Human biospecimens are the foundation for the development of the precision medicine, including effective translational medical research and development of personalized molecular diagnostics. Human sample validation studies can provide key data from early stage discovery through preclinical research, drug safety evaluation, biomarker development, patient pre-selection (companion diagnostics) and entry of novel compounds into the clinic. At the gene and protein expression level, human tissues can be used to identify specific molecular entities involved in human disease (e.g. in cancer, those regulating tumor growth, metastasis, and drug resistance). Along with preclinical development work on the mechanism of action for lead compounds, the information obtained from studies with human specimens greatly facilitates the design of early phase clinical trials, assisting in the identification of the patient population that would most likely benefit from the targeted experimental medicine.
Modern biomedical research requires continuous supply of legally and ethically acquired high quality human biospecimens and associated clinical and molecular data. Companies and academic laboratories focused on development of targeted therapies and specific molecular diagnostic tests may face serious challenges in building state-of-the-art programs geared towards the analyses of specific molecules (nucleic acids, lipids, proteins, etc.), which may play critical roles in governing severe human conditions (cancer, asthma, rheumatoid arthritis, etc.) due to lack or insufficient quality/quantity of human biospecimens suitable for their commercial research and development programs.
Regulatory and legal issues on human tissue procurement for research purposes, preservation of pre-analytical biospecimen variables, collection of biospecimens using standardized protocols based on best practices, clinical data collection and management under the HIPPA Privacy Rules, clinical network management, biobank sustainability and finding trained experts – all these matters could make biobanking difficult for an occasional biobanking project of an individual laboratory.
Cureline, a global expert on human tissue acquisition, offers integrated services for commercial biobanking and sample processing to ensure your program success in what matters most: creating a personalized treatment approach for every patient and developing the most effective medicines and early detection/monitoring programs.