This DEEP Measures-led precompetitive mission seeks to align industry stakeholders on regulatory-ready digital measures for respiratory conditions, beginning with COPD and non-CF bronchiectasis, creating a shared scientific foundation that accelerates evidence generation and regulatory engagement.
The Challenge
Digital measurement technologies are increasingly used in respiratory drug development, yet inconsistent definitions, variable methodologies, and limited consensus around fit-for-purpose digital solutions slow regulatory confidence and cross-study comparability.
Misaligned approaches across pharmaceutical sponsors, technology providers, academic groups, and regulatory bodies make it harder to demonstrate that digital measures are reliable, meaningful, and ready to support endpoint claims, particularly for cough-related and other respiratory symptoms that could serve as primary or supportive endpoints in COPD and non-CF bronchiectasis programs.
Our Goal
This DEEP Measures-led mission, in collaboration with participating sponsors, seeks alignment on what should be measured, how it should be measured, and how digital solutions can be evaluated independent of any specific device. It will define measurement concepts and device-agnostic solution standards grounded in clinically meaningful concepts, with particular emphasis on digital approaches to tracking cough-related and other respiratory symptoms, and will use early FDA and EMA engagement to de-risk downstream digital endpoint development for sponsor programs.
How We'll Get There
Through a structured, stepwise process executed on the DEEP platform, we'll:
- Develop Measurement Definitions (MDs): targeted qualitative literature review to build conceptual models around Meaningful Aspects of Health (MAHs), Concepts of Interest (COIs), and candidate digital outcome measures, refined to specific Contexts of Use and drug targets
- Build device-agnostic Target Solution Profiles (TSPs) that define measurement requirements and inform solution selection criteria, building directly on the Measurement Definitions established in Step 1
- Conduct Digital Measurement Solutions (DMS) landscaping to identify and evaluate fit-for-purpose digital technologies capable of capturing the defined measurement concepts and meeting the TSP requirements
- Pursue Early Regulatory Engagement (FDA / EMA) securing feedback on the proposed Measurement Definitions and Target Solution Profiles to inform future digital measure development strategy
- Share reusable, regulatory-ready outputs back to participating sponsors and the broader respiratory community, informing both shared industry understanding and individual sponsor-specific endpoint strategies
Why This Matters
- For cross-industry research: Aligned measurement definitions and device-agnostic standards will improve measurement validity, enable meaningful cross-study comparison, and strengthen evidence generation for digital endpoints in respiratory drug development.
- For your organization: Early FDA and EMA feedback on shared definitions de-risks your downstream endpoint strategy, reduces duplicated regulatory groundwork, and positions your teams for more confident digital endpoint adoption in COPD and non-CF bronchiectasis programs.
- For the industry: A common scientific foundation enables clearer dialogue with regulators, health technology assessment bodies, and notified bodies - accelerating the path from digital innovation to acceptable, comparable endpoints across sponsors.
- For patients: Better measurement standards mean better evidence and more patient-relevant outcomes, leading to therapies that meaningfully reduce the daily burden of respiratory disease.
Join Us
This mission invites organizations actively working on - or planning to work on - digital measures in respiratory disease, including:
- Pharmaceutical sponsors with active or planned COPD and non-CF bronchiectasis programs seeking regulatory-ready digital endpoints
- Technology companies developing digital health technologies (DHTs) for cough and respiratory symptom measurement - including acoustic sensors, wearable devices, smartphone-based platforms, and breathing-pattern analytics
- Academic and clinical research teams pioneering respiratory digital measurement, symptom phenotyping, or patient-reported respiratory outcomes
Your contribution can take many forms - funding, expertise, prior work, or access to validation data - that shape the mission. DEEP's built-in legal framework and mission contracting services simplify collaboration for all partners who wish to engage.
Indicative timeline: the mission is expected to span approximately 9 months, with staggered activities across measurement definition, solution profiling, technology landscaping, and early regulatory engagement.
Interested in co-creating digital measures for respiratory conditions? Contact us to find out more about this mission.
