In a market where multiple respiratory biologics show comparable FEV1 and exacerbation improvements, the evidence strategy is the differentiator. For Medical Affairs teams, the pressure is familiar: deliver payor-ready outcomes — ED visit reduction, steroid burden, hospitalisations, treatment persistence — in populations that reflect real-world clinical practice, on timelines that maintain competitive advantage in narrow launch windows.

Where site-based approaches are reaching their limits — recruitment speed, access to older, comorbid, polypharmacy, and mobility-limited patients, consistent longitudinal data capture outside the clinic — the operational model needs to evolve alongside the evidence ambition. 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 addressing these constraints in practice.

Why This Matters Now

• Multiple biologics with similar efficacy — the differentiation window is narrowing
• Payors and HTA bodies expect real-world, patient-relevant outcomes earlier in the lifecycle
• Recruitment timelines are now the critical path to launch
• The gap between what dossiers typically include and what decision-makers weigh is widening

What You’ll Hear

How respiratory programmes are:

• Accelerating recruitment timelines through decentralised and hybrid models that reach patients site-only approaches miss
• Reaching broader, more representative populations — including older, comorbid, and mobility-limited patients rarely captured in pivotal data
• Capturing consistent, diagnostic-grade respiratory data remotely using validated tools such as home spirometry (e.g. GoSpiro) — across both mobile and immobile patients, at home and in community settings
• Generating payor-relevant endpoints — exacerbations, ED visits, steroid burden, hospitalisations, treatment persistence — with real-world rigour
• Designing Phase 3b/4 and prospective RWE studies that balance speed, quality, and regulatory credibility

What You’ll Leave With

• A clear picture of what payors and HTA bodies require in respiratory biologic evidence packages — and where the gaps are
• A practical framework for accelerating recruitment while expanding into representative, real-world populations
• How remote diagnostics enable richer, more consistent datasets from diverse patient populations outside the clinic
• How to structure Phase 3b/4 and RWE studies for both speed and submission credibility on launch-relevant timelines

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