Explore the Agenda
7:00 am Check in & Light Breakfast
8:05 am Program Director’s Welcome
8:15 am Chairs Opening Remarks
Understanding & Adapting to a Changing Pulmonary Landscape with an Evolving Treatment Paradigm
8:30 am Nerandomilast as a New Benchmark in Pulmonary Fibrosis: Lessons Learned 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?
9:00 am Patient Voice
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?
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
Maximising Preclinical Packages to Provide Enhanced Confidence in Candidate Selection
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 Enhancing Translational Confidence: Human-Led Drug Discovery & Model System Validation
- Leveraging human-derived data and cross-institutional data sharing to uncover novel therapeutic targets in IPF with higher confidence
- Using multi-omics approaches to deeply characterize pulmonary fibrosis preclinical model systems and align them with human biology
- Building robust translational bridges between patient data and discovery platforms to refine candidate selection and de-risk early development
12:00 pm 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.
Track 2: Late Translation & Clinical
Demonstrating Efficacy & Value in a Maturing Landscape with Background Standards of Care
11:00 am Exploring Multi Marker Modelling to Inform Prediction Modelling for Optimizing Patient Selection
- Exploring multi-marker modeling and the potential of combining plasma biomarkers, telomere length, and radiomics to refine patient selection
- Assessing how biomarkers can inform combination therapy strategies and predict treatment response through responder analyses
- Evaluating emerging data on biomarker-driven patient stratification to enhance clinical trial efficiency and success
11:30 am Designing Feasible, Efficient & Effective Clinical Trials in an Era of Expanding Treatment Options
- Explore challenges in patient recruitment, including identifying patients still at risk of disease progression despite SOC treatment
- Optimize inclusion/exclusion criteria and trial design to ensure feasibility while maintaining clinical relevance in a rapidly evolving treatment landscape
- Examine how study design and statistical analyses must adjust for background therapy’s impact on FVC decline, hospitalization rates, and mortality
12:00 pm Roundtable Discussion: Designing for Impact: Ensuring New IPF Therapies Stand Out in an Evolving Treatment Landscape
As the IPF treatment landscape evolves, developers must consider how to design therapies that stand out not only scientifically but also clinically and commercially. This interactive discussion will explore how to ensure new treatments demonstrate enough value for clinical adoption, regulatory approval, and long-term reimbursement success.
- Setting a Higher Bar for Efficacy: Assessing whether small reductions in lung function decline are enough, or if novel therapies need to show broader benefits in patient well-being and disease modification
- Trial Design for Differentiation: Exploring how study endpoints, patient selection, and biomarker strategies can help new therapies stand out in a space where standard-ofcare options are expanding
- The Reality of Combination Therapy: Discussing how to evaluate the standalone and additive effects of therapies that will likely be used in combination rather than as monotherapies
- Future Considerations for Reimbursement: Examining how payers might assess value when multiple treatment options exist, and whether cost-effectiveness modeling should be incorporated into early development strategies.
12:30 pm Lunch Break
Track 1: Emerging Biology & Early Translation
Mapping the Next Frontier in IPF Drug Development with Novel Therapeutic Approaches
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
- Leveraging gene and RNA-based therapies to address underlying disease drivers beyond traditional antifibrotics
- Advancing innovative delivery systems to enhance lungspecific targeting while ensuring patient safety
- Assessing the current landscape of gene and RNA therapies in IPF and the path to regulatory and clinical success
Track 2: Late Translation & Clinical
Innovations in Clinical Development & Clinical Trial Enrichment for Improved Probability of Therapeutic Outcome
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 Session reserved for Vitalograph
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.
4:15 pm 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
4:45 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
- How payer perspectives can and should influence clinical trial design earlier in development to support future reimbursement and access
5:15 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
5:45 pm Chairs Closing Remarks
5:50 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!