Summit Agenda
Time
Title
Speakers
08:15-09:00
Registration and Welcome Coffee
09:00-09:05
Opening Remarks from Sanofi
Erik Sundermann (Co-Chair)
09:00-09:05
Welcome and Introduction
Lynn Rochester (Chair)
Session 1:
Digital Biomarkers Applied in Clinical Development
09:00-09:05
Introduction to Session 1
Erik Sundermann, Sanofi
09:05-09:25
Adoption of Real-World Digital Mobility Outcomes in Clinical Development: An Update from Mobilise-D Consortium
Lynn Rochester, University of Newcastle
09:25-09:45
Quantification of Cognitive Impairments in Preclinical and Early Alzheimer’s Disease using Remote Assessments of Cognition, Function and Behavior
Thanneer Malai Perumal, Roche
09:45-10:05
Advancing Digital Health Technologies and Digital Biomarkers of Human Movement
Kristen Sowalsky, Clario
10:05-10:05
Introduction to Spotlight Talks
Erik Sundermann, Sanofi
10:05-10:15
Building a Framework for Digital Biomarker Development and Supporting Industry Collaboration
Matteo Lai, Empatica
10:15-10:25
Remote and Continuous Assessment of Exercise Capacity in Pulmonary Arterial Hypertension with a Wrist-Worn Accelerometer
Dzmitry Kaliukhovich, The Janssen Pharmaceutical Companies of Johnson & Johnson
10:25-10:35
Developing a digitally-enhanced Six Minute Walk Test
Mark Matson, DS Medidata
10:35-11:15
Panel and Q&A
Moderator: Erik Sundermann
Panelists: Lynn Rochester, Thanneer Malai Perumal, Matteo Lai, Bryan McDowell, Mark Matson
11:15-11:45
Networking Break
Session 2:
From Evidence Generation to Patient Centricity
11:45-11:50
Introduction to Session 2
Steven Bourke, Personal Pulse
11:50-12:10
The Importance of Integrated Patient Engagement
Victoria DiBiaso, Sanofi
12:10-12:30
From Patient to Disease Course Heterogeneity Centricity – The Challenge of Developing Digital Measurements of Latent Progression
Shibeshih Belachew, Biogen
12:30-12:50
Digital Biomarkers of Quality of Life: Incorporating Daily Life into Clinical Trials
Katarzyna Wac, University of Geneva
12:50-13:50
Networking Break / Lunch
13:50-13:50
Introduction to Spotlight Talks
Steven Bourke, Personal Pulse
13:50-14:00
Empowering the Employee-Patient to Drive Innovation and Value in Pharma
Aurelia Topol, Sanofi
14:00-14:05
Long-term continuous monitoring in clinical trials.
Richard Thomas, CEO, ActivInsights
14:05-14:10
Enabling the Development and Use of Digital Biomarkers through a Multi-Modal Evidence Generation Platform
Colin Weller GM, Medable
14:10-14:20
Enabling Sensitive Digital Biomarkers while Eliminating Patient Burden through a Clinical Trial Platform Powered by Radio Waves
Rahul Hariharan, Emerald
14:20-14:55
Panel and Q&A:
Moderator: Steven Bourke
Panelists: Victoria DiBiaso, Shibeshih Belachew, Katarzyna Wac, Aurelia Topol, Rahul Hariharan
14:55-15:20
Networking Break
Session 3:
Ensuring Regulatory Acceptance and Driving Market Access
15:20-15:20
Introduction to Session 3
Rebecca Lumsden, Sanofi
15:20-15:40
Digital Endpoints for Health Technology Evaluation: Artificial or Real-Life Intelligence?
François Maignen, NICE
15:40-16:00
Digitalisation as a Facilitator to Patient-Centric Development
Solange Corriol-Rohou, Astra Zeneca
16.00-16:10
Myth Busting in Digital Endpoints & Regulatory
Lada Leyens, Takeda
16:10-16:10
Introduction to Spotlight Talk
Rebecca Lumsden
16:10-16:20
SV95C - Bridging the Gap from Digital Hype to Qualified Partner
Yacine Bechichi, Sysnav Healthcare
16:20-16:30
Spotlight Recap Regulatory Acceptance
Rebecca Lumsden
16:30-17:00
Panel and Q&A:
Ensuring Regulatory Acceptance and Driving Market Access
Moderator: Rebecca Lumsden
Panelists: Lada Leyens, Solange Corriol-Rohou, Francois Maignen, Aurelia Topol
17:00-17:05
Closing Remarks
Lynn Rochester
17:05-18:00
Networking Apéro
Venue
6 December, 2023