8th Annual
Digital Biomarkers
in Clinical Trials
Summit
Digital Biomarkers
in Clinical Trials
Summit
25 JUNE 2025 | BASEL | ROCHE BUILDING 1
A PRECOMPETITIVE CONSORTIUM OF EXPERTS WORKING TO LEVERAGE DIGITAL BIOMARKERS AS ENDPOINTS TO DRIVE THE ACCELERATION OF DRUG DEVELOPMENT
PRESENTED BY
A PRECOMPETITIVE CONSORTIUM OF EXPERTS WORKING TO LEVERAGE DIGITAL BIOMARKERS AS ENDPOINTS TO DRIVE THE ACCELERATION OF DRUG DEVELOPMENT
"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
Now in its eighth 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 (DHT) supplement existing biomarker strategies.
Join 40+ speakers and advisors, 300+ senior-level pharma, clinical trials, technology and digital health executives in-person on June 25, 2025 at Roche Headquarters in Basel to learn, network, develop and improve the way pharma clinical trials utilize mobile-enabled, wearables, and decentralized clinical trial 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, decentralized clinical trials & biomarkers strategies in clinical research. If you’re involved with R&D, sales & marketing, information technology, data management, patient recruitment, retention, adherence, artificial intelligence, digital health, digital biomarkers, decentralized trials, quantitative or translational medicine - this is the place to be.
Join 40+ speakers and advisors, 300+ senior-level pharma, clinical trials, technology and digital health executives in-person on June 25, 2025 at Roche Headquarters in Basel to learn, network, develop and improve the way pharma clinical trials utilize mobile-enabled, wearables, and decentralized clinical trial 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, decentralized clinical trials & biomarkers strategies in clinical research. If you’re involved with R&D, sales & marketing, information technology, data management, patient recruitment, retention, adherence, artificial intelligence, digital health, digital biomarkers, decentralized trials, quantitative or translational medicine - this is the place to be.
Location
ROCHE BUILDING 1
BASEL, SWITZERLAND
BASEL, SWITZERLAND
Date & Time
25 June 2025, 08:00 - 18:30 Basel Time (GMT+2)
IN PARTNERSHIP WITH
2025 AGENDA RELEASED!
LATEST DEVELOPMENTS IN
DIGITAL BIOMARKERS
DIGITAL BIOMARKERS
1. Digital Biomarkers in Obesity / Cardiovascular
Beyond the more established field of measuring activity levels and other symptoms with DHTs, what additional measurement approaches are being explored within obesity and cardiovascular?
2. Digital Biomarkers in Neuroscience
Showcasing the biggest impacts Digital Biomarkers have had in Neuroscience clinical development today
3. Digital Biomarkers in Women's Health
Exploring burgeoning opportunities for leveraging Digital Measures to uncover insights in Women's Health
4. Digital Biomarkers in Immunology and Immunotherapy
What Digital Biomarker use cases are actively being explored in immunology and immunotherapy? What are the major advances in monitoring safety?
5. Measuring what Matters to Patients and Regulatory Path Forward
Are there differences between what can technically be measured and what patients would like us to measure?
What can be done to accelerate Digital Endpoint development?
What role can partnerships between patients, Digital Health Technology (DHT) vendors, clinical trial sites & biopharmaceutical companies play?
What are the challenges within the current regulatory landscape, and how can these be addressed?
2025 Speakers and Advisors
Geoffrey Kerchner
Vice President, Global Head of Neurodegeneration
Vice President, Global Head of Neurodegeneration
ROCHE
Diane Stephenson
Vice President, Neurology
Vice President, Neurology
CRITICAL PATH INSTITUTE
Meri Kay Scott
Associate VP, Digital Health
Associate VP, Digital Health
ELI LILLY AND COMPANY
Christian Gossens
Chapter Lead, Digital Biomarkers
Chapter Lead, Digital Biomarkers
ROCHE
Nikolay Manyakov
Sr. Director, Data Science
Sr. Director, Data Science
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Thanneer Malai Perumal
Digital Biomarker Technology Lead
Digital Biomarker Technology Lead
ROCHE
Sarah Ernst
Head of Clinical Innovation Strategy and Implementation
Head of Clinical Innovation Strategy and Implementation
SANOFI
Timothy Kilchenmann
Patient Monitoring Value Stream Lead
Patient Monitoring Value Stream Lead
ROCHE
Bola Grace
Sr Director, Digital Biomarkers, Real World Data & Analytics
Sr Director, Digital Biomarkers, Real World Data & Analytics
GSK
Robert Hirten
Clinical Director, Hasso Plattner Institute for Digital Health
Clinical Director, Hasso Plattner Institute for Digital Health
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Arne Muller
AD, Senior Principal Data Scientist, Clinical Digital Endpoints
AD, Senior Principal Data Scientist, Clinical Digital Endpoints
NOVARTIS
Valentina Ticcinelli
Biosensors Lead
Biosensors Lead
UCB
Frédérique Guilbert
Clinical Strategy Lead for Digital Endpoint
Clinical Strategy Lead for Digital Endpoint
SANOFI
Jonas Dorn
Digital Biomarker Technology Lead
Digital Biomarker Technology Lead
ROCHE
Jane Wells
Global COA Lead
Global COA Lead
SANOFI
Rea Lehner
Digital Biomarker Science and Technology Lead
Digital Biomarker Science and Technology Lead
ROCHE
Charles Nduka
Clinician, NHS, Founder and Chief Scientific Officer
Clinician, NHS, Founder and Chief Scientific Officer
EMTEQ LABS
Matthew Wipperman
Associate Director, Digital Medicine
Associate Director, Digital Medicine
REGENERON
Matteo Lai
CEO
CEO
EMPATICA
Catherine Adans-Dester
Sr. Manager, Digital Biomarkers
Sr. Manager, Digital Biomarkers
REGENERON
Frank Kramer
Senior Director, Digital Health
Senior Director, Digital Health
BAYER
Scott Small
Sr Director, Transformational Prevention Unit Product Innovation Lab
Sr Director, Transformational Prevention Unit Product Innovation Lab
NOVO NORDISK
Stijn Rogiers
Head Data Integration and Standards
Head Data Integration and Standards
Argenx
Ieuan Clay
Director, Science
Director, Science
VIVOSENSE
Brian Murphy
Co-Founder & CSO
Co-Founder & CSO
CUMULUS NEUROSCIENCE
Dan Karlin
Chief Medical Officer
Chief Medical Officer
MINDMED
Ela Bingel-Erlenmeyer
Regulatory Program Lead, Integrated Solutions
Regulatory Program Lead, Integrated Solutions
ROCHE
Jeremy Wyatt
Chief Executive Officer
Chief Executive Officer
ACTIGRAPH
Jessica Braid
Head of Digital Innovation, PCOR
Head of Digital Innovation, PCOR
ROCHE
Catherine Hjelmeset
Lupus Europe Patient Advisory Network
Lada Leyens
EUCAN Regulatory TA Head GI and Inflammation
EUCAN Regulatory TA Head GI and Inflammation
TAKEDA
Cathelijne de Gram
EU Regulatory Policy Leader
EU Regulatory Policy Leader
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Michael Steinhauser-Mitter
Data Scientist
Data Scientist
MYSUGR
Pau Herrero
Algorithm & Decision Support Tech Lead
Algorithm & Decision Support Tech Lead
ROCHE DIAGNOSTICS
Nick Taptiklis
Head of R&D
Head of R&D
CAMBRIDGE COGNITION
Kate Lyden
Chief Science Officer
Chief Science Officer
VIVOSENSE
Salma Ajraoui
Principal, Digital Health Technology Practice
Principal, Digital Health Technology Practice
IQVIA
Marie McCarthy
Digital Endpoint Lead
Digital Endpoint Lead
NOVARTIS
Lorenza Angelini
Data Scientist, Digital Biomarker Data Insights
Data Scientist, Digital Biomarker Data Insights
ROCHE INFORMATION SOLUTIONS
Sara Pagnamenta
Digital Biomarker Biomedical Engineer
Digital Biomarker Biomedical Engineer
ROCHE
Andrew Zimmermann
Founder & CEO
Founder & CEO
BEHAVIOR DESIGN COLLECTIVE
Jonas Krauss
VP Business
VP Business
SLEEPIZ
2025 Conference Agenda
8:30
Welcoming Words & Introduction
Timothy Kilchenmann, Patient Monitoring Value Stream Lead, Roche (Conference Chair)
Christian Gossens, Chapter Lead, Digital Biomarkers, Roche Diagnostics
8:35
Opening Remarks from Roche
Geoffrey Kerchner, Vice President, Global Head of Neurodegeneration, Roche
Session 1
DIGITAL BIOMARKERS IN CARDIOVASCULAR / OBESITY
Showcasing the biggest impacts Digital Biomarkers have had on cardiovascular and obesity clinical development today
8:45
CASE STUDY: Digital Health Technologies Utilized in Chronic Weight Management Studies
Meri Kay Scott, Associate Vice President, Digital Health Research & Development, Eli Lilly & Company
9:05
CASE STUDY: A New Paradigm for Device Usability and Measures in Obesity Clinical Research
Matteo Lai, CEO, Empatica
9:25
CASE STUDY: Roche Continuous Glucose Monitoring: Algorithm Development, Approval and Use Cases in Clinical Trials
Pau Herrero, Algorithm and Decision Support Tech Lead, Roche Diagnostics
Michael Steinhauser-Mitter, Data Scientist, mySugr gmbh
9:45
CASE STUDY: Digital Measures in Orthostatic Disorders
Matthew Wipperman, Associate Director, Digital Medicine, Regeneron
Catherine Adans-Dester, Sr. Manager, Digital Biomarkers, Regeneron
10:05
PANEL DISCUSSION: Digital Biomarkers in Cardiovascular / Obesity Today
• Where does the industry stand currently on digital biomarkers and digital measures in cardiovascular / obesity?
• Beyond the more established field of measuring activity levels and other symptoms with DHTs, what additional measurement approaches are being explored within obesity and cardiovascular?
Meri Kay Scott, Associate Vice President, Digital Health Research & Development, Eli Lilly & Company
Christian Gossens, Chapter Lead, Digital Biomarkers, Roche Diagnostics
Charles Nduka, Clinician, NHS, Founder and Chief Scientific Officer, Emteq Labs
Scott Small, Senior Director, Transformational Prevention Unit Product Innovation Lab, Novo Nordisk
Moderated by Jonas Dorn, Digital Biomarker Technology Lead, Roche
10:30
NETWORKING BREAK AND POSTER VIEWING
Session 2
DIGITAL BIOMARKERS IN NEUROSCIENCE
Showcasing the biggest impacts Digital Biomarkers have had in Neuroscience clinical development today
11:00
CASE STUDY: Digital Biomarker Solution for Parkinson's Disease: From Validation to Application in Clinical Trials
Lorenza Angelini, Data Scientist, Digital Biomarker Data Insights, Roche Information Solutions
Sara Pagnamenta, Digital Biomarker Biomedical Engineer, Roche
11:20
CASE STUDY: Patient Engagement with Active Digital Assessments in the Real World
Nick Taptiklis, Head of R&D, Cambridge Cognition
11:40
Laying the Foundation for Digital Endpoints in Parkinson’s Clinical Trials: the Critical Path for Parkinson’s 3DT experience
Diane Stephenson, Vice President, Neurology, Critical Path Institute
12:00
PANEL DISCUSSION: Digital Biomarkers in Neuroscience Today
• A discussion around the biggest impacts Digital Biomarkers have had in Neuroscience clinical development today
• Progress and evolution of digital biomarkers as primary endpoints in clinical trials
Daniel Karlin, Chief Medical Officer, MindMed
Valentina Ticcinelli, Biosensors Lead, UCB
Brian Murphy, Co-Founder and CEO, Cumulus Neuroscience
Arne Müller, Associate Director, Sr. Principal Data Scientist, Clinical Digital Endpoints, Novartis
Moderated by Thanneer Malai Perumal, Digital Biomarker Technology & Science Leader, Roche
12:25
NETWORKING LUNCH
Session 3
DIGITAL BIOMARKERS IN WOMEN'S HEALTH
Exploring burgeoning opportunities for leveraging Digital Measures to uncover insights into Women's Health
13:20
CASE STUDY: Rethinking Sleep Endpoints in Menopause Drug Trials through DHTs
Frank Kramer, Senior Director, Digital Health & Real World Sciences, Bayer Pharma AG
Jonas Krauss, VP of Business, Sleepiz
Session 4
DIGITAL BIOMARKERS IN IMMUNOLOGY AND IMMUNOTHERAPY
What Digital Biomarker use cases are actively being explored in immunology, and immunotherapy? What are the major advances in monitoring patient safety?
13:35
CASE STUDY: Digital and Wearable Biomarkers of Inflammatory Disease Flare and Medication Response
Robert Hirten, Clinical Director, Hasso Plattner Institute for Digital Health, Icahn School of Medicine at Mount Sinai
13:55
CASE STUDY: Utilizing Digital Health Technologies to Transform Access to Safe and Effective Immunotherapy Treatments
Jeremy Wyatt, CEO, Actigraph
14:15
CASE STUDY: Validation of at-Home Video-Supervised eSpirometry to Enable Decentralized Clinical Trials
Frédérique Guilbert, Clinical Strategy Lead for Digital Endpoint, Sanofi
Jane Wells, Global COA Lead, Sanofi
14:35
PANEL DISCUSSION: Digital Biomarkers in Immunology, Immunotherapy and Women's Health
• What new and novel measurement approaches are being explored within Immunology?
• Are there first success stories? What have been the challenges? Are there differences between what can technically be measured and what patients would like us to measure?
• Where are current applications of the use of digital measures for women's health? Where are there further opportunities for investigation?
Sarah Ernst, Head of Clinical Innovation Strategy and Implementation, Sanofi
Bola Grace, Sr. Director, Digital Biomarkers, Real World Data & Analytics, GSK, Professor of Practice, UCL
Nikolay Manyakov, Sr. Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine
Salma Ajraoui, Principal, Digital Health Technology Practice, IQVIA
Moderated by Rea Lehner, Digital Biomarker Science and Technology Lead, Roche
• Are there first success stories? What have been the challenges? Are there differences between what can technically be measured and what patients would like us to measure?
• Where are current applications of the use of digital measures for women's health? Where are there further opportunities for investigation?
Sarah Ernst, Head of Clinical Innovation Strategy and Implementation, Sanofi
Bola Grace, Sr. Director, Digital Biomarkers, Real World Data & Analytics, GSK, Professor of Practice, UCL
Nikolay Manyakov, Sr. Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine
Salma Ajraoui, Principal, Digital Health Technology Practice, IQVIA
Moderated by Rea Lehner, Digital Biomarker Science and Technology Lead, Roche
15:00
NETWORKING BREAK AND POSTER VIEWING
Session 5
MEASURING WHAT MATTERS TO PATIENTS AND REGULATORY PATH FORWARD
Are there differences between what can technically be measured and what patients would like us to measure?
What can be done to accelerate Digital Endpoint development?
What role can partnerships between patients, Digital Health Technology (DHT) vendors, clinical trial sites & biopharmaceutical companies play?
What are the challenges within the current regulatory landscape, and how can these be addressed?
What can be done to accelerate Digital Endpoint development?
What role can partnerships between patients, Digital Health Technology (DHT) vendors, clinical trial sites & biopharmaceutical companies play?
What are the challenges within the current regulatory landscape, and how can these be addressed?
15:30
CASE STUDY: Unlocking the Value of Patient-Centered Digital Measures
Ieuan Clay, Director, Science, Vivosense
Stijn Rogiers, Head, Data Integration and Standards, Argenx
15:50
CASE STUDY: No Efficacy without Engagement - the Importance of Behavior Design during Early DHT Solution Development
Andrew Zimmermann, Founder and CEO, Behavior Design Collective
16:05
Patient Perspective on DHTs in Clinical Trials
Catherine Hjelmeset, Lupus Europe Patient Advisory Network
16:15
PANEL DISCUSSION: Measuring what Matters to Patients through Digital Endpoints
Andrew Zimmermann, Founder and CEO, Behavior Design Collective
Jane Wells, Global COA Lead, Sanofi
Kate Lyden, Chief Science Officer, Vivosense
Catherine Hjelmeset, Lupus Europe Patient Advisory Network
Moderated by Jessica Braid, Head of Digital Innovation, PCOR, Roche
16:40
CONCLUDING PANEL DISCUSSION: Outlook Moving Forward
• The value of digital endpoints from the perspective of different stakeholders
• Progress with shaping the ecosystem to optimise digital measures development and adoption in medicine development and registration
• Key takeaways and next steps from all stakeholders within the digital measures community
Diane Stephenson, Vice President, Neurology, Critical Path Institute
Lada Leyens, EUCAN Regulatory TA Head GI and Inflammation, Takeda
Cathelijne de Gram, EU Regulatory Policy Leader, Johnson & Johnson Innovative Medicine
Marie McCarthy, Digital Endpoint Lead, Novartis
Moderated by Ela Bingel-Erlenmeyer, Regulatory Program Lead - Integrated Solutions, Digital - Devices - Diagnostics, Roche
17:00 - 18:30
NETWORKING APÉRO
Sponsored by:
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Did you miss the Digital Biomarkers Summit?
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Digital Biomarkers Summit 2020
Teaser Video
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
Venue
Hosted in Partnership with Roche
Roche-Turm (Bau 1), Grenzacherstrasse 124, 4070 Basel, Switzerland
Roche-Turm (Bau 1), Grenzacherstrasse 124, 4070 Basel, Switzerland
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.
Hotel Room Block
Hyperion Hotel Basel
(4 Star Hotel) Hyperion Hotel Basel in Basel, Switzerland
Location: Messepl. 12, 4058 Basel, Switzerland
In Basel's tallest habitable building, the HYPERION Hotel Basel is next to the Basel Messe trade fair center and just a short walk from the Old Town. It offers a sauna and a fitness center. Each of the 224 non-smoking guest rooms offers panoramic views of the city, free WiFi, air conditioning, refreshing bath products, a safe, hair dryer, and flat-screen TV with Sky channels.
PanAgora Pharma has a conference room block at the Hyperion Hotel Basel - just 1km from Roche Building 1. To book your room at the preferred room block rate, please use this link: DBM Summit Room Block at Hyperion Hotel Basel
***The Room Block closes on 13 May 2025, so we encourage all attendees staying in Basel to please make your reservation before then.
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