"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 third year hosted by 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 15+ speakers, 250+ senior-level pharma, clinical trials, technology and digital health executives virtually on June 24th, 2020 at Roche 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
VIRTUAL MEETING
Date & Time
24 June 2020, 13:00 - 17:00 Basel Time (GMT+2)
IN PARTNERSHIP WITH:
ARE DIGITAL BIOMARKERS READY FOR AN AAAA RATING?

OVERALL THEMES:

1. The State of Digital Biomarkers Today

2. Best Practices for Digital Protocol ADHERENCE

3. How Can the Industry Come to AGREEMENT between Classical Physician Assessments and the new Digital Measures?

4. Where Can the Industry Collaborate on AUGMENTATION?

5. How Can Life Sciences work with Regulatory AUTHORITIES to Accelerate Adoption?
Conference Agenda
13:00 AM

Welcoming Words & Introduction

Chairperson: Christian Gossens, Global Head, Digital Biomarkers, Roche
13:10 PM

Opening Remarks from Roche

Bryn Roberts, SVP, Global Head of Operations and Informatics, Roche
13:15 PM

KEYNOTE PANEL: The State of Digital Biomarkers Today


• State of the art pipelines to transfer data from patient to data scientist
• Applications of AI and Machine Learning
• A discussion of analytic automation and visualization best practices
• Transforming clinically relevant symptoms into digitally measurable biomarkers

SESSION SPEAKERS:
Christian Gossens, Global Head, Digital Biomarkers, Roche
Ray Dorsey, Director, University of Rochester Center for Health + Technology (CHeT)
Michelle Crouthamel, Managing Director, Digital Health Strategy & Implementation, AbbVie
Shibeshih Belachew, Sr. Medical Director, Head of Early Clinical Development for MS, Biogen
Moderator: Bryn Roberts, SVP, Global Head of Operations and Informatics, Roche

13:30

MICRO BREAK
13:35

HIGHLIGHTS OF THE YEAR IN DIGITAL BIOMARKERS
13:35

CHeT CASE STUDY: The Future of Clinical Trials - Decentralized Studies & Digital Biomarkers

Ray Dorsey, Director, University of Rochester Center for Health + Technology (CHeT)

13:55

AbbVie CASE STUDY: The Pursuit of Novel Digital Endpoints

Michelle Crouthamel, Managing Director, Digital Health Strategy & Implementation, AbbVie

14:15

BREAK


Sponsors: VivoSense & ActiGraph
14:25

CASE STUDY: Collaborating on Developing Digital Biomarkers
ActiGraph and VivoSense

The landscape of wearable sensors in clinical trials has proven difficult to navigate for many, including sponsors and vendors. Collaboration around the development of digital endpoints is required to extract the most from new digital technologies. Actigraph and VivoSense have collaborated to develop novel digital biomarkers with a focus on quality data, accuracy, validation, compliance and endpoint effect. In this discussion, we will share a case study of one such novel endpoint and our steps for future development.

Kate Lyden, Lead Scientist, VivoSense
Jeremy Wyatt, CEO, ActiGraph

14:45

PFIZER CASE STUDY: Deploying an Analytics Solution for Monitoring Nighttime Scratch and Sleep Quantity in Atopic Dermatitis

Problem and development of digital biomarkers for Scratch and Sleep in Atopic Dermatitis
• Deploying digital biomarkers at scale
• Initial approach to processing incoming data
• Leveraging cloud technology (AWS) to improve workflows (scalability, repeatability, reduce cost)
• Looking forward: Other thoughts/ideas on how to deploy digital biomarkers at scale
       • Ex: Running algorithms locally on IoT devices
       • Initial thoughts on pros v cons of different approaches

Nikhil Mahadevan, Data Scientist, Digital Medicine & Translational Imaging, Pfizer
Yiorgos Christakis, Data Scientist, Digital Medicine & Translational Imaging, Pfizer

15:05

PHYSIQ Case Study: Taking off the training wheels with Digital Biomarkers in Clinical Trials

In this “conceptual” case study that combines lessons from actual cases (while protecting identities), we consider use of sensors to support digital endpoints in a hypothetical HF study. We suggest it is time to take off the training wheels with respect to adoption of scalable biosensor data in clinical trials. We contrast alternate approaches to designing in wearable sensors and the risks of ad hoc sensor choice. We examine messaging that can be used by digital health thought leaders to educate their audiences about pertinent choices for selecting infrastructure for driving optimal use of digital biomarkers.


Matt Pipke, CTO, PhysIQ

15:25

BREAK


Sponsor: PhysIQ
15:40

OUTLOOK FOR DIGITAL BIOMARKERS
 

15:40

CASE STUDY: Outcome Measures based on Digital Health Technology Sensor Data

Kirsten Taylor, Biomarker and Experimental Medicine Leader, Roche
Hannah Staunton, Principal Clinical Outcomes Research Scientist, Roche
Florian Lipsmeier, Digital Biomarker Data Analysis Team Lead, Roche

16:00

MJFF CASE STUDY: Leveraging Partnerships to Support Digital Biomarker Development

Digital biomarkers represent a remarkable opportunity to substantially impact and, possibly transform, therapeutic development. However, the field is still nascent, and the digital biomarker world can feel like the ‘wild west’ in which there are multiple approaches, players, opinions and thoughts on how to truly harness, leverage and apply the potential of digital biomarkers. The Michael J. Fox Foundation for Parkinson’s Research has played a central role in establishing multi-stakeholder partnerships to connect dots and leverage expertise to accelerate the development of useful digital biomarkers for Parkinson’s disease and we will present a snapshot of lessons learned and insights from these partnerships.

Sohini Chowdhury, Deputy CEO, Michael J Fox Foundation for Parkinson’s Research

16:20

MICRO BREAK
16:25

PANEL DISCUSSION: Outlook for Digital Biomarkers in the post-COVID-19 Environment

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


Arne Müller, Data Scientist, Digital Endpoints, Novartis
Carrie Northcott, Director, Digital Medicine & Translational Imaging, Pfizer
Sohini Chowdhury, Deputy CEO, Michael J. Fox Foundation for Parkinson's Research
Dudley Tabakin, CEO, VivoSense
Moderator: Christian Gossens, Global Head, Digital Biomarkers, Roche

16:50

Concluding Overall Q&A Session

Led by: Christian Gossens, Global Head, Digital Biomarkers, Roche
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Digital Biomarkers Summit 2020
Teaser Video
Speakers and Advisors
Christian Gossens
Global Head, Digital Biomarkers
ROCHE
Bryn Roberts
SVP, Global Head of Operations, pRED
ROCHE
Ray Dorsey
Director
UNIVERSITY OF ROCHESTER CENTER FOR HEALTH & TECHNOLOGY
Michelle Crouthamel
Managing Director, Digital Health & Technology
ABBVIE
Sohini Chowdhury
Deputy CEO
MICHAEL J FOX FOUNDATION FOR PARKINSON'S RESEARCH
Shibeshih Belachew
Sr. Medical Dir., Head of ECD for MS
biogen
Kirsten Taylor
Biomarker and Experimental Medicine Leader
ROCHE
Arne Müller
Data Scientist, Digital Endpoints
NOVARTIS
Jeremy Wyatt
President
ACTIGRAPH
Nikhil Mahadevan
Data Scientist, Digital & Translational Imaging
PFIZER
Kate Lyden
Lead Scientist
Vivosense
Dudley Tabakin
CEO
Vivosense
Michelle Longmire
CEO
MEDABLE
Hannah Staunton
Principal Clinical Outcomes Scientist
ROCHE
Florian Lipsmeier
Digital Biomarker Data Analysis Team Lead
ROCHE
Matt Pipke
CTO
PHYSIQ
Carrie Northcott
Director, Digital Medicine & Translational Imaging
PFIZER
Yiorgos Christakis
Data Scientist, Digital Medicine & Translational Imaging
PFIZER
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2019 Conference Highlight Video
2020 Presentation Videos
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
2019 Conference Photo Gallery
Location
Hosted in Partnership with Roche
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 2020
Where the World meets to Accelerate the Development of Digital Biomarkers
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