New developments at Eurofins

NGP. How do Eurofins meet the needs of the biopharmaceutical drug development sector?

DS. Drug development continues to undergo significant changes from technical, medical, regulatory, and financial perspectives. As the overall population is aging and living longer due to medical advancements there is a continuous demand for pharmaceutical agents that can increase survivability and improve the quality of life. To meet these demands technical and medical advancements must be continuously incorporated into the drug development process.

At the same time that technical laboratory requirements and advancements are required for drug development there is the continued pressure for hitting key timeline milestones in the most cost effective manner. Eurofins Medinet is a global central laboratory that not only provides services that ensure accuracy and timeliness of results based on routine laboratory testing requirements for clinical trials, but also provides the scientific flexibility to develop and implement new tests and strategies that support the rapidly changing demands of modern medicine and drug development. This is currently accomplished in two notable Centers of Excellence that exist within the Eurofins Medinet family; Anti-Infective Services and BioMarker/BioAnalytics.

The Anti-Infective Services is supported by an experienced microbiology group specifically organized to help the biopharmaceutical industry meet the requirements and challenges that are unique to the development of antimicrobial agents. BioMarkers/BioAnalytics is a key and rapidly growing component needed to support clinical trials across a wide array of therapeutic areas, from cardiology to oncology, and Eurofins expertise in this area provides another flexible and important service for the industry.

NGP. How does your integrated central laboratory service benefit your clients?

DS. The broad range of services and global presence that Eurofins Medinet has, has allowed clients to have a ‘one-stop shop’ for both routine and esoteric testing, regardless of where in the world the trials are undertaken. This minimizes clients’ having to deal with multiple service providers, gives them direct access to leading experts in our specialty testing areas, and provides them a single source for the data that is critical to their product’s development. This all translates into greater efficiency, greater time-savings, and greater cost effectiveness.

NGP. How do you ensure that your client’s projects reach them at the best possible quality and safety levels?

DS. First, we are highly available to our clients so that as new needs arise or previous needs are changed they can communicate and discuss these needs with us in a timely fashion. This level of communication keeps us on top of our client’s timeline expectations. With the timeline requirements in mind all of our testing and data transfer processes are always closely monitored using QC and QA programs with all processes being carefully documented in our standard operating systems. To ensure this is maintained these processes are continuously evaluated through internal audits, audits by clients, and subscription to accrediting agency such as the College of American Pathologists.

NGP. Have you employed any new technologies recently to help you meet client’s demands faster or more safely?

DS. In our special areas of Anti-Infective Services and BioMarkers/BioAnalytics we are continuously bringing new testing platforms and study designs to meet the specific needs of individual client products and programs. In addition, with flexibility being one of our core competencies we also are continuously developing, validating, and deploying new assays required to perform laboratory-based assessment of the many new and unique therapeutic products under development.

NGP. Eurofins launched a new Medinet laboratory in May 2007, what do you hope to achieve through this new lab?

DS. Actually two labs were launched in this time frame to expand our offerings on a technical and on a geographic level. The laboratory in Aurora, Colorado, was established as the BioMarker Center for Eurofins in the United States and will, along with our lab in Breda, the Netherlands, continue to spearhead the expansion of expertise in BioMarker development and testing worldwide. Our laboratory in Singapore was launched to provide clients with geographic proximity for the routine testing of specimens obtained during clinical trials being conducted in the Asia-Pacific region. This ensures a closer management of transportation costs, maintenance of specimen integrity, and an overall more efficient turn around time of data.

NGP. How do you intend to strengthen your global position in the future?

DS. Successful product development in the biopharmaceutical industry depends on the availability of the latest technology, timeliness, accuracy, and cost effectiveness. We will strengthen and grow our business by continuing to improve our capabilities and capacities to hit on all four of these aforementioned ‘cylinders’ without ever compromising quality or integrity. Laboratory services have been, and will continue to be, a critical and necessary component to new drug development and they will not go away; neither will Eurofins Medinet.

BIO

Dr. Daniel F. Sahm, Ph.D. is the President of Eurofins Medinet, Inc. Sahm most recently served as Vice President and Global Head of Eurofins Medinet Anti-Infective Services where he directed efforts to support the biopharmaceutical industries discovery and development of antimicrobial agents. Over the past 20 years, Sahm's research interests have focused on antimicrobial resistance, its detection in clinical laboratories, surveillance, and resistance mechanisms. Sahm has authored numerous scientific articles and book chapters on the subject of antimicrobial drug resistance and surveillance, and has been selected to serve on several editorial boards. Prior to joining Eurofins Medinet, Sahm was an Associate Professor of Pathology and Medicine at the Washington University School of Medicine and was Co-Director of Clinical Microbiology at Barnes-Jewish Hospital in St. Louis, Missouri.