In early 2020 the Moderna Clinical Biomarker team began considering the need for an unprecedented requirement, building clinical grade immunological and functional assays to support a vaccine trial for a novel virus. Over the next year the assays that were rapidly developed by academic, government and commercial partners were used for all phases of clinical development and eventual BLA. This talk will focus on the challenges of those assay developments and their utilization in Moderna's COVID-19 vaccine.

Information has become the currency of our time. Information management and analytics are helping clinical teams advance insight-driven programs by helping to maximize information to deliver operational excellence, competitive agility, and overall efficiencies. Current clinical designs and complex biomarker-driven trials have pushed specimen management organizations to innovate old processes and tools to take advantage of advances in technology that can better manage data, improve intelligence, and shape strategies. 

Tumor tissue biopsies are critical biospecimens for endpoint and exploratory analysis in oncology trials. The collection difficulty, burden to patient, and inability of some sites to evaluate prior to submitting samples, results in tumor tissue quality and quantity variability. While tumor samples may "pass" the assay standards for IHC, they frequently fail assay requirements for genetic/genomic analysis resulting in a loss of data, time, and money. In an effort to better evaluate downstream testing success, BMS has created a Spotfire-based visualization of H&E pathology review fields and Pass/Fail rates of assays. Integrating this biospecimen metadata with result’s outcome and visualizing in Spotfire allows BMS to interrogate >100 studies across multiple programs and >2000 sites to identified trends which contribute to assays’ success and failure. This analysis provides a feedback-loop which improves collection instructions and site selection/training, highlights contribution of indication to assay success, and serves as a quality check prior to submitting samples for costly analysis.

The inclusion of China in global clinical trials brings unique challenges to the biospecimen/biomarker space due to requirements of the 2019 Regulations of Management of Human Genetic Resources (HGR) of the People’s Republic of China. This presentation will discuss the application process through the HGR Administration of China (HGRAC), including navigating data and intellectual property sharing as well as sample and data management activities, with emphasis on ensuring compliance and oversight of the process.

Multinational pharmaceutical companies conducting clinical trials in China have been facing new challenges in regulation, quality, and operations. These challenges include special requirements on biomarker assay and diagnostic development for China submission studies, variable levels of development experience and quality standards from vendors, and complexities of logistics to implement technology platforms supporting clinical trials. The presentation will discuss the learnings we have obtained in development of biomarker and diagnostic assays for China clinical studies.

China’s 2019 Human Genetic Resources Regulations regulate the collection, preservation, utilization, and provision to third parties including the export of Chinese human genetic resources.  The HGRAC  creates significant challenges to conducting clinical research in China.  This session will provide an over o the HGRAC regulation and implications to biospecimen and biomarker operations.   

This case study session demonstrates how Jounce Therapeutics used a platform approach and the elluminate Clinical Data Cloud to aggregate external sample inventories and clinical operational data from disparate sources. By integrating sample data and providing self-service visualization access, the Jounce team enabled real-time insights and greater efficiency via the automation of manual processes. Learn about the analytics and outcomes of this new approach to biomarker sample and patient data tracking. 

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

Despite the advanced technological world we are living in today, the reconciliation and tracking of clinical trial samples has remained a mostly manual task. Companies have built in-house systems, piloted external systems, or used a combination of different approaches, but no one has yet to completely master the automation of this process. We are looking at a new approach, one that may change a traditional clinical trial activity.

By linking biospecimen metadata, informed consent, and biomarker data across multiple LIMS and inventories, you can create an annotated virtual biorepository. Join our presentation to learn how cross-functional teams are using technology-enabled solutions on study, across studies, and across their entire portfolio, to:

• Address site performance, data quality, and query resolution
• Ensure regulatory compliance 
• Save resources using stored samples to advance research beyond current study

Why is the execution of biomarker clinical research so challenging? For a relatively straight forward trial, with qualifying patients readily available, the difficulty is in connecting study resources with the right patients, at the point of care, at the right time. We will examine EHR integration methodologies, risk stratification, similarity scoring, resource alerts, built-to-suit user-interface tools, and business models that deliver consistent results, that are 5-fold the typical enrollment expectations.