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March 24, 2026 12:00 PM ET / 4:00 PM GMT | 60 Minutes

Beyond FEV1: Similar Efficacy, Different Outcome

Mar 24
4:00 pm
GMT
Differentiating Respiratory Assets Through Patient-Centered Evidence

In crowded respiratory markets - particularly asthma and COPD biologics - where multiple therapies show comparable FEV1 and exacerbation improvements, the assets best positioned for favorable coverage and reimbursement are those that can demonstrate real-world value payors, HTA bodies, and prescribers use in formulary decisions.

Generating that evidence means reaching populations that reflect real-world clinical practice - including comorbid, polypharmacy, and community-based patients less commonly represented in pivotal trial data. It means capturing outcomes such as ED visit reduction, steroid burden, and treatment persistence with sufficient rigor for payor and HTA submissions, on timelines that maintain competitive advantage in narrow launch windows. It also means deploying novel approaches - digital biomarkers and remote spirometry - that go beyond conventional evidence generation to differentiate with both payors and physicians.

This webinar provides a framework for doing that. Drawing on examples from respiratory biologic programs and real-world endpoint capture, panelists will discuss what payors and physicians require, how to design Phase 3b, 4, and prospective RWE studies that deliver it, and where remote diagnostics add value.

Key Takeaways:

  • How patient-centered endpoints  (e.g. exacerbations, ED visits, steroid burden hospitalizations, treatment persistence) translate into payor-relevant outcomes that drive coverage decisions in competitive respiratory markets
  • What payors and HTA bodies need to see in respiratory biologic evidence packages - and where current submissions often fall short
  • Validated approaches for capturing real-world respiratory outcomes using remote diagnostics, where appropriate
  • Practical examples of how evidence strategies have been structured to create competitive differentiation in crowded respiratory markets

Chair
Dr. John Matthews
Chief Medical Officer
ReCode Therapeutics, Guy's and St Thomas' NHS Foundation Trust, Imperial College
Pulmonologist and clinical drug developer with over 21 years of experience across all phases of development, including large and small molecules and inhaled drug delivery. Previously held leadership roles at GSK, Roche/Genentech, and 23andMe. Ph.D. in respiratory clinical pharmacology from Imperial College London.
Panelists
Dr. John Hurst
Professor & Pro Vice Provost
University College London
NIHR Global Health Research Professor and senior academic clinician with a research focus on exacerbation phenotyping and biomarker-driven patient stratification in airways disease. Former Senior Clinical Lead to the UK National respiratory audit programme (NACAP), Associate Editor at the European Respiratory Journal, and a Key Opinion Leader to major pharmaceutical companies.
Joanne Fletcher, PHD
Former Clinical Lead Respiratory Biologics
GSK
R&D leader with 20+ years in respiratory clinical operations. At GSK, she was instrumental in delivering the landmark Salford Lung Studies, among the largest pragmatic real-world effectiveness trials ever conducted in respiratory medicine.
Andrew Cournoyer
SVP, Head Access Experience Team
Precision AQ
Recognised managed care leader and payor industry expert with over 20 years of experience in drug coverage benefit design, market access, and formulary strategy. Specialises in optimising pharmaceutical access across commercial and Medicare lines of business, with deep expertise in the reimbursement decisions, innovative contracting, and utilisation management programmes that shape how payors evaluate and differentiate competing therapeutics.
José Ramos, MEd, RRT, RPFT
Director, IDN & Clinical Trials
Monitored Therapeutics
Lung function testing specialist since 1995, formerly Director of the Pulmonary Function Laboratory network at Cleveland Clinic. Now leads clinical trials operations for MTI's GoSpiro, one of the few diagnostic-quality home spirometers validated for regulatory submissions.
Malcolm Fogarty
Global Head, Strategic Partnerships
Lindus Health
Healthcare leader with 20+ years scaling health and technology businesses, including at GSK & Haleon. At Lindus Health, he works with pharma and biotech sponsors to design and execute best-practice Phase 3b/4 and RWE studies that generate the differentiated data physicians, payors and guideline bodies need to see.
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