Explore the Agenda
7.30 Light Breakfast
8:25 am Chairs Opening Remarks
8:30 am AI Showcase for Drug Development & Advances in Fibrosing Lung Disease
- Learn about the robust clinical data curation, global normalization and advanced data power to drive radical progress in drug development for fibrosing lung diseases
- See quantifiable Artificial Intelligence (AI) advances that this data has already powered, including various disease quantification tools and emerging innovations
- Discuss the long-term vision of imaging in fibrosing lung diseases, including the potential inclusion of lung cancer screening for risk scoring of ILA’s
- Learn about Project Opus, a new, real-time observational study that applies AI and machine learning technology to the spirometry, environmental, and imaging data
9:00 am Panel Discussion: Rethinking Endpoint Selection to Accelerate Innovation in Pulmonary Fibrosis Drug Development
Imaging offers a direct window into disease progression, but its role in predicting treatment response and improving trial design remains uncertain. While AI-driven imaging shows promise, regulatory acceptance and standardization are key challenges. This panel will explore how imaging can enhance clinical trials and accelerate drug development.
Key Discussion Points:
- What role can imaging play as a surrogate or co-primary endpoint? How close are we to standardized, validated imaging biomarkers, and what can be learned from oncology or neurology?
- How should the field approach integration of patient-reported outcomes and real-world evidence to reflect lived patient experience?
- What are the key regulatory considerations in validating novel endpoints, whether AI-derived, biomarker-based, or functional? How can stakeholders proactively align on evidentiary standards?
- How can trial sponsors, academic experts, and regulators collaborate to build a more flexible, data-driven framework for endpoint selection in future studies?
10:30 am Morning Break
Track 1: Emerging Biology & Early Translation
Assessing Repair & Regeneration: A New Era or the Next Clinical Trap?
11:00 am Deep Diving into the Biology of Pulmonary Fibrosis: Where Does Repair, Regeneration & Remodeling Play a Role?
- Examining key cell types involved in fibrosis progression and their role in repair and regeneration
- Identifying where in the disease process intervention could drive meaningful tissue repair and prevent irreversible damage
- Exploring emerging strategies in cell therapy, regenerative medicine, and molecular targets to restore lung function
11:30 am Promoting Tissue Regeneration Through Modulation of AT2 Receptor Pathway
- Harnessing the AT2 receptor pathway to drive lung tissue repair and counteract fibrotic remodeling in pulmonary diseases, a distinct mechanism from conventional antifibrotics
- Exploring the regenerative potential of C21, an AT2R agonist, to restore alveolar epithelial function and promote vascular integrity
- Advancing a new class of regenerative therapies by targeting endogenous repair pathways, with a focus on improving clinical outcomes through enhanced lung function, symptom relief, and disease modification.
12:00 pm Exploring Elimination of Senescent Cells Through Activation of Endogenous Immune Surveillance Mechanism
- Investigating the role of tissue-resident immune cells in identifying and clearing senescent cells implicated in pulmonary fibrosis progression
- Evaluating Deciduous Therapeutics’ novel strategy to restore immune surveillance as a therapeutic approach to halt or reverse fibrotic remodeling.
- Highlighting preclinical data supporting immune modulation over direct senolytic strategies to improve safety, selectivity, and long-term efficacy in IPF
Track 2: Late Translation & Clinical
Innovations in Clinical Development
11:00 am Redefining Cough in IPF: Central Mechanisms, Patient Impact & Therapeutic Opportunity
- Exploring refractory chronic cough as a distinct clinical burden in IPF and ILDs: what are we missing in current trial designs?
- Is cough the “itch of the lung”? Drawing translational parallels between chronic cough and other hypersensitization syndromes like atopic dermatitis
- Mechanistic insights: The role of centrally acting, unscheduled opioid receptor modulators in treating IPF-related cough versus peripherally targeted approaches
- Clinical considerations in trial design, endpoint selection, and measuring meaningful improvement for patients living with IPF-related chronic cough
11:30 am Designing Clinical Trials with Patients in Mind to Align Scientific Goals with Real-World Needs
- Integrating fatigue, cough, and other patient-centered outcomes into clinical trial design – How can we better capture the true impact of therapies on quality of life?
- Developing endpoints that go beyond regulatory approval to deliver meaningful data for patients and clinicians
- Leveraging Insight from Patient Organizations to improve recruitment, retention and relevance
12:00 pm How Can the Evolution of Trials & Guidelines in Pulmonary Hypertension Inform Future Efforts in IPF/ILD?
- Lessons from the evolution of endpoints in PH trials: from 6-minute walk test to composite and patient-centric outcomes
- Applicability of combination and sequential therapy strategies in IPF/ILD clinical development
- How changes in PH guidelines have influenced trial design – and what that could mean for future IPF/ILD guidance
12:30 pm Lunch Break
1:30 pm Exploring Elimination of Senescent Cells Through Harnessing RNA Based Biology
- SENISCA have discovered a new and druggable cause of cellular ageing, dysregulated mRNA processing
- We have designed an RNA therapeutic with a unique MoA capable of restoring levels of splicing regulators back within their homeostatic limits for selective reprogramming of senescent cells
- We have demonstrated efficacy for our new approach in primary human IPF patient cells and in precision cut lung slices from patients with IPF and other interstitial fibrosis disorders
2:00 pm Panel Discussion: Exploring the Feasibility and Future of Lung Regeneration in IPF: Challenges, Opportunities, and Emerging Therapies
Panel Discussion Points:
- Is complete lung regeneration achievable, or is the primary goal to halt further tissue damage and improve function in IPF?
- What are the potential risks (e.g., tumorigenesis, stem cell activation) versus the promising benefits of regenerative therapies?
- Which biomarkers are crucial to track and validate the success of regenerative approaches in IPF?
- How can insights from tissue engineering, oncology, and other regenerative medicine areas inform and advance lung regeneration therapies for IPF?
- Which regenerative approaches are showing real potential for recovery versus those focusing on disease modification in the IPF treatment landscape?
1:30 pm Redefining the Diagnostic Landscape: Early Detection of ILD & the Clinical Relevance of ILA
- Clarifying the distinction between ILA and early-stage ILD to inform diagnosis and management
- Predicting progression to ILD using imaging, exposure history, and autoimmune features
- Establishing early detection infrastructure through dedicated ILA clinics and surveillance strategies
2:00 pm Collaborative Acceleration: PROLIFIC Consortium Update on Advancing PF Research Through Real-World Data & Biomarker Integration
- Explore how the PROLIFIC Consortium is leveraging longitudinal clinical data and biosamples across diverse care settings to refine our understanding of pulmonary fibrosis progression and treatment outcomes
- Get the latest updates on multi-center efforts to identify, validate, and implement molecular and imaging biomarkers that can predict progression, inform trial design, and personalize care
- Understand how this NIH-funded initiative is creating a robust framework to support open science, harmonized data collection, and future clinical trials by bringing together academic centers, biobanks, and industry partners
2:30 pm Afternoon Break
Deep Diving into Considerations for Combination Therapy
3:00 pm Panel Discussion: Rethinking Combination Strategies in IPF: From Preclinical Models to Patient Selection
With momentum building around combination approaches in IPF, this panel will explore how to design smarter strategies grounded in mechanistic complementarity, translatable models, and biomarker-driven patient selection.
Key Talking Points:
- Identifying orthogonal vs. redundant mechanisms to guide rational combination design
- Reassessing preclinical models to better evaluate multi-drug interactions, safety, and efficacy
- Using biomarkers and radiomics to refine patient stratification and predict response
- Defining when standard-of-care therapy isn’t enough and how to optimize add-on strategies for maximum impact
What’s Next: Explore Emerging Therapeutics with the Potential to Revolutionize the Landscape
3:30 pm Unlocking mRNA Biology for IPF: Advancing Small Molecule Approaches to Modulate Protein Translation
Session Reserved for Anima Biotech
3:50 pm Targeting Pro-Fibrotic Macrophage Signatures & CCN Biology: Translating Preclinical Insights into a Next-Gen IPF Therapeutic
- Highlighting precision-cut lung slices and airway basal cell bronchosphere assays as predictive tools for translational validation
- Demonstrating modulation of pro-fibrotic macrophage markers in human-derived systems in collaboration with FibroFind and Antiverse
- Exploring the therapeutic rationale behind targeting CCN signaling pathways in the context of previous setbacks and renewed opportunities in IPF
4:10 pm Restoring Lung Homeostasis: A Dual-Target Approach to Treating IPF through Epithelial Repair and Inflammation Modulation
- Addressing IPF at the Source: Targeting the dysfunctional crosstalk between the epithelium and immune system as a root cause of disease progression.
- EPHX2 Inhibition as a First-in-Class Strategy: Leveraging sEH inhibition to resolve inflammation and restore lipid signaling pathways essential for epithelial barrier integrity.
- A New Era in Anti-Fibrotic Therapy: Integrating insights from lung homeostasis biology to inform preclinical validation and future clinical translation
4:30 pm Exploring a Novel TGF-β Pathway Modulator
- GTX-11, an orally available TGF-β pathway modulator, has shown potent anti-fibrotic, anti-inflammatory, and vascular-protective effects across multiple preclinical models, including bleomycin-induced lung fibrosis, patient-derived fibroblasts, and precision-cut lung slices (PCLS)
- With an excellent preclinical safety and toxicology profile, GTX-11 effectively reduces SMAD2/3 activation, fibroblast-to-myofibroblast transition, and vascular dysfunction, positioning it as a promising therapeutic candidate
- Now in Phase I clinical trials, GTX-11 represents a promising new approach for treating fibrotic interstitial lung diseases (ILDs), offering potential advantages over existing therapies