"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 20+ speakers, 250+ senior-level pharma, clinical trials, technology and digital health executives in-person 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
2022 DIGITAL BIOMARKERS SUMMIT AGENDA TOPICS

2022 THEME:
Detecting Treatment Effects with Digital Biomarkers

1. Detecting Treatment Effects with Digital Biomarkers

Examples of where dBM have successfully detected treatment effects and made a difference to drug development

2. Developing Digital Measures


Digital measurement validation and how they complement traditional measures
 Demonstrating Objectivity, Sensitivity (to change), Ecological Validity, Reliability

3. Pitfalls with Detecting Treatment Effects

Data Equivalence, Missing Data, Drop Outs, Technical Issues 

4. Outlook on Moving Digital Measurements to have an Impact on Drug Development

The state of the field today and the challenges and opportunities for using digital measures in regulatory filings in future


2022 Speakers and Advisors
Christian Gossens
Global Head, Digital Biomarkers
ROCHE
Scott Oloff
SVP, Data & Analytics
ROCHE
Thibaud Guymard
General Manager, Digital Measurement Solutions
BIOGEN
Jelena Curcic
Sr. Data Scientist, Biomarker Development, Digital Endpoint Analytics
NOVARTIS
Stephen Ruhmel
Associate Director, Clinical Innovation
 JANSSEN
Valeria De Luca
Associate Director, Senior Principal Data Scientist
NOVARTIS
Christine Guo
Chief Scientific Officer
ACTIGRAPH
Kate Lyden
Chief Science Officer
VIVOSENSE
Dan Karlin
Chief Medical Officer
MINDMED
Abhishek Pratap
Group Head, AI & Digital Health
CAMH
Jonas Dorn
Digital Biomarker Technology Lead
ROCHE
 Erkuden Goikoetxea
Medical Device Innovation Lead
UCB
Valentina Ticcinelli
Biosensors Analytics Expert
UCB
Florian Lipsmeier
Digital Biomarker Data Analysis Team Lead
ROCHE
Chris Edgar
Chief Scientific Officer
COGSTATE
Nicklas Linz
Chief Executive Officer
KI: EleMENTS
Timothy Kilchenmann
Digital Biomarker Scientist
ROCHE
Tracey Robertson
Head of Patient & Site Engagement Capability Management
BOEHRINGER INGELHEIM
Rinol Alaj
Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation
REGENERON
Kirsten Taylor
Biomarker & Experimental Medicine Leader
ROCHE
Lada Leyens
Global Regulatory Lead, Clinical Trial Innovation & Digital Health
ROCHE
Jennifer Sorinas Nerin
Discovery Postdoc
NOVARTIS
Mark Matson
Sr. Solutions Specialist, Sensor Cloud
MEDIDATA
Alexander Mion
Head of Division Clinical Trials
SWISSMEDIC
John Varaklis
Chief Strategy Officer
PHYSIQ
Alexis Mathieu
Co-founder and Sr. Advisor
FEETME
Seid Hamzic
Data Science Academy Fellow
NOVARTIS
Jonas Wiedemann
Specialist Biostatistician
LUNDBECK
Chris Benko
Chief Executive Officer
KONEKSA
Thomas Kustermann
Biomarker & Experimental Medicine Leader
ROCHE
Marzia Antonella Scelsi
Sr. Statistical Scientist
ROCHE
2022 Conference Agenda
8:45

Welcoming Words & Introduction

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

Opening Remarks from Roche

Scott Oloff, SVP of Data & Analytics, Roche
9:00

DETECTING TREATMENT EFFECTS WITH DIGITAL BIOMARKERS

Examples of where dBM have successfully detected treatment effects and made a difference to drug development
9:00

Case Study: Utilizing smart insoles to assess early signs and progression in Parkinsonian gait – application in clinical research in neurodegenerative diseases and beyond.

Parkinsonian gait is one of several motor symptoms that are the hallmarks of Parkinson’s disease, including slowness of movement and tremors. Motor symptoms in Parkinson’s disease come from a lack of control over movements and difficulty initiating muscle movements. Gait disturbances can be detected throughout the progression of the disease: reduced amplitude of arm swing, reduced smoothness of locomotion, low speed, reduced stride length, shuffling steps, etc. However, gait can be difficult to assess and quantify through the usual clinical evaluation and in addition patient performance is associated with huge variability due to daily fluctuation. Hence, gait parameters as assessed objectively by a digital tool have a huge potential as biomarkers in relation to diagnosis/differentiation, tracking of disease progression, clinical trial outcome, etc., and therefore can support both researchers and clinicians in their decision making.

The FeetMe devices provide a platform for digital gait measurement the application of which can be adapted to the scope. The smart insoles can collect data ranging from fully controlled settings using standard gait tests to completely remote real life home monitoring, in an objective, quantifiable way, overcoming the limitations of the currently available technologies.

Gait`N`Park is a clinical study that was initiated in collaboration between Lundbeck, Lille University Hospital and FeetMe with the objective to assess “Markers of Disease Progression and Gait Within the Parkinsonian Population”. The study design and the first insight into the preliminary results reflect the flexible use of the technology and serve as a great example of the advantages of real world gait monitoring in a research setting.

Jonas Wiedemann, Specialist Biostatistician, Lundbeck
Alexis Mathieu, Co-founder and Senior Advisor, FeetMe
9:20

CASE STUDY: Exploratory analysis of the effect of delayed-start prasinezumab on motor sign progression measured with the Roche PD Mobile Application v2: PASADENA Phase II Parts 1 and 2

In this case study, we show how the Roche Parkinson's Disease Digital Biomarker Application identified a persistent reduction in bradykinesia progression when comparing the early-start prasinezumab group compared with the delayed-start group. The case study illustrates how digital biomarker approaches can be used to detect treatment effects.

Thomas Kustermann, Biomarker and Experimental Medicine Leader, Biomarkers and Translational Technologies Neuroscience and Rare Diseases (NRD), Roche Pharma Research and Early Development
Marzia Antonella Scelsi, Senior Statistical Scientist, Roche Pharma Development Data Science
9:40

CASE STUDY: Assessing sensitivity to change through a benign cognitive challenge model - A digital endpoint study

Digital endpoints hold promise as more sensitive and less burdensome efficacy endpoints to improve drug development in neuroscience. We will present Novartis’ strategy to advance and de-risk the inclusion of digital endpoints in clinical trials. We will focus on our non-interventional methodology study carried out in early Alzheimer’s disease. Specifically, we will discuss how we introduced a mild cognitive challenge model to evaluate the sensitivity to change of 10 novel digital technologies.

Jennifer Sorinas Nerin, Postdoctoral Fellow, Novartis Institutes for BioMedical Research
10:00

KEYNOTE PANEL: Using Digital Biomarkers to Detect Treatment Effects; the State of the Field


• 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

Thibaud Guymard, General Manager, Digital Measurement Solutions, Biogen Digital Health
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

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

NETWORKING BREAK

Sponsored by: VivoSense
10:50

DEVELOPING DIGITAL MEASURES

Validating Novel Digital Measures and Establishing their Complementarity to Traditional Clinical and Non-Clinical Measures
10:50

CASE STUDY: The Latest in Developing and Implementing Digital Biomarkers for Drug Development

Chris Benko, CEO, Koneksa

11:10

CASE STUDY: Using Voice Digital Biomarkers in Janssen’s
“Autonomy” Alzheimer’s Phase II study

Clinical trials for Alzheimer’s Disease (AD) have shifted focus to earlier phases of the disease and
therefore recruit from a more general population with little-to-no symptoms of dementia.
Screening for these studies is long, costly, and often experiences a high screen-fail rate due to a
lack of adequate pre-screeners to verify AD pathology. This recruitment problem is accompanied
by high costs and timely expansion of AD clinical trials. Thus, recruitment is a major limiting factor
to drug development for AD.

Trial efficiencies may be realized with the introduction of light-weight, cost-effective and scalable
biomarkers used as a pre-screening step during recruitment. Beyond traditional “wet” biomarkers
measuring biological processes (e.g. based on cerebrospinal fluid daws), behavioral signs such as
impaired cognition is an easy-to-observe hallmark of AD and present throughout all phases of the
disease trajectory including the early stage of Mild Cognitive Impairment (MCI). Speech biomarkers
that detect cognition are especially promising because they provide a reliable, valid, and objective
endpoint for early AD and, moreover, allow for an automatic, non-invasive assessment, making
them a scalable and low-burden tool which is optimal for screening scenarios in a broad
population.

We will present on how the speech biomarker for cognition of ki:elements (ki:e SB-C) is
implemented into Jansen’s Phase II study “Autonomy” through an automated telephone call, how it
is used in parallel to traditional outreach and questionnaires, and how it is used to select patients
that are likely to fit inclusion criteria.

Steve Ruhmel, Associate Director, Janssen Clinical Innovation
Nicklas Linz, CEO, ki: elements

11:30

CASE STUDY: Meta-analysis of Actigraphy Data in Early Phase Clinical Trials

Valeria De Luca, Associate Director & Senior Principal Data Scientist, Novartis Institutes for BioMedical Research
Seid Hamzic, Data Science Academy Fellow, Novartis Institutes for BioMedical Research

11:50

CASE STUDY: Developing Digital Measures To Detect Treatment Effects:
Validating digital measures and establishing their relationship to traditional measures

This presentation will review potential advantages to the consideration of a range of validity evidence, driven by explicit context(s) of use and the relative value of construct validity evidence. Potential advantages of digital measures and the validation evidence that might demonstrate these will be considered. Keeping the end in mind from the outset of development may help to guide the successful generation of validity evidence. A unitary model of validation in which several types of evidence contribute to an evaluation of validity for a given context of use may be more valuable than taking the view that there are discrete types of validity, each with binary outcomes.

Chris Edgar, Chief Scientific Officer, Cogstate
12:10

PANEL DISCUSSION: Challenges in Validating Digital Measures

Steve Ruhmel, Associate Director, Janssen Clinical Innovation
Valeria De Luca, Associate Director & Senior Principal Data Scientist, Novartis Institutes for BioMedical Research
Mark Matson, Sr. Solution Specialist, Sensor Cloud, Medidata
Chris Edgar, Chief Scientific Officer, Cogstate

Moderated by Kirsten Taylor, Biomarker & Experimental Medicine Leader, Roche
12:35

NETWORKING LUNCH


Sponsor: Biofourmis
13:30

PITFALLS WITH DETECTING TREATMENT EFFECTS

Scientific, Clinical, Statistical, Operational & Technical Challenges and How to Overcome them
13:30

CASE STUDY: Making Digital Biomarkers a Success in Roche Clinical Trials: addressing missing data, drop outs and data equivalence

High frequency data collection with digital health technologies poses unique opportunities but also challenges for clinical trials. We discuss lessons learned from trials across Roche, covering themes including Missing Data, Drop Outs, and Data Equivalence.

Jonas Dorn, Digital Biomarker Technology Lead, Roche
Timothy Kilchenmann, Digital Biomarker Scientist, Roche


13:50

CASE STUDY: Impact of Data Quantity & Quality on Development of Robust Digital Endpoints in Decentralized Studies

COVID-19 pandemic has further accelerated the adoption of digital health technology in clinical trials enabling over 220 digitally augmented trials in 2021 alone. Researchers and trialists can reach a larger diverse target population and frequently assess their health by collecting individualized real-world data actively and passively. Such a scalable remote observational model helps investigators develop a better and holistic understanding of people’s day-to-day experiences of living with a health condition that ultimately will help improve our understanding of individualized health-related behavior and related outcomes.

However, several real-world challenges related to the quantity and quality of real-world data collected from the target population have surfaced. These include but are not limited to equitable recruitment and long-term retention of the target population. In this talk, I will summarize the ongoing learnings related to real-world data collection from three large-scale multinational studies that have enrolled over 20,000 participants (from young and healthy kids to patients with severe depression). Specifically, I will focus on two key topics:

1. Potential biases may impact the collection of health-related data using active and passive data streams, such as participants' socio-demographics, willingness/concerns, varying participation incentives, disease severity, and technical limitations across iOS and Android ecosystems.

2. Varying quality of sensor-based data collected from smartphones and wearables and its impact on developing robust digital endpoints. I will demonstrate digital signal processing-based data quality metrics to help assess the completeness, correctness, and consistency within and across participants and devices. For example, real-world factors such as device issues (e.g., hardware, software, network) and user-related (e.g., unintended or non-compliant device usage, non-wear).

Abhishek Pratap, Group Head AI & Digital Health, Centre for Addiction and Mental Health (CAMH), Toronto


14:10

CASE STUDY: Digital Clinical Measures in Rett Syndrome: ECG Derived Respiration

Kate Lyden, Chief Science Officer, VivoSense

14:30

CASE STUDY: Technical Challenges from Past & Current Partnerships at UCB

Valentina Ticcinelli, Biosensors Analytics Expert, UCB
Erkuden Goikoetxea, Medical Device Innovation Lead, UCB


14:50

PANEL DISCUSSION: Overcoming Challenges with Detecting Treatment Effects

Scientific, Clinical, Statistical, Operational & Technical Challenges and How to Overcome them

Jonas Dorn, Digital Biomarker Technology Lead, Roche
Valentina Ticcinelli, Biosensors Analytics Expert, UCB
John Varaklis, Chief Strategy Officer, PhysIQ

Moderated by: Timothy Kilchenmann, Digital Biomarker Scientist, Roche
15:20

NETWORKING BREAK

Sponsored by: ActiGraph

15:55

FUTURE DIRECTIONS

Upcoming Opportunities and Challenges for increasing the impact of Digital Biomarkers in Drug Development
15:55

CASE STUDY: Back to the Future: Moving Beyond Concurrent Criterion Validation

MindMed is developing a set of drugs for brain health disorders that target mechanisms of action that have been sidelined due to cultural concerns and legal restrictions that have persisted for decades. Despite this complicated history, the development of these drugs can follow a development pathway that resembles traditional psychiatric drug development. An opportunity in this paradigm is the concurrent creation, validation, and clearance of digital measurement and treatment tools to support both our clinical trials, and the clinical application of our drugs. Dr. Karlin, the Chief Medical Officer of MindMed, and the Head of Digital Medicine will discuss the underlying foundations of these efforts, and the research questions being explored. Taking a long view of what validation can mean is central to the efforts. While much of the general work on digital measurement has focused on concurrent criterion validation, MindMed's position is that predictive clinical validation is the only way that measurement in medicine has historically progressed and is similarly essential to allow for modern measurements to be truly medically meaningful. Using this framework, MindMed is creating products that represent legitimate medical progress and create value for the company, providers, and most importantly patients.

Dan Karlin, Chief Medical Officer, MindMed

16:15

CASE STUDY: Sensor-based Digital Health Technology: Navigating the Path from Digital Data to Clinical Impact

Key takeaways from the recent FDA DHT Draft guidance and more

Christine Guo, Chief Scientific Officer, ActiGraph
16:35

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

Tracey Robertson, Head of Patient & Site Engagement Capability Management, Boehringer Ingelheim
Alexander Mion, Head of Clinical Trials Department, Swissmedic
Rinol Alaj, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

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


17:00 - 19:00

NETWORKING APÉRO


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
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...