ABOUT THE EVENT
Join us for the third Digital Biomarker Summit USA, which will bring industry thought leaders together on May 13, 2025, to share updates in the digital health technology and digital biomarker space.
This year's one-day event will discuss how the industry can continue to collaborate on digital measurement and digital endpoints, share case studies on recent work on digital biomarkers in clinical trials, a future beyond digital endpoints, and the importance of working with patients to determine which measures matter.
This year's one-day event will discuss how the industry can continue to collaborate on digital measurement and digital endpoints, share case studies on recent work on digital biomarkers in clinical trials, a future beyond digital endpoints, and the importance of working with patients to determine which measures matter.
BACKGROUND
Just a few decades ago, we relied on wristwatches to tell us the time. Today, a quick flick of the wrist can tell us so much more: our pulse, activity levels, sleep patterns; even our blood oxygen levels.
Digital Health Technologies (DHTs) such as smartwatches and other sensor technologies like fitness trackers, eyeglasses, shoe insoles, and other familiar objects we all carry or wear, are now more prevalent in society, transforming how people track and manage their own health data. And with the increase in the reliability and accessibility of DHTs, the healthcare industry is working to incorporate these technologies and revolutionize and resulting digital biomarkers into clinical studies.
Digital Health Technologies (DHTs) such as smartwatches and other sensor technologies like fitness trackers, eyeglasses, shoe insoles, and other familiar objects we all carry or wear, are now more prevalent in society, transforming how people track and manage their own health data. And with the increase in the reliability and accessibility of DHTs, the healthcare industry is working to incorporate these technologies and revolutionize and resulting digital biomarkers into clinical studies.
Unlike conventional endpoints, digital biomarkers measure physiological functions through noninvasive wearable sensors or digital health technologies. These sensors can provide objective and quantitative measurements of the pharmacologic effects of an investigational product, allowing us to better interpret patients’ treatment responses and physiological processes. Digital Biomarkers can also mean a more timely and accurate collection of clinical trial data often in real-time, real-world settings. Beyond that, digital biomarkers also provide opportunities to enhance the patient experience, potentially reducing the time patients need to visit the clinic.
While this influx of DHTs creates new and exciting opportunities for researchers, there are also challenges and considerations when working to successfully develop a scalable digital biomarkers framework. The entire approach – from experimental design, operations, data collection, and analysis – is vastly different than traditional in-clinic assessment resulting in the need to define procedures, roles, and the expertise required to properly draw inferences between the measurement and the observed biological or lifestyle construct of interest.
In 2023, Regeneron convened industry thought leaders at our headquarters in Tarrytown, NY for the inaugural Digital Biomarker Summit USA to share work currently underway with DHTs and digital biomarkers with the goal of propelling the industry forward through education and collaboration. The meeting showcased examples across a variety of domains, including motor function/mobility, cognitive function, sensory function, and physiological measurement, spotlighted how design thinking methodologies play a key role in developing digital biomarkers, and discussed regulatory guidance and frameworks to help the development and implementation of novel digital endpoints within clinical trials.
2025 DIGITAL BIOMARKER SUMMIT USA AGENDA TOPICS
2025 SPEAKERS AND ADVISORS
Bari Kowal
Senior Vice President, Development Operations, Portfolio Management and Biostatistics Data Management
Senior Vice President, Development Operations, Portfolio Management and Biostatistics Data Management
REGENERON
Carrie Northcott
Head of Digital Sciences
Head of Digital Sciences
PFIZER
Brian Winger
Associate VP, Digital Health Research & Development
Associate VP, Digital Health Research & Development
LILLY
Rinol Alaj
Head of Digital Health Technologies
EVENT CHAIR
Head of Digital Health Technologies
EVENT CHAIR
REGENERON
Gayle Wittenberg
VP Neuroscience Precision Measures
VP Neuroscience Precision Measures
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Marissa Dockendorf
Executive Director, Head of Digital Clinical Measures
Executive Director, Head of Digital Clinical Measures
MERCK
Jie Ren
Director, Data Science, Digital Clinical Measures
Director, Data Science, Digital Clinical Measures
MERCK
Larsson Omberg
EVP, Data Science
EVP, Data Science
KONEKSA
Sooyoon Shin
Senior Manager, Digital Biomarkers
Senior Manager, Digital Biomarkers
VERILY
Diana Rofail
Executive Director, Global Head, Patient-Centered Outcomes Research & Digital Health
Executive Director, Global Head, Patient-Centered Outcomes Research & Digital Health
REGENERON
Kevin Weinfurt
James B. Duke Distinguished Professor, Department of Population Health Sciences
James B. Duke Distinguished Professor, Department of Population Health Sciences
DUKE UNIVERSITY
Chad Gwaltney
President
President
GWALTNEY CONSULTING
Matthew Wipperman
Associate Director, Digital Medicine
Associate Director, Digital Medicine
REGENERON
Catherine Adans-Dester
Senior Manager, Digital Biomarkers
Senior Manager, Digital Biomarkers
REGENERON
Jie Shen
Director, Digital Science
Director, Digital Science
ABBVIE
Danielle Shiller
Medical Director
Medical Director
ABBVIE
Rolando Acosta
Manager, Biostatistics
Manager, Biostatistics
REGENERON
Shawn Mishra
Senior Digital Biomarker Lead
Senior Digital Biomarker Lead
REGENERON
2025 CONFERENCE AGENDA
9:00
Welcome and Opening Remarks
Bari Kowal, Senior Vice President, Development Operations, Portfolio Management and Biostatistics Data Management, Regeneron
9:10
KEYNOTE PRESENTATION
Chasing My Cure: Lessons from Biomarker-guided Precision Medicine
Chasing My Cure: Lessons from Biomarker-guided Precision Medicine
David Fajgenbaum, MD, MBA, MSc
Co-Founder & President, Every Cure
National Bestselling Author, Chasing My Cure
Physician-Scientist, University of Pennsylvania
9:35
Movement Matters: Physical Activity in Patients with Cachexia and Cancer
Carrie Northcott, Head of Digital Sciences, Pfizer
9:55
Harnessing Digital Biomarkers and Data Science: Paving the Way for Accelerated Drug Development in Parkinson’s Disease
Marissa Dockendorf, Executive Director, Head of Digital Clinical Measures, Merck
Jie Ren, Director, Data Science, Digital Clinical Measures, Merck
10:15
AUDIENCE Q&A:
Biomarkers Go Digital - From Measurement to Digital Endpoint - How to Work Together on the Frontier of Clinical Discovery
Biomarkers Go Digital - From Measurement to Digital Endpoint - How to Work Together on the Frontier of Clinical Discovery
Carrie Northcott, Head of Digital Sciences, Pfizer
Marissa Dockendorf, Executive Director, Head of Digital Clinical Measures, Merck
Jie Ren, Director, Data Science, Digital Clinical Measures, Merck
10:35
NETWORKING BREAK AND POSTER VIEWING
11:00
From Passive to Active Assessments: A Collaborative Approach to Clinical Validity of a Digital Neuroscience Toolkit for Early Parkinson’s Disease
Larsson Omberg, EVP Data Science, Koneksa
11:20
Measuring the Morning: At-home Assessment of Spinal Mobility in Axial Spondyloarthritis
Jie Shen, Director, Digital Science, AbbVie
Danielle Shiller, Medical Director, AbbVie
11:40
Utilization of Digital Measures in Chronic Weight Management
Brian Winger, Associate Vice President, Digital Health Research & Development, Eli Lilly and Company
12:00
AUDIENCE Q&A:
Implementing Digital Biomarkers in Clinical Trials
Implementing Digital Biomarkers in Clinical Trials
Larsson Omberg, EVP Data Science, Koneksa
Brian Winger, Associate Vice President, Digital Health Research & Development, Eli Lilly and Company
Jie Shen, Director, Digital Science, AbbVie
Danielle Shiller, Medical Director, AbbVie
12:15
LUNCH AND NETWORKING
1:15
Beyond Diagnosis: Integrating Multi-Domain Measures for Precision Neuroscience
Gayle Wittenberg, VP Neuroscience Precision Medicine, Johnson & Johnson Innovative Medicine
1:35
Gait Assessment with Digital Health Technologies in Parkinson’s Disease with Levodopa Treatment
Shawn Mishra, Senior Digital Biomarker Lead, Regeneron
Rolando Acosta, Manager, Biostatistics, Regeneron
1:55
Digital Endpoints for Parkinson’s Disease Trials: Comprehensive Approach to Confirm Treatment Efficacy Signal on Motor Symptoms using Active and Passive Measures
Sooyoon Shin, Senior Manager, Digital Biomarkers, Verily
2:15
AUDIENCE Q&A:
Future Beyond Digital Endpoints - Examples of how Wearables play a role within AI, Digital Phenotyping, and the Future of Observational Research
Future Beyond Digital Endpoints - Examples of how Wearables play a role within AI, Digital Phenotyping, and the Future of Observational Research
Gayle Wittenberg, VP Neuroscience Precision Medicine, Johnson & Johnson Innovative Medicine
Sooyoon Shin, Senior Manager, Digital Biomarkers, Verily
Shawn Mishra, Senior Digital Biomarker Lead, Regeneron
Rolando Acosta, Manager, Biostatistics, Regeneron
2:30
NETWORKING BREAK AND POSTER VIEWING
3:00
Patient Experience and Measurement Science in the Era of Digital Biomarkers
Diana Rofail, Executive Director, Global Head, Patient-Centered Outcomes Research & Digital Health, Regeneron
3:20
Leveraging Sensor-based Functional Outcomes to Further Enhance our Understanding of the Patient Experience
Chad Gwaltney, President, Gwaltney Consulting
3:40
Establishing Patient-relevant Clinical Meaningfulness for an SBFO
Kevin Weinfurt, James B. Duke Distinguished Professor, Department of Population Health Sciences, Duke University
4:00
AUDIENCE Q&A:
Patient Perspective - Working with Patients to Determine Measures that Matter
Patient Perspective - Working with Patients to Determine Measures that Matter
Diana Rofail, Executive Director, Global Head, Patient-Centered Outcomes Research & Digital Health, Regeneron
Chad Gwaltney, President, Gwaltney Consulting
Kevin Weinfurt, Vice Chair of Faculty, Department of Population Health Sciences, Duke University
4:20
CONCLUDING REMARKS
4:30
NETWORKING RECEPTION AND POSTER VIEWING
2025 Scientific Poster Presentations
Nocturnal Scratch in Atopic Dermatitis: Advancements in Digital Measurement and Regulatory Qualification
Presenter:
Jacqueline Thong, DEEP Measures
Cough & Lung Sounds as Digital Biomarkers: Early Detection and Monitoring of Cardiorespiratory Status Using a Novel Wearable Stethoscope
Presenter:
Nick Delmonico, Strados Labs
Multivariate Machine Learning Based Predictions of Parkinson’s Disease Severity using Remote Sensor-Based Assessments
Presenter:
David Anderson, Clinical ink
Operationalizing Wearables for Home-Based Health Monitoring
Presenter:
Wessam Sonbol, Delve Health
Beyond severity: Objective evaluation of the functional impact of tremor on quality of life
Presenter:
Rabie Fadil, Great Lakes Neurotechnologies
Objective, audio-based monitoring of retching and expulsion events is feasible in patients with GP
Presenter:
Yishu Gong, Takeda
Automatic Intelligibility Rating in Parkinson’s Disease: A Multilingual Approach
Presenter:
Nicklas Linz, ki:elements
Concurrent Cognitive Impairment and Amyloid-Beta PET Status Estimation with Additive Ensemble Machine Learning
Presenter:
Ali Jannati, Linus Health
Acoustic Analysis-based Machine Learning Approaches to Screening for Aspiration Risk in Older Adults with Swallowing Dysfunction
Presenter:
Anaïs Rameau, NYU
Linking p-tau217 in an at-risk population to objective markers of speech and language
Presenter:
Adam Vogel, Redenlab
Digital Endpoints in Pharmaceutical Clinical Trials: Key Trends and Insights
Presenter:
Caprice Sassano, ICON
Computer Vision based Assessment of Limb Motor Function in ALS using Remote Monitoring of Activities of Daily Living
Presenter:
David Suendermann-Oeft, Modality.AI
CoughSync : a Stanford University CS342 collaboration with Regeneron Development Innovation
Presenters:
Miguel Angel Fuentes Hernandez, Stanford University
Vishnu Ravi, Stanford Mussallem Center for Biodesign, Stanford University
Henry Wei, Regeneron
Validation of Shoebox PureTest audiometry
Presenters:
Rolando Acosta, Regeneron
Erin Robertson, Regeneron
Influence of wearable cardiac monitor positioning on heart rate and posture measurements.
Presenter:
Catherine Adans-Dester, Regeneron
Presenter:
Jacqueline Thong, DEEP Measures
Cough & Lung Sounds as Digital Biomarkers: Early Detection and Monitoring of Cardiorespiratory Status Using a Novel Wearable Stethoscope
Presenter:
Nick Delmonico, Strados Labs
Multivariate Machine Learning Based Predictions of Parkinson’s Disease Severity using Remote Sensor-Based Assessments
Presenter:
David Anderson, Clinical ink
Operationalizing Wearables for Home-Based Health Monitoring
Presenter:
Wessam Sonbol, Delve Health
Beyond severity: Objective evaluation of the functional impact of tremor on quality of life
Presenter:
Rabie Fadil, Great Lakes Neurotechnologies
Objective, audio-based monitoring of retching and expulsion events is feasible in patients with GP
Presenter:
Yishu Gong, Takeda
Automatic Intelligibility Rating in Parkinson’s Disease: A Multilingual Approach
Presenter:
Nicklas Linz, ki:elements
Concurrent Cognitive Impairment and Amyloid-Beta PET Status Estimation with Additive Ensemble Machine Learning
Presenter:
Ali Jannati, Linus Health
Acoustic Analysis-based Machine Learning Approaches to Screening for Aspiration Risk in Older Adults with Swallowing Dysfunction
Presenter:
Anaïs Rameau, NYU
Linking p-tau217 in an at-risk population to objective markers of speech and language
Presenter:
Adam Vogel, Redenlab
Digital Endpoints in Pharmaceutical Clinical Trials: Key Trends and Insights
Presenter:
Caprice Sassano, ICON
Computer Vision based Assessment of Limb Motor Function in ALS using Remote Monitoring of Activities of Daily Living
Presenter:
David Suendermann-Oeft, Modality.AI
CoughSync : a Stanford University CS342 collaboration with Regeneron Development Innovation
Presenters:
Miguel Angel Fuentes Hernandez, Stanford University
Vishnu Ravi, Stanford Mussallem Center for Biodesign, Stanford University
Henry Wei, Regeneron
Validation of Shoebox PureTest audiometry
Presenters:
Rolando Acosta, Regeneron
Erin Robertson, Regeneron
Influence of wearable cardiac monitor positioning on heart rate and posture measurements.
Presenter:
Catherine Adans-Dester, Regeneron
CONFERENCE PHOTOS
Location
Hosted at Regeneron
785 Old Saw Mill River Rd
Tarrytown, NY 10591
Tarrytown, NY 10591
Join us at Digital Biomarkers
Summit USA
Summit USA
If you're interested in joining us, kindly submit your expression of interest below. We will be in touch soon!
Click the link below, and you will be redirected to enter the event password. From there, you will be able to access registration.
© 2025 PanAgora Pharma, a division of PanAgora Conference Group, LLC. All Rights Reserved.