8:25 am Chair’s Opening Remarks

Examining IPF Clinical Trial Design to Expand Therapeutic Development for ILDs

8:30 am Identifying & Highlighting Differences Between IPF & PPF to Inform Future Clinical Trial Endpoints

  • Anna Podolanczuk Assistant Professor - Pulmonary & Critical Care Medicine, Weill Cornell - Cornell University

Synopsis

  • Understanding how endpoints differ for studies of progressive pulmonary fibrosis in comparison to IPF to navigate trial design

9:00 am Adapting Clinical Trial Design & Endpoints for ILD Therapeutic Development: Harnessing Digital Health Technology (DHT) Endpoints

Synopsis

  • Selecting and expanding the ILD patient population
  • Adapting clinical trials using digital health technology to facilitate remote monitoring of patients health status
  • Incorporating the patient perspective into clinical trial design
  • Assessing digital endpoints across fibrotic ILDs studies

9:30 am Roundtables: Navigating PPF Inclusion Criteria for Clinical Trial Design: Do We Include Only Specific Progressive Fibrosis?

Synopsis

To consider the patient population and other considerations of inclusion and exclusion criteria in therapeutic development

– PPF trial design vs. IPF trial design

– PPF trial design vs ILD trial design

– IPF trial design vs ILD trial design

Harnessing a Combination of Preclinical Models to Effectively Predict ILD Therapeutic Efficacy

10:00 am Transitioning Inhaled Preclinical Studies to the Clinic: Development of PRS-220, an Inhaled Anticalin Protein targeting CTGF/CCN2 for the Treatment of Lung Fibrosis

Synopsis

  • Highlighting benefits of local intervention via inhalation versus systemic administration of drugs
  • Using inhaled Anticalin proteins as a novel class of biotherapeutics for respiratory disease
  • Illuminating the development and preclinical characterization of PRS-220, a novel inhaled CTGF inhibitor, that is in clinical development for the treatment of lung fibrosis

10:30 am Morning Break

11:30 am Using a Combination of Preclinical Models: The Way Forward for Mechanisms – Based Clinical Translation

  • Satish Madala Professor & Basic Science Director, University of Cincinnati

Synopsis

  • Understanding which models suitably predict translatability to the clinic
  • Navigating the therapeutic window when variability is high with a comprehensive set of preclinical studies
  • Exploring preclinical modelling across ILDs to transition from IPF to ILD indications
  • Harnessing computerized approaches to access laboratory and preclinical data to cut costs and therapeutic development time
  • Understanding cellular and molecular mechanisms underlying progressive fibrosis in ILDs
  • Limiting exposure to the lungs to reduce systemic side effects

12:00 pm Exploring the Consistency of Readouts Across Preclinical Models to Evaluate the Use of Novel Fibrosis Models in Preclinical Therapeutic Development

Synopsis

  • Implementing precision cut lung slices and 3D tissue models in conjunction with the bleomycin model to attain therapeutic confidence
  • Harnessing artificial intelligence in preclinical development
  • Using CT scans as a biomarker of therapeutic efficacy
  • Looking to the future of ILD preclinical research – what should be implemented to improve the robustness of therapeutics moving into the clinic?

12:30 pm Lunch

Applying a Precision Medicine Approach to Select & Personalize Therapies for PPF & ILDs

1:30 pm Engineering 3D Lung Models for Drug Discovery and Validation

Synopsis

  • Highlighting a bottomup approach for modeling pulmonary fibrosis
  • Exploring cell-cell and cell-microenvironment interactions in the lung
  • Harnessing the model to explore therapeutic efficacy and the chemical cues of fibrosis

2:00 pm Reversing Translational Efforts to Identify New Pathways Contributing to ILD-Expanding the gp130-Dependent Cytokine Axis

Synopsis

  • Analyzing the fibrotic pathways to understand the fibrotic pathways across ILDs
  • Treating both the fibrotic features and inflammatory features of CT-ILDs to improve therapeutic outcomes
  • Discussing novel and/or additional development pathways in IPF and ILD to shine a spotlight on innovative therapeutic development

2:30 pm Oligonucleotides as Potential Therapies for Pulmonary Fibrosis

Synopsis

  • Discussing the unmet clinical need for pulmonary disease treatment which could be targeted using oligonucleotide therapies
  • Considering the biological barriers and challenges with delivering oligonucleotide therapies to the lung and potential solutions
  • Examining the potential delivery methods to pulmonary tissue and utilization of different routes of administration when investigating oligonucleotide therapies for the lung

3:00 pm Roundtable Discussions: Evaluating the Potential of Immunosuppressive & Antifibrotic Combinational Strategies for ILD Precision Medicine

Synopsis

This is your opportunity to join the immersive and interactive discussions on your round table to evaluate immunosuppressive and antifibrotic therapeutics for CT-ILD and PPF precision medicine. Looking to the future for

personalized medicines for patients in need

3:30 pm Chair’s Closing Remarks