ABOUT THE EVENT

Join us for the second Digital Biomarker Summit USA, which will reconvene industry thought leaders on May 14, 2024, to share updates and new work within the digital health technology and digital biomarker space. 

This year's one-day event will discuss how the industry can work together on digital measurement and digital endpoints, share case studies on recent work on digital biomarkers in clinical trials, provide examples of how wearables play a role within AI, digital phenotyping and its impact on observational research, and spotlight updates on regulatory readiness to adopt these new ways of measuring endpoints.

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.



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.
2024 DIGITAL BIOMARKER SUMMIT USA AGENDA TOPICS
2024 SPEAKERS AND ADVISORS
Bari Kowal
Senior Vice President, Development Operations, Portfolio Management and Biostatistics Data Management
REGENERON
Tim McCarthy
Head of Biomeasures Endpoints and Study Technologies
PFIZER
Michelle Crouthamel
Head of Digital Science
ABBVIE
Bibi Bielekova
Chief, Neuroimmunological Diseases Section
NIH
Marissa Dockendorf
Executive Director, Digital Clinical Measures
MERCK
Rinol Alaj
Head of Digital Health Technologies
EVENT CHAIR
REGENERON
Dan Karlin
Chief Medical Officer
MINDMED
Olivier Harari
VP Clinical Genetic Medicines & Experimental Sciences
REGENERON
Basker Gummadi
Senior Director, Digital Biomarkers
GSK
Lukas Adamowicz
Senior Data Scientist
PFIZER
Jeremy Wyatt
Chief Executive Officer
ACTIGRAPH
Yiorgos Christakis
Senior Data Scientist
PFIZER
Adam Vogel
Professor of Speech Neuroscience
UNIVERSITY OF MELBOURNE
Matteo Lai
CEO
EMPATICA
Lada Leyens
Sr. Director, EUCAN Regulatory TA Head GI2
TAKEDA
Bryan Hansen
Director of Data Science & Digital Health, Neuroscience
JOHNSON & JOHNSON INNOVATIVE MEDICINES
Laureano Moro-Velazquez
Assistant Research Professor
JOHNS HOPKINS UNIVERSITY
Amir Lahav
Founder and CEO
Skymed Digital
Carrie Northcott
Head of Digital Sciences
PFIZER
David Suendermann-Oeft
Founder and CEO
MODALITY.AI
Purva Pandya
Sr. Director Regulatory Strategy, Digital
BAYER
Jie Shen
Director of Digital Health
ABBVIE
Martijn Niessen
CEO
MCROBERTS
Matthew Goodwin
Interdisciplinary Professor
NORTHEASTERN UNIVERSITY
Tarik Yardibi
Director, Digital Health Sciences
TAKEDA
Stephen Ruhmel
Clinical Strategy Lead for Digital Endpoints
SANOFI
Chris Benko
CEO
KONEKSA
Jacek Urbanek
Director, Biostatistics
REGENERON
Darrian Rice
Principal Biostatistician
REGENERON
Catherine Adans-Dester
Manager, Digital Biomarkers
REGENERON
Oren Levy
Medical Director, Clinical Sciences
REGENERON
Brian Winger
Associate VP, Digital Health R&D
ELI LILLY
Chris Leptak
EVP, Drugs and Biologics
GREENLEAF HEALTH
Sooyoon Shin
Clinical Science Lead, Digital Biomarkers
VERILY
2024 CONFERENCE AGENDA
9:00
Welcome and Opening Remarks

Bari Kowal, Senior Vice President, Development Operations, Portfolio Management and Biostatistics Data Management, Regeneron
9:05
KEYNOTE PRESENTATION

Vijay Govindarajan, Coxe Distinguished Professor, Tuck School of Business, Dartmouth
9:35
Developing Digital Biomarkers to Maximize their Clinical Utility

Bibi Bielekova, Chief, Neuroimmunological Diseases Section, NIH
9:55
Wearable Biosensing to Predict Imminent Aggressive Behavior in Psychiatric Inpatient Youths with Autism

Matthew Goodwin, Interdisciplinary Professor, Northeastern University
10:15
PANEL DISCUSSION: Biomarkers Go Digital - From Measurement to Digital Endpoint - How to Work Together on the Frontier of Clinical Discovery

Michelle Crouthamel, Head of Digital Health, AbbVie
Dan KarlinChief Medical Officer, MindMed
Olivier Harari, Vice President, Clinical Genetic Medicines and Experimental Sciences, Regeneron
Tim McCarthy, Head of Biomeasures Endpoints and Study Technologies, Pfizer

Moderated by Rinol AlajHead of Digital Health Technologies, Regeneron
10:40
NETWORKING BREAK
11:10
DHTs in Chronic Pain Studies: Collaborative Development between Eli Lilly and Empatica

Matteo Lai, CEO, Empatica
Brian Winger, Associate VP, Digital Health R&D, Eli Lilly
11:30
Enabling Efficient, Large-Scale Cloud-Based Processing of Unstructured Clinical Trial Data

Yiorgos Christakis, Senior Data Scientist, Pfizer

Lukas Adamowicz, Senior Data Scientist, Pfizer
11:50
Speech as a Fit for Purpose Clinical Outcome Assessment: Parkinson’s Disease and ALS

Adam Vogel, Professor of Speech Neuroscience, University of Melbourne
12:10
PANEL DISCUSSION: Implementing Digital Biomarkers in Clinical Trials

Marissa Dockendorf, Executive Director, Digital Clinical Measures, Merck
Bryan Hansen, Director of Data Science and Digital Health, Neuroscience, Johnson & Johnson Innovative Medicines
Basker Gummadi, Senior Director, Digital Biomarkers, GSK
Oren Levy, Medical Director, Clinical Sciences, Regeneron

Moderated by Chris Benko, CEO, Koneksa
12:35
LUNCH AND NETWORKING
1:30
Digital Biomarker Development to Characterize Hemodynamic Response to Postural Changes

Catherine Adans-Dester, Manager, Digital Biomarkers, Regeneron
Darrian Rice, Principal Biostatistician, Regeneron
1:50
Mobilise-D: Connecting Digital Mobility Assessment to Clinical Outcomes for Regulatory & Clinical Endorsement

Martijn Niessen, CEO, McRoberts
2:10
Towards Digital Phenotyping for Patients with Immunological Diseases

Jie Shen, Director, Digital Science, AbbVie
2:30
PANEL DISCUSSION: Future Beyond Digital Endpoints - Examples of how Wearables play a role within AI, Digital Phenotyping, and the Future of Observational Research

David Suendermann-Oeft, Founder and CEO, Modality.AI
Stephen Ruhmel, Clinical Strategy Lead for Digital Endpoints, Sanofi
Jacek Urbanek, Director, Biostatistics, Regeneron
Adam Vogel, Professor of Speech Neuroscience, University of Melbourne

Moderated by Amir Lahav, Founder and CEO, SkyMed Digital
2:55
NETWORKING BREAK
3:30
From Bellerophon to Beyond: ActiGraph's Journey in Digital Endpoints and Regulatory Advancement

Jeremy Wyatt, CEO, ActiGraph
3:50
Usage of Digital Devices to Quantify Nocturnal Scratch and Beyond in Clinical Trials

Tarik Yardibi, Director, Digital Health Sciences, Takeda
4:10
Demystifying Regulatory Acceptance of Digitally Derived Endpoints: Learnings from a Pilot with EMA

Lada Leyens, Director and Member of the Board, DEEP Measures
Carrie Northcott, Head of Digital Sciences, Pfizer
4:30
CONCLUDING PANEL DISCUSSION:
Regulatory Readiness

Purva Pandya, Senior Director, Global Regulatory Strategy Digital, Bayer
Sooyoon Shin, Clinical Science Lead, Digital Biomarkers, Verily
Laureano Moro-Velazquez, Assistant Research Professor, Johns Hopkins University
Lada Leyens, EUCAN Regulatory TA Head GI2, Takeda

Moderated by Chris Leptak, Executive Vice President, Drug & Biological Products, Greenleaf Health
5:00
NETWORKING SESSION

2023 CONFERENCE PHOTOS
Location
Hosted at Regeneron
785 Old Saw Mill River Rd
Tarrytown, NY 10591
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Summit USA
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