These include large international networks of biobanks and other collection sites. They also include other brokers. Samples often originate in Eastern Europe and parts of Asia and Central and South America.
While brokers provide biotechs with a vital service, it is also problematic. Brokers are generally unwilling to reveal the source of their samples. This is because to do so would risk circumvention and loss of future profits. So for business reasons, the samples provided to biotechs may lack provenance information. Without this information, how can biotechs assess sample reliability? How can they trust the foundations of their research? This is a major problem. Biotechs play a key role in the development of new therapies and diagnostics. Yet, they lack the biospecimen resources needed to play this role effectively.
What can we do?
There are many things we can do to rectify this situation. We can encourage public sector biobanks to supply biotech companies. We can also encourage brokers to reveal their sources.
(1) Incentives For Public Sector Biobanks To Supply Biotechs
To be realistic, sharing samples with outside requesters comes at a cost. It takes many hours to review sample requests and check feasibility, gather associated data and package and arrange transportation. All of this comes on top of the work involved in collecting, processing and storing samples. So there need to be significant incentives to justify the extra work required. These include:
- Biobanks should be allowed to charge fees that take full account of all the necessary work.
- Funding agencies should make it a condition of funding that biobanks make samples available to biotechs.
- Funding agencies and patient groups should encourage biobanks to be more transparent about access policies and the distribution of their samples.
As noted in a recent editorial, “Thus far, funders have not only turned a blind eye to grantees refusing to share but also shrunk funding for repositories. Funders need to change direction on both fronts. Biomedical research progress and reproducibility depend on it” (Nature Biotechnology Editorial, 2020).
(2) Incentives For Brokers To Reveal Their Sources
If brokers do not reveal the source of their samples, this presents a problem (Hofman et al., 2017). Their clients are unable to assess the reliability of the samples. They may be unable to tell whether samples come from a professional biobank or a poorly managed collection site in some distant country.
New regulatory requirements for approval of new drugs and diagnostics may change this. One example is the new European regulation governing the manufacture of in vitro diagnostic devices (IVDs). This regulation, known as IVDR, comes into force on the 26th of May 2022. It requires the provision of information about the provenance of samples used for IVD validation. It also requires the use of biobanks that meet certain quality management standards (Dagher et al., 2019).
Such regulations will encourage biotechs to get their samples from known sources. They will also encourage brokers to reveal their sources. To do this, brokers may need to change their business models. For example, they can make use of non-circumvention clauses in their contracts. This way, they can reveal their sources without the risk of losing future business opportunities. At the same time, they can support more ethical and reproducible research.
About the author
Compton, C. Garbage In, Garbage Out: The hidden reason laboratory test results may not be as reliable as they seem. The Pathologist 03.16.2018 https://thepathologist.com/diagnostics/garbage-in-garbage-out
Dagher, G. et al., Pre-analytical processes in medical diagnostics: New regulatory requirements and standards. New Biotechnology 52, 121-125 (2019). https://pubmed.ncbi.nlm.nih.gov/31102798/
Editorial: ‘Thank you for sharing.’ Nature Biotechnology 38, 1005 (2020). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454550/
Hewitt, R.E. Biobanking: the foundation of personalized medicine. Curr Opin Oncol 23:112–119 (2010). https://pubmed.ncbi.nlm.nih.gov/21076300/
Hofman, P. et al. Point of View: Traceability and Transparency Should be Mandatory for All Human Biospecimens. Applied Clinical Trials (2017). https://www.appliedclinicaltrialsonline.com/view/point-view-traceability-and-transparency-should-be-mandatory-all-human-biospecimens
Filed Under: Biospecimens