Central testing

Clinical trials to collect data on the safety and efficacy of new medicinal products increasingly require specialised testing on top of safety assessment. What are the benefits of integrating specialised testing into central laboratory services? NGP asked James Chennells, Global Head of Strategic Sourcing Pharma Development Services for Bayer Healthcare Procurement, and Luc Leroy, CEO of Eurofins Medinet.

NGP. When selecting a central laboratory services provider for a global clinical trial, what are the key drivers in the selection process?
JC. As we operate a selection process that includes the use of short-listed suppliers, many items are considered in advance such as quality of testing, certification and data management capabilities. This means the key drivers are focused on study specific items such as: the ability to cover the required geographies and demonstration of the ability to apply past experience to overcome potential logistical challenges; cost including appropriate strategies to minimise shipping costs especially when frozen samples are involved; project management including assessment of lab project manager and reporting tools. When specialised testing is included, the ability to conduct that testing or an appropriate plan to acquire required equipment and or expertise must be in place. And we always consider previous experience, i.e. if the aforementioned criteria are underpinned by a proven track record of a supplier with Bayer this brings added credibility to their proposals.

LL. Experience has taught us that the selection process for central laboratory service providers can cover a wide scope from in-depth investigation of the organization, including quality audits, to fairly straightforward contract negotiations. In providing services to (bio)pharmaceutical companies, we have experienced relatively straightforward selection processes where the client was able to identify the service criteria that have proven to pose a challenge over and above the basic service levels requirements. Working closely together in a respectful partnership creates the opportunity to elaborate in our proposal on how these challenges have been overcome in the past and the ‘lessons learnt’, so we can grow together.

The current emphasis on biomarkers by the FDA has generally increased the complexity of clinical studies. While such developments often trigger a selective focus on support services like project management and logistics management, one must not forget that analytical method selection, validation and standardisation is pivotal to meet regulatory requirements. The combination of the need to ship biomarker samples frozen, and the trend to move the implementation of clinical studies into emerging markets, increases the pressure on logistics, both in management and cost. Therefore Eurofins Medinet recognises a clear benefit in a balanced geographical coverage and has moved to provide the required services in the appropriate geographical locations.

NGP. Would you select a lab on a fit-for-purpose basis or anticipate on country expansion and or additional testing requirements throughout the study?
LL. As a truly global central laboratory services organisation with the ability to meet customer analytical needs anywhere in the world, we are striving to accommodate any fit-for-purpose selection. Our six wholly-owned globally standardised laboratories provide value to our clients that perhaps is not always identified when compared to a central laboratory company with less fully-controlled operations and geographical coverage. For example, when patient recruitment is not hitting target and the client wishes to add China to the study program, this may prove to be very challenging for some central laboratory providers, but is turnkey for us.

JC. We select on a fit for purpose basis but this selection is done from a selection of global providers so the ability to expand geographically or testing services is already addressed. However every effort should always be made to select based on final scope especially testing requirements. There is probably more variability amongst labs in terms of capabilities and costs of the more specialised tests than their abilities to service additional countries.

NGP. Does a dedicated central laboratory organization deliver added value over a ‘full service’ CRO?
JC. No, this is a question we regularly ask and as yet do not see conclusive evidence that one model or the other offers significant added value, differentiation or cost savings.

LL. Being a fully dedicated central laboratory services organization, we are completely focussed on laboratory testing services and associated services like logistics management, project management and data management. Central laboratory services are our only business, and therefore it gets our undivided attention to meet and exceed the market requirements by constantly improving our performance and procedures. Clients will discover and appreciate the added value in our speed and timeliness, achieving planned completion dates with the highest data quality whilst maintaining specimen integrity.

NGP. Clinical trials currently include more and more specialised testing on top of safety assessment. Do you see the benefits of integrating these specialised testing services, e.g. biomarkers and immunogenicity testing, into the central laboratory services?
LL. Integrating specialised testing with basic safety assessments provides time and money savings for our clients. Apart from consolidating the laboratory services, logistics management, project management and data management efforts are combined into one synergetic approach. Having one party responsible for all testing increases transparency and lowers the risk of errors occuring. Consolidated laboratory data can be provided within days after the last visit of the last patient, enabling statistical review to commence instantly.

JC. Integrated testing may provide benefits around the single source concept i.e. data, management contacts and reports. It also, of course, means fewer shipments, which reduces costs and potential problems. We do, however, have in-house expertise and capacity for testing and always prefer to utilise that before outsourcing.

NGP. Which type of testing would you rate most important for integration?
JC. It is very difficult to make a general statement in this regard as it always depends on the available in-house expertise and capacities to conduct a specific testing.

LL. Our laboratory testing portfolio is one of the broadest currently available in the market, e.g. safety assessment, toxicokinetics, PK/PD, exploratory and end-point biomarkers, microbiology testing, genomic services and histology. From our twenty years of experience and scientific accomplishments, we are able to quickly adapt to trends in the market place. For example we have been quite successful in performing immunogenicity testing programmes. Additionally, our open and flexible organizational structure enables us to evaluate exploratory biomarkers during the study and anticipate within the study.

Luc Leroy, the CEO of Eurofins Pharma Services, is in charge of the Group’s laboratory network including Eurofins Medinet, serving the pharmaceutical industry. He obtained a degree in Applied Economics from the Catholic University of Leuven in Belgium and initially worked in banking at ING and investment banking at GIMV/GIMVINDUS. Since then, he has worked at SGS in various positions including Managing Director of the Benelux and France Life sciences operations and most recently as their Managing Director for the UK.

James Chennells is Head of Global Strategic Sourcing Pharma Development Services within the Bayer Healthcare procurement organisation. He heads a team responsible for outsourcing services to support the Bayer Schering Pharma Global Development organisation. He obtained a degree in Applied Biology from Southampton University in the UK and initially worked in Clinical Operations in the CRO industry with Icon. Since then, Chennells has worked in various positions in CRO Business Development with Covance and Kendle.