Explore the Agenda
7:00 am Check in & Light Breakfast
7:50 am Program Director’s Welcome
7:55 am Chairs Opening Remarks
Understanding & Adapting to a Changing Pulmonary Landscape with an Evolving Treatment Paradigm
8:00 am Evaluating Nerandomilast in Pulmonary Fibrosis: Learning Lessons From the Clinical Development Program
- How did the preclinical and translational data inform the design of the phase II and phase III trials? What were the key trial design features, patient populations, endpoints, and readouts that contributed to the successful outcome?
- How were the insights from both preclinical and clinical stages integrated into a cohesive development strategy that led to a positive phase III readout? What can we learn for future trials in IPF?
8:30 am Advancing Rentosertib: An AI-Discovered TNIK Inhibitor Targeting IPF in Global Phase 2 & 3 Trials
- Detailing the discovery and development of Rentosertib (INS018_055), a first-in-class small molecule TNIK inhibitor identified through end-to-end generative AI
- Overview of clinical progression: positive safety and efficacy signals from a completed Phase 2a trial, with Phase 2b in the US and a Phase 3 trial underway in China
- Reflections on the integration of AI in early discovery and translational development, and navigating multinational clinical trial strategies for IPF
9:00 am Uncover Opportunities to Engage with Patients through the Pulmonary Fibrosis Foundation
9:15 am Panel Discussion: Navigating the Evolving IPF Treatment Landscape: Implications for Drug Discovery & Development
With Nintedanib and Pirfenidone approaching patent expiration, the IPF treatment landscape is at a pivotal moment. The industry is now exploring next-generation therapies, combination strategies, and novel mechanisms of action to address the remaining unmet needs in fibrosis progression and lung function preservation. However, as new therapeutic approaches emerge, challenges arise in clinical trial design, endpoint selection, and regulatory pathways.
This panel will examine the evolving IPF treatment paradigm, discuss the role of combination therapy, and explore how the
upcoming shifts will influence drug discovery, clinical development, and patient outcomes.
Discussion Points:
- What impact will the upcoming patent expirations of Nintedanib and Pirfenidone have on innovation and investment in IPF drug development?
- How are combination therapy strategies shaping the future of IPF treatment, and what are the key scientific and regulatory hurdles to address?
- What lessons can we learn from the development of past fibrosis treatments to optimize clinical trial design, including endpoints beyond FVC?
- With new mechanisms in development, what biomarkers and surrogate markers can better predict treatment efficacy and guide future therapeutic strategies?
- How do we ensure that novel therapies advance patient outcomes while maintaining accessibility and regulatory compliance in an evolving landscape?
- How evolving payer expectations around value, outcomes, and cost-effectiveness should inform early clinical trial design in IPF to support future market access, especially as next-generation therapies and combination strategies emerge
10:00 am Speed Networking
This informal session provides the perfect opportunity to connect with the industry frontrunners and key opinion leaders in the pulmonary fibrosis field. Establish meaningful connections to build upon for the rest of the conference and gain exclusive first-hand insights into the latest research and developments driving progression in the pulmonary fibrosis field.
10:45 am Morning Break
Track 1: Emerging Biology & Early Translation
11:00 am Building the Foundation for Success: Unpacking the Discovery & Preclinical Development of Nerandomilast
What were the key scientific hypotheses and mechanistic insights that shaped the discovery of Nerandomilast, and how was its target pathway prioritized for development?
- Which preclinical models, assays, and biomarkerscwere instrumental in demonstrating early efficacy and translatability? What differentiated these findings from past failures in the field?
- How did the integration of pharmacodynamic data, toxicology, and translational biomarkers enable informed decisionmaking and de-risk progression into clinical trials?
11:30 am Roundtable Discussion: Advancing Modelling in IPF: The Challenges, Opportunities & Next Steps
As we seek to refine our understanding of IPF pathogenesis and therapeutic response, advanced disease modelling remains a critical challenge. This interactive roundtable discussion allows you to share your thoughts on the current limitations in modelling approaches, strategies for improvement, and the feasibility of global initiatives to enhance research resources.
- Beyond the Bleomycin Model: Discussing alternative models such as patient-derived organoids, AI-driven models, and humanized systems to improve disease predictability
- Tissue Scarcity: Exploring the feasibility of a coordinated effort to collect biopsy samples globally for research, addressing logistical and ethical concerns
- Explanted Lungs in Research: Evaluating the role of lungs from transplant recipients in studying disease progression, and their relevance to early-stage IPF
- Building Predictive Models: Identifying criteria for next-gen models that integrate multi-omics and patient samples to enhance translational relevance.
12:00 pm Unveiling GHB1589: A Precision Oligo Therapy for the Treatment of IPF
- Presenting GHB1589, a precision microRNA replacement therapy with potential application across seven fibrotic diseases, including IPF
- Tracing its journey from target discovery, based on analysis of over 3,100 human subjects, through to preclinical research findings
- Showcasing a blood-based biomarker assay designed to identify patients with low microRNA expression, enabling a precision treatment approach
Track 2: Late Translation & Clinical
11:00 am Exploring Multi Marker Modelling to Inform Prediction Modelling for Optimizing Patient Selection
- Exploring multi-marker modeling and the potential of combining biomarkers to improve prognostication and patient selection for ILD clinical trials
- Assessing how biomarkers can be used to predict treatment response in ILD
- Evaluating multi-modal biomarker strategies that incorporate data from clinical, genomic, proteomic, and imaging domains to improve outcome discrimination in ILD
11:30 am Examining the Use of Oscillometry in IPF Drug Development
- Introducing oscillometry and its function as a measurement tool, and its position compared to traditional endpoints like FVC and imaging for monitoring disease progression in IPF
- Outlining key practical considerations for integrating oscillometry into trial design, including optimal timing, standardization, device requirements, data analysis, and how it can complement established endpoints to enhance confidence in clinical decisions
12:00 pm Yinfenidone (HEC585): A Promising New Drug Candidate for the Treatment of Pulmonary Fibrosis
- A potential best-in-class drug candidate that is >100-fold more potent than pirfenidone in vitro and has longer half-life allowing once daily dosing
- Preliminary results from a Phase 2 clinical study in IPF patients showed more pronounced effect on FVC at 24 weeks with improved safety and tolerability
- Key preclinical and clinical data will be presented for the first time
12:10 pm Unraveling the Extracellular Matrix and its Remodelling to Improve the Understanding of Pharmacological Effects in Patients with Pulmonary Fibrosis
- Association between ECM remodeling biomarkers and IPF severity/progression
- Reduction of ECM biomarkers in IPF/ILD clinical trials and link to lung function improvement
- Fibrogenesis biomarkers in preclinical models to support early drug development
12:30 pm Lunch Break
Track 1: Emerging Biology & Early Translation
1:30 pm Panel Discussion: Rethinking IPF Drug Development: Learning from the Past & Defining the Future of Target Discovery
- Assessing past and present targets, what has the field learned from antifibrotic failures, and is there still potential in pathways like TGF-β?
- Exploring emerging therapeutic strategies from repair and regeneration to RNA-based therapies, cell and gene therapy, and immunomodulation
- Identifying unmet opportunities by exploring what mechanisms remain underexplored, where should research efforts be focused next to drive meaningful progress?
2:00 pm Examining Cell Therapy in IPF: Harnessing ADCs & Leveraging Non-Cytotoxic TGF-β Payload to Selectively Target IPF & Reduce Toxicity
- Exploring the potential of ADCs to selectively deliver therapeutics while minimizing systemic toxicity
- Revaluating specific targeting of TGF-β in fibrosis by leveraging non-cytotoxic payloads to modulate TGF-β signaling without adverse effects
- Integrating ADCs with emerging approaches to enhance efficacy and safety in IPF treatment
2:30 pm IPF Treatment: Exploring Novel Approaches for Disease Modification
- Inhaled antisense as a novel paradigm for lung therapeutics
- Advancing innovative technology enables the targeting, interrogation, and validation of genes associated with IPF that may be difficult to reach with other approaches
- Exploring MUC5B as a Novel IPF Target: Pros, Cons, and Proof-of-Concept Data
Track 2: Late Translation & Clinical
1:30 pm Stratifying Patients for Improved Trial Outcomes – High-Risk vs Low-Risk in the Maverick IPF Survival Trial
- Exploring the premise of stratifying patients by risk level (high vs low)
- Shifting focus from FVC decline to survival as a primary endpoint in clinical trials, and how this could offer more meaningful insights into treatment efficacy for IPF
- Discussing the role of proteomics and biomarkers in identifying high-risk patients and optimizing trial design to better reflect patient populations likely to benefit from treatment.
2:00 pm Panel Discussion: Practical Considerations for Optimizing Spirometry & Other Endpoints in Pulmonary Fibrosis Clinical Trials
- A moderated discussion between PureTech and Vitalograph about the common challenges that clinical trials face and practical strategies to overcome them
- Puretech review how they designed and conducted their Phase 2b IPF study to maximise data quality
- Key learnings PureTech are taking into their Phase 3 preparations
- A study coordinator’s perspective on how sponsors can further support teams at sites to improve patient experiences and ease of trial conduct is shared
2:30 pm Integrating Patient Perspectives Into Clinical Trial Design: Lessons from Recruitment & Outcome Selection
- Selecting outcomes that reflect real patient priorities, from symptom relief to quality of life to align trials with patient needs
- Exploring strategies that have succeeded (and failed) in engaging and keeping patients in trials to enhance recruitment and retention
- Ensuring protocols are patient-friendly while maintaining scientific and regulatory rigor to optimize clinical trial design
3:00 pm Afternoon Break & Poster Session
Exploring the Latest Clinical Progress in the Pulmonary Fibrosis Landscape
3:30 pm Panel Discussion: Hear from the Clinicians – What Will Constitute First-Line Therapy for IPF in an Evolving Landscape?
With new therapies on the horizon, the IPF treatment landscape is evolving. This panel brings together leading clinicians and academics to explore how emerging drugs will fit into current treatment paradigms. Experts will discuss the clinical decision-making process for first-line therapy, balancing efficacy, safety, and patient-specific factors.
4:00 pm Human Precision-Cut Tissue Slices as a Preclinical Platform for Development & Testing of Anti-Fibrotic Therapeutics
- Human precision-cut lung slices retain the cellular complexity and architecture of the native tissue in cultureÂ
- Established, dynamic models of tissue inflammation and fibrogenesis in precision-cut lung slicesÂ
- Application of PCLS for drug testing, target engagement and fibrogenesis in PCLS
4:30 pm Advancing Anti-Fibrotic Innovation: A Clinical Update on Deupirfenidone & Considerations for Real-World Access
- Overview of the clinical development journey of deupirfenidone, including key learnings from the Phase 2b study and plans for advancing to Phase 3
- Discussion of trial design rationale, patient population, endpoints, and positioning within the current IPF treatment landscape
5:00 pm Imaging-Based Machine Learning in Fibrotic Lung Disease: A Platform for Precision Medicine and Trial Deployment
- A presentation of deep learning-based imaging biomarkers that predict clinical outcomes, enrich trial cohorts, and track treatment response in interstitial lung disease
- Explore advanced applications, including the use of imaging-derived data to support synthetic control arms and accelerate therapeutic development
- Describe our platform and deployment methods used to match patients to trial eligibility criteria and integrate imaging biomarkers into clinical research workflows
5:30 pm Progressing Admilparant, an LPA1 Antagonist, Through Phase 3 for IPF & PPF: An Update on Progress, Perspectives & Positioning
- Explore the latest developments in the Phase 3 program, including trial design evolution, enrollment strategy, and global rollout progress
- Reflect on key learnings from the Phase 2 study and how they informed the transition to late-stage development
- Discuss how LPA1 antagonism may fit into an increasingly crowded and combinationdriven pulmonary fibrosis treatment landscape
6:00 pm Chairs Closing Remarks
6:00 pm Poster Session & Networking Drinks Reception
Unwind and connect with fellow attendees over drinks while exploring cutting-edge poster presentations in the pulmonary fibrosis space. This informal session offers the perfect opportunity to spark meaningful conversations, share your latest developments, and gain fresh insights from peers across the field. Whether you’re presenting or just browsing, this is a session that cannot be missed!