Implementing biomarkers in clinical trials involves multiple stages, from early project strategy, to study setup and CRO oversight, to data delivery and report writing. This presentation will showcase how small language models and AI tools enhance efficiencies throughout the biomarker planning process.

In today’s clinical trials, effective biospecimen metadata management is crucial for accurate data integration and informed decision-making. At Bristol Myers Squibb, we improve specimen management by centralizing, standardizing, and validating metadata across systems, aligned with ICH E6(R3) standards, and by using software for visualization, transparency, and stakeholder collaboration. This hybrid approach simplifies logistics, ensures audit readiness, and promotes continuous improvement. We share best practices in system architecture and integration, focusing on automation, operational excellence, and quality-driven growth in biospecimen management.

As the importance of successful biospecimen readouts continues to grow, we are familiar with manual processes contributing to operational inefficiencies and error. Traditional sample management methods, such as spreadsheets, are not capable of supporting large trials and increase the risk of missed collections, lost shipments, lab queries, protocol deviations, and even patient replacement. Electronic sample management platforms have the potential to streamline specimen tracking and improve collection and analysis rates.

Biospecimen management in clinical research remains a complex landscape, strained by misaligned processes, inconsistent tools, and disparate nomenclature between sponsors, sites, labs, and other stakeholders. To truly understand what we are aiming to solve, we must clearly dissect the problem. This case study presentation walks attendees through the creation of the ecosystem-wide problem statement and details initiatives underway to solve for them.

Biospecimen management is a critical aspect of clinical trials conducted at academic research institutions and community sites, playing a vital role in the advancement of medical research, drug development, and precision medicine. However, managing biospecimen effectively presents logistical and ethical challenges. Explore how global pharma and lab vendor strategies translate to site management and impact study participants, including how you can become part of the solution.

As biomarker-driven development shapes clinical decisions, biospecimen management must move from a downstream task to a strategic function. This session shows how intentional design, cross-functional alignment, and fit-for-purpose governance reduce risk and data loss. Real-world examples highlight common pitfalls and practical fixes. Attendees will leave with clear ways to align biospecimen strategy to clinical and biomarker goals while balancing operational realities.

Biospecimen plans influence cost, burden, data quality, and operational success across clinical trials. This presentation explores BMS’s journey to digitize specimen planning by integrating assay-first logic, curated standards, and dynamic study-design capabilities into a unified tool. We will share obstacles, practical lessons from automating complex plans, and new opportunities for standardized outputs, improved vendor setup, and greater transparency throughout the specimen life cycle.

This session offers a practical interpretation of ICH E6(R3) through the lens of biospecimen operations. Attendees will gain clarity on new regulatory expectations and how they affect collection, handling, storage, and traceability. With real-world insights and actionable compliance strategies, the presentation bridges regulatory theory with operational reality—equipping research teams to align their biospecimen practices with evolving global standards.

The newly adopted ICH E6 (R3) guideline for Good Clinical Practice highlights biospecimens as vital data sources impacting the reliability of trial results. The guideline promotes proactive risk assessment, data integrity, robust documentation, and leveraging digital tools to ensure specimen quality and traceability. We will summarize key themes in the guidance and provide strategies to implement a quality framework for specimen management to minimize the risks associated with specimen collection, processing, storage, and transport.

Pharmaceutical research and development has strategically evolved its outsourcing models, leveraging external contract research organizations (CROs) to enhance operational efficiency, access specialized expertise, and accelerate drug development. The outsourcing model has progressed from transactional engagements to strategic, long-term partnership with CROs, ensuring flexibility, innovation and compliance with global regulatory standards as well as Novartis internal quality standards. Biomarkers present even more challenges with fit for purpose assay considerations, biomarker platform availabilities, kit and reagents upgrades by manufacturers, data transfers between internal and external platforms. This presentation will explore best practices for strategic vendor management in biomarker analysis, including aligning partner capabilities with program goals, ensuring data quality and value-added CRO service propositions. Real-world case examples will illustrate how pharma organizations are striking the right balance between flexibility and focus, ensuring on time deliverables, data quality, and driving biomarker-driven decision-making.

CBP will provide an overview of major U.S. regulatory authorities governing biological material importations, guidelines for acceptable and unacceptable cargo descriptions, examples of non-compliant shipments of biological materials and pharmaceutical products, and provide essential resources and important contacts for support.

The presentation outlines the role of the Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE) within CBP. It details the center’s structure, industry collaboration, enforcement responsibilities, and classification guidance for various pharmaceutical, healthcare, and chemical imports. It also highlights coordination with other government agencies and provides resources for compliance and trade facilitation.

Monitoring temperature control is a vital responsibility in clinical supply, extending beyond deep-frozen storage. Even products stored at ambient conditions require monitoring to ensure they avoid freezing or overheating. This session explains how tracking at defined supply chain touchpoints enables data collection, trending, and timely intervention. By leveraging value stream checkpoints, organizations can proactively maintain product integrity, safeguarding quality while minimizing risks across distribution and storage environments.

Kit wastage had spiraled beyond expectations—demanding urgent, strategic intervention. This talk presents our multi-pronged approach that includes addressing operational inefficiencies, refining processes with our partners, and empowering site-friendly practices to reverse the trend. Small, strategic shifts that build over time to reduce waste, boost efficiency, and embed sustainability into the fabric of clinical operations. Discover how a holistic strategy curbs waste and turns chaos into control.