The post-approval evidence challenge in respiratory biologics is a study design problem: how to capture the outcomes payors and physicians need, in the populations pivotal trials were not designed to reach, on timelines the competitive landscape demands.

For clinical development teams, that means Phase 3b/4 and prospective RWE studies built for patient-centred outcomes — ED visits, hospitalisations, steroid burden, treatment persistence — across broader, more representative populations: older, comorbid, polypharmacy, and mobility-limited patients. It means accelerating recruitment through community-based and hybrid approaches. And it means integrating remote diagnostics — such as validated home spirometry — that capture consistent, diagnostic-grade data from patients across age groups and mobility levels without requiring clinic visits, while maintaining the rigour required for payor and HTA submissions.

Where site-only models are reaching their limits on speed, population breadth, and consistent real-world data capture, the study design itself needs to account for that — particularly in respiratory conditions where variability, adherence, and environment matter.

In this webinar, panelists from across pharma, managed care, academic medicine, and clinical operations discuss how respiratory programmes are designing studies that address these constraints.

Why This Matters Now

• Multiple biologics with similar efficacy — post-approval evidence is now the differentiator
• Payors and HTA bodies expect real-world, patient-relevant outcomes from representative populations earlier in the lifecycle
• Recruitment timelines are the critical path — study designs that cannot enrol diverse patients efficiently will miss the window
• Remote diagnostics are maturing rapidly, enabling broader enrolment and richer data capture outside the clinic

What You’ll Hear

How respiratory programmes are:

• Designing Phase 3b/4 and prospective RWE protocols with broader inclusion criteria, real-world endpoints, and community-based enrolment
• Enrolling older, comorbid, and mobility-limited patients through decentralised and hybrid models that accelerate recruitment timelines
• Integrating remote spirometry (e.g. GoSpiro) and digital biomarkers to capture consistent, diagnostic-grade respiratory data from both mobile and immobile patients, complementing in-clinic assessments
• Selecting and designing for patient-centred endpoints that meet the evidence bar for payor and HTA submissions
• Balancing speed, patient diversity, and submission-grade rigour in post-approval study design

What You’ll Leave With

• Key design decisions that determine whether post-approval evidence is credible enough to influence coverage — endpoint selection, population breadth, and data capture approach
• How remote diagnostics enable broader enrolment and richer longitudinal data without compromising data quality
• Practical examples of how post-approval studies have been structured to balance speed, diversity, and rigour
• How clinicians and payors view evidence from remote devices versus in-clinic measurements