Human tissue samples and biofluid specimens such as
blood samples are invaluable at all stages of drug/ therapeutic development, from target discovery and validation through to product testing for safety or efficacy, including FDA/ EMEA cross-reactivity panel testing.
Human tissues are also necessary to develop and test diagnostics, with both patient samples from a variety of stages (or titers, for viral
infections, for example) and normal healthy age, sex and sometimes ethnicity-matched control donor samples being required.
Moreover, biomarker discovery by analysis of patient tissue samples is increasingly being used to facilitate non-invasive or less-invasive assessment patients’ responses to treatment during trials, or to anticipate at an early stage the development of side-effects such as organ damage. Predictive and prognostic biomarkers are also being deployed to stratify patient populations to predict their likely response or outcome, based on disease stage and likely treatment response. This stratification or personalization of medicine enables clinical trials to be more streamlined, first discovering, and then targeting, those patients most likely to benefit from a particular treatment. These inflammatory, cancer, cardiovascular or other disease clinical biomarkers, whether based around genetic or protein biomarker analysis, may then be further developed as biomarker assays and ultimately companion diagnostics. Biomarker research typically uses
frozen tissue samples or
FFPE samples.
Fresh intact organs or tissue samples, and biofluid specimens such as whole blood, are the most realistic model environment before going into the clinic and enable functional, in-depth analyses to be conducted on human samples from a huge variety of people before going into the clinic.
Fresh human biofluids, such as blood samples, and fresh tissues/ specimens are therefore essential to fundamental research as well as drug, medical device, biomarker or diagnostic discovery, development and validation. Fresh human tissues are employed in studies as part of target identification and validation, biomarker discovery, and to assess the safety and/or efficacy of new or modified drugs, biotherapeutics/biologicals and medical devices. Fresh human tissues are used in research and development (R&D) across the full range of human biological systems, including cardiovascular (CV), neurological, reproductive, digestive, excretory, hepatic, dermal, ocular, respiratory, immunological, metabolic and endocrine systems research.
Fresh human biospecimens are also used to evaluate potential new clinical diagnostics/theranostics in a clinically-relevant setting.Such tissues play a vital role in the development of personalized medicine & in determining which patients or users are likely to respond well, or alternatively, to suffer side-effects, as a result of using a particular drug.Please contact us at
info@biobankonline.com to find out how we can help you to achieve your R&D goals.
