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June, 2008                                                                                                                            Home

Well Characterized Biospecimens for biomarker discovery and validation Biomarker Development has been identified as one of the most important areas for improving drug development and diagnosis by The FDA’s Critical Path Initiative. Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Under this initiative, the FDA has created an Opportunities List which outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies. The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers; clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. The main causes of failure in the clinic include safety problems and lack of effectiveness: inability to predict these failures before human testing or early in clinical trials dramatically escalates costs. The goal of critical path research is to develop new, publicly available scientific and technical tools such as biomarkers that make the development process itself more efficient and effective and more likely to result in safe products that benefit patients. Biomarker development has therefore been identified as one of the two most important areas by the FDA’s Critical Path program. Such tools will make it easier to identify earlier in the process those products that do not hold promise, thus reducing time and resource investments, and facilitating the process for development of medical products that hold the most promise for patients. Biomarkers are measurable characteristics in animals or humans that can help predict the performance of a product during development, reducing uncertainties about safety or effectiveness. Biomarker discovery and validation are active but emerging fields of endeavor. Well characterized biospecimens that accurately reflect various disease states are critical to successful biomarker discovery and development research. The quality of samples analyzed will ultimately determine the quality of biomarkers produced. Factors such as human tissue quality, history, outcomes and storage conditions must therefore be taken into consideration. Finally, researchers must also ensure that human tissue samples and biofluids are ethically collected and consented for research. Access to diseased tissues provides a great opportunity to identify disease-related target/biomarkers and to investigate any disease-related differences in the pharmacology of drug compounds. After the biomarker discovery phase, the next phase involves the development of a validated biomarker that can be tracked during clinical trials and tested to determine appropriate patient care. Clinicians prefer diagnostic biomarkers that utilize test specimens that can be collected in the least evasive manner possible or are collected as part of standard treatment protocols. It is for this reason that most diagnostic biomarkers are tested using serum and plasma. Asterand’s Quad SetTM Plus biospecimen protocol is a unique offering to accelerate such biomarker validation studies. Quad SetTM Plus biospecimens collections consist of a tumor and normal sample, each then sliced into two pieces. We preserve one piece in Liquid Nitrogen or Isopentane and the other is fixed in formalin and is available as FFPE sample. In addition, serum and plasma samples from the same clinical case are available. Quad SetTM Plus biospecimens are accompanied by extensive clinical data making them ideal for biomarker validation studies. All of Asterand’s biospecimens are obtained using stringent standard operating procedures and ethical protocols to provide assurance to the researcher that the material will meet their scientific needs. In addition, the Quad SetTM Plus biospecimens would be ideal for the diagnostic biomarker validation platform due to availability of both tissues and biofluids from same donor case thus eliminating the need to pool samples and preserving intrinsic biological information present in samples. The lack of new candidate biomarkers has also been attributed to less effective discovery stage research. It has been suggested that a combination of methods should be used to detect biomarkers. For example, besides searching for biomarkers in blood, researchers should also focus their discovery efforts on site of disease, or the fluid bathing the tissue of interest or serum or plasma. Asterand offers a range of biofluids (blood, serum, plasma) from various diseases and conditions. We maintain a significant bank of samples from a diverse group of diseases and ethnic populations for immediate shipment to customers. All samples are available as non-pooled aliquots from individual cases. This is important as most practitioners tend to agree that the intrinsic biological variability present in individual samples contains important information, and unless you have the appropriate informatics and biostatistical tools, pooling is not appropriate. Each aliquot is accompanied by detailed clinical information from the specific case and undergoes Asterand’s standard quality assurance measures. If your research requires biospecimens collected using a specialized protocol, we offer ProCURETM service. Due to our worldwide donor network, we are uniquely positioned to supply human tissues and biofluids with associated clinical data from a range of therapeutic areas and various ethnicities. This also includes collection of fresh human tissues and collection of synovial fluids from both surgical and post mortem donors.

ASTERAND SUPPORTS HUMAN DRUG DISCOVERY AND TRANSLATIONAL MEDICINE THROUGH THE PROVISION OF HIGH QUALITY WELL CHARACTERIZED HUMAN BIOMATERIALS AND PRECLINICAL RESEARCH SERVICES

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