"Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables or digestibles. The data collected is typically used to explain, influence and/or predict health-related outcomes. Digital biomarkers also represent an opportunity to capture clinically meaningful, objective data." Digital biomarkers journal
SAVE THE DATE - the 5th Annual Digital Biomarkers Summit will take place June 29, 2022 at Roche Building 1 in Basel!
Now in its fifth year hosted in partnership with Roche in Basel, the Digital Biomarkers in Clinical Trials Summit is the first and only global forum of its kind to focus on ways for pharma clinical trials to take advantage of new opportunities to collect better data and improve the patient experience; as well as how these new digital health tools supplement existing biomarker strategies.

Join 130+ speakers, 250+ senior-level pharma, clinical trials, technology and digital health executives virtually on June 29, 2022 at Roche Headquarters in Basel to learn, network, develop and improve the way pharma clinical trials utilize mobile-enabled, wearables, and IoT capabilities to improve existing biomarker strategies, improve patient experience and collect better data.

Global experts converge at the forefront of wearable sensor technology, data management, analytics, connected device & biomarkers strategies in clinical trials. If you’re involved with R&D, sales & marketing, information technology, data management, patient recruitment, retention, adherence, digital health, digital biomarkers, quantitative or translational medicine - this is the place to be.
Location
ROCHE BUILDING 1
BASEL, SWITZERLAND
Date & Time
29 June 2022, 10:00 - 17:00 Basel Time (GMT+2)
IN PARTNERSHIP WITH
2021 DIGITAL BIOMARKERS SUMMIT AGENDA TOPICS

OVERALL THEMES:

1. The State of Digital Biomarkers Today

Where does the industry stand currently?

2. Digital Biomarker Development Amidst the COVID-19 Pandemic


Challenges for ongoing Clinical Trials
Comparison between Site-based and De-Centralized Trials
Which features seem to be stable during the Pandemic?
Adherence Challenges & Successes in times of Quarantine
Impact of Regulatory Responses on the Clinical Trials
Missing clinical validation data - was the pandemic too early?


3. Digital Biomarkers Post-COVID

What will be different after the Pandemic?
What is holding us back from our Endpoints?
Has the Pandemic slowed down the use of Digital Biomarkers, or not?
What have we learned so far?
Cross Industry Collaboration - can Digital Biomarkers be like Vaccines?


2021 Speakers and Advisors
Christian Gossens
Global Head, Digital Biomarkers
ROCHE
Paulo Fontoura
SVP, Global Head Neuroscience, Immunology, Ophthalmology, Infectious & Rare Diseases Clinical Development
ROCHE
Ruth Schneider
Assistant Professor of Neurology
UNIVERSITY OF ROCHESTER CENTER FOR HEALTH & TECHNOLOGY
Jennifer Goldsack
Executive Director
DIGITAL MEDICINE SOCIETY (DiME)
Diane Stephenson
Executive Director, Critical Path for Parkinson's
 Critical Path Institute
 (C-Path)
Brian Tracey
Director, Statistics
TAKEDA
Steve Steinhubl
Chief Medical Officer
PHYSIQ
Arne Müller
Data Scientist, Digital Endpoints
NOVARTIS
Florian Lipsmeier
Digital Biomarker Data Analysis Team Lead
ROCHE
Jian Yang
Sr. Director, Digital Health
ELI LILLY & COMPANY
Kate Lyden
Chief Science Officer
Vivosense
Lauren Oliva
New Technologies Policy Lead, Director, Global Regulatory Policy
Biogen
Matt Biggs
VP of Applied Science
ACTIGRAPH
Larsson Omberg
VP, Systems Biology
SAGE BIONETWORKS
Fai Ng
Professor of Rheumatology
NEWCASTLE UNIVERSITY
Tom Switzer
Digital Health Scientist
GENENTECH
Mark Sapp
Product Line Owner, Digital Health
JANSSEN
2021 Conference Agenda
13:00 PM

Welcoming Words & Introduction

Chairperson: Christian Gossens, Global Head, Digital Biomarkers, Roche
13:10 PM

Opening Remarks from Roche

Paulo Fontoura, SVP, Global Head of Neuroscience, Immunology, Ophthalmology, Infectious and Rare Diseases Clinical Development, Roche
13:15 PM

KEYNOTE PANEL: The State of Digital Biomarkers Today



• Where does the industry stand currently?
• How impactful are Digital Biomarkers in the meanwhile for the pharmaceutical industry?
• Digital Biomarker development in times of a pandemic. Challenge or catalyst?
• Key insights when transforming clinically relevant symptoms into digitally measurable biomarkers
• Progress and evolution of pre-competitive collaborations

Paulo Fontoura, SVP, Global Head of Neuroscience, Immunology, Ophthalmology, Infectious and Rare Diseases Clinical Development, Roche
Jen Goldsack, Executive Director, Digital Medicine Society (DiMe)
Dr. Ruth Schneider, Assistant Professor of Neurology, Center for Health + Technology, University of Rochester 
Fai Ng, Professor of Rheumatology, Newcastle University

Led by: Christian Gossens, Global Head, Digital Biomarkers, Roche
13:30

MICRO BREAK
13:35

HIGHLIGHTS OF THE YEAR IN DIGITAL BIOMARKERS
13:35

CHeT CASE STUDY: The Future of Clinical Trials - Decentralized Studies & Digital Biomarkers

The traditional site-based, in-person research study is inaccessible to and burdensome for individuals with Parkinson’s disease, which is a neurodegenerative disease with no cure, and relies on scales that are administered in the clinic, often by trained personnel. Decentralized studies flip this paradigm, collecting data directly from participants in their homes. In AT-HOME PD, 226 participants from two phase 3 clinical trials are being followed longitudinally using video visits, online surveys, and smartphone-based assessments. Using the mPower smartphone application, participants complete a series of active motor tasks on a regular basis and can also enable passive data collection. With this study, we aim to identify new digital measures of disability and severity.

Dr. Ruth Schneider, Assistant Professor of Neurology, Center for Health + Technology, University of Rochester 
Larsson Omberg, VP, Sage Bionetworks
13:55

CASE STUDY: Adherence and Missing Clinical Validation Data in Time of the Pandemic

Florian Lipsmeier, Data Analysis Team Lead for Digital Biomarkers, Roche

14:15

BREAK


Sponsor: VivoSense
14:25

CASE STUDY: Novel Digital Biomarkers for Sleep

Brian Tracey, Director, Statistics, Takeda

14:45

CASE STUDY: Getting Wrist Actigraphy Fit (for Purpose) to Assess Sleep


A New Method to Overcome the Challenges of Disrupted Sleep in Clinical Populations


Kate Lyden, Chief Science Officer, VivoSense
15:05

MICRO BREAK


Sponsor: PhysIQ
15:05

DIGITAL BIOMARKERS POST-COVID
15:10

PANEL DISCUSSION: Scaling the Adoption of Digital Biomarkers Across the Enterprise

- The realizations within your organization that motivated a push to investing in digital infrastructure. For example, what are the challenges and limitations to a one-off, study-by-study approach? What’s been the impact on design, implementation, and downstream value extraction? Etc.
- In transitioning to a scalable approach, what are some of the key requirements you identified?
- Upon getting that infrastructure in place, how are you approaching driving adoption across the organization, particularly among those who are not experts in digital medicine?


Mark Sapp, Product Line Owner, Digital Health, Janssen

Tom Switzer, Digital Health Scientist, Genentech
Jian Yang, Sr. Director, Digital Health, Eli Lilly and Company


Led by: Dr. Steve Steinhubl, Chief Medical Officer, PhysIQ
15:30-15:35

MICRO BREAK


Sponsor: ActiGraph
15:35

CASE STUDY: Speech as a Clinical Endpoint in Friedreich’s Ataxia

Friedreich’s ataxia is an inherited, progressive, neurodegenerative disease that typically begins in childhood. Disease severity is commonly assessed with rating scales, such as the modified Friedreich’s Ataxia Rating Scale (mFASRS) including bulbar function and auxiliary tests such as the PATA speech test that is administered by the neurologist counting PATA syllables in a 10 seconds test. In this study we have explored different at-home self-administered digital endpoints in a pediatric Friedreich’s Ataxia population and aged matched controls including an automated version of the PATA test recorded remotely and analysed automatically. Bulbar function scoring in mFARS is discrete and has less resolution than the automated PATA test, participants with low bulbar scoring (normal function) already show lower syllable rates . Also, variability in syllable rates correlate with the total mFARS disease score as well as with activities of daily living scores (total ADL). Study participants found the speech test overall easy to use. However, the PATA test does not assess communication and verbal expression skills which should be addressed with specific speech test.

Arne Müller, Data Scientist, Digital Endpoints, Novartis

15:50

PANEL DISCUSSION: Outlook for Digital Biomarkers in the post-COVID-19 Environment

• Next steps for the digital biomarker community
• Discussion of partnerships, regulatory progress
• The pursuit of passive patient monitoring & improved protocol adherence

Diane Stephenson, Critical Path for Parkinson's, Critical Path Institute (C-Path)
Arne Müller, Data Scientist, Digital Endpoints, Novartis
Lauren Oliva, New Technologies Policy Lead, Director, Global Regulatory Policy, Biogen
Matt Biggs, VP of Applied Science, ActiGraph

Led by: Christian Gossens, Global Head, Digital Biomarkers, Roche


16:15

Concluding Overall Q&A Session

Christian Gossens, Global Head, Digital Biomarkers, Roche
Did you miss the Digital Biomarkers Summit 2021?
Sign up below for the complete video coverage and slide decks from each session of the conference.
Digital Biomarkers Summit 2020
Teaser Video
Interested in Sponsorship & Exhibition Opportunities?
2021 Conference Presentations
Paulo Fontoura
ROCHE
Paulo Fontoura, Christian Gossens, Jennifer Goldsack, Ruth Schneider, Fai Ng
Roche, DIME, Chet, Newcastle University
Ruth Schneider & Larsson Omberg
CHET & Sage Bionetworks
Florian Lipsmeier
ROCHE
Brian Tracey
Takeda
Kate Lyden
VIVOSENSE
Steve Steinhubl, Jian Yang, Mark Sapp, Tom Switzer
PHYSIQ, ELI LILLY & CO, JANSSEN & GENENTECH
Diane Stephenson, Arne Müller, Matt Biggs & Lauren Oliva
C-PATH, NOVARTIS, ACTIGRAPH & BIOGEN
2020 Conference Presentations
Christian Gossens
ROCHE
Keynote Panel
Roche, Abbvie, Chet, biogen
Ray Dorsey
CHET
Michelle Crouthamel
AbbVie
Kate Lyden & Jeremy Wyatt
Vivosense & ACtigraph
Sohini Chowdhury
MJFF
Nikhil Mahadevan & Yiorgos Christakis
pfizer
Matt Pipke
physiq
Kirsten Taylor, Florian Lipsmeier & Hannah Staunton
roche
Concluding Panel
Mjff, Novartis, roche, Pfizer & vivosense
2019 Conference Presentations
Bryn Roberts
ROCHE
Dan Karlin
HEALTHMODE
Timothy Kilchenmann
ROCHE
Valentin Hamy
GSK
Emilio Merlo Pich
TAKEDA
Ben Vandendriessche
BYTEFLIES
Peter Groenen
IDORSIA
Michelle Longmire
MEDABLE
Ieuan Clay
NOVARTIS
Valeria De Luca
Novartis
Sohini Chowdhury
Michael J FOx Foundation for Parkinson's Research
Arne Müller
NOVARTIS
Conference Highlights from the 2019 Digital Biomarkers Summit hosted at Roche
Conference Photo Gallery
Location
Hosted in Partnership with Roche
The office high-rise, Building 1, is a key pillar of Roche's site development strategy. With its straightforward yet unmistakable design, it blends in perfectly with the Roche grounds and the Basel cityscape. With 41 floors and workspace for around 2,000 employees, the office high-rise also shows a clear commitment to the Basel site.
 Join us at the Digital Biomarkers in Clinical Trials Summit 2022
Where the Industry Meets to Accelerate the Development of Digital Biomarkers

Processing Registration...