Value of Biobanking
Biospecimens contain vast amounts of information that can advance clinical research. In order to capitalize on this value, proper sample collection and storage is required during clinical trials. Biorepositories of clinical samples with proper informed consent can answer regulatory questions of safety and efficacy, elucidate unexpected outcomes during trials, and enable pharmacovigilance testing of marketed compounds.
The U.S. FDA has acknowledged the value of creating these biorepositories in the draft guidance on clinical pharmacogenomics. The draft document states that pharmacogenomics information from drug development and postmarketing studies can improve the effectiveness and safety of drugs. An important prerequisite to successful use of genetic information in drug development is the appropriate collection and storage of DNA samples from all clinical trials. Storing DNA samples allows for analysis during and/or after a clinical study is finished.
Some recent examples of the link between clinical specimen collection, pharmacogenomic analysis, and drug development include vemurafenib (Zelboraf), a recently approved drug that is effective against advanced melanoma with a specific mutation in the BRAF gene, and crizotinib (Xalkori), which is active against advanced-stage lung cancer with an ALK fusion mutation.
Gentris works with clients to design biorepository and sample logistics solutions that enable high quality pharmacogenomics studies. Clinical sites can receive training in sample collection and handling with seamless shipping to Gentris’ facility in Morrisville, NC. Once samples arrive at Gentris, they are entered into a state-of-the-art LIMS system that tracks samples from receipt and accessioning through extraction and purification ending with storage in the biorepository. Clients are assured that samples are maintained in optimal conditions at a cutting edge facility that complies with U.S. FDA GLP and ISBER Best Practice guidelines.