Our present healthcare system focuses on treating people when they are ill rather than keeping them healthy. We have been using big data and remote monitoring approaches to monitor people while they are healthy to keep them that way and detect disease at its earliest moment presymptomatically. We use advanced multiomics technologies (genomics, immunomics, transcriptomics, proteomics, metabolomics, microbiomics) as well as wearables and microsampling for actively monitoring health. Following a group of 109 individuals for over 13 years revealed numerous major health discoveries covering cardiovascular disease, oncology, metabolic health and infectious disease. We have also found that individuals have distinct aging patterns that can be measured in an actionable period of time. Finally, we have used wearable devices for early detection of infectious disease, including COVID-19 as well as microsampling for monitoring and improving lifestyle. We believe that advanced technologies have the potential to transform healthcare and keep people healthy.

The end-to-end clinical sample management remains the area of focus and opportunity for improvements for many pharma and biotech companies. It directly impacts operational efficiency, data integrity/quality, and clinical trial speed. We will present a solution based on commercially available IT platforms covering sample collection planning, sample data ingestion, QC/clean up, and reconciliation. The system is also expected to work in concert with electronic sample requisition forms which will also be discussed.  

This presentation will share Merck Sharp & Dohme's process and technology to address enterprise-level inefficiencies and inconsistencies in the reporting of biospecimens to enable real-time comparison, evaluation, and decisions. A cross-functional stakeholder workstream was created to assess the biospecimen lifecycle process, beginning with the protocol through metadata accumulated days, weeks, and years after the physical collection. The team assessed each step & stakeholder’s responsibility for contributions to these examples, systems, and ideas to build a “perfect process from study build to final disposition”. The feedback received was used to plot each step to aggregate the data for intersections, divergences, and gaps to determine our requirements. Once defined, we used these requirements to discover a platform that can meet all our needs. We continue to identify efficiencies within the biospecimen workstream which will positively impact our sites, clinical, data management, quality, and suppliers’ team interactions.  The overall effect of these efficiencies harmonizes the data from multiple sources to one metadata stream allowing for enhanced real-time decisions and actions.

Strategic outsourcing leveraging external resources is key to streamlining biospecimen operations. The push towards precision medicine has led to increased collection of biomarker specimens which can be tested as a study endpoint or stored until needed to enhance future scientific discovery. This presentation will highlight steps to strategically outsource components of biospecimen operations to enhance efficiency, maintain data integrity, ensure compliance, and achieve successful outcomes in research and development endeavors.

CDISC has introduced a number of Study Data Tabulation Model (SD) domains for biomarker data. There are distinct domains for data generated from genomic, cell phenotyping, proteomic, histopathology, microbiology, and immunogenicity assessments. Formatting biomarker data according to the CDISC domains is required for FDA and PMDA regulatory submissions. It also standardizes data from different laboratories and studies for analysis for internal decision- making and inclusion in publications and conference presentations.

Informed Consent is one of the most fundamental aspects of clinical research yet companies struggle with managing global requirements, varying IRB/EC opinions, and ensuring patient understanding of the trial. This presentation will discuss progress made to optimize informed consent for our trials, including standardization of biomarker, future research, and sample collection information, as well as efforts to achieve a more patient-friendly document.

Research programs are successful when participants feel engaged and invested. A “return of results” program that provides meaningful personal information back to participants, can be incredibly effective, driving gratitude and longitudinal engagement. One groundbreaking example is the NIH All of Us Research Program, which has enrolled over 500,000 individuals and is returning hereditary disease risk analysis, pharmacogenomics, and recreational genetics. This talk describes the process, principles and impact. 

Embark on a journey into the future of informed consent with the next-gen paradigm. This groundbreaking concept seamlessly automates and globally translates traditional documents, breaking language barriers while maintaining local relevance. Witness the transformative leap in patient communication, enhancing accessibility and specificity. Join us to explore the innovative features that mark a pivotal shift in healthcare and research, shaping the landscape of patient-centric communication practices.

Intelligent (BI/AI) data should not be intimidating or overwhelming to the operational scientist in biomarker laboratories, biorepositories, and other areas in our organizations. Scientific organizations use business intelligence (BI) tools to develop dashboards that display and explain events that have happened (WHAT) to transform instincts into informed decisions. Integrated technologies have allowed the convergence of BI and Artificial Intelligence (AI) to allow for the understanding of causation in such events (WHY) by integrating powerful technologies like augmented analytics. This transformation from the WHAT to understanding the WHY facilitates the transformation from analysis to insights.

The Cancer Moonshot Biobank (moonshotbiobank.cancer.gov) is a National Cancer Institute (NCI)-sponsored study that aims to accelerate cancer research through the collection of longitudinal blood and tissue biospecimens from cancer patients receiving standard-of-care therapy. The biospecimens, generally small biopsies, and accompanying medical data are being collected from community hospitals across the US from a diverse set of participants and are being made available to accelerate research progress in cancer. Evidence-based, well-documented, and consistent procedures are being used to collect specimens of known quality. The Biobank will provide a networked biospecimen resource which will serve the goal of the Cancer Moonshot.

Microsampling technologies enable clinical trials to reach broader populations, collect additional samples during or post-study, and help reduce patient burden. This presentation will review various aspects for implementation on clinical trials and will cover several topics, including the main areas for microsampling impact on clinical trials, operational planning for microsampling implementation, and considerations for microsampling approach in relation to bioanalytical utility and data interpretation.

DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes. This talk will discuss the post-COVID strategies for connected devices implementation in hybrid trials.

This talk will focus on the use of digital health technologies(DHTs) to advance medical product development—from assessment to interventions in real-world settings. I will share learnings from clinical research studies to help inform the development of robust digital endpoints and interventions focusing on improving behavioral outcomes.

This presentation will share the NIH Framework for digital technologies' validation in clinical trials.