"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 7th Annual Digital Biomarkers Summit will take place June 26, 2024 at Roche Building 1 in Basel!
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, 250+ 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
Date & Time
26 June 2024, 08:45 - 19:00 Basel Time (GMT+2)
IN PARTNERSHIP WITH

2023 DIGITAL BIOMARKERS SUMMIT AGENDA TOPICS

2023 THEMES:

1. Digital Biomarkers in Clinical Trials Today

Showcasing the biggest impacts Digital Biomarkers have had on treatment efficacy measurement in clinical development today; are trial size and duration reductions in reach?

2. Frontiers In Digital Biomarkers: Measuring Novel Disease Domains


Beyond the more established field of measuring activity levels and motor symptoms with DHTs, what additional measurement approaches are being explored (e.g. speech, cognition, vital signs, weight, etc.)?
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. Frontiers In Digital Biomarkers: Upcoming Drug Development Use Cases beyond Efficacy Measurement

Beyond measuring efficacy, what Digital Biomarker use cases are actively being explored? What are the major advances in monitoring safety? What are the major advances in screening patients? What novel trial designs is the field seeking to enable?  

4. Accelerating Digital Biomarker Development and Adoption

What can be done to accelerate Digital Biomarker development?
What are the current challenges in the regulatory space and how can regulators support?
What are the challenges with consortium efforts and how can these be addressed?
What role can partnerships between vendors and Pharmaceutical companies play?


2023 Speakers and Advisors
Christian Gossens
Global Head, Digital Biomarkers
ROCHE
Gennaro Pagano
Expert Medical Director & Group Leader, Neuroscience and Rare Diseases
ROCHE
Doina Sirbu
Medical Device Innovation Lead
UCB
Jelena Curcic
Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics
NOVARTIS
Erin Robertson
Digital Biomarker Lead
REGENERON
Timothy Kilchenmann
Digital Biomarker Scientist
ROCHE
Christine Guo
Chief Scientific Officer
ACTIGRAPH
Shelby Bachman
Research Scientist
VIVOSENSE
Dan Karlin
Chief Medical Officer
MINDMED
Paul Strijbos
Neurotech Innovation Leader
ROCHE
Jonas Dorn
Digital Biomarker Technology Lead
ROCHE
 Sheraz Khan
Director Data Science
PFIZER
Valentina Ticcinelli
Biosensors Analytics Expert
UCB
Florian Lipsmeier
Digital Biomarker Data Analysis Team Lead
ROCHE
Damien Eggenspieler
Director of Healthcare
SYSNAV
Piper Fromy
ADRD Project Head
DIGITAL MEDICINE SOCIETY
Rana Zia Ur Rahman
Data Scientist in Digital Health
JANSSEN
Nikolay Manyakov
Sr. Director, Data Science
JANSSEN
Rinol Alaj
Head of Digital Health Technologies
REGENERON
Claudia Mazzà
Lead Data Scientist in Gait and Posture
BIOGEN
Lada Leyens
Global Regulatory Lead, Clinical Trial Innovation & Digital Health
ROCHE
Jennifer Sorinas Nerin
Data Scientist
NOVARTIS
Francesca Cormack
Chief Scientist
CAMBRIDGE COGNITION
Arne Müller
AD, Sr. Principal Data Scientist in Clinical Digital Endpoints
NOVARTIS
Basker Gummadi
Senior Director, Digital Biomarkers
GSK
Mireille Muller
Regulatory Strategy Executive Director
NOVARTIS
Kai Langel
Sr. Director, Global Regulatory Strategy & Intelligence
JANSSEN
Chris Chatham
Global Head of Innovation, Product Development Neuroscience
ROCHE
Antonio Del Santo
Principal Medical Director, Product Development Safety
ROCHE
Felix Kluge
Senior Data Scientist
NOVARTIS
Rolando Acosta
Principal Biostatistician
REGENERON
John Varaklis
Chief Strategy Officer
PHYSIQ
Cécile Ollivier
Managing Director Europe
C-PATH
Beatriz Rocha
VP/Head Global Regulatory Affairs and Product Development
FORTREA
Mark Matson
Managing Partner, Patient Cloud
MEDIDATA
Matteo Lai
CEO
EMPATICA
2023 Conference Agenda
8:45

Welcoming Words & Introduction

Christian Gossens, Global Area Head, Digital Biomarkers, pRED Data & Analytics, Roche
8:50

Opening Remarks from Roche

Gennaro Pagano, Expert Medical Director & Group Leader, Neuroscience and Rare Diseases, Roche Pharma Research and Early Development (pRED)
9:00

DIGITAL BIOMARKERS IN CLINICAL TRIALS TODAY

Showcasing the biggest impacts Digital Biomarkers have had on treatment efficacy measurement in clinical development today; are trial size and duration reductions in reach?
9:00

CASE STUDY: Measures of Physical Activity Approved as Primary Endpoint in Pivotal Cardiopulmonary Study

Christine Guo, Chief Scientific Officer, ActiGraph
9:20

CASE STUDY: Sample size and trial duration reductions in Parkinson's Disease and Huntington's Disease - the impact of DHTs

Florian Lipsmeier, Digital Biomarker Data Analysis Team Lead, Roche
Jonas Dorn, Digital Biomarker Technology Lead, Roche
9:40

CASE STUDY: The Latest in Digital Biomarkers in Neuroscience and Detecting Treatment Effects

Jelena Curcic, Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics, Novartis
10:00

KEYNOTE PANEL: Digital Biomarkers in Clinical Trials Today


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

Florian Lipsmeier, Group Leader, Digital Biomarkers Data Analysis, pRED Data & Analytics, Roche
Jelena Curcic, Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics, Novartis
Dan Karlin, Chief Medical Officer, MindMed
Claudia Mazzà, Lead Data Scientist in Gait and Posture, Biogen

Led by: Christian Gossens, Global Area Head, Digital Biomarkers, pRED Data & Analytics, Roche
10:25

NETWORKING BREAK
10:50

FRONTIERS IN DIGITAL BIOMARKERS: MEASURING NOVEL DISEASE DOMAINS

Beyond the more established field of measuring activity levels and motor symptoms with DHTs, what additional measurement approaches are being explored (e.g. speech, cognition, vital signs, weight, etc.)?
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?
10:50

CASE STUDY: Speech Complexity as a Traceable Sign of Cognitive Decline in early stages of Alzheimer's Disease

Jennifer Sorinas Nerin, Data Scientist, Novartis Institutes for BioMedical Research (NIBR)
11:10

CASE STUDY: Objective Measures of Physical Function and Fitness in Cancer Survivors

Shelby Bachman, Data Scientist, Vivosense
11:30

CASE STUDY: Nocturnal Scratch as a Digital Endpoint for Atopic Dermatitis, presenting the precompetitive collaboration work

Doina Sirbu, Medical Device Innovation Lead, UCB
11:50

CASE STUDY: Wearable Based Sleep Assessments in Daily Life

Rana Zia Ur Rehman, Data Science and Digital Health, Janssen
12:10

PANEL DISCUSSION: Frontiers in Digital Biomarkers - Measuring Novel Disease Domains

Basker Gummadi, Senior Director, Digital Biomarkers, GSK
Arne Müller, Sr. Principal Data Scientist, Clinical Digital Endpoints, Novartis
Doina Sirbu, Medical Device Innovation Lead, UCB
Matteo Lai, CEO, Empatica
Rana Zia Ur Rehman, Data Science and Digital Health, Janssen

Moderated by Chris Chatham, Global Head of Innovation, Product Development Neuroscience, Roche
12:35

NETWORKING LUNCH
13:30

FRONTIERS IN DIGITAL BIOMARKERS: UPCOMING DRUG DEVELOPMENT USE CASES BEYOND EFFICACY MEASUREMENT

Advances in patient screening, safety monitoring and other use cases
13:30

CASE STUDY: Acute Respiratory Illness Surveillance (AcRIS): Predicting Respiratory Illness from Voice Using AI/ML

Sheraz Khan, Director of Digital Medicine Data Science, Pfizer
13:40

CASE STUDY: Developing Auditory Science Biomarkers: Use of Digital Composite Covariates to Optimize Screening and Sample Size for Clinical Trials

Erin Robertson, Digital Biomarker Lead, Regeneron
Rolando Acosta, Principal Biostatistician, Regeneron
14:00

CASE STUDY: Beyond Efficacy: Clinical Interactions, Safety and Multimodel Measurement of Disease

Dan Karlin, Chief Medical Officer, MindMed
14:20

CASE STUDY: Digital Cognitive Measurement : Addressing Challenges in CNS Drug Development

Francesca Cormack, Chief Scientist, Cambridge Cognition
14:40

PANEL DISCUSSION: Frontiers in Digital Biomarkers - Upcoming Drug Development Use Cases beyond Efficacy Measurement

Advances in patient screening, safety monitoring and other use cases

Rinol Alaj, Head of Digital Health Technologies, Regeneron
Antonio Del Santo, Principal Medical Director, Product Development Safety, Roche
Nikolay Manyakov, Sr. Director, Data Science and Digital Health, Janssen
John Varaklis, Chief Strategy Officer, PhysIQ

Moderated by: Timothy Kilchenmann, Digital Biomarker Scientist, Roche
15:05

NETWORKING BREAK

Sponsored by: ActiGraph

15:30

ACCELERATING DIGITAL BIOMARKER DEVELOPMENT AND ADOPTION

Where can collaborations across the ecosystem of pharmaceutical companies, consortia, digital biomarker vendors and/or regulators be especially impactful for moving the field forwards?
15:30

CASE STUDY: Development of SV95C as a Regulatory-Qualified Digital Endpoint for use in Pivotal Trials

Paul Strijbos, Neurotech Innovation Leader, Roche
Damien Eggenspieler, Director of Healthcare, SYSNAV Navigational Technologies
15:45

CASE STUDY: Defining digital measures in ADRD: A public resource for researchers, device developers, payers and regulators

Piper Fromy, ADRD Project Head, Digital Medicine Society (DiMe)
16:00

CASE STUDY: Developing the At-home Six Minute Walk Test

Traditional functional measures like the six-minute walk test are commonly used despite the widely held perception that they are imperfect and subjective. Frequent and objective quantitation of patient functioning in real-world environments using medical-grade sensors offers an exciting new option while reducing patient burden. Medidata and Labcorp have joined forces to reinvent the most commonly used functional test in life science research. Speakers will outline the study objectives and approach, provide status, and preview some interim data from the ongoing project.

Mark Matson, Managing Partner, Patient Cloud, Medidata
Beatriz Rocha MD, PhD, VP/Head Global Regulatory Affairs and Product Development & Market Access Consulting, Fortrea
16:20

IMI IDEA-FAST: PARADE OF WORKSTREAMS
 
IMI Mobilise-D Real-world Digital Mobility Outcomes - a Comparison of Wrist vs. Lower Back worn Sensors
Felix Kluge, Senior Data Scientist, Novartis

IDEA-FAST Feasibility Study - Cognition Data: Coverage and Correlation with PROs
Valentina Ticcinelli, Biosensors Analytics Expert, UCB

16:40

PANEL DISCUSSION: Regulatory Outlook

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

Mireille Muller, Regulatory Strategy Executive Director, Novartis
Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen
Cécile Ollivier, Managing Director Europe, Critical Path Institute (C-Path)
Monique Al, Coordinating/special advisor at CCMO, Vice-chair CTCG

Moderated by Lada Leyens, Global Regulatory Lead, Clinical Trial Innovation & Digital Health, Roche


17:10 - 19:00

NETWORKING APÉRO


Did you miss the Digital Biomarkers Summit 2022?
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
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 2024
Where the Industry Meets to Accelerate the Development of Digital Biomarkers

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