Conference registration open with continental breakfast and coffee served

Carrie Northcott, Head of Digital Medicine and Translational Imaging, Pfizer (Pfizer Chair)
Charmaine Demanuele, VP, Data Science & Digital Health, Johnson & Johnson Innovative Medicine (J&J Chair)
Phil Murphy, Head of Imaging & Digital Health, Johnson & Johnson Innovative Medicine (J&J Chair)

Carrie Northcott, Head of Digital Medicine and Translational Imaging, Pfizer (Pfizer Chair)

Jarjieh "Jay" Fang, Director, HVE, Patient-Centered Outcome Assessment, Pfizer

Progress with sensor-based digital measures in clinical trials is often judged by formal qualification or use as a primary endpoint in a pivotal trial. While milestones matter, they do not capture the full range of roles digital measures can play in drug development. We argue that progress should also be judged by whether a measure is fit for its intended role and informs a development or regulatory decision. Using DiMe’s Library of Digital Endpoints, this presentation maps where sponsors have registered these measures and examines what further evidence is needed to understand their contribution.

Krista Leonard-Corzo, Senior Research Scientist, Vivosense
Benjamin Vandendriessche, CEO, Digital Medicine Society

• How investment in digital measures is creating value beyond capturing disease progression in ways that matter to patients and clinicians
• How to build confidence with investigators, sites, HCPs and patients and show clear value in care
• Discussions around ROI and context of use

Kevin “Kip” Thomas, Director, Boston University
Jarjieh "Jay" Fang, Director, HVE, Patient-Centered Outcome Assessment, Pfizer
Sarah Ernst, Head of Clinical Innovation Strategy and Implementation, Sanofi
Thomas Bartlett, Rare Disease Patient & Advisor - Myasthenia Gravis

Moderated by:
Carrie Northcott, Head of Digital Medicine and Translational Imaging, Pfizer (Pfizer Chair)

Kara Chappie, Project Lead, DMTI, Pfizer (Session Chair)

Matt Czech, Associate Director, Digital Science, AbbVie

Pirinka Tuttle, Director, Digital Medicine & Translational Imaging, Pfizer

• Digital phenotyping to standardize patient categorization, reduce cohort heterogeneity, and optimize trial population selection
• Tracking subtle disease trajectories and detecting early-stage shifts to capture changes in progression missed by episodic clinical scales
• Opportunities to deliver more value to patients and achieve label expansion

Daniel Karlin, Chief Medical Officer, Definium Therapeutics
Seemi Kazmi, Global Head of Digital Health, Bristol Myers Squibb
Matteo Lai, CEO, Empatica
Bhaskar Dutta, Head, Digital Health and Medical Affairs Technologies, Alexion Pharmaceuticals

Moderated by:
Phil Murphy, Head of Imaging and Digital Health, Johnson & Johnson

Srinivasan Vairavan, Director, Data Science, Digital Health, Johnson & Johnson Innovative Medicine (Session Chair)

Anahita Kyani, Director, Neuroscience Digital Biomarkers, Johnson & Johnson Innovative Medicine

Zain Asad, MD, Associate Professor Cardiology, Cardio Oncology, University of Oklahoma

• How combining continuous digital data (e.g., actigraphy, sleep patterns, vocal biomarkers) with traditional analog measures (e.g., lab tests, advanced imaging, EHR, and genomics) can accelerate clinical research
• What it will take to use machine learning models to synthesize multiple streaming features into a single composite endpoint 

Benjamin Vandendriessche, CEO, Digital Medicine Society (DiMe)
Derek Hill, Professor of Digital Health, UCL
Kevin Maresca, Head of Clinical & Translational Imaging, Pfizer
Junrui Di, Director, Data Science and Digital Health Neuroscience, Johnson & Johnson
Francesco Onorati, Director, Statistics, Quantitative Sciences, Takeda

Moderated by:
Srinivasan Vairavan, Director, Data Science, Digital Health, Johnson & Johnson Innovative Medicine

Nunzio Camerlingo, Associate Director, AI/ML Quantitative & Digital Sciences, Pfizer (Session Chair)

Speaker TBA, Medable

Last year at this summit, we conducted a panel that discussed a "reduce, reuse, recycle" approach to digital measures: consolidating fragmented evidence from public-private partnerships into a shared, searchable foundation. One of the challenges acknowledged in this discussion was that physical activity, one of the most widely captured digital measure domains, may have limited success getting regulator buy-in until the field agrees on what it means. 

The Physical Activity Harmonization Mission, launched this past summer takes that next step. Six sponsoring organizations across pharma, academia and tech, together with DEEP Measures are building a disease-agnostic conceptual framework, refined through a Delphi consensus process with more than 30 stakeholders, including patients, clinicians and regulators. 

Panelists will share how this work is advancing a common standard, where consensus has been hardest to reach, and what a harmonized foundation means for the return on investment in digital measures.

Jared Worful, Head of Digital Health Technology & Real-World Science, Bayer
Deepak Kumar, Associate Professor, Department of Physical Therapy, Boston University
Carrie Northcott, Head of Digital Medicine and Translational Imaging, Pfizer

Moderated by:
Jacqueline Thong, General Manager, US, DEEP Measures

Laura Taraboanta, Project Lead, Digital & Translational Imaging, Pfizer
Bola Grace, Professor of Practice, UCL
Kate Lyden, Chief Science Officer, Vivosense

Moderated by:
Ryan Barraco, Director, Regulatory Policy, Johnson & Johnson Innovative Medicine