7:00 am Check-In & Breakfast
7:45 am Chairs Opening Remarks
Synopsis
From Setbacks to Breakthroughs in the Battle Against Pulmonary Fibrosis in the Past Year Since the 7th IPF Summit: Where Are We Now?
Exploring the Current State of Play in the Progressive Pulmonary Fibrosis Field
8:00 am Examining the Phase 2b BEACON-IPF Trial of Bexotegrast for Patients with IPF
Synopsis
• Exploring key study design and attributes of the phase 2b trial
• Exploring the selected clinical study design including patient populations, biomarker panel, endpoint selection and beyond
• Looking on to the phase 3 study, what is next?
8:30 am Imaging biomarker development in fibrotic lung disease; applying deep learning to unsolved problems
Synopsis
- Reliable biomarkers allowing early disease detection, prediction of progression and measurement of therapeutic response are urgently needed in fibrotic lung diseases. Advances in deep learning technology have created new opportunities to identify, develop and validate new biomarkers by more precisely quantifying clinical and subclinical pulmonary disease.
- Specific imaging challenges to which deep learning may be applied include improved imaging diagnostics, classification of limited interstitial lung abnormalities based on disease behavior and prediction of the progressive pulmonary fibrosis using baseline imaging data.
- Qureight addresses these unmet clinical needs via imaging-based biomarker approaches. The presentation will focus on Qureight's deep learning models for classifying and quantifying disease severity in fibrotic lung disease, and their use in clinical trial and real-world patient imaging datasets
9:00 am Distilling Phase 3 Commencing of BMS’ LPA1 Antagonist for IPF & PPF
Synopsis
• Investigating the current clinical development and progress of BMS’ lysophosphatidic acid receptor 1 (LPA1) antagonist
• Exploring phase 2 readouts implications on phase 3 study design and exploring the process of enrolling a large-scale phase 3 study
9:30 am Exploring Patient Perspectives – Patient Representative
9:45 am Panel Discussion: Incorporating Industry Perspectives When Examining Existing & Evolving Endpoints – “Feels, Functions, Survives”
Synopsis
• Exploring the industry’s interpretations of Feels, Functions, Survives and the practical considerations and implications on drug development
• What is it going to take for the regulators to see beyond FVC and how can we as the industry precompetitive and come together to action this
• What additional surrogates of mortality are available, can we infer these from other diseases?
• Highlighting the importance of collaboration between researchers, regulators, clinicians, and patient advocates to drive the adoption of patient-centred endpoints
10:30 am Speed Networking & Morning Break
Synopsis
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.
Track 1: Emerging Biology & Early Translation
Chair: Marilyn Glassberg, Professor & Chair, Department of Medicine, Loyola University
Leveraging the Latest Advancements in Pulmonary Fibrosis Recapitulation to Enhance Preclinical Modelling & Drive the Field Forward
11:15 am Leveraging Induced Pluripotent Stem Cells to Replicate Genetic & Cellular Characteristics of Individual Patient Biology
Synopsis
• Utilizing iPSCs for improved testing of drug efficacy in preclinical models that more closely mimic human lung tissue • Examining the promise of personalized models to identify different IPF patient subtypes and improve patient segmentation for improved clinical trial design
11:45 am Modelling the Repair Mechanisms to Better Understand the Regeneration Pathway & Uncover Novel Effective Therapeutics
Synopsis
• Examining distinct aspects of repair, from epithelial regeneration, collagen deposition, and immune response
• Defining the critical need for mechanistic understanding of fibrosis reversal mechanisms to identify drug candidates • Need for reliable biomarkers for assessing patient response to treatment for fibrosis stabilization or reversal
12:15 pm Navigation the Limitations of Cellular Assays for Novel Target Identification & Validation
Synopsis
• Leveraging state of the art techniques to examine macrophage biology
• Exploring novel assays and methodologies to study complex biology through dimension reduction to screen in vivo relevant phenotype
Track 2: Late Translation & Clinical
Chair: Fernando Martinez, Chief of Pulmonary & Critical Care, Weill Cornell University
Harnessing the Latest Imaging Technologies for Earlier & Improved Diagnostics, Prognostication & Disease Progression Tracking
11:15 am Examining Optical Imaging for Minimally Invasive Visualization of Lung Microstructure for Diagnosis & Progression Tracking
Synopsis
- How Endobronchial-Based OCT can identify microscopic features in patients and its promise for early detection and diagnosis of ILD
- Exploring the potential of OCT for differentiating fibrotic from non-fibrotic interstitial lung disease in patients with low confidence CT findings
- Investigating the emerging use of OCT for monitoring disease progression and response to treatment
11:45 am Exploring the Role of Brainomix E-Lung Imaging Biomarkers in the Evaluation of Interstitial Lung Disease
Synopsis
• Evaluating the ability for AI powered CT based biomarkers to identify patients at risk of future disease progression from a baseline CT scan
• Assessing the sensitivity of quantitative e-Lung CT biomarkers to treatment efficacy and progressive pulmonary fibrosis
• Opportunity for e-Lung biomarkers to improve clinical trial design and Real-World clinical practice
12:15 pm Uncovering Minimally Invasive Biomarkers in the Extracellular Matrix That Accurately Reflect Pulmonary Conditions
Synopsis
• Examining the desperate need for reliable biomarkers for assessing drug efficacy beyond just clinical endpoints like FVC decline
• Promise of AI for unbiased and quantitative measures of disease progression and the potential use as a surrogate endpoint
• Exploring multi-modal biomarkers, combining blood, imaging, and beyond to paint a more complete picture of disease progression
12:45 pm Lunch Break
Track 1: Emerging Biology & Early Translation
Uncovering a Translational Framework of Preclinical Modelling to Enhance the Predictive Power & Navigate from Bench to Bedside for the Next-Gen Therapeutics
1:45 pm Building an Eco-System of Translational Models to Provide Enhanced Confidence in Candidate Mechanism of Action
Synopsis
• Exploring a translational framework to cross-validate findings across models for enhanced confidence
• Exploring candidate selection profiles and the level of confidence needed for go-no-go decisions
• Establishing a standardized protocol of readouts across models to improve data consistency and translatability
2:15 pm Enhancing Modelling of PK/PD in Preclinical Models to Better Predict Dosing Strategies & Enhanced Mechanistic Insights
Synopsis
• Divulging the intersection where pharmacology meets clinical trial design from optimal dosing regimes
• Exploring how modelling can uncovering limitations such as fast clearance and the importance of anticipating limitations to better prepare for clinical trials
• Utilizing data driven design for identifying optimal targets, refining treatment regimens to accelerate drug discovery
2:45 pm Leveraging Biomarkers to Unveil Mechanistic Insights in Early Translational Development to Decode Pulmonary Fibrosis
Synopsis
• Explore how biomarker analysis provides critical insights into the pathophysiology of IPF, shedding light on the key molecular pathways involved
• Discover how leveraging biomarkers enables the identification of targeted interventions like LTI-03 to protect lung epithelium and inhibit fibroblast-mediated fibrosis expansion in patients with IPF.
Track 2: Late Translation & Clinical
Evolving Measures of Progress: Surrogate, Exploratory, & Composite Endpoints for Earlier Detection of Clinical Benefit
1:45 pm IPF, Clinical Trial Endpoints and the Challenges They Present
Synopsis
- Failure of phase 3 clinical trials for IPF despite promising phase 2 trials limit the availability of new drugs in IPF
- IPF is a heterogenous disease. Understanding the different subgroups will help advance therapeutic options
- FVC is an important endpoint for clinical trials but reliable and reproducible results are important to reconcile data from multicenter clinical trials
2:15 pm From Symptom to Surrogate Endpoint: Where Does Cough Fit in IPF Drug Development
Synopsis
• Despite the significance of cough to patients with IPF, there is limited understanding of cough mechanisms, whether inflammatory, fibrotic, sensory
• Investigating cough as a surrogate endpoint in clinical trials for disease progression and treatment efficacy
• Coverage of design and validation of cough specific clinical trial design
2:45 pm Session Reserved for Fortrea
3:15 pm Afternoon Break & Poster Session
Synopsis
Immerse yourself in an engaging and informal session, join your peers in a relaxed atmosphere that encourages meaningful conversations and discussions. Explore a range of exciting poster presentations and showcase your own developments in the Pulmonary Fibrosis world. Don’t miss out on the chance to connect, learn, and present. Get ready to be impressed!
4:00 pm Building a Novel Dry Powder Delivery Platform and Applications in IPF
Synopsis
- Highlighting the already established success of MannKind’s proprietary dry powder delivery platform
- Presenting a status update on the Phase 1 study of Nintedanib DPI
- Exploring what’s next for Nintedanib DPI
4:30 pm Human Precision-Cut Tissue Slices as a Preclinical Platform for Development & Testing of Anti-Fibrotic Therapeutics
Synopsis
• Human precision-cut lung slices retain the cellular complexity and architecture of the native tissue in culture
• Established, dynamic models of tissue inflammation and fibrogenesis in precision-cut lung slices
• Application of PCLS for drug testing, target engagement and fibrogenesis in PCLS
5:00 pm Analyzing Design of a Phase 3 Trial for Inhaled Treprostinil
Synopsis
• Exploring the scientific rationale behind inhaled Treprostinil
• Phase 3 trial design and special considerations of inhaled candidate for evaluating the long-term safety and tolerability of Treprostinil
5:30 pm Chairs Synopsis of Day One
5:45 pm Ambassador’s Evening & Drinks Reception
Forge the Future of Progressive Pulmonary Fibrosis Therapeutics with An Evening of Dialogue
What is in Store?
Synopsis
Engage with your IPF community’s foremost thought leaders and pioneering figures in a laid-back setting, fostering ongoing dialogues and delve deeper into the ground-breaking insights exchanged earlier in the day. Benefit from the perspectives of industry trailblazers, and fearlessly pose insightful questions to extract forward-thinking insights that will influence the future landscape of IPF treatments.
Panel Discussion: Interrogating Recent Phase 2 & Phase 3 Failures by Dissecting Targets & MOA & Chosen Biomarkers, Endpoints, Patient Populations & Beyond to Bridge the Late Translational Gap
The last 12 months have been a turbulent year with high profile and unexpected clinical failures whereby Galecto and FibroGen’s phase 2 and phase 3 trials both failed to meet their primary endpoint of lung function (FVC). Having both showed immense promise experts in the space really can’t place their bets as where the next approval is coming from when these candidates looked so promising until late-stage clinical trials. Therefore, there is the opportunity to double down on the challenges and learn from these clinical failures and take the lessons learned into current therapeutic development.