"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 supplement existing biomarker strategies.
Join 35+ speakers, 350+ 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 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.
Join 35+ speakers, 350+ 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 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
BASEL, SWITZERLAND
Date & Time
26 June 2024, 08:45 - 19:00 Basel Time (GMT+2)
IN PARTNERSHIP WITH
2024 PRELIMINARY 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 Biomarker Development & Adoption - Multi-Stakeholder Perspectives
What can be done to accelerate Digital Biomarker development?
What role can partnerships between patients, vendors, sites & Pharmaceutical companies play?
What are the challenges with consortium efforts and how can these be addressed?
What are the current challenges in the regulatory space and how can regulators support?
2024 Speakers and Advisors
Timothy Kilchenmann
Patient Monitoring Value Stream Lead
Patient Monitoring Value Stream Lead
ROCHE
Bryn Roberts
SVP, Global Head of Data & Analytics
SVP, Global Head of Data & Analytics
ROCHE
Vanessa Vallejo
Senior Clinical Scientist
Senior Clinical Scientist
NOVARTIS
Jelena Curcic
Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics
Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics
NOVARTIS
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
Julia Gómez Camblor
Product Manager, Digital Health & Artificial Intelligence
Product Manager, Digital Health & Artificial Intelligence
GENENTECH
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
Jonas Dorn
Digital Biomarker Technology Lead
Digital Biomarker Technology Lead
ROCHE
Cristina Duran
President / CEO
President / CEO
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
Rinol Alaj
Head of Digital Health Technologies
Head of Digital Health Technologies
REGENERON
Rana Zia Ur Rahman
Data Scientist in Digital Health
Data Scientist in Digital Health
JOHNSON & JOHNSON INNOVATIVE MEDICINE
Christine Guo
Chief Scientific Officer
Chief Scientific Officer
ACTIGRAPH
Chris Benko
CEO
CEO
KONEKSA HEALTH
Francesca Cormack
Chief Scientist
Chief Scientist
CAMBRIDGE COGNITION
Shelby Bachman
Research Scientist
Research Scientist
VIVOSENSE
Aude Clement
Regulatory Senior Program Director Personalised Healthcare
Regulatory Senior Program Director Personalised Healthcare
ROCHE
Tilo Hache
Director, Strategy and Planning Lead
Director, Strategy and Planning Lead
NOVARTIS
Sebastian Holst
Biomarker Experimental Medicine Leader
Biomarker Experimental Medicine Leader
ROCHE
Antonio Del Santo
Principal Medical Director, Product Development Safety
Principal Medical Director, Product Development Safety
ROCHE
2024 Conference Agenda
8:45
Welcoming Words & Introduction
Timothy Kilchenmann, Patient Monitoring Value Stream Lead, Roche
8:50
Opening Remarks from Roche
Speaker TBA
9:00
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 Variravan, Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine
9:20
CASE STUDY: Digital Cognitive Measurement : Addressing Challenges in CNS Drug Development
Francesca Cormack, Chief Scientist, Cambridge Cognition
9:40
CASE STUDY TBA
Speaker TBA, Roche
10:00
CASE STUDY: Evaluation of Digital Technologies for Home-based Assessment of People with ALS
Vanessa Vallejo, Senior Clinical Scientist, Novartis
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
Sebastian Holst, Biomarker Experimental Medicine Leader, Roche
Jelena Curcic, Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics, Novartis
Daniel Karlin, Chief Medical Officer, MindMed
Additional panelists TBA
Led by: Thanneer Malai Perumal, Digital Biomarker Technology & Science Leader, Roche
10:45
NETWORKING BREAK
11:10
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: Using a Wearable Patch to Develop a Digital Monitoring Biomarker of Inflammation in Response to LPS Challenge
Rana Zia Ur Rehman, Data Science in Digital Health, Johnson & Johnson Innovative Medicine
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: New Methods in Clinical Trials to Improve Patient Experience, Accelerate Timelines, and Improve Outcomes – the Use of Digital Health Technologies to reach these goals with Oncology Patients
Cristina Duran, President and CEO, Evinova
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
Additional panelists TBA
Moderated by David Nobbs, Digital Biomarker Technology & Science Lead, Roche
12:35
NETWORKING LUNCH
13:30
DIGITAL BIOMARKERS IN CARDIOVASCULAR, METABOLISM, IMMUNOLOGY AND OPHTHALMOLOGY
Beyond measuring efficacy, what Digital Biomarker use cases are actively being explored? What are the major advances in monitoring safety?
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 TBA
Speaker TBA, Novartis
14:40
PANEL DISCUSSION: Digital Biomarkers in Cardiovascular, Metabolism, Immunology and Ophthalmology
Beyond measuring efficacy, what Digital Biomarker use cases are actively being explored? What are the major advances in monitoring safety?
Rinol Alaj, Head of Digital Health Technologies, Regeneron
Julia Gómez Camblor, Product Manager, Digital Health and Artificial Intelligence, Genentech
Speaker TBA, Novartis
Moderated by: Jonas Dorn, Digital Biomarker Technology Lead, Roche
15:05
NETWORKING BREAK
Sponsored by: ActiGraph
15:30
DIGITAL ENDPOINT DEVELOPMENT AND ADOPTION - MULTI-STAKEHOLDER PERSPECTIVES
What can be done to accelerate Digital Biomarker development?
What role can partnerships between patients, vendors, sites & pharmaceutical companies play?
What are the challenges with consortium efforts and how can these be addressed?
What are the current challenges in the regulatory space and how can regulators support?
What role can partnerships between patients, vendors, sites & pharmaceutical companies play?
What are the challenges with consortium efforts and how can these be addressed?
What are the current challenges in the regulatory space and how can regulators support?
15:30
PATIENT PERSPECTIVE
Speaker TBA
15:50
CLINICAL TRIAL SITE / HCP PERSPECTIVE
Speaker TBA
16:05
CASE STUDY: The Digital Endpoint Collaboration to accelerate Outcome DEvelopment, (DECODE)
Christine Guo, Chief Scientific Officer, ActiGraph
16:25
CASE STUDY: Public-Private Partnerships : IMI-Mobilise D Lessons Learned
Tilo Hache, Director, Strategy and Planning Lead, Novartis Institutes for BioMedical Research (NIBR)
16:40
CASE STUDY: Regulatory Acceptance Pathways: EFPIA DEEP EMA Pilot
Speaker TBA
16:55
CONCLUDING PANEL DISCUSSION: Multistakeholder Perspectives and Outlook Moving Forward
• Next steps for all stakeholders within the digital biomarker community
• Discussion of partnerships, regulatory progress
• The pursuit of passive patient monitoring & improved protocol adherence
Christian Gossens, Digital Biomarker Chapter Lead, Roche Information Solutions, Roche Diagnostics
Peter Fernandes, Former CEO, Chief Regulatory, Safety and Quality Officer, Bellerophon Therapeutics
Mireille Muller, Regulatory Strategy Executive Director, Novartis
Moderated by Aude Clement, Regulatory Senior Program Director Personalised Healthcare, Roche
17:20 - 19:00
NETWORKING APÉRO
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Digital Biomarkers Summit 2020
Teaser Video
Teaser Video
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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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