Creating Digital Biomarkers with Real-World and Existing Data

Life Sciences, Clinical Trials, Biomarkers, Healthcare, Digital Health,
  • Thursday, February 02, 2023

Digital health technologies have the potential to revolutionize medicine, shifting the focus from reactive treatment to proactive prevention of acute illness. Although many of these technologies have existed for up to 30 years, adoption has been slow. The primary reason is there are few accepted digital biomarkers that indicate whether a person is getting better or worse — let alone identify when an intervention is recommended.


Validating a digital biomarker can be a huge task. The biomarker must be shown to reliably measure every application in every population where it will be employed. Often thousands of people must be monitored over an extended period to validate a single digital biomarker for a single condition. But that is not the only challenge. Currently, most of the scientific work on this issue is conducted in highly tailored studies tying a specific biomarker to a specific condition in a specific population and often to the action of a specific therapeutic. As a result, the Digital Medicine Society’s Library of Digital Endpoints (aka biomarkers) now has more than 70 distinct measures of activity and 55 measures of sleep. Healthcare providers cannot be expected to apply dozens of different measures of essentially the same phenomenon. These need to be standardized. All together, these challenges may seem insuperable.

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The featured speakers believe these challenges can be overcome by leveraging real-world data and reusing existing data, so the benefits of digital medicine can finally be reaped. This webinar will cover:

  • What to look for in digital biomarkers
  • What it takes to validate a digital biomarker
  • Why real-world data are critical to this effort
  • A case study showing how to reuse existing data to validate an open-source digital biomarker
  • Key success factors to enable reuse of data
  • Regulatory and clinical decision-making factors
  • Patient privacy issues

Attendees looking to develop and/or validate digital biomarkers will find this webinar very informative. Register today to learn more about creating digital biomarkers with real-world and existing data.


Dr. Daniel R. Karlin, MindMed

Dr. Daniel R. Karlin, MD, MA, Chief Medical Officer, MindMed

Dr. Daniel R. Karlin joined MindMed as Chief Medical Officer in February 2021 following MindMed’s acquisition of HealthMode, the company he co-founded and led as CEO.

Prior to HealthMode, Dan built and led clinical, informatics and regulatory strategy for Pfizer’s Digital Medicine and Innovation Research Lab. He also served as Global Clinical Lead for psychiatry clinical compounds at Pfizer. He previously served as the Founder and Chief Medical Officer at Column Health, a leading technology-enabled psychiatry and addiction practice. He is a strategic advisor to several pharmaceutical, biotech and health technology companies. He is also a founding Advisor to the Digital Biomarkers Journal, Founder and Board Member, Digital Medicine Society (DiMe), and is on committee Leadership Digital Drug Development Tools at Critical Path Alzheimer’s Disease, MJFF and Mental Health IT at the APA.

Dan is board-certified in psychiatry, addiction medicine and clinical informatics. He is an Assistant Professor of Psychiatry at Tufts University School of Medicine. He graduated with degrees in neuroscience and behavior (BA), and clinical informatics (MA), Columbia University; Medicine (MD), University of Colorado School of Medicine.

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Dr. James Connolly, ATU Donegal, Atlantic Technical University, Co. Donegal, Ireland

Dr. James Connolly, Lecturer in Computing at Atlantic Technical University, Co. Donegal, Ireland

Dr. James Connolly is an experienced lecturer and researcher with a demonstrated history of working in the higher education industry. He is skilled in digital healthcare and connected health, big data analytics and artificial intelligence. Dr. Connolly is a strong education professional with a Doctor of Philosophy (PhD) focused on a combination of wearable technology and computing from Ulster University.

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Dr. William Crown, Brandeis, The Heller School for Social Policy and Management

Dr. William Crown, Distinguished Scientist at Brandeis, The Heller School for Social Policy and Management

Dr. William Crown is a Distinguished Research Scientist in the Heller School. He is an internationally recognized expert in real-world data analysis, focusing upon research designs and statistical methods for drawing causal inferences from transactional health care datasets such as medical claims and electronic health records. Bill began his career at the Heller School in the early 1980s focusing on the demography and health economics of aging and taught a series of statistics courses in the Heller PhD program. He left Brandeis in the mid-1990s to lead health economics consultancies at Truven and Optum. From 2013-2020, he was Chief Scientific Officer at OptumLabs where he provided methodological guidance on a portfolio of research projects with specific focus on causal inference in database studies, simulation of health care systems and application of operations research methods to health policy questions.

He received his doctorate degree in regional economic modeling from the Massachusetts Institute of Technology, and a Master of Arts in Economics from Boston University. He has an extensive record of empirical comparative effectiveness studies and methodological publications in clinical and health policy journals. Dr. Crown was the President of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) between 2013-14. He currently co-chairs the ISPOR Task Force on Machine Learning and is particularly interested in the intersection of machine learning and causal inference methods, as well as transparency in the conduct and reporting of empirical health care research.

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Geoff Gill, Verisense Health

(Moderator) Geoff Gill, President, Shimmer Research Inc.

Geoffrey Gill is the President of Shimmer Americas. He is the Founder of the Verisense Digital Health Panel, which is creating a large, longitudinal database of raw digital sensor data, patient-reported outcomes and real-world data. He is also a Co-Founder of the Open Wearables Initiative.

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Who Should Attend?

  • Large pharma companies (sponsors) running clinical trials
  • Mid-market biotech companies
  • Clinical research organisations
  • Medical and life science researchers
  • Those in the public or private sectors that have an interest in digital clinical trials and the digital clinical industry
  • Providers/payers/insurance companies
  • Regulators
  • KOLs

What You Will Learn

Attendees will gain insights into:

  • What to look for in a digital biomarker
  • What it takes to validate a digital biomarker
  • How to leverage real-world data and existing data to develop and validate digital biomarkers
  • Key success factors in reusing existing digital health data
  • What are some of the regulatory and clinical decision-making considerations
  • How to manage patient privacy issues

Xtalks Partner

Verisense Health

Verisense Health is a digital health software and data management company. The company is leveraging its Verisense wearable sensor platform and Verisense Digital Health Panel to create a digital biobank that researchers can use to conduct digital health research without needing to collect new patient data. The company is headquartered in Cambridge, MA with additional offices in Malaysia.

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