ORGANIZED AND FUNDED BY REGENERON, AT REGENERON'S TARRYTOWN CAMPUS
SPONSORED BY SCIENCE, HOSTED BY REGENERON
OVERVIEW

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.
ABOUT THE EVENT

The Digital Biomarker Summit USA will convene industry thought leaders who will share work currently underway with DHTs and digital biomarkers with the goal to propel the industry forward through education and collaboration.

The one-day, invite-only event on May 10, 2023 will showcase examples across a variety of domains, including motor function/mobility, cognitive function, sensory function, and physiological measurement. Additionally, the Summit will demonstrate how design thinking methodologies play a key role in developing digital biomarkers and discuss regulatory guidance and frameworks to help the development and implementation of novel digital endpoints within clinical trials.
DIGITAL BIOMARKERS SUMMIT USA AGENDA TOPICS
SPEAKERS AND ADVISORS
Xuemei Cai
Head of Clinical Research, Digital Sciences
PFIZER
Lada Leyens
Global Regulatory Lead, Clinical Trial Innovation & Digital Health
ROCHE
Gary Herman
SVP, Early Clinical Development & Experimental Sciences
REGENERON
Michelle Crouthamel
Head of Digital Science
ABBVIE
Rinol Alaj
Head of Digital Health Technologies
EVENT CHAIR
REGENERON
Erin Robertson
Digital Biomarker Lead
REGENERON
Christine Guo
Chief Scientific Officer
ACTIGRAPH
Kong Chen
Co-Director of Metabolic Clinical Research Unit
NIH CLINICAL CENTER
Marissa Dockendorf
Executive Director, Global Digital Analytics & Technologies
MERCK
Brian Tracey
Director, Statistics
TAKEDA
Michael Kremliovsky
Sr. Director of Medical Devices & eHealth
BAYER
Roslyn Young-Daniels
President & Founder
BLACK HEALTH MATTERS
Olivier Harari
VP, Early Clinical Development
REGENERON
Michelle Shogren
CEO
INNOVATE IN WHAT YOU DO!
Rolando Acosta
Principal Biostatistician
REGENERON
Jennifer Schrack
Associate Professor of Epidemiology
Johns Hopkins University
Dina Katabi
Co-Founder
EMERALD INNOVATIONS
Matteo Lai
CEO
EMPATICA
Ian Lennox
Chairman of the Board
yPRIME
Jennifer Goldsack
CEO
Digital Medicine Society
Jacek Urbanek
Director, Biostatistics
REGENERON
Kate Lyden
Chief Science Officer
VIVOSENSE
Chris Benko
CEO
KONEKSA HEALTH
Patrick Floody
Executive Director, Global Clinical Trial Services
REGENERON
Ju Ji
Sr. Advisor, Advanced Analytics and Data Science
ELI LILLY & CO.
Jeremy Wyatt
CEO
ACTIGRAPH
Michelle Longmire
CEO
MEDABLE
Stefan Avey
Principal Scientist, Data Sciences
JANSSEN / IDEA FAST MEMBER
Peter Fernandes
CEO
BELLEROPHON
Chris Leptak
EVP, Drug & Biological Products
GREENLEAF HEALTH
Sooyoon Shin
Clinical Science Lead, Digital Biomarkers
VERILY
Yaël Bensoussan
Chief, Division of Laryngology
USF HEALTH VOICE CENTER
Chris Economos
VP, Head of Life Sciences
EKO
Amir Lahav
Digital Health Advisor
PHARMA AND MEDTECH
Purva Pandya
Sr. Director Regulatory Strategy, Digital
BAYER
Andreja Avbersek
Sr. Medical Director Clinical Sciences
REGENERON
Conference Agenda
8:30
Welcome and Opening Remarks
Gary Herman, SVP, Early Clinical Development & Experimental Sciences, Regeneron
8:40  
Keynote Speaker
Seth Godin
9:10
Digital Biomarkers and Drug Development:  A post-regulator's Perspective

Chris Leptak, EVP, Drug and Biological Products, Greenleaf Health
9:30
PANEL DISCUSSION: Regulatory Preparedness

Chris Leptak, EVP, Drug and Biological Products, Greenleaf Health
Jennifer Goldsack, CEO, Digital Medicine Society

Purva Pandya, Sr. Director Global Regulatory Strategy, Digital, Bayer
Kate Lyden, Chief Science Officer, Vivosense

Moderated by Lada Leyens, Global Regulatory Lead, Clinical Trial Innovation & Digital Health, 
Roche
10:00
NETWORKING BREAK
10:30
The Pfizer R&D Journey into Digital Biomarkers

Xuemei Cai, Head of Clinical Research, Digital Sciences, Pfizer
10:50
Novel Measures of Excessive Daytime Sleepiness

Brian Tracey, Director of Statistics, Takeda
11:10
Developing Auditory Science Biomarkers

Erin Robertson, Digital Biomarker Lead, Regeneron
Rolando Acosta
, Principal Biostatistician, Regeneron
11:30
Remote Detection and Monitoring of Hand-Foot Skin Reaction in Patients on Regorafenib Therapy

Michael Kremliovsky, Sr. Director of Medical Devices & eHealth, Bayer
11:50
PANEL DISCUSSION: Developing Digital Biomarkers

Olivier Harari, VP Early Clinical Development, Regeneron
Chris Benko
, CEO, Koneksa Health

Ju Ji, Sr. Advisor, Advanced Analytics and Data Science, Eli Lilly & Co.
Marissa Dockendorf, Executive Director, Global Digital Analytics & Technologies, Merck

Moderated by Rinol Alaj, Head of Digital Health Technologies, Regeneron
12:20
LUNCH AND NETWORKING
1:30
Innovate with Regulators to Leverage DHT Data as Patient-Centric Primary Endpoints

Christine Guo, Chief Scientific Officer, Actigraph
Peter Fernandes, CEO, Bellerophon Therapeutics
1:50
The Bridge2AI Voice Project- The power of large consortiums to fuel Voice AI research

Yaël Bensoussan, Chief, Division of Laryngology, USF Health Voice Center
2:10
Energy Expenditure as Digital Biomarkers of Energy Balance and Body Weight Regulation

Kong Chen, Co-Director of Metabolic Clinical Research Unit, NIH Clinical Center
2:30
Developing Cross-Disease Multicomponent Digital Biomarkers of Fatigue: IMI IDEA-FAST

Stefan Avey, Principal Scientist, Data Sciences, Janssen
2:50
HOW I BUILT THIS
A panel discussion with founders of successful digital health tech companies, diving into their stories and insights, success and failures and unexpected paths to success.

Jeremy Wyatt, CEO, Actigraph

Michelle Longmire, CEO, Medable
Matteo Lai, CEO, Empatica
Ian Lennox, Chairman of the Board, YPrime, Healthcare Tech and Services Investor

Moderated by Michelle Shogren, CEO,
 Innovate in What You Do! LLC
3:30
NETWORKING BREAK
4:00
Use of Wearables to Expand Diversity in Clinical Research

Sooyoon Shin, Clinical Science Lead, Digital Biomarkers, Verily
4:20
Emerald: A Clinical Trial Platform Powered by AI and Radio Waves

Dina Katabi, Co-Founder, Emerald Innovations
4:40
Physical Activity Monitoring in the National Health and Aging Trends Study (NHATS)

Jennifer Schrack, Associate Professor of Epidemiology, Johns Hopkins University 
PI of National Health and Aging Trends Study (NHATS)
5:00
CONCLUDING PANEL DISCUSSION:
FUTURE BEYOND DIGITAL ENDPOINTS

Amir Lahav, Digital Health Advisor for Pharma and Medtech
Chris Economos, VP and Head of Life Sciences, Eko

Roslyn Young-Daniels, President & Founder, Black Health Matters
Jacek Urbanek, Director, Biostatistics, Regeneron

Moderated by 
Michelle CrouthamelHead of Digital Science, AbbVie
5:30
NETWORKING SESSION - LIGHT DINNER TO BE PROVIDED

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