Focus Day

•  Exploring overlap in clinical presentation, progression patterns, and outcomes across IPF and CTD-ILD
• What emerging molecular and biomarker insights reveal about shared and distinct disease mechanisms in fibrotic ILDs
• Implications for diagnosis, patient stratification, and therapeutic development across heterogeneous ILD populations

This interactive session gives you the opportunity to be part of the discussion, share your ideas and hear from your peers on their thoughts.

Among the key talking points to consider:

• To what extent do IPF and autoimmune-related ILDs represent distinct diseases versus different expressions of a shared fibrotic process, and what does that mean for how we classify and study them?
• Are we currently measuring true biological disease activity in fibrotic ILDs, or mainly late-stage damage, and how might emerging biomarkers change how we define progression and guide treatment?

The Current State of Play in ILD Drug Development

The Current State of Play in ILD Drug Development

This session will examine how patient advocacy organizations are shaping IPF, PPF, and ILD drug development across the full development lifecycle, with a focus on trial design, regulatory engagement, reimbursement considerations, and sustained patient involvement.

• Explore how patient advocacy groups influence clinical trial design, enrolment strategies, and the selection of meaningful endpoints in IPF, PPF, and ILD studies
• Understand the role of patient organizations in shaping regulatory discussions and supporting access considerations for novel therapies
• Identify practical approaches for pharma to build effective, long-term partnerships with patient groups that extend beyond recruitment into ongoing engagement and advocacy  

• Examining how interstitial lung abnormalities detected through screening imaging may represent the earliest stages of fibrotic lung disease and identifying the clinical features that predict progression to clinically significant ILD
• Exploring emerging circulating biomarkers, genetic risk factors, and proteomic signatures associated with disease severity, mortality risk, and likelihood of progression
• Understanding how early identification of high-risk patients could enable earlier therapeutic intervention and more efficient recruitment into ILD clinical trials

• Moving beyond broad disease labels to a molecular understanding of ILD, exploring how multi-omic and biomarker-driven approaches are beginning to define patient subtypes based on underlying biology rather than clinical classification alone
• Advancing strategies to identify patients at risk of progression, including how circulating biomarkers, imaging, and molecular signatures can be integrated to predict disease trajectory and enable earlier, more confident intervention
• Interrogating the “lumping vs splitting” debate in ILD and PPF, and what a precision medicine framework means for patient stratification, clinical trial design, and the future development of targeted therapies

Progressive Pulmonary Fibrosis or PPF represents a heterogeneous clinical construct rather than a single disease. Defining it accurately, enrolling the right patients, and selecting meaningful endpoints remain the biggest challenges in translating promising therapies from bench to bedside. This afternoon track explores these complexities, combining clinical insights, trial design lessons, and actionable strategies for real-world development.

• What basket and multi-indication trial designs are revealing about shared fibrotic biology across ILD subtypes
• Key lessons from recent studies including INBUILD, FIBRONEER-ILD, ALOFT and other progressive fibrosis programs
• How heterogeneous patient populations impact endpoint selection, signal detection, and interpretation of efficacy
• What these trials teach us about trial design in a combination therapy and background-standard-of-care era

Fireside Chat: Designing the ‘Right’ PPF Trial – A Clinician & Developer Dialogue

• Identifying likely progressors by integrating clinical features, pulmonary function trends, imaging patterns, and recognizing the limitations of current PPF definitions
• Examining the current operational and scientific tension by exploring conflicts between ideal trial protocols and real-world patient heterogeneity, including practical recruitment, adherence, and site capability
• Balancing trial design with real-world practice, exploring conflicts, compromises, and the tension between idealized protocols and patient heterogeneity, including the artifact of a 52 week trial duration
• Collaborative perspective integrating clinician judgement, standardized imaging, and enrichment strategies to improve trial success as well as ability to generalize trial data to real-world patients

Designing the ‘Right’ PPF Trial: Clinical Reality vs Drug Development Needs

This interactive session gives you the opportunity to be part of the discussion, share your ideas and hear from your peers on their thoughts.

Among the key talking points to consider:

• Debating whether a standardized definition of PPF is needed across clinical trials and regulatory frameworks
• Exploring how different progression criteria influence trial enrolment, patient selection, and interpretation of treatment efficacy
• Discussing how a harmonized framework could accelerate drug development and improve comparability across PPF studies

This session takes the discussion one step further, discussing actionable strategies for designing trials that are scientifically robust and clinically feasible.

• What are the clinician adaptations needed from standardized imaging to robust progression tracking and integration of real world data
• What will drug developers need to compromise on? Acceptance of subjectivity, broader inclusion, hybrid models combining quantitative metrics and clinical judgement
• What are the pragmatic trial designs: real-world-aligned endpoints, scalable enrichment strategies, and adaptable study protocols

Drug development in interstitial lung diseases has traditionally focused on individual conditions such as IPF or connective tissue disease–associated ILD. However, increasing evidence suggests that many ILDs converge on shared fibrotic pathways. As PPF has emerged as a cross-disease construct to enable trial design, this raises a critical question: are we building therapies for diseases, or for fibrosis itself?

Key Discussion Points:

• What is best disease vs phenotype-driven development? Should therapies be developed for individual ILDs, or for fibrotic progression across diseases through constructs like PPF?
• How indication strategy influence trial design from patient stratification, endpoint selection, and the likelihood of detecting meaningful treatment effects
• Navigating the regulatory and commercial realities of broader indications vs disease-specific labels for approval, positioning, and reimbursement
• As shared fibrotic biology becomes clearer, should drug development move toward mechanism-based approaches rather than traditional disease categories?