A new association involving major players in Big Pharma is working to establish best industry practices for handling patients’ biological samples, or biospecimen, during clinical trials.
Clinical trial technology firm Slope announced June 25 that it had formed the Biospecimen Management Consortium (BMC) alongside GSK, Moderna, Novartis, Roche, Takeda, ILiAD and Teal Health. The companies will collaborate on initiatives around improving inefficiencies in the biospecimen management lifecycle, starting with an industry survey to see where practices currently stand.
“Lack of control and visibility to biospecimen lifecycle and their metadata is a direct result of a clinical ecosystem that is fragmented, siloed and reliant on people and processes which can still rely on paper-based approaches,” Xavier Briand, associate director at Novartis, said in the announcement. “To drive sample excellence we must unite as an industry to establish a baseline, identify gaps and challenge the status quo.”
Biospecimens are a critical component of clinical trials, as tissue, blood, urine, plasma and other samples give researchers a way to align what they see clinically with what’s happening on a molecular level. Biospecimens are used to find and validate drug targets, understand how diseases work, identify and create screening tests for biomarkers and study genes. They’ve become even more important in the age of personalized medicine, as sponsors aim to match patients with the drugs best suited for their disease.
But there are plenty of places in the biospecimen lifecycle where things can go wrong, especially if there are communication lapses between stakeholders about each others’ processes. That can lead to wasted patient samples and inaccurate data that ultimately undermines clinical trials.
“We owe it to patients to ensure every sample taken has every possible chance to be used in pursuit of new therapies,” Anna Kosenko, team lead of clinical biomarker sample and data operations at Takeda, said in the announcement. “The BMC aims to shine a light on the aspects of the processes that need to change and help break down existing silos among the various stakeholders and systems that drive clinical research.”
Ahead of its industry survey, BMC is currently taking suggestions regarding the type of best practices that should be implemented, where the consortium should focus its efforts and what it should prioritize. Membership is currently open to pharma and biotech companies and will be expanded to clinical trial sites in 2025.