Photo: Jörg Ladwig
Peer M. Schatz is CEO of Qiagen, a supplier of life science research tools and employer of 1,400 people in 12 countries. Schatz has a Master's degree in finance from the University of St. Gall, Switzerland, and an MBA in finance from the University of Chicago. He is also a member of the Advisory Board of the Frankfurt Stock Exchange.
In many ways the laboratory tools we use today may remind us of computers in the late 1970s. In those days, systems were mostly incompatible and were dedicated to specific tasks. When the first personal computers emerged, these systems were integrated: "Cut and paste" became ubiquitous, and it became possible to share and compare data over multiple and geographically dispersed platforms. A main driver for development was the standardization of the interfaces and communication protocols were standardized. The more complex and interrelated the applications, the more important...
TRENDS IN PRECLINICAL, CLINICAL DIAGNOSTICS
In academia, we are seeing an increase in networked research and a greater demand for accelerating preclinical research. Preanalytical processing is a major influence on the quality of analytical results. This influence increases exponentially when the research results from different laboratories drive joint research efforts in networks. Roadmaps and regulatory frameworks increasingly reach into pre-clinical research. This trend leaves no room for uncertainty; full regulatory compliance of any tool is therefore critical. At Qiagen, we try to ensure the removal not only of quality risk in sample processing, but also all uncertainty as to compliance with regulations, frameworks, or roadmaps.
This trend towards making research comparable across analyses and geographic boundaries also confirms the need to be present in all major countries, to have the highest quality standards, to meet all regulatory requirements, and most importantly, to have a total commitment to focus.
Almost 25% of Qiagen's sales are generated from clinical diagnostics, and Qiagen has a range of products that are compliant with key regulatory frameworks in the United States or Europe. In addition to the diagnosis of infectious diseases and disease susceptibility, the market is facing another area of increasing importance: the screening of patients for clinical trials of targeted drugs, and ultimately for personalized medicine.
Astra Zeneca's lung-tumor drug, Iressa, according to results published in April 2004, showed a significantly higher-than-normal response rate in patients with a certain enzyme pattern. In July 2004, NitroMed announced that the Phase III clinical trial of its heart failure treatment, BiDil, had been stopped early because of the significant survival benefit seen in African-American heart-failure patients. On the other hand, in late September 2004, Merck had to withdraw its COX-2 inhibitor drug, Vioxx, because data compiled by Kaiser Permanente suggested that patients who took Vioxx had a higher cardiovascular risk than those who did not take the drug.
In November 2003, the US Food and Drug Administration published the draft of new guidelines accelerating the use of molecular biology in clinical research, and the preselection of patients to increase clinical trial safety. The FDA recommended genotyping and gene expression profiling of patients in clinical trials to allow for the selection of specific patients for trial enrollment, and to help in determining the correct dose. In addition, the FDA expects further detailed information on specific drug metabolisms (pharmacogenomics), pharmacokinetics, and subject stratification, to support scientific arguments and the validation of biomarkers.
The proven ability to seamlessly integrate sample collection, stabilization, and purification and handling technologies into complex diagnostic workflows has become increasingly important as patient samples are used for larger numbers of tests and in more diversified settings. Integrated technologies such as PreAnalytiX's PAXgene (a joint venture between Qiagen and Becton Dickinson), allow consistent and easy blood collection, stabilization, and purification of nucleic acids for large-scale analyses. Such products have become essential standards for the further development of these markets and will ensure that survey data from pharmacogenomic trials and Phase I-III clinical trials are not biased. The use of universally available, standardized tools in clinical research allows greater speed and flexibility as well as a diagnostic perspective. This streamlines and increases the reliability of clinical assay development and drug-development programs.
Consistent or standardized processes are also the bedrock for the commercialization of molecular biology technologies in molecular diagnostics, which stands to benefit in a very significant way from the advancements and successes in molecular biology-related research. Molecular biological methods are already an integral part of everyday laboratory routine, including genetic identification in forensics and in paternity testing. They are also today's standard in the diagnosis of infectious diseases such as HIV, hepatitis B and C, as well as human papillomavirus (HVP). In addition, molecular diagnostics companies have been successful in developing specific standardized tests for predisposition to cancers of the lung, intestine, prostate, pancreas, liver, stomach, and skin. The list of such predisposition tests is getting longer every day.
With an ever increasing number of samples and the dissemination of molecular biology approaches in the life sciences and health care, we observe a very significant need for consistent and comparable solutions that have highest performance but are also simple. The pharmaceutical and diagnostics industries are demanding less complex analytical platforms to increase the ease of use and decentralize the analytical work between different laboratories and hospitals.
The breadth of sample types that can be analyzed is increasing both in research and in diagnostics and now includes more "live" sample material such as various tissue formats and whole blood. This significantly increases the scope of available sample quality. At the same time, the sensitivity and cost of downstream analysis has increased. Samples that need processing are often limited in amount or partially degraded. Tool providers must cover a wide spectrum of different products and technologies to meet all the different requirements in these markets and to find the best solution for future needs. This can be done only with a commitment and focus. By delivering innovative technologies and solutions, tool providers continue to advance standards and enable researchers in academic and industrial environments to achieve breakthroughs in healthcare. This leads to an improvement in living conditions, which will contribute to improving people's lives.
Science has achieved such incredible successes in the last few years, and the advancements seem to be accelerating. It was very fitting that the scientific world started the new millennium with the successful completion of the greatest scientific challenges of recent years: the publication of the sequence of the human genome. While in itself a dramatic and hugely significant event, it stands for the spectacular speed at which science overall is advancing.