Put to the Test

NGP.Can you give a little background to the company and describe some of the standout achievements?
RW. Eurofins Medinet has been around for over 20 years performing laboratory testing for pharmaceutical clinical trials. We pride ourselves on being flexible to the needs of our customers, on providing much needed access to our scientific experts, and advising our customers on how to develop the most scientifically relevant programs to achieve the greatest success. These efforts, as well as our demonstrated dedication to the success of the clinical trials we manage, resonates very well with our customers.

Given our success and as a wholly owned subsidiary of Eurofins Scientific, a leading worldwide bioanalytical laboratory testing company, we are able to respond to market trends by investing in ways that less financially robust companies find difficult. One way we have achieved the highest level of quality is by building, owning and operating our labs. We launched a lab in Singapore in 2007 which acts as our SE Asia hub for all clinical trials, and our most outstanding and recent achievement is the opening of our very own lab just north of Shanghai, China in March 2008. This is an accomplishment we are extremely proud of. We are now one of two other labs in the region that can truly meet the growing demands of our clients as they venture into this emerging market.

NGP. Can you explain how you have been adapting to some of the emerging trends in the pharmaceutical industry?
RW. This is a very good question and one that we put a lot of thought and effort into achieving. We provide a great value add to our customers, specifically by offering a ‘one-stop-shop’ for the analytical components of their drug development programs. We execute this concept in two ways: globally and scientifically. From a scientific perspective, we integrate biomarker development, microbiology testing and consultation for preclinical and clinical applications, as well as bioanalytical science to service clinical studies. This creates a highly effective program, increases data efficiencies, and through a single point of contact for project management, streamlined communications and well defined study implementation.

Globally, we are building, owning, and managing our labs, creating greater economic value, peace of mind that analyses are consistent, providing closer access to clinical trial subjects, while reducing turn-around-time (TAT) for testing and reporting results. We can provide complete scientific approaches, as well as identical procedures and methodologies worldwide. At the end of the day, our customers reap the upside while minimizing the risks they might encounter by using a service provider that follows a ‘partner lab’ approach.

As a whole, we have moved away from a 100 percent partnership model that you see with many other global central laboratories to one where we own and manage our labs. This model lends itself very well to having greater control and agility to develop globally, to ensuring the highest quality standards for analysis, and to conduct large global clinical trials. For our clients, these attributes become critical decision points when choosing a lab, especially when we all seemingly have the same capabilities.

NGP. The company has been expanding rapidly opening new laboratories to meet the demands of global clinical trials testing. Can you tell us about some of your new facilities, and what you hope to achieve through them?
RW. Today, Eurofins Medinet owns six laboratories worldwide, all of which are strategically located in key markets. Our newest facilities in Singapore, Shanghai and Denver were built from the ground up. We designed the lab to be scaleable for growth, and to enable us to increase scope of lab services that we already see our customers demanding. In addition, the laboratories were fitted with the identical analytical equipment as we use in the USA and Europe and are served by our global LIMS, hosted centrally and via dedicated networks to ensure that data is always available 24/7. Finally, we took great care to hire the highest qualified staff and management who have been instrumental in making those labs a success.

NGP. What have been some of the biggest challenges you’ve faced during the expansion and how has the company been able to overcome them?
RW. Our expansion is a result of both acquisitions and building our own labs worldwide, each having their own specific challenges. With the merger of Focus Bio-Inova, a global central lab in Washington DC and Paris, we went through an integration process where we looked at the ‘best practices’ of both organizations and made a concerted effort to improve the resulting brand, Eurofins Medinet. As with any integration, the greatest challenge was identifying and implementing the technologies, whether is was laboratory methodologies or a LIMS. This accomplishment set the stage for building up brand new labs in Denver, Singapore and Shanghai.

Also, particularly in Singapore and China, learning and adapting to local cultural mores, business practices and regulatory environments has been a real learning experience that has brought value to our global organization and by extension, to the customers.

NGP. How has the company innovated to improve the services it offers to its customers?
RW. First and foremost, we listen to our customers so we are better prepared to make improvements and build for the future. One way we have done this is by having a dedicated biomarker services group made up of highly accomplished scientists, using the most advanced technologies. Given the importance of biomarkers to define the most accurate and effective treatments, we play a critical role to help our clients develop and select targeted biomarkers that make the most sense for the therapeutic focus of any trial.

We’ve taken this one step further, and have integrated our biomarker services across our bioanalytical and central laboratory services. We are therefore able to provide specialized validation for a clinical trial, or to support any GLP requirements for bioanalysis.

NGP. Looking to the future, what developments can you see taking place at the company over the next 12-18 months?
RW. We have several interesting developments either in process or planned that will increase our capabilities and capacity to integrate a broad range of laboratory testing services.

Given the importance of biomarkers in drug development, we are making critical decisions in the technologies we use, with emphasis on those that are most scientifically relevant to a broad range of therapeutic areas.

With regard to unique biomarkers, we are developing specialized tests as well as setting up daily tests that would otherwise be typically batch tested. Eurofins Medinet’s biomarker group is already developing specialized tests and helping pharmaceutical companies large and small make better, smarter decisions that lead to more accurate, timely, and cost effective results.

We’ve recognized that biomarkers are often not a one-size-fits-all solution, so we also endeavor to provide customized assay development with optimization of assay sensitivity based upon the up-regulation or down-regulation of the metabolic pathway. We are also exploring the metabolome and the proteome for additional combinatorial biomarkers to help clients better demonstrate therapeutic effect and safety.

Eurofins Medinet will remain focused on expanding our operations in key emerging markets so we quickly respond to the demands of large global clinical trials. Access is critical, as is sample viability to a successful clinical trial. We believe that our approach to centralize in our owned labs is a sound one, and that coupled with hiring the most highly qualified individuals who have local knowledge and expertise, will continue to produce secure, high quality results.

Finally, by October 2008, our Washington DC laboratory will relocate just a few miles from the current location, into a larger, state of the art facility with triple the lab space. The Eurofins Medinet lab will be situated within close proximity of three major international airports, all of which have direct service to major metro areas around the world. We pay very close attention to the infrastructure around our lab locations to improve sample transport times. We are all very excited about this development and the future of full service central laboratory.

About Robert Willis
Robert Willis is the VP for International Laboratory Development at Eurofins Medinet and is responsible for establishing central laboratory services in new locations, integrating worldwide central laboratory operations, and managing sub-contractor laboratory relationships. Robert also represents Eurofins Medinet as a member of the Metrics Champion Consortium and is the lead for Eurofins Medinet central laboratory performance metrics initiative. Robert has broad range of experience clinical development laboratory services and has held positions in quality assurance and global operations management.