This article examines three different industry players that require biospecimen suppliers to meet their human tissue procurement needs.
- Large pharmaceutical companies
- Large in vitro diagnostics companies
- Small and medium enterprises (SMEs) in healthcare biotechnology
We describe the differences between these actors. Also, we highlight the particular difficulties that small biotechs experience in human tissue procurement.
Biospecimen Suppliers To Large Pharmaceutical Companies
The pharma industry needs biospecimens for early-stage drug discovery done in-house. It also needs biospecimens during its clinical trials. For example, this may be to measure the effectiveness of new drug candidates. Or it may be or assess potential side effects (Mackenzie, 2014).
Pharma companies can access biosamples from their clinical trials. As a result, many of them have developed their in-house biobanks. Unfortunately, regulatory factors often limit the use of these samples. This limitation is because of the specificity of the informed consent (Lindpaintner, 2011).
Pharma companies have large enough budgets to pay commercial biospecimen procurement. Therefore, this is often the route chosen.
Pharma may get biosamples from academic biobanks. Biobanks sometimes provide samples through supply agreements. Alternatively, they may provide them in the setting of research collaboration. However, there are many problems to be overcome for such partnerships to succeed.
- It is often difficult for pharma to locate suitable biobanks. It may also be difficult for pharma to gain access.
- Timelines for establishing contractual agreements with academia may be too long. This problem is because the industry sector has to work on very short timelines.
- Sometimes, academia has unacceptable requirements for co-publication and IP sharing.
It is worth noting that sample requests from pharma may be challenging to meet. This is because requests tend to be broad and for large numbers of samples. Also, pharma often needs very detailed clinical information about the donor (Mackenzie, 2014).
Biospecimen Suppliers To Large In Vitro Diagnostics Companies
Examples of large in vitro diagnostics (IVD) companies include Roche Diagnostics and Abbott Diagnostics. Also, Siemens, Thermo Fisher Scientific and Becton Dickinson. Also, Sysmex, bioMérieux, and Ortho Clinical Diagnostics.
IVD companies have human tissue procurement needs for biomarker discovery and validation work. Unlike pharma companies, they do not have direct access to clinical trial samples. Instead, they may get biosamples from academic biobanks. They may also get them from commercial sources. Another approach is to get biosamples through partnerships with pharma companies, as is the rule for developing companion diagnostics. Sometimes pharma companies bring IVD companies under their own roof through mergers and acquisitions. For example, the acquisition of Ventana by Roche.
Biospecimen Suppliers To SMEs In Healthcare Biotechnology
Many biotech companies are micro, small or medium-sized enterprises, known as SMEs. According to European Union definitions, SMEs have fewer than 250 employees. Also, their annual revenue does not exceed EUR 50 million. There are SMEs in 3 main biotechnology categories: healthcare, industrial and agricultural. This section only relates to SMEs in healthcare biotechnology.
SMEs need biospecimens for the development of new drugs and diagnostics. First, they incubate emerging research projects to a more commercial position. Then they sell or out-license the resulting products (Mackenzie, 2014).
The Importance of SMEs
The importance of SMEs for the pharmaceutical research field is well recognised. For example, according to the European Innovative Medicines Initiative (IMI):
‘SMEs are key players in the European pharmaceutical research and development landscape, and we strongly encourage their participation in our projects’.
SMEs Have Problems With Biosample Access
Significantly, the UK Medicines Discovery Catapult and Bioindustry Association stated in their 2018 annual report:
‘ … over 80% of SMEs surveyed agreed that access to biosamples is hugely important for commercial development … as many as 80% found accessing UK samples unexpectedly difficult with the result that 75% imported samples from abroad’. 2018 State of the Discovery Nation
Recognising the biosample access problems of SMEs in the UK has been crucial. Yet, we should realise that this is not only a problem in the UK. Indeed biotech companies around the world have great difficulty in finding suitable biospecimen suppliers.
Unlike pharma companies, small biotech companies do not have large budgets. Nor do they have large teams of sample procurement staff. They have generally not had time to develop networks for biospecimen procurement. Furthermore, early-stage biotechs do not have direct access to clinical trials. So the fact biotechs have difficulty sourcing biosamples is perhaps not surprising. The question is, what can we do to improve the situation for biotechs?
This article is on the Biosample Hub blog. Other posts in this blog include:
- Why Academic / Hospital Biobanks Should Provide Biosamples to Industry
- Ensuring Public Support For Biobank Cooperation With Industry
- The Main Actors Providing Biosamples To Industry
- Biosample Needs of Different Industry Players
- The Dual Role of Academic Biobanks
- What is Commodification?
- Acceptable Transactions in Biobanking
- Why Biobank Access Policies Should Be Publicly Available
- Biospecimen Provenance: What Researchers Need To Know
The Biosample Hub platform https://biosamplehub.org/ encourages ethical sourcing of biosamples for the industry sector.