Click on the underlined links to view the recordings
Day 1 - Thursday, 15.09.2022
Hörsaal G3
11:00 – 12:30
Registration
12:00 - 12:30
Quick Lunch - Foyer D Nord
12:30 – 12:40
Jörg Goldhahn (ETH Zürich)
Head of Institute of Translational Medicine
12:40 – 12:50
Remote Digital Monitoring for Medical
Product Development Workshop, 02/2020
Steve Hoffmann (FNIH)
Associate Vice President, Research Partnerships
12:50 – 12:55
Workshop Introduction and Charge
Ieuan Clay (VivoSense)
Director, Science
Qualification of New Digital Evidence
13:00 – 16:30
Use Case 1: Mobilize-D
Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement
13:00 – 13:10
Arne Müller (Novartis)
Senior Principal Data Scientist in Clinical Digital Endpoints
13:10 – 13:35
Patient Involvement & Monitoring Strategy
Allison Keough (Trinity College, Dublin)
Assistant Professor of Healthcare Innovation
13:35 – 13:50
Parkinson’s Disease Testimonial and Mobility
Tova Gur Arieh (Nitzan)
Director of Resource Development & International Relations
13:50 – 14:15
Clinical validation of Digital Mobility Outcomes
Clemens Becker (Robert Bosch Hospital, Stuttgart, Germany)
Head of Clinical Gerontology and Rehabilitation
14:15 – 14:40
Technical Validation (sensor, algorithms & app)
Andrea Cereatti
Full Professor in Biomedical engineering at the Polytechnic University of Turin.
14:40 – 15:10
Coffee Break - Foyer D Nord
15:10 – 15:35
Regulatory Strategy and Achievements
Wim Dartee (Novartis)
Global Lead Combination Products and Medical Devices
15:35 – 16:30
Q&A
Moderator: Arne Müller
16:30 – 17:00
Apéro - Foyer D Nord
17:00 – 20:30
Use Case 2: IDEA-FAST
Identifying digital endpoints to assess fatigue, sleep and activities in daily living in neurodegenerative disorders and immune-mediated inflammatory diseases
17:00 – 17:10
Fai Ng (Newcastle University)
Professor of Rheumatology
17:10 – 17:30
The Patient Voice Patient Recorded Videos
17:30 – 17:50
Fai Ng (Newcastle University)
Professor of Rheumatology
17:50 – 18:00
Discussion, Q&A
Moderator: Lada Leyens
18:00 – 18:20
Christopher Bull (Newcastle University)
Lecturer, Digital Health and Software Engineering
Francesca Cormack (Cambridge Cognition)
Chief Scientist
18:20 – 18:40
Wojtek Piwko (Takeda)
Associate Director, EUCAN Regulatory Lead
David Nobbs (Roche)
Digital Biomarker Disease Area Lead
18:40 – 19:20
Apéro - Foyer D Nord
19:20 – 19:45
Moderator: Lada Leyens
19:45 – 20:30
Discussion, Q&A
Attendees
20:30 – 21:30
Apéro riche (Buffet) - Foyer D Nord
Click on the underlined links to view the recordings
Day 2 - Friday, 16.09.2022
Hörsaal F30
11:00 – 12:30
Registration
12:00 – 12:30
Quick Lunch - Foyer D Nord
12:30 – 12:35
Day 1 Recap and Day 2 Overview
Ieuan Clay (VivoSense)
Director, Science
12:35 – 13:00
Reverse Translation: A Patient Testimonial
to Utility and Application
Elena Izmailova (Koneksa Health)
Chief Science Officer
From Efficacy to Effectiveness
13:00 – 16:30
Use Case 3: Roche DHTs for SMA
Digital Health Technologies to better measure outcomes in Spinal Muscular Atrophy
13:00 – 13:10
Foteini Orfaniotou (Roche)
Group Leader Digital Health
13:10 – 13:35
Novel digital outcome measures and validation frameworks, including regulatory and access considerations
Thanneer Malai Perumal (Roche)
Digital Biomarker Science & Technology Lead
Lada Leyens (Roche)
Regulatory Senior Director
Julian Nam (Roche)
Access Strategy Lead
13:35 – 13:55
Nicole Gusset (SMA Europe, SMA Schweiz,
Swiss Neuromuscular Diseases Association)
Patient expert
13:55 – 14:10
David Jacquier (University Hospital, Lausanne)
Neurologist
14:10 – 14:25
HCP Perspective: physiotherapist
Tina Duong (Stanford University)
Physical Therapist, Director, Clinical Outcomes
Research & Development
14:25 – 14:40
Holger Bless (fbeta GmbH)
Partner, Head, Healthcare Research & Mkt Access,
Head of Digital Health
14:40 – 15:10
Coffee Break - Foyer D Nord
15:10 – 15:50
Moderated Panel discussion
Moderator: Ieuan Clay (VivoSense),
Panelists, Speakers
Steve Xu (Sibel Health) CEO
15:50 – 16:30
Moderator: Ieuan Clay (VivoSense)
16:30 – 19:15
Use Case 4: AMP® SCZ Program
The Accelerating Medicines Partnership® Program
– Schizophrenia
16:30 – 16:45
Patient Engagement and Challenges
Carlos Larrauri (NAMI)
NAMI Board Member, Patient, Advocate
16:45 -17:25
Translating Research into Clinical Design
Justin Baker (McLean Institute for Technology in Psychiatry)
Scientific Director
John Torous (Beth Israel Deaconess Medical Center)
Assistant Professor of Psychiatry
17:25 - 17:55
Apéro - Foyer D Nord
17:55 -18:15
Francis Shen (Univ. of Minn. School of Law)
Professor of Law
18:15 - 18:35
Erlend Lane (Beth Israel Deaconess Medical Center)
Clinical Research Assistant
18:35 - 18:55
Cecilia McGough (students with Psychosis)
Executive Director
18:55 - 19:15
+ Q & A
Moderator: Justin Baker
19:15 - 19:45
Apéro - Foyer D Nord
19:45 - 20:45
Moderator: Steve Bourke
Effy Vayena
Kate Lyden
Katarzyna Wac
Luca Foschini
20:45 - 21:00
Steve Hoffman (FNIH)
Associate Vice President, Research Partnerships