Explore the Agenda
8:15 am Light Breakfast & Networking
8:20 am Chair’s Opening Remarks
Advancing Consent Management & Tracking to Enable Compliant Sample Utilization Across Trials
8:30 am The Silent Killer of Biospecimen Value: Poor Consent Content & Management
- Strengthening biospecimen value through robust consent
- Managing country- and site-level consent requirements and limitations
- Advancing documentation and system strategies to enable compliant research use of biospecimens
9:00 am Protecting Patient Rights Through Consent to Sample Traceability
- Understanding the challenges of managing multiple consent types
- Designing clinical trials for real time consent and withdrawal tracking
- Operationalizing participant withdrawals across the sample life cycle
9:30 am Session Reserved for Astoriom & Embleema
Presentation Details to be Announced
10:00 am Managing IVDR Requirements & Country-Specific Submission Processes to Maintain European & RoW Market Access
- Navigating IVDR compliance across European countries to protect ongoing market access
- Addressing country-specific export restrictions in Brazil, China and France to keep global trials moving
- Balancing regulatory requirements with operational feasibility to avoid costly protocol amendments
10:30 am Morning Break & Networking
Applying AI-Driven Biomarker Operations to Reduce Operational Burden & Accelerate Decision-Making
11:30 am Leveraging AI & Automation to Speed Up Biomarker Operations & Quality of Delivery
- Biomarker operations is highly manual and time consuming
- Implementing AI and automation to address bottlenecks in the end-to-end biosample flow
- Harnessing AI can significantly reduce manual tasks and the overall quality biomarker results
12:00 pm AI-Augmented Biomarker Operations: Pilot Use Cases, Adoption & Efficiency Gains
- Building AI-enabled biomarker operations by developing a structured initiative to identify and develop targeted use cases and resources to accelerate routine biomarker operation activities
- Creating a sustainable framework for AI adoption, including user training, humanin- the-loop quality control, prompt standardization, and approaches for maintaining inspection readiness
- Using defined success metrics, team surveys, and operational dashboards to track AI adoption, capability growth, and efficiency gains, demonstrating how AI can transform biomarker operations while preserving scientific and quality oversight
12:30 pm Lunch Break & Networking
Driving Data Integration & Standardization to Enhance Biomarker Insights & Improve Cross-Study Comparability
1:30 pm Panel Discussion: Breaking Down Data Silos: Aligning Sponsors, Labs & Platforms on Standardized, Analysis-Ready Datasets
- Reconciling disparate lab data formats and delivery systems to identify where standardization efforts should focus first
- Assigning ownership of data harmonization across sponsors, central labs, and technology providers to close accountability gaps
- Prioritizing which integration points would unlock the most value for cross-study comparability, and what’s currently blocking them
2:00 pm Linking Sample Results with Clinical Metadata to Accelerate Meaningful Insights
- Connecting biomarker results with essential clinical context to unlock meaningful insights
- Leveraging external partners to support harmonized, analysis-ready datasets
- Maximizing sample value through AI-driven analysis to power next-generation biomarker science
2:30 pm Afternoon Break & Networking
Maximizing Biobanking & Long-Term Storage Strategies to Preserve Sample Integrity & Unlock Future Value
3:30 pm Session Reserved for Azenta Life Sciences
Presentation Details to be Announced
4:00 pm Managing Post-Trial Sample Disposition & Storage Decisions to Enable Future Research
- Determining which samples to retain in long-term storage to protect future research value
- The importance of future research and the availability of high-quality samples
- Applying the same rigorous tracking to long-term storage as on-study management to safeguard sample integrity and balancing the costs of biobanking against future scientific value to justify continued investment