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Lab Trends

Most of us recognise that the centralised model is very straightforward for outsourcing and procurement. It is also easy to harmonise all assays in one central location. Furthermore, this model facilitates query resolution and data management, and eases the pharma company’s auditing of its central lab. However, there are disadvantages to such a centralised model.

For instance, the high cost of shipping around the world, which must be undertaken if all samples are going to one single location, may not be feasible or practical. Secondly, companies may also encounter complex issue queries with diverse languages and different time zones, so swift resolution may be impossible. Finally, when dealing with a single lab, there may be limited access to specialised tests and technologies.

A fully decentralised model, however, revolves around central labs in different jurisdictions to address specific needs. One of the main advantages is that each lab is fully customised to meet required services and needs. The decentralised lab is well adjusted to all local jurisdictions and regulations, easing the process of performing issue queries in local languages and time zones. This model also optimises test cost-savings in emerging markets. In addition, shipping costs are lower, due to fewer shipments. Decentralisation also offers flexible access to required technologies and testing capabilities – depending on the locations involved – and is ideal for meeting turnaround time requirements.

The fully decentralised model does have its own disadvantages; it may be burdensome for outsourcing and procurement, while requiring overly high maintenance to ensure fully customised service everywhere. With this model’s multiple contact points, performing consolidation of all issue queries in different languages and time zones may be overly complex. Decentralisation is not practical for test harmonisation, and it requires intricate data management reconciliation, along with labour-intensive auditing processes and procurement activities.

A FUSION OF SORTS

Let’s consider a hybrid model, characterised by a central lab with many wholly owned facilities that are strategically located to address global trials, while also offering the ability to manage access to a minimal number of preferred speciality labs to address either challenging jurisdictions or regulations, or even specific esoteric biomarker assays that require scientific expertise that isn’t found everywhere.

Over the last two decades, we have witnessed the entire spectrum from fully centralised to fully decentralised models, with the pendulum swinging from one extreme to the other. However, the industry trend today is clearly opting for the hybrid model, which offers several compelling advantages. It is fairly easy to take advantage of the best of both models at the same time: outsourcing is straightforward, with one contact point all the way through the trial; optimal savings on shipments can be realised, as well as volume discounts with specialised third-party labs. The hybrid model also provides better access to optimised test harmonisation. Issue query resolution is straightforward, thanks to local languages and time zones, and it is simple to reconcile data management. Turnaround time is streamlined, with different labs located strategically around the world, and the hybrid model offers a simplified auditing process for pharma.

COLLABORATION IS KEY

Cooperation between sponsors and central labs is essential. Through collaborative agreements with diagnostic labs, central labs for example might offer a more exhaustive biomarker and esoteric test portfolio with globally harmonised, state-of-the-art testing platforms. This strategic partnership enables the central lab to get involved very early on, from the development of a de novo biomarker assay to meet specific customer needs, to rolling it out into clinical trials and developing companion diagnostic products in collaboration. This strategic partnership is based on a hybrid model and leverages the strengths of both organisations to provide clients with unprecedented scientific capabilities, in addition to optimal timelines and cost savings in one contracted relationship. For example, a collaboration between a central lab and a major diagnostic lab will prove beneficial to both companies because of the synergy created by offering complementary services. More importantly, customers will benefit from an advanced scientific portfolio and knowledge base, as well as a more effective and efficient service relationship.

Moving away from a buyer/service-provider business model towards an authentic partnership model between pharma, central labs and other stakeholders, such as couriers, will help to leverage specific expertise, generate cost reductions and increase efficiencies when running clinical trials.

TRENDS TO WATCH

In 2011, a number of factors are worth watching in view of their impact on the central lab model. These include:

Centralisation for Highly Specialised Biomarker Development
Centralisation may be a necessity for oncology trials involving specialised biomarkers. A good example is anatomical pathology and immuno-histochemistry for tumour biopsies. Centralisation will help to ensure test harmonisation, including the critical pathological review. It is well known that interpretation of tumour staining may differ from one pathologist to another, therefore imagine the potential variability that can occur when 20 pathologists are involved in reviewing slides from all over the world, in a trial that runs over a period of several months or years. So a compromise could be to centralise the pathological review using digital pathology.

Biomarkers: Oncology Trials and Companion Diagnostics
More biomarkers, and even drug target-related biomarkers, are being used in oncology trials. However, these biomarkers are often very specific to drug classes and hence are not generally applicable to all cancer drugs. As a result, central labs face an economic challenge around the profitability of developing, validating and deploying such very specialised tests in Phase I or early Phase II for targeted therapies.

The interest of central labs in implementing novel biomarkers in early trials is low because they are not profitable. Another concern is the attrition rate between early Phase I and Phase II, and then between Phase II to Phase III. In many cases, it is often only when drugs move to Phase III, with the use and deployment of biomarkers, that they become profitable for central labs.

Fortunately, there are several potential solutions to these challenges. The first is to involve academia or pharma internal resources earlier on, and to plan for early technology transfer to the central lab for late Phase II and Phase III studies. Another option is risk sharing, where the central lab takes on the responsibility of implementing, validating and deploying the biomarkers – even for non-profitable Phase I and Phase II – but the risk would be shared by both the pharma company and the central lab. If the trial does not progress to Phase III, the full validation cost would be paid by the pharma company. However, if the trial does in fact progress to Phase III, there would be a discount, and the validation could be entirely paid for by the central lab.

Another possibility is for pharma to use biomarkers to develop companion diagnostics. For example, a pharmaceutical company would work with central labs that have close relationships with diagnostic firms, in order to offer technological expertise to develop biomarker assays de novo and to bring them to clinical trial at Phase I or early Phase II. In addition, these companies could develop potential companion diagnostics in late Phase II or III, because they possess the regulatory expertise to bring medical devices to market and hence, facilitate parallel registration of the drug in companion diagnostics.

Chinese Situation
In China, the current limitations on exporting biological samples out of the country and, more importantly, the impossibility of systematically exporting biopsies and other DNAcontaining tissue from China is raising issues. The obvious solution is for pharma to use Chinese labs to perform anatomical pathology, immuno-histochemistry and other molecular diagnostic testing for tumour biopsies or analysis of circulating tumour cells (CTCs). However, it is preferable to use central labs with wholly owned facilities in China to ensure seamless data delivery, rather than local labs where the quality and the experience in running global trials may not yet be at the required level.

CONCLUSION

Central laboratory business models will continue to evolve, along with changes in customer requirements, scientific advances, regulatory guidelines and geographic considerations. Nonetheless, the current trend is certainly to favour the use of a central lab. On one hand, this offers a worldwide geographical footprint, fully harmonised test platforms and a single protocol and data management system; and on the other hand, it is flexible enough to manage samples and data consolidation with preferred third-party labs for highly specialised testing.


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Patrice Hugo is the Chief Scientific Officer at Clearstone Central Laboratories. He is responsible for the implementation of new tests, and the global scientific and clinical harmonisation of Clearstone’s testing capabilities. Patrice has more than 15 years of senior scientific leadership experience. He completed his PhD in Experimental Medicine at McGill University in Montreal, Canada, before undertaking five years of post-doctoral research in Melbourne, Australia and at the Howard Hughes Medical Institute in Denver, Colorado.
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