Defining, Designing and Deploying Digital Biomarkers in Clinical Trials

Many drug development sponsors are interested in understanding how a digital biomarker strategy can improve patient-centricity their trial. However, may feel uncertain about where – and sometimes even why – to start. From concerns surrounding regulatory acceptance to defining digital endpoints and deployment plans and digital data collection, there are many factors to consider before incorporating new tools and processes into a clinical trial.

This educational webinar is ideal for drug development sponsors that want to learn about the role of digital biomarkers in clinical trials and hear from several thought leaders as they discuss the key concerns with digital biomarker technologies, their implementation and regulatory acceptance. With a focus on strategic design and considerations for creating digital endpoints as part of an overarching deployment plan, the presenters will also cover many of the key pillars in the adoption and implementation of digital devices in a today’s “new normal” with decentralized or hybrid clinical trial elements.

Register today to be a part of this timely and highly relevant discussion that will also offer attendees a chance to pose their own questions and get real-time responses from several thought leaders.

Speakers

Jennifer Goldsack, MChem, MA, MBA, Executive Director, Digital Medicine Society (DiMe)

Jen Goldsack co-founded and serves as the Executive Director of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Goldsack’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine. Goldsack holds a master’s degree in chemistry from the University of Oxford, England, a masters in the history and sociology of medicine from the University of Pennsylvania, and an MBA from the George Washington University.

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Christian Knaus, Senior Director, Client Development, SnapIoT Inc.

Christian Knaus has worked globally in clinical trials since 2006. At what was then known as VIASYS Clinical Research (now ERT), he accrued his first acumen in the respiratory field as a project manager producing spirometry solutions as well as ePRO devices with PEF-Meters for clinicians as well as patient home-monitoring and adding cardiac safety and all things eCOA to his experience portfolio over the years. Since 2016, Knaus has spearheaded the path toward paperless clinical trials including eCOA solutions, BYOD solutions and wearables. In his role at ICON, he was at the forefront of the SaaS movement for clinical app development where he was instrumental in building an industry-leading eCOA team of Project Managers that spans the US, UK and Germany.

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Cristina Green, Executive Director, Decentralized Clinical Trials, Covance

Cristina Green is a clinical trial executive with over 23 years of experience in drug development at Covance. Over the course of her career, Green has overseen trials and led teams across data management, project management and clinical operations. She joined the decentralized clinical team in 2017 after leading the clinical operations function for North America for 4.5 years and then Latin America for 2 years. In her current role, Green works closely with sponsors on their strategic plans for decentralized clinical trials across their portfolio of studies.

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Jane Myles , Director, Decentralized Trials Implementation, Covance

Jane Myles is a clinical operations expert and clinical trials innovator, with a background as a pharmacologist and toxicologist. She has extensive experience working globally across late stage portfolios and helps drive innovation into the design and execution of trials to get medicines to patients faster and to decrease the burden on patients and sites. She has worked directly with pharmaceutical companies in global trial management roles and as an operational program leader. Myles contributed to the development and approval of many life-changing medications including Rituxan, Tarceva and Gazyva.

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