Slope Spearheads Launch of Biospecimen Management Consortium to Drive Sample Excellence in Clinical Research

Update : 26th June, 2024

Slope has announced the formation of a new industry-led consortium to enable the future of complex clinical research by driving sample excellence. Founding members of the Biospecimen Management Consortium (BMC) include GRAIL, GSK, ILiAD, Moderna, Novartis, Roche, Takeda, and Teal Health.

The BMC will drive a variety of initiatives aimed at developing best practices and industry standards, streamlining biospecimen lifecycle operations and data management, and influencing regulatory policy.

"This consortium is the first of its kind dedicated to the nuanced biospecimen-related operational, regulatory, and data management challenges faced in the execution of clinical trials," said Amy Ripston, Executive Director, Biospecimen Management Consortium. "The criticality of this work cannot be understated, and it is imperative that we begin to address existing challenges so we don't impede scientific advancement."

The rise of personalized medicine and other complex clinical research is increasing the reliance on biospecimen data that is derived from patient samples — whether blood, urine, tissue, etc. Despite advances in science, there still exist inefficiencies and gaps in biospecimen lifecycle management that must be addressed to improve data quality and patient outcomes.

"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," said Xavier Briand, Associate Director, Novartis. "To drive sample excellence we must unite as an industry to establish a baseline, identify gaps, and challenge the status quo."

The BMC's objective is to drive innovation at the intersection of people, process, and technology — for more efficient, compliant, and higher-quality trials. The consortium's first initiative is to launch an industry survey to better understand current practices, derived from both qualitative and quantitative metrics, in an effort to define a roadmap for the discipline.

"I have seen firsthand the impact current biospecimen management processes have on the entire ecosystem, from the challenges at clinical research sites in managing complex sample collection schemas to the lack of visibility and traceability of those samples to multiple destination labs," said Diana Steinbuesch, BioX Operations Portfolio Leader, Roche. "I am excited to join the BMC to start moving the needle in the right direction."
"We owe it to patients to ensure every sample taken has every possible chance to be used in the pursuit of new therapies," said Anna Kosenko, Team Lead, Clinical Biomarker Sample & Data Operations, Takeda. "The BMC aims to shine a light on the aspects of the process that need to change, and help break down existing siloes among the various stakeholders and systems that drive clinical research."

The BMC welcomes additional pharmaceutical or biotechnology organizations to join this initiative, and in 2025, membership will be expanded beyond sponsors to include clinical research sites. Future membership expansion will be determined by its founding members.

To be notified of new initiatives and progress, please follow us on LinkedIn and visit our website to be added to our mailing list. The BMC also openly welcomes novel ideas and suggestions for areas of improvement within biospecimen lifecycle management. To submit an idea, please visit: https://www.biospecimen-consortium.org#ideas

 

About BMC

The Biospecimen Management Consortium is a clinical trial industry partnership focused on raising awareness of the importance and criticality of biospecimen management, and driving best practices and industry standardization for industry-wide sample excellence. For purposes of the Consortium, biospecimen management is defined as the end-to-end process from lab kit management through sample collection, processing, storing, shipping, tracking, resulting, and long-term storage of samples for future research. For more information, visit biospecimen-consortium.org.

About Slope

Slope is a clinical trial technology company that believes, as an industry, we must ensure patients receive the experience they consented to and that their valuable samples are protected. Slope will serve as the host of the BMC to provide a platform for the industry to discuss challenges, create best practices, and help drive progress on its initiatives. For more information, visit slopeclinical.com.

Source : Slope


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