Explore the Agenda
8:00 am Check-In & Light Breakfast
8:30 am Chair’s Opening Remarks
8:50 am Reducing Pre-Analytical Variability: Building Site Management Strategies That Deliver High-Quality Biomarker Samples at Scale
- Standardizing collection, processing, and handling procedures across global sites to reduce pre-analytical variability and improve biomarker data quality
- Strengthening collaboration between biomarker, laboratory, and clinical operations teams to ensure consistent protocol execution from site to sample receipt
- Implementing practical site management strategies that improve compliance, minimize sample errors, and support reliable downstream biomarker analysis
Garbage In, Garbage Out: Optimizing Sample Strategy & Pre-Analytical Quality to Strengthen Clinical Confidence
9:00 am Session Reserved for Almac
Presentation Details to be Announced
9:30 am Building Fit-for-Purpose Biospecimen Ecosystems: Standardizing Sample Science to Advance Biomarker Discovery & Validation
- The reliability of biomarker research depends not only on assay performance, but also on the quality, consistency, and suitability of the biospecimens being analyzed. Examining how standardized collection, processing, storage, and controls can preserve specimen integrity and improve the reproducibility of biomarker data across multi-site studies
- Drawing on lessons from the Cancer Moonshot Biobank, the discussion will highlight practical approaches to building harmonized biospecimen infrastructures that support fit-for-purpose sample use throughout clinical development from early biomarker discovery and assay development to analytical validation and clinical application
- Exploring how to optimize end-to-end biospecimen workflows, align specimen requirements with assay and research objectives, and generate robust, clinically meaningful data at scale
10:00 am Morning Break & Speed Networking
As the biomarker operations and biospecimen management community unites under one roof for the first time, this dedicated networking session is designed to help you build meaningful new connections with peers shaping sample strategy, biomarker delivery and operational excellence across clinical trials. Connect with leaders from pharma, biotech, central labs, diagnostics and academia, to establish relationships that flourish long after the summit concludes.
Improving Site Management to Improve Consistency & Streamline Sample Collection
11:00 am Advancing Biospecimen Management: An Interactive Biospecimen Management Consortium (BMC) Roundtable
- Introducing the BMC and its mission to advance biospecimen management through ecosystem-wide collaboration
- Facilitating an interactive roundtable discussion on the operational, process, and data challenges impacting biospecimen management today
- Exploring opportunities for greater collaboration to improve consistency, quality, and operational excellence across the biospecimen lifecycle
11:45 am Harmonizing Laboratory Manuals Across Trial Sites to Enable Consistent Biospecimen Handling & Analysis
- Standardizing laboratory manual formats and instructions to give every site consistent guidance and cut confusion
- Creating familiar, user-friendly materials to boost site adoption and reduce collection errors
- Establishing industry-wide norms to help sites collect and process samples correctly the first time
12:15 pm Lunch Break & Networking
Harnessing Sample Tracking & Software Platforms to Streamline End-to-End Biomarker Operations, Improve Visibility & Strengthen Chain of Custody
1:15 pm Panel Discussion: Choosing Build vs. Buy for Sample Tracking Technology & Making Either Work at Scale
- Weighing custom-built platforms against off-the-shelf LIMS and sample tracking software to match technology investment to trial complexity and organizational maturity
- Confronting Integration Reality: Connecting sample tracking systems with CTMS, LIMS, and central lab databases without creating new data silos
- Debating who owns technology decisions, translational science or clinical operations, and how that ownership shapes adoption and long-term scalability
Moderated by:
1:45 pm Session Reserved for Slope
Presentation Details to be Announced
2:15 pm Development of New Tools & Processes to Enable Real Time Visibility of Samples & Associated Data
- Exploring what the "lab of the future "must deliver, including real-time biospecimen visibility, to support the growing complexity and pace of modern clinical trials
- Building an enterprise ecosystem that provides synchronous visibility across biospecimen operations, laboratory data, and clinical data to enable informed operational decision-making
- Shaping the future of biomarker operations by leveraging automation, integrated data ecosystems, and predictive analytics to improve biospecimen visibility, mitigate operational risks, and support precision medicine at scale
2:45 pm Afternoon Break & Networking
Reimagining the Operating Model: From Fragmented Infrastructure to Scalable Biomarker Operations
3:15 pm Building a Data-Driven Operating Model to Optimize Biospecimen Management & Biospecimen Operations
- Enabling Earlier Trend Detection: Leveraging integrated data and real-time operational monitoring to identify emerging trends, recurring issues, and operational risks before they impact sample quality, study timelines, or data integrity
- Improving Operational Efficiency: Replacing manual, reactive processes with automated insights that enable faster decision-making, targeted interventions, and more efficient biospecimen operations
- Building a Scalable, Predictive Operating Model: Establishing standardized digital workflows, governance, and analytics that support consistent execution and enterprise-wide scalability, while transforming operational data into actionable intelligence that strengthens quality oversight, inspection readiness, and proactive study management
3:45 pm Managing Global Biomarker Operations Across Borders: Navigating Country-Specific Regulations & Geopolitical Complexity at Scale
- Aligning issue escalation and operational governance across globally distributed teams to keep sample delivery consistent regardless of region
- Navigating country-specific regulatory challenges, including China’s HGRAC requirements and the US PROTECT Act, to keep global trials moving without costly delays
- Building a collaborative operating model with central lab providers that anticipates geopolitical and regulatory shifts, rather than reacting to them after they derail a trial
4:15 pm Panel Discussion: Moderated by TruTechnologies
Presentation Details to be Announced
Moderated by:
4:45 pm Transforming Clinical Laboratory Processes Through Near Real-Time Visibility, Automated Laboratory & Operational Intelligence
- Piloting integrated digital solutions, including a digitized Schedule of Events (SOE) intended to support faster, lower-error trial start-up and a sample collection and tracking technology designed to provide near real-time visibility into biospecimens from point of collection through testing
- Working toward a single source of truth for sample management by developing a common language and strengthening lab-to-sponsor data flow across sites, external labs, and vendors, contributing to the advancement of industry practice in pharma and clinical laboratories