Pharma/biotech industry outsourcing trends in Biomarker studies
A recent article by E. Langer (E. Langer, “Another In-House Operation Gets Outsourced” (2015) Pharmaceutical Technology 39 (6)) describes the growing trend in companies worldwide to outsource some of their key activities. Apart from those traditionally outsourced (e.g. API biologics manufacturing, fill / finish operations, etc), analytical testing is on a growing trend, and estimations indicate that it will be the area of fastest growth for outsourcing.
At tebu-bio, we are well aware of this. Some years ago, we took the strategic decision of having our own lab. We did not want to limit assistance to our customers to technical advice or logistics solutions, but to really provide support in their key projects, enabling them to access the most innovative tools in the market.
At the Biomarkers team, we are seeing some trends that we would like to share with you today.
Trend #1 – Personalised Medicine
The increased interest (and demand) for personalised medicine means that, when developing a drug, even at the very basic stages, biomarkers have to be taken into account (either diagnostic, prognostic or predictive). This means that researchers have to look beyond the “usual suspects”. The markers appearing in publications are not enough anymore. More and more labs need to profile and hunt for novel biomarkers.
When one wants to profile for finding new and relevant biomarkers, it means that the results of these profiling experiments will be the basis of the research of the group (or the clinical study) for the coming two or three years.
More and more, we are contacted by researchers telling us that they don’t want to play any games with this. Use of profiling tools is quite simple, but as any experimental technique, it has its tips & tricks. So very plainly, these researchers prefer to count on outside expertise to do the profiling experiments, so that they can concentrate on data analysis and further validation studies with more “routine” techniques.
Trend # 2 – Beyond Clinical Biochemistry & Pathological Anatomy
For years, clinicians / CROs would send their samples to in-house Clinical Biochemistry or Pathological Anatomy labs to check for the relevant biomarkers in their cohorts. This is still a very fruitful cooperation between different units. However, more and more clinical studies require the analysis of a given set of biomarkers that can not longer be analysed in these departments (either because of the markers per se, or the technologies needed to analyse them, or due to lack of personnel).
In this case, there are two options. Either to invest in new technologies (that sometimes require major investments in capital equipment), or to outsource. The trend to outsource for technologies that are used maybe once or twice in the whole clinical assay is growing, as is growing the need for outsourcing companies able to provide confidentiality, expertise and fulfilment of deadlines, which is critical for any clinical assay.
Trend #3 – Stratification of cohorts
There is an increasing tendency to stratify the patients entering a cohort for a given clinical assay. Criteria for patients entering a given study are increasing over the years, so it is not so easy to find patients fulfiling all criteria (if it ever was!). This means that samples are more precious than ever.
Even if the outsourcing trend includes overseas suppliers, there is also a growing trend to preferably outsource to suppliers in the same continent, at least to make transportation and customs delivery safest. Europe, without frontiers between countries, allows shipment of precious samples without the need to go through customs. Not that there are usually problems there. But you know, Murphy’s law.
Trend #4 – Neutrality
When researchers/clinicians contact us to outsource a clinical study, they normally have a technology already in mind. Since we are an independent lab, we will always provide the best solution, even if it is not what they were thinking of at the beginning.
It is true that we have our favourite technologies, but it all depends on the study. For example, if a project involves the profiling of a high number of biomarkers to compare different conditions (e.g. response vs. resistance to a treatment), we will normally recommend Raybiotech for secretome studies, Full Moon for kinome studies or Toray’s 3D-Gene for miRNA studies. On the other hand, if a project involves the quantification of less than, say, 20 secretome biomarkers, we will normally recommend Quansys. If quantification involves more than 25 markers, we will recommend Raybiotech.
It really depends on each study, so we have in-depth discussions with our customers to understand their project better and provide the right solution.
Are you looking for an outsourcing partner? Don’t hesitate to contact our lab or our experts at the Biomarkers team!