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

  • Cara Williams Vice President & Head of Preclinical Biology: Inflammation & Immunology Research Unit, Pfizer

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

  • Nina Patel Director – Clinical Development & Medical Affairs ILD, Boehringer Ingelheim

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

  • Farrell Simon Vice President & Head of US Marketing, Trevi Therapeutics

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

  • Peter Fernandes Vice President & Chief Regulatory, Quality & Safety Officer, Bellerophon Therapeutics

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

  • Elizabeth Renzoni Consultant Respiratory Physician, Honorary Senior Lecturer, Imperial College London

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

  • Simon Walsh Consultant Thoracic Radiologist, Machine Learning Scientist & Imaging Chair, Imperial College London

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

4:30 pm End of Conference Day One