Explore the Agenda
8:00 am Check In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
Diving into Clinical Endpoints & Leveraging Patient Feedback to Guide Potentially Meaningful COPD Outcomes & Demonstrate Clinical Efficacy
9:00 am Imaging Mucus Plugs in COPD: Quantitative Evaluation and Clinical Impact
- Mucus plugging can be identified and quantified reliably on CT using standardized definitions and reading processes, maximizing the value of imaging in clinical trials
- Emerging quantitative analysis approaches enable detailed assessment of mucus burden and spatial distribution, improving characterization and understanding of clinical impact
- Reductions in mucus plug burden have been observed after initiation of advanced therapies, supporting mucus plugging as a potential imaging marker of treatment response
9:30 am Panel Discussion: Thinking Beyond Exacerbations & Lung Function to Define the Future of Clinical Endpoints
- Should COPD drug development move beyond exacerbation reduction as the dominant endpoint, and what alternative measures could better capture meaningful clinical benefit?
- How clinically meaningful are early improvements in lung function, and could they serve as valid endpoints for evaluating acute COPD treatments?
- What additional endpoints could better reflect patient benefit, including symptom improvement, quality of life, or disease progression?
- How do regulatory expectations currently shape endpoint selection in COPD trials, and where might there be flexibility for innovation?
- What strategies can developers use to demonstrate robust clinical value when proposing novel endpoints to regulators and payers?
10:15 am Morning Break & Networking
Biomarker Driven Strategies for Disease Modification & Patient Stratification in a Heterogeneous Condition
11:15 am Advancing Biomarker‑Driven Therapeutic Strategies in COPD by Linking CC16 Biology to Disease Modification
- Understand how loss of airway epithelial integrity, reflected by reduced CC16 levels, defines biologically distinct COPD endotypes and enables patient stratification beyond symptoms and exacerbation history toward underlying disease mechanisms
- Gain insight into how CC16, when integrated with complementary biomarkers such as sRAGE and fibrinogen, informs prediction of lung function decline, emphysema progression, and therapeutic responsiveness using human translational and longitudinal datasets
- Highlighting how replacement and augmentation of SCGB1A1 directly targets epithelial dysfunction, inflammation, and fibrosis, supporting a disease‑modifying treatment strategy that goes beyond bronchodilation to preserve lung function and reduce exacerbation burden
11:45 am Roundtable Discussion: Targeted Patient Segmentation Strategies to Unlock Therapeutic Response in a Heterogeneous Condition
- Explore how an endotype‑driven stratification framework that integrates clinical features, molecular biomarkers, and environmental exposure history can improve treatment selection and therapeutic precision in COPD
- Understand how identifying patients most likely to benefit from biologic or targeted interventions, such as those with eosinophilic or other mechanistically defined subtypes, may accelerate successful outcomes and guide personalized approaches
- Appreciate why better patient stratification, beyond traditional spirometric or broad clinical categories, could dramatically reduce trial size and duration while enhancing the predictive validity of clinical endpoints
12:30 pm Lunch & Networking Break
Targeting the Root Drivers of COPD Through Mucus Removal, Tissue Regeneration & Protease Inhibition
1:30 pm Regenerative Therapeutics for COPD: Mechanistic Approaches to Tissue Repair & Clinical Translation
- Accelerating clinical impact through mucus clearance exploring strategies to target mucus obstruction as a reversible driver of airflow limitation, enabling faster demonstration of clinical benefit compared with interventions aimed at reversing structural lung damage
- Leveraging cell therapy for lung regeneration, utilizing nebulized cell-based interventions to modulate gene activity, reconstruct extracellular matrix, and restore lung tissue integrity
- Develop mechanistic biomarkers and integrate expanded access data to enhance dose selection, monitor early efficacy, and de-risk clinical trial design
2:00 pm Discovery & Development of New Generation of Neutrophil Elastase Inhibitor AK0705 for Treatment of Acute Exacerbation COPD
- Discovery and optimization of AK0705 as a reversible covalent neutrophil elastase inhibitor, originally identified by Scripps Research Institute, followed by a strategic collaboration for preclinical and clinical development
- Exploring the pharmacological and efficacy profile across COPD and inflammatory disease models, highlighting its unique reversible covalent binding mechanism and picomolar potency, whilst demonstrating good in vivo anti-inflammatory activity in three established animal models as potent as dexamethasone
- Preclinical development progress and clinical translation strategy, including completion of final preclinical studies and the planned transition into first‑in‑human Phase 1 clinical evaluation within the next 10 months