"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 seventh 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 26, 2024 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 26, 2024 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
26 June 2024, 08:00 - 18:30 Basel Time (GMT+2)
IN PARTNERSHIP WITH
2024 AGENDA RELEASED!
DIGITAL BIOMARKERS: A VIEW ACROSS THERAPY AREAS
1. Digital Biomarkers in Neuroscience
Showcasing the biggest impacts Digital Biomarkers have had in Neuroscience clinical development today
2. Digital Biomarkers in Oncology
Beyond the more established field of measuring activity levels and motor symptoms with DHTs, what additional measurement approaches are being explored within Oncology?
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?
3. Digital Biomarkers in Immunology and Cardiovascular
Beyond measuring efficacy, what Digital Biomarker use cases are actively being explored? What are the major advances in monitoring safety?
4. Digital Endpoint Development & Adoption - Multi-Stakeholder Perspectives
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 with the current ecosystem and how can these be addressed?
How can regulators support the adoption of these novel tools/methodologies for medicine development and registration?
2024 Speakers and Advisors
Azad Bonni
SVP, Global Head of Neuroscience & Rare Disease
SVP, Global Head of Neuroscience & Rare Disease
ROCHE
Erkuden Goikoetxea
Medical Device Innovation Lead
Medical Device Innovation Lead
UCB
Vanessa Vallejo
Senior Clinical Scientist
Senior Clinical Scientist
NOVARTIS
Timothy Kilchenmann
Patient Monitoring Value Stream Lead
Patient Monitoring Value Stream Lead
ROCHE
Srinivasan Vairavan
Director, Digital Health Data Science
Director, Digital Health Data Science
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Christian Gossens
Chapter Lead, Digital Biomarkers
Chapter Lead, Digital Biomarkers
ROCHE DIAGNOSTICS
Sarah Ernst
Head of Clinical Innovation Strategy and Implementation
Head of Clinical Innovation Strategy and Implementation
SANOFI
Peter Fernandes
Former CEO, Chief Regulatory Officer
Former CEO, Chief Regulatory Officer
BELLEROPHON THERAPEUTICS
Daniel Karlin
Chief Medical Officer
Chief Medical Officer
MINDMED
Thanneer Malai Perumal
Digital Biomarker Technology Lead
Digital Biomarker Technology Lead
ROCHE
Julia Gómez Camblor
Product Manager, Digital Health & Artificial Intelligence
Product Manager, Digital Health & Artificial Intelligence
GENENTECH
Luis Garcia-Gancedo
Head of Digital Health Strategy, Oncology
Head of Digital Health Strategy, Oncology
EVINOVA
Mireille Muller
Regulatory Strategy Executive Director
Regulatory Strategy Executive Director
NOVARTIS
Nikolay Manyakov
Sr. Director, Data Science
Sr. Director, Data Science
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Sachin Shah
Digital Biomarker Lead
Digital Biomarker Lead
GSK
Rana Zia Ur Rehman
Data Scientist in Digital Health
Data Scientist in Digital Health
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Jeremy Wyatt
Chief Executive Officer
Chief Executive Officer
ACTIGRAPH
Jonas Dorn
Digital Biomarker Technology Lead
Digital Biomarker Technology Lead
ROCHE
Bill Simpson
Head of Clinical Science
Head of Clinical Science
CAMBRIDGE COGNITION
Shelby Bachman
Research Scientist
Research Scientist
VIVOSENSE
Aude Clement
Regulatory Senior Program Director
Regulatory Senior Program Director
ROCHE
Tilo Hache
Director, Strategy and Planning Lead
Director, Strategy and Planning Lead
NOVARTIS
Chris Benko
CEO
CEO
KONEKSA HEALTH
Kirsten Taylor
Biomarker and Experimental Medicine Leader
Biomarker and Experimental Medicine Leader
ROCHE
Richelle Flanagan
Co-Founder
Co-Founder
MYMOVESMATTER
David Nobbs
Digital Biomarker Technology & Science Lead
Digital Biomarker Technology & Science Lead
ROCHE
Matteo Lai
CEO
CEO
EMPATICA
Lars Masanneck
Clinician Scientist
Clinician Scientist
University of Düsseldorf
Brian Murphy
Co-Founder & CSO
Co-Founder & CSO
CUMULUS NEUROSCIENCE
William Johnston
Director, Digital Endpoint Lead
Director, Digital Endpoint Lead
NOVARTIS
Rinol Alaj
Head of Digital Health Technologies
Head of Digital Health Technologies
REGENERON
Lada Leyens
EUCAN Regulatory TA Head GI2
EUCAN Regulatory TA Head GI2
TAKEDA
Erin Robertson
Senior Manager, Digital Biomarkers
Senior Manager, Digital Biomarkers
REGENERON
Antonio Del Santo
Principal Medical Director, Product Development Safety
Principal Medical Director, Product Development Safety
ROCHE
Arne Müller
Assoc. Dir., Clinical Digital Endpoints
Assoc. Dir., Clinical Digital Endpoints
NOVARTIS
Jaydev Thakkar
Chief Operating Officer
Chief Operating Officer
BIOFOURMIS
Thorsten Vetter
Senior Scientific Officer, Scientific Evidence Generation Department
Senior Scientific Officer, Scientific Evidence Generation Department
EUROPEAN MEDICINES AGENCY (EMA)
Diane Stephenson
Executive Director
Executive Director
CRITICAL PATH (C-PATH)
Matthew Roché
Director, Outcomes Research
Director, Outcomes Research
CHDI FOUNDATION
Sebastian Holst
Biomarker Experimental Medicine Leader
Biomarker Experimental Medicine Leader
ROCHE
Andrea Pilotto
Assistant Professor
Assistant Professor
UNIVERSITY OF BRESCIA
Rachel Newsome
Product Manager
Product Manager
CAMBRIDGE COGNITION
2024 Conference Agenda
8:45
Welcoming Words & Introduction
Timothy Kilchenmann, Patient Monitoring Value Stream Lead, Roche
8:50
Opening Remarks from Roche
Azad Bonni, SVP, Global Head of Neuroscience and Rare Disease, Roche
Session 1
DIGITAL BIOMARKERS IN NEUROSCIENCE
Showcasing the biggest impacts Digital Biomarkers have had on neuroscience clinical development today
9:00
CASE STUDY: Precision Psychiatry through Digital Phenotyping
Srinivasan Vairavan, Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine
9:20
CASE STUDY: Development and Validation of Speech Biomarkers for use in CNS Clinical Trials
Bill Simpson, Head of Clinical Science, Cambridge Cognition
Rachel Newsome, Product Manager, Cambridge Cognition
9:40
CASE STUDY: Evaluation of Digital Technologies for Home-based Assessment of People with ALS
Vanessa Vallejo, Senior Clinical Scientist, Novartis
Arne Müller, Assoc. Dir., Sr. Principal Data Scientist, Clinical Digital Endpoints, Novartis
10:00
CASE STUDY: Development of a Remote Cognitive DHT for Alzheimer's disease and beyond
Thanneer Malai Perumal, Digital Biomarker Technology & Science Leader, Roche
Kirsten Taylor, Biomarker and Experimental Medicine Leader, Group Leader, Neurocognitive, Digital and Clinical Computational Biomarkers, Roche
10:20
PANEL DISCUSSION: Digital Biomarkers in Neuroscience Today
• Where does the industry stand currently on digital biomarkers in neuroscience?
• Key insights when transforming clinically relevant symptoms into digitally measurable biomarkers in neuroscience
• Progress and evolution of digital biomarkers as primary endpoints in clinical trials
Thanneer Malai Perumal, Digital Biomarker Technology & Science Leader, Roche
Erkuden Goikoetxea, Medical Device Innovation Lead, UCB
Lars Masanneck, Clinician Scientist, University of Düsseldorf, Chairman, German Society of Digital Medicine
Brian Murphy, Co-Founder and CEO, Cumulus Neuroscience
Matthew Roché, Director, Outcomes Research, CHDI Foundation
Moderated by Daniel Karlin, Chief Medical Officer, MindMed
10:45
NETWORKING BREAK
Session 2
DIGITAL BIOMARKERS IN ONCOLOGY
Beyond the more established field of measuring activity levels and motor symptoms with DHTs, what additional measurement approaches are being explored within Oncology?
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?
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?
11:10
CASE STUDY: Evaluation of Digital Measurement Tools for Temperature Monitoring as a Digital Biomarker for CRS
Erin Robertson, Sr. Manager, Digital Biomarkers, Regeneron
11:30
CASE STUDY: Digital Measures of Physical Function in Oncology: Longitudinal, Multimodal Measurement in an Interventional Trial with the Sony mHealth Watch
Shelby Bachman, Data Scientist, Vivosense
11:50
CASE STUDY: Exploring the world of Physiology for Inflammation Monitoring
Rana Zia Ur Rehman, Data Science in Digital Health, Johnson & Johnson Innovative Medicine
12:10
PANEL DISCUSSION: Digital Biomarkers in Oncology
• Beyond the more established field of measuring activity levels and motor symptoms with DHTs, what additional measurement approaches are being explored within Oncology?
• 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?
Antonio Del Santo, Principal Medical Director, Product Development Safety, Roche
Nikolay Manyakov, Sr. Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine
Luis Garcia-Gancedo, Head of Digital Health Strategy, Oncology, Evinova
Jaydev Thakkar, Chief Operating Officer, Biofourmis
Moderated by David Nobbs, Digital Biomarker Technology & Science Lead, Roche
12:35
NETWORKING LUNCH
Session 3
DIGITAL BIOMARKERS IN CARDIOVASCULAR, METABOLISM, IMMUNOLOGY AND OPHTHALMOLOGY
Common themes across a diversity of therapy areas
13:30
CASE STUDY: Objective Digital Measures of Cough in Drug Development
Julia Gómez Camblor, Product Manager, Digital Health & Artificial Intelligence, Genentech
13:50
CASE STUDY: Patient Centric Prognostic Biomarker for Sickle Cell Disease
Chris Benko, CEO, Koneksa Health
14:10
CASE STUDY: Taking the plunge with Actigraphy in the US - Lessons Learned
Peter Fernandes, Former CEO, Chief Regulatory, Safety and Quality Officer, Bellerophon Therapeutics
14:25
CASE STUDY: Digital Endpoints of Physical Function in Knee Osteoarthritis Clinical Trials - How much Data is Enough?
William Johnston, Digital Endpoint Lead, Data, Design & Clinical Innovation Development, Novartis
14:40
PANEL DISCUSSION: Digital Biomarkers in Cardiovascular, Metabolism, Immunology and Ophthalmology
Common themes across a diversity of therapy areas
Julia Gómez Camblor, Product Manager, Digital Health and Artificial Intelligence, Genentech
Sarah Ernst, Head of Clinical Innovation Strategy and Implementation, Sanofi
Sachin Shah, Digital Biomarker Lead, GSK
Matteo Lai, CEO, Empatica
Moderated by Jonas Dorn, Digital Biomarker Technology Lead, Roche
Julia Gómez Camblor, Product Manager, Digital Health and Artificial Intelligence, Genentech
Sarah Ernst, Head of Clinical Innovation Strategy and Implementation, Sanofi
Sachin Shah, Digital Biomarker Lead, GSK
Matteo Lai, CEO, Empatica
Moderated by Jonas Dorn, Digital Biomarker Technology Lead, Roche
15:05
NETWORKING BREAK
Session 4
DIGITAL ENDPOINT DEVELOPMENT AND ADOPTION - MULTI-STAKEHOLDER PERSPECTIVES
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 with the current ecosystem and how can these be addressed?
How can regulators support the adoption of these novel tools/methodologies for medicine development and registration?
What role can partnerships between patients, Digital Health Technology (DHT) vendors, clinical trial sites & biopharmaceutical companies play?
What are the challenges with the current ecosystem and how can these be addressed?
How can regulators support the adoption of these novel tools/methodologies for medicine development and registration?
15:30
PATIENT PERSPECTIVE
Richelle Flanagan, Co-Founder, MyMovesMatter
15:50
CLINICIAN AND CLINICAL SITE PERSPECTIVE
Andrea Pilotto, Assistant Professor, University of Brescia
16:05
PUBLIC-PRIVATE PARTNERSHIPS: IMI-Mobilise D Lessons Learned
Tilo Hache, Director, Strategy and Planning Lead, Novartis Biomedical Research
16:20
TECH-PHARMA CONSORTIUM: The Digital Endpoint Collaboration to accelerate Outcome DEvelopment, (DECODE)
Jeremy Wyatt, Chief Executive Officer, ActiGraph
16:40
REGULATORY ACCEPTANCE: EFPIA DEEP EMA Pilot
Mireille Muller, Executive Director, Regulatory Strategy, Novartis
16:55
CONCLUDING PANEL DISCUSSION: Multistakeholder Perspectives and 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
Florian Lipsmeier, Digital Biomarker Data Insights Subchapter Lead, Roche
Peter Fernandes, Former CEO, Chief Regulatory, Safety and Quality Officer, Bellerophon Therapeutics
Lada Leyens, EUCAN Regulatory TA Head GI2, Takeda
Thorsten Vetter, Senior Scientific Officer, Scientific Evidence Generation Department, European Medicines Agency (EMA)
Diane Stephenson, Executive Director, Critical Path Institute (C-Path)
Moderated by Aude Clement, Regulatory Senior Program Director, Roche
17:20 - 18:30
NETWORKING APÉRO
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Digital Biomarkers Summit 2020
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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
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.
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