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

Beyond FEV1: Similar Efficacy, Different Outcome

Closing Evidence Gaps Faster with Representative Populations, Real-World Endpoints, and Remote Diagnostics

When multiple respiratory biologics show comparable FEV1 and exacerbation data, the differentiation challenge shifts to the evidence strategy: which outcomes, in which populations, generated on what timeline — and whether you get there before a competitor does.

For medical leads, that increasingly means evidence from the patients current pivotal data misses: older, comorbid, polypharmacy, and mobility-limited populations in community settings. Outcomes that reflect how these diverse, real-world patients respond to treatment. And an operational approach that can deliver it at the speed the competitive window demands — where site-only models are reaching their limits on both recruitment pace and population breadth.

In this webinar, panelists from across pharma, managed care, academic medicine, and clinical operations discuss how respiratory programmes are closing these evidence gaps in practice.

Why This Matters Now

  • Multiple biologics with similar efficacy — the differentiation window is narrowing
  • Guideline bodies and prescribers need real-world evidence from representative populations to differentiate therapies in practice
  • Evidence gaps identified today may be closed by a competitor tomorrow
  • Site-only models are reaching their limits on both speed and the population breadth physicians need to see

What You’ll Hear

How respiratory programmes are:

  • Identifying the evidence gaps that matter most to prescribers and guideline bodies — beyond FEV1 and exacerbation rates
  • 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 patients of all age groups and mobility levels, at home and in community settings
  • Translating evidence gaps into actionable Phase 3b/4 and prospective RWE study designs that deliver evidence faster
  • Generating clinically meaningful longitudinal data that supports differentiation with both physicians and payors

What You’ll Leave With

  • A clear view of which patient-centred outcomes matter most to prescribers and guideline bodies when differentiating respiratory biologics
  • How remote diagnostics generate clinically meaningful data from diverse populations that conventional approaches miss
  • Practical approaches to translating evidence gaps into study designs that reach representative populations faster
  • How to structure Phase 3b/4 and RWE studies that balance clinical relevance, speed, and submission credibility

Register here!

Mar 24, 2026 12:00 PM ET / 4:00 PM GMT
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 whose research on exacerbation phenotyping and biomarker-driven stratification informs how respiratory biologics are differentiated in clinical practice — particularly the need for evidence that reflects real-world patient heterogeneity. Associate Editor at the European Respiratory Journal and Key Opinion Leader advising major pharmaceutical companies on evidence gaps in airways disease.
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, which enrolled representative real-world populations across community settings, and in translating medical strategy into post-approval evidence programmes that addressed physician and guideline-body evidence requirements for respiratory biologics.
Andrew Cournoyer
SVP, Head Access Experience Team
Precision AQ
Managed care leader with over 20 years advising pharmaceutical teams on evidence strategies for payor and HTA submissions. Deep expertise in the formulary decisions, coverage policies, and utilisation management programmes that shape how competing respiratory biologics are positioned and accessed — and why evidence from representative, real-world populations carries increasing weight.
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. Leads clinical trials operations for MTI’s GoSpiro, a diagnostic-quality home spirometer validated for regulatory submissions. GoSpiro enables remote spirometry data capture across diverse patient populations — including older and mobility-limited patients who may not attend regular clinic visits — generating clinically meaningful longitudinal data that can inform medical strategy and guideline discussions.
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 partners with pharma and biotech medical teams to design and execute Phase 3b/4 and RWE studies that close evidence gaps faster — reaching the diverse, representative populations physicians and guideline bodies need to see in competitive respiratory markets.

Register below:

Copyright © 2026 Lindus Health Limited. All rights reserved. 145 Tremont Street, Boston, MA 02111