Explore the Agenda
8:25 am Chairs Opening Remarks
Advancing Pulmonary Fibrosis Drug Development at a Global Scale for Wider Patient Benefit
8:30 am Panel Discussion: Providing Practical Insights into Conducting Effective Global Clinical Trials that Remain Efficient, Compliant, & Scientifically Robust
As pulmonary fibrosis trials continue to expand globally, sponsors must navigate an increasingly complex operational landscape. Differences in regulatory expectations, site capabilities, patient access, and trial infrastructure across regions can significantly influence study timelines, enrolment success, and data quality.
Key Discussion Points Include:
- Navigating regional regulatory and ethics requirements, including how differing approval timelines, IRB/ethics committee expectations, and evolving regulations in emerging markets can impact global trial execution
- Strategies for identifying and activating high-performing sites, engaging investigators with varying levels of ILD expertise, and preventing under-enrolment or inactive sites across geographically diverse trial networks
- Managing the operational complexities of multinational trials, including drug distribution, cold chain logistics, imaging standardization, biomarker collection, and cross-border data integrity while maintaining compliance with GCP and regional privacy regulations
- Lessons from recent global IPF studies on designing scalable protocols, anticipating operational bottlenecks, and integrating hybrid or decentralized approaches to maintain efficiency without compromising data quality
9:29 am Redefining Clinical Endpoints in Pulmonary Fibrosis & Moving Beyond FVC to Capture True Treatment Impact
9:30 am Opportunity to Partner & Present
Please contact sponsor@hansonwade.com for more information.
10:00 am Panel Discussion: Endpoints Evolution in Pulmonary Fibrosis: FVC, Multi-Modal Measures & Imaging in a Changing Trial Landscape
Forced Vital Capacity remains the anchor endpoint for pulmonary fibrosis trials and the filed remains split on torn on its value. What’s more the field is evolving to capture a more complete picture of disease progression and therapeutic impact. This panel will dig into FVC and secondary endpoints, the emerging role of quantitative HRCT and other imaging biomarkers, the evidence required for regulatory acceptance, standardization across providers, and the integration of multi-modal endpoints into trial design, all to ensure you leave with a clear understanding of how to design trials that balance traditional FVC measurements with innovative endpoints, enabling robust efficacy assessment, regulatory alignment, and differentiation in an increasingly complex ILD landscape.
- The continued relevance of FVC as a surrogate for disease progression and mortality in IPF and PPF
- How secondary endpoints can complement FVC to reveal meaningful changes in symptoms, quality of life, and disease biology
- Advances in quantitative imaging, including AI-driven HRCT, and the pathway toward regulatory qualification
- Strategies for integrating multi-modal endpoints into trial design without overcomplicating study execution
- Practical considerations for trial sponsors: standardization, subgroup analysis, and managing background therapy
Interactive Roundtable Discussion – Audiences follow-on reflections from the panel
- How should we integrate multi-modal endpoints into IPF trial design without overcomplicating execution?
- What evidence is still needed for broader regulatory acceptance of imaging and novel endpoints?
- Are current endpoint strategies in IPF still fit for purpose in an era of combination therapies and smaller treatment effects?
10:45 am Morning Break
Track 1: Emerging Biology & Early Translation
Examining the Next Generation of Targets with the Potential to Revolutionize the Treatment Paradigm
11:30 am New Target Spotlight Session
- Reserved for Boehringer Ingelheim
12:00 pm Restoring Alveolar Integrity in IPF: Targeting AT2 Receptor Biology with ATRAGs & Advancing Disease Modifying Potential in the Phase 2b ASPIRE Trial
- Exploring how dysfunction of alveolar type 2 (AEC2) cells drives loss of lung integrity and initiates fibrotic remodeling, positioning epithelial repair as a novel therapeutic strategy
- Understanding how angiotensin II type 2 receptor agonists (ATRAGs), including buloxibutid, activate protective signaling pathways to promote alveolar repair, restore tissue homeostasis, and reduce fibrotic progression
- Reviewing the design of the global, randomized, placebo controlled ASPIRE study evaluating buloxibutid over 52 weeks, including its focus on FVC outcomes, background standard-of-care integration, and potential to demonstrate disease-modifying effects in IPF
Track 2: Late Translation & Clinical
Advancing Patient Centred Care in IPF to Move Beyond Lung Function to Symptom Burden to Improve Quality of Life
11:30 am Panel Discussion: Which Patient-Reported Outcomes Should We Use in IPF Trials and Care to Ensure were Measuring What Matters to Patients
- Comparing commonly used IPF patient-reported outcome measures, including ERS-IPF, K-BILD, cough-specific instruments, and Living with IPF to understand their strengths, limitations, and clinical relevance
- Exploring why PRO use varies across trials, including regulatory expectations, endpoint selection, and differences in therapeutic mechanisms
- Discussing whether the field should move toward standardized PRO frameworks to better capture symptoms such as cough, breathlessness, fatigue, and overall quality of life
12:00 pm Addressing Adverse Effects, Adherence, & Drug Discontinuation to Manage Treatment Burden in IPF
- Understanding the real-world challenges associated with current antifibrotic therapies, including gastrointestinal side effects, tolerability issues, and the high annual discontinuation rates seen in clinical practice
- Exploring strategies to improve treatment adherence and quality of life through supportive care, dose optimization, and multidisciplinary management approaches
- Discussing how future therapies and trial designs may reduce treatment burden while maintaining clinical benefit for patients living with IPF
12:30 pm Lunch Break
1:30 pm Panel & Audience Discussion: Where Will the Next Wave of Fibrosis Targets Come From?
Despite decades of research, therapeutic development for IPF and progressive pulmonary fibrosis remains constrained by limited target diversity and high clinical attrition. With advances in single-cell technologies, imaging, and human tissue models, the field is rethinking how to discover and validate the next generation of fibrosis targets.
Discussion Topics Include:
- Reassessing Historical Pathways: Revisiting canonical mechanisms such as TGF-β signaling, integrins, and inflammatory mediators, what have we learned, and do these pathways still hold untapped therapeutic potential?
- Emerging Target Opportunities: Exploring epithelial repair, fibroblast heterogeneity, immune modulation, and regenerative biology as potential avenues for next-generation interventions.
- Bridging Preclinical Insights to Clinical Readouts: How preclinical findings and cellular-level insights can guide trial design, biomarker selection, and patient stratification; challenges of relying solely on lung function endpoints (FEV/FVC); and leveraging multi-omics, spatial biology, and imaging technologies to accelerate target validation and predict meaningful clinical outcomes.
- Forward-Looking Questions: Which cellular or molecular readouts best predict clinical efficacy? Can we design trials focused on fibrosis biology rather than aggregated lung function metrics? How can new technologies inform both target discovery and endpoint selection for more translatable therapies?
1:30 pm Insights from Phase 2a Development of a Novel Immune-Modulating Therapy in IPF on Translating Mechanism into Meaningful Clinical Signals
- What early clinical and molecular signals tell us about targeting upstream immune pathways, including how gene expression, serum biomarkers, and immune modulation can demonstrate impact on core drivers of fibrosis such as myofibroblast activation, ECM deposition, and epithelial injury
- Evaluating evidence for fibrosis resolution and lung repair, including signals of basement membrane restoration and epithelial cell transition, and how these reshape expectations for what ‘efficacy’ looks like in IPF trials
- Positioning novel therapies in an evolving treatment landscape, including where immune-modulating and regenerative approaches may sit alongside existing antifibrotics, and what differentiation is required to support combination strategies and future standard-of-care integration
2:00 pm From Concept to Clinic: Advancing Novel Mechanisms & Regenerative Approaches in IPF as an Emerging Biotech
- Sharing the journey of progressing a novel therapeutic concept into the clinic in IPF as a startup, including key scientific, operational, and funding challenges faced when building a program in a high-risk, high-reward disease area
- Exploring the shift beyond traditional antifibrotic approaches toward repair and regeneration-focused strategies, and the critical considerations when developing therapies targeting novel, and not yet widely validated, mechanisms
- Translating cross-disease learnings into IPF clinical development, including how prior experience in other respiratory indications has informed trial design, endpoint selection, and strategies to demonstrate early signals of efficacy
2:30 pm Tea Break
2:45 pm Chairs’ Recap of the Track Sessions: Coming Together Across the Therapeutic Development Stages to Harness a Complete Picture of the Pulmonary Fibrosis Field
Diving into Combination Therapy: From Preclinical Rationale to Clinical Implementation
3:00 pm Visualizing Response in a Multi-Drug Era: Can Imaging Guide Mechanism, Monitor Impact & Inform Smarter Combination Strategies?
- Exploring how emerging modalities (e.g., cryo-fluorescence tomography, spatial tissue mapping, quantitative imaging) could move beyond static readouts to interrogate where and how therapies are acting within lung compartments—and whether mechanism of action can be localized in vivo
- As pulmonary fibrosis moves toward multi-drug regimens, discussing whether imaging alongside multi-omics could help clarify the relative contribution of individual therapies, including overlapping or complementary mechanisms
- Considering whether serial, spatial imaging could enable more dynamic treatment decisions—guiding when to add, maintain, rotate, or withdraw therapies based on localized response rather than global endpoints
- Outlining current feasibility, key limitations, and what must evolve for imaging-driven treatment optimization to become clinically actionable
3:30 pm Panel Discussion: Translating Preclinical Combination Data into Clinical Development Strategy
- Strategies for testing new investigational agents on top of standard-of-care drugs (Nintedanib, Pirfenidone, Nerandomilast), including selecting appropriate patient populations, managing heterogeneity, and adapting inclusion/exclusion criteria to balance scientific rigor with feasibility
- Evaluating potential pharmacodynamic and pharmacokinetic interactions, predicting additive, synergistic, or antagonistic effects, and translating mechanistic insights from preclinical models into clinical trial design to ensure patient safety while maximizing therapeutic benefit
- Leveraging biomarkers, imaging readouts, and exploratory endpoints to validate mechanism-of-action, identify early signals of efficacy, and design trials that are both regulatory-compliant and clinically meaningful, while learning from existing trials and real-world experience