As clinical development portfolios expand, biospecimen operations function must balance scalability with efficiency, quality, and compliance. This presentation describes how a biomarker operations organization transformed its operating model to support scalable clinical development. Key topics include organizational optimization and evolution from manual sample tracking to automated processes. Attendees will gain practical insights from a successful case on how a rapidly growing biotech company develops operational scalability in biospecimen management.

Consumers can track a package, a rideshare, or even a pizza delivery in real time, yet many clinical trial teams continue to face challenges obtaining end-to-end visibility into specimen movement. As trials become increasingly biomarker-driven and operationally complex, the ability to understand where specimens are, how they move, and what risks may impact them has become critical to study success. This session follows the specimen journey from collection through testing and storage, highlighting common visibility gaps, operational challenges, and opportunities to leverage specimen movement data to improve oversight, reduce risk, and support more proactive trial execution.

This presentation explores the challenges that drove the evaluation and implementation of digital sample management solutions, from identifying operational gaps to enabling greater visibility, efficiency, and data quality. Building on last year’s discussion and attendee interest, it will examine measurable implementation outcomes and the insights gained beyond initial objectives. The presentation offers a forward-looking perspective on digital transformation, providing practical lessons for sponsors, vendors, and industry leaders.

Every biospecimen represents a participant’s contribution to science. Whether that contribution supports a single clinical trial or enables discoveries for years to come depends on preserving the participant’s intent throughout the clinical trial lifecycle and beyond. This session introduces the Chain of Consent: continuous alignment of protocols, informed consent, EDC systems, and operational processes. We’ll explore how gaps arise, their impact on future specimen use, and pathways for preserving participant intent. As an industry, we’re becoming better stewards of biospecimens; we must also become equally good stewards of participant intent.

Biospecimen outcomes begin long before the first sample is collected. This presentation shares insights from a sponsor- and site-led industry working group that explored how protocol design influences specimen value, operational execution, and study challenges across the clinical trial lifecycle. Key themes and practical guidance will highlight how upstream decisions often drive downstream complexity, creating opportunities for more intentional, fit-for-purpose collection strategies and improved protocol design.

As clinical trial protocols become increasingly complex, operational considerations are often introduced too late in the study design process, resulting in downstream impacts on study start-up, database design, laboratory specifications, site burden, and study execution. Specimen Lifecycle Management (SLM) provides a unique cross-functional perspective that connects protocol requirements to operational reality. This presentation explores integrating SLM earlier into protocol development and study planning to identify specimen-related risks, improve standardization, streamline start-up activities, and reduce costly rework. Attendees will learn practical approaches for aligning protocol design, laboratory strategy, specimen management planning, and operational execution to create more efficient and executable clinical trials.

Most pharma clinical functions have embraced use of AI tools to enable science and operations in recent years. In this presentation we will share Novartis Biomarker Development experiences with using AI common and custom-developed applications to enhance efficiencies throughout clinical biomarker planning, execution, and data delivery processes.

AutoMapper is a web-based solution that automates and standardizes specimen data mapping and translation across clinical studies. Integrated with Sample Tracking Tool, it identifies unmapped values, streamlines source-to-target alignment, and synchronizes updates to maintain data consistency. By replacing manual mapping activities, AutoMapper reduces errors, improves data quality, and accelerates data readiness for downstream use. The solution demonstrates how existing technology investments can be repurposed to increase operational efficiency and scalability.

Biomarker 360 is a secure, scalable, and interactive application that provides scientists with centralized access to harmonized, analysis-ready biomarker data. with robust security and role-based access controls, sensitive data is only available to authorized users within a governed environment. By consolidating disparate data sources into a single platform with integrated pipelines, it significantly reduces analysis turnaround time. Scientists can explore data across studies, modalities, and analytes through an interactive experience featuring dynamic visualizations including volcano plots, spaghetti plots, heatmaps, box plots, and customizable summary views with dynamic filtering and drill-down capabilities to quickly isolate and interrogate biomarker endpoints of interest.

Not all samples carry the same risk. This presentation explores how Bristol Myers Squibb developed and implemented a Critical to Quality biospecimen documentation strategy aligned with ICH E6(R3) and E8. Using risk assessments and sample stability oversight, documentation requirements were refined to prioritize samples most critical to patient safety and study outcomes. Attendees will gain practical lessons for building efficient, fit-for-purpose biospecimen processes.

Pharmaceutical research and development has strategically evolved its outsourcing models, leveraging external contract research organizations (CROs) The outsourcing model has progressed from transactional engagements to strategic, long-term partnership with CROs, ensuring 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.

Increasing trial complexity and compressed start-up timelines make streamlined biospecimen operations a business-critical requirement for reducing site burden, improving sample logistics, and advancing environmental sustainability goals. Coordinated planning across all sample types during the preparation of the schedule of assessments enables implementation of simplified logistics and optimization of sample shipments to reduce site and environmental burden.

Biospecimen kit planning, ordering, and waste management during the conduct of clinical trials present challenges for all stakeholders. In a recent cross-stakeholder round table discussion, the BMC explored root causes of these issues with the goal of identifying sustainable solutions. This presentation will share insights and prioritized recommendations from the discussion, focusing on how the BMC will advance these ideas into scalable improvements that reduce variability, waste, and operational burden.

Rare disease trials face unique biospecimen challenges, including small and geographically dispersed patient populations, limited sample volumes, complex collection requirements, and the need to balance scientific objectives with participant and site burden. Integrating biospecimen strategy early in protocol and trial design can help address these challenges, improve study feasibility, reduce operational complexity, and support the generation of high-quality, fit-for-purpose data. This presentation will explore practical considerations for connecting trial objectives, sampling plans, visit schedules, logistics, and downstream testing needs from the outset.