Chairperson: Christian Gossens, Global Head, Digital Biomarkers, Roche

• 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

Paulo Fontoura, SVP, Global Head of Neuroscience, Immunology, Ophthalmology, Infectious and Rare Diseases Clinical Development, Roche
Jen Goldsack, Executive Director, Digital Medicine Society (DiMe)
Dr. Ruth Schneider, Assistant Professor of Neurology, Center for Health + Technology, University of Rochester 
Fai Ng, Professor of Rheumatology, Newcastle University

Led by: Christian Gossens, Global Head, Digital Biomarkers, Roche

The traditional site-based, in-person research study is inaccessible to and burdensome for individuals with Parkinson’s disease, which is a neurodegenerative disease with no cure, and relies on scales that are administered in the clinic, often by trained personnel. Decentralized studies flip this paradigm, collecting data directly from participants in their homes. In AT-HOME PD, 226 participants from two phase 3 clinical trials are being followed longitudinally using video visits, online surveys, and smartphone-based assessments. Using the mPower smartphone application, participants complete a series of active motor tasks on a regular basis and can also enable passive data collection. With this study, we aim to identify new digital measures of disability and severity.

Dr. Ruth Schneider, Assistant Professor of Neurology, Center for Health + Technology, University of Rochester 
Larsson Omberg, VP, Sage Bionetworks

Florian Lipsmeier, Data Analysis Team Lead for Digital Biomarkers, Roche

Friedreich’s ataxia is an inherited, progressive, neurodegenerative disease that typically begins in childhood. Disease severity is commonly assessed with rating scales, such as the modified Friedreich’s Ataxia Rating Scale (mFASRS) including bulbar function and auxiliary tests such as the PATA speech test that is administered by the neurologist counting PATA syllables in a 10 seconds test. In this study we have explored different at-home self-administered digital endpoints in a pediatric Friedreich’s Ataxia population and aged matched controls including an automated version of the PATA test recorded remotely and analysed automatically. Bulbar function scoring in mFARS is discrete and has less resolution than the automated PATA test, participants with low bulbar scoring (normal function) already show lower syllable rates . Also, variability in syllable rates correlate with the total mFARS disease score as well as with activities of daily living scores (total ADL). Study participants found the speech test overall easy to use. However, the PATA test does not assess communication and verbal expression skills which should be addressed with specific speech test.

Arne Müller, Data Scientist, Digital Endpoints, Novartis

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

Diane Stephenson, Critical Path for Parkinson's, Critical Path Institute (C-Path)
Arne Müller, Data Scientist, Digital Endpoints, Novartis
Lauren Oliva, New Technologies Policy Lead, Director, Global Regulatory Policy, Biogen
Matt Biggs, VP of Applied Science, ActiGraph

Led by: Christian Gossens, Global Head, Digital Biomarkers, Roche