Digital Biomarker Summit USA

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