A freshly created coalition consisting of major Big Pharma players has been set to develop guidelines for handling patients’ bio-materials, or biospecimens, in research studies. Slope, a clinical trial technology firm, disclosed that it has established the Biospecimen Management Consortium (BMC) with the participation of GSK, Moderna, Novartis, Roche, Takeda, ILiAD, and Teal Health. Thus, the consortium will focus on activities aimed at optimizing the biospecimen management lifecycle. The initial activity will involve a questionnaire to a set of industry participants in order to determine the current state of biospecimen handling practices.
Xavier Briand from Novartis Europe as an Associate Director stressed the problems that arise from the clinical environment which is still mostly centralized and not unified, and which often uses documents and paper forms. “If we wish to set the bar and strive for sample superiority, we need to first collectively come together and determine a standard by which to judge our progress, and where there is a dearth of progress, push forward,” Briand said in the announcement.
According to the type of study, clinical trials require biomaterials such as tissue, blood, urine, and plasma. Thus, the applications of these reagents include defining interactions between clinical findings and molecular level, identifying and proving targets, revealing disease pathology, inventing biomarker-based analysis systems, and investigating genes. These samples have become even more valuable in the current times when the development of the concept of personalized medicine necessitates defining which drug should treat a certain patient’s condition.
However, several conditions within the biospecimen supply chain can falter for a number of reasons, especially due to deficits of coordination with the involved parties. Failure in such scenarios can lead to loss of patient samples and also wrong results, which can seriously jeopardize clinical trials. ‘It’s important that as a company, and as a provider of biomarker samples, we give it every possible opportunity to be used in the pursuit of new therapies,’ said Anna Kosenko, Team Lead of Clinical Biomarker Sample and Data Operations at Takeda. The BMC is going to shed light on which process areas require enhancement and to unravel the silos currently present in processes and relations between the different parties and systems involved in clinical research.
Before surveys of the industry are conducted, BMC is seeking opinions on what is the best practices to employ, where should the focus be and what should be emphasized on. It is presently limited to pharmaceutical and biotech businesses and will extend to clinical trial facilities in the next three years.
