Driving Sample Excellence: Q&A with Amy Ripston

Amy Ripston
Executive Director
Biospecimen Management Consortium

Slope recently announced the launching of the Biospecimen Management Consortium (BMC), and new group focused on ensuring sample excellence in clinical trials. The group’s executive director, Amy Ripston, spoke with Pharmaceutical Executive about the group, it’s goals, and the importance of this work in the modern world.

Pharmaceutical Executive: What are the goals of the BMC?
Amy Ripston: The Biospecimen Management Consortium (BMC) was formed to elevate industry-wide excellence in sample management, raise the bar for data integrity and quality, and enable the future of complex clinical research.

To accomplish this, 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.

These initiatives will take a critical look at existing processes including, but not limited to, incorporating biospecimens into study protocols, lab and data management strategy, sample tracking, query management, data structure, governance, flow, and reconciliation, and ideal clinical study team structure to facilitate proper biospecimen and data oversight.

The BMC will then define key milestones and deliverables to start moving the industry forward.

PE: What challenges do clinical trial sites and sponsors face when managing patient samples?
Ripston: Research sites, labs, CROs, and sponsors often operate in silos and rely on paper-based processes for sample management, leading to a lack of cohesion, communication, and data flow among the various stakeholders involved on a single trial. The complex and fragmented nature of the biospecimen lifecycle presents several challenges.

This disjointed ecosystem, coupled with inefficient workflows, creates an environment where sites are more prone to miss critical sample collections, mishandle samples, and experience issues with accurately and efficiently capturing and sharing sample metadata. Sponsors, on the other hand, lack real-time visibility to their samples across various sites and labs, and do not have the data they need to make critical study decisions.

Ultimately, the majority of sites aren’t properly equipped to manage complex trials, and the majority of sponsors aren’t properly equipped to exercise oversight of complex trials. These fundamental issues can delay study milestones, jeopardize the patient experience on a clinical trial, and impede successful study outcomes.

To address these challenges, it’s critical for the industry to come together and bridge the gaps between stakeholders. The BMC offers a platform for key players in the clinical trials space to collaborate, share insights, and develop a comprehensive understanding of one another’s challenges. This collaborative approach not only fosters a sense of unity but facilitates the development of best practices that can be adopted across the industry.

PE: How is personalized medicine impacting data privacy?
Ripston: Personalized medicine, or precision-based medicine, has introduced complexities regarding data privacy, particularly concerning assay results from biospecimen analysis. Unlike biospecimen metadata, which is typically pseudonymized during collection and processing, assay results can contain sensitive personal health information (PHI). For instance, companion diagnostic tissue collections involve pathology reports that influence trial eligibility and standard of care decisions. Transmitting these reports between commercial testing labs and sites can inadvertently expose PHI, highlighting regulatory challenges in safeguarding patient privacy. Thus, while the collection of samples and the related metadata remains secure, assay results pose significant privacy risks, necessitating stringent data protection measures and regulatory compliance.

PE: What role will pharmaceutical companies have in developing best practices for managing samples?
Ripston: To effect real change in sample management, pharmaceutical companies need to have a unified voice in the standardization of operational set-up and data reporting that impacts the sample integrity and data flow in a clinical trial.

This is especially important because the clinical ecosystem is fragmented and siloed, with each commercial lab and technology solution supporting sites and labs having their own process and data standards. As the buyer of those services, pharmaceutical companies have the influence, as a collective group, to establish best practices and drive standardization that will ultimately benefit the entire industry and protect precious patient samples.

The consortium's first initiative is to launch an industry survey to better understand the current practices within biospecimen management, identify gaps and opportunities for innovation. The 8 sponsor founding member organizations will leverage the results of the survey, in conjunction with suggestions submitted through the BMC website and their own collective experiences, to develop best practices.

Survey results and best practices will be published by the BMC.