Examining Inflammatory Interstitial Lung Disease from a Drug Development Perspective
8:25 am Chair’s Opening Remarks
8:30 am Registration & Networking
9:00 am Comparing & Contrasting Fibrotic & Inflammatory ILDs in Order to Comprehensively Understand Key Differences in Their Development & Progression & Learning How This Influences Drug Development
Synopsis
- Identifying disease signatures and key cellular players in fibrosis
associated with ILDs - Examining Autoimmune versus Idiopathic progressive lung fibrosis
- Assessing pan fibrotic mechanisms versus disease specific mechanisms –
how best to treat pulmonary fibrosis
9:30 am Understanding How to Define Patient Populations, Select Optimal Intervention Points & Outline Clear Therapeutic Outcomes to Streamline the Design & Development of Therapies for Inflammatory ILDs
Synopsis
- Utilizing clinical parameters versus radiographic parameters to define
patient subgroups - Clinical versus physiologic versus radiologic parameters to determine
timing of intervention - Choosing clinical trial outcomes in a heterogeneous trial population
10:00 am Designing Trials for Inflammatory ILDs in 2022 & Beyond: Spotlight on Ssc-ILD
Synopsis
- Revealing lessons learned from recent scleroderma ILD clinical trials
- Discussing trial design in at-risk population for ILD versus those with
clinical or established ILDs - Understanding what factors you must consider to optimize success of
your therapeutic during clinical trials
10:30 am Speed Networking
11:00 am Morning Break & Networking
Biomarkers 101: Exploring the Emerging Consensus on Which Biomarker is the Most Useful for ILD Drug Development
11:30 am OSIC Project – Exploring Imaging Based Biomarkers, CT Scans/ Data Collection to Predict FVC Decline
Synopsis
- Using a database to streamline IPF/ILD imaging
- Using CT Scans to predict mortality
- Encouraging data sharing to optimize effort to find useful CT based
biomarkers
12:00 pm Exploring Biomarkers for Differential Diagnosis of Interstitial Lung Diseases
Synopsis
- Investigating the potential of biomarkers for ILD diagnosis
- Analyzing multiple types of biomarkers for ILD diagnosis
- Discussing advantages and disadvantages of biomarkers for ILD
diagnosis
12:30 pm Lunch & Networking
Revealing Supportive Care & Symptom Management for ILD Treatment
Revealing Supportive Care & Symptom Management for ILD Treatment
1:00 pm Exploring the Impact & Importance of Quality of Life on the Patient Journey
Synopsis
• What is the importance of inclusion of QoL measures in ILD trials?
• How to choose meaningful QoL measures?
• What are the linkages between QoL measures and impact on
reimbursement?
Exploring Endpoints for Clinical Trials
1:30 pm Devising & Developing Composite Endpoints Which are Realistic & Achievable to Use in Your Next Clinical Trial
Synopsis
- Robust clinical endpoints should be able to measure a clinically meaningful
improvement in the disease being treated, that is sensitive and reproducible - Composite endpoints are gaining increasing use as they incorporate multiple
domains of disease progression, enabling more events captured in a shorter period.
But which ones to include that are realistic and achievable is open to debate - The recent introduction of a single phase 3 endpoint for improvement
in physical activity using accelerometry has been gaining acceptance.
Experience with both the composite or single (old or new) will be discussed
2:00 pm Exploring Endpoints in the Context of Inflammatory ILDs: Debating Which Factors You Must Measure to Accurately Assess the Efficacy of Treatment in Inflammatory vs Fibrotic ILDs
Synopsis
- Learning how to distinguish which endpoints to use for fibrotic vs
inflammatory ILDs - How to effectively utilize endpoints to measure treatment efficacy in
interstitial lung disease - Exploring challenges associated with utilizing endpoints for ILDs in 2022
and beyond
2:30 pm Afternoon Break & Networking
Innovative Imaging for Interstitial Lung Disease
3:30 pm Machine Learning & Interstitial Lung Disease: A Deep Dive
Synopsis
• Understanding how machine learning can be utilized to inform respiratory
drug development
• Exploring computer-aided image analysis, machine learning and computer
vision for interstitial lung disease
• Looking into the crystal ball: Uncovering the future of imaging for ILDs
Discovering Lumping vs Splitting Through a Wider Lens
4:00 pm Scrutinizing the Practicalities of Deciding When to Lump or Split in the Context of Disease Progression in Order to Inform & Optimize Your ILD Drug Development Strategy
Synopsis
- Understanding the difference between targeted therapies and more
broadly antifibrotic approaches - How to evolve biomarkers in applying splitting strategies
- Lumping as a means to speed up patient recruitment