Conference Day One - September 20, 2023

7:00 am Registration

Synopsis

Register, Grab a Coffee, and Find a Seat

Driving the Pulmonary Fibrosis Field Forward: Benchmarking Therapeutics in Development Against the Standard of Care to Hail a New Era of Disease-Modifying Drugs for the Patient

8:00 am Chair’s Opening Remarks

  • Fernando Martinez Chief of Pulmonary & Critical Care, Weill Cornell Medical College

8:30 am What is the Current View of the Standard of Care? What Would ‘Good’ or Even ‘Great’ Look Like in the Next Era of Pulmonary Fibrosis?

  • Joyce Lee Associate Professor, University of Colorado Denver

Synopsis

  • Highlighting from a clinician and patient perspective the view on the standard ofcare
  • Looking to the future of IPF drug development: Do we view it as IPF or PPF?

Exploring & Comparing the Phase 2 Clinical Readouts: Navigating in-human Studies, Phase 3 & Beyond

9:00 am Phase 2 Study Results for Agents That Target LPA1 & JNK1 in Pulmonary Fibrosis

  • Steven Greenberg Vice President, Disease Area Head, Pulmonology, Bristol Myers Squibb

Synopsis

  • Comparing BMS-986278 (LPA1 antagonist) and CC-90001 (JNK1 inhibitor) programs in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF): scientific rationale; study designs
  • Key results from BMS-986278 and CC-90001 phase 2 trials
  • Looking to phase 3 for the LPA1 program

9:30 am Illuminating IPF Study Design Considerations & Practical Implications

  • Mark Dowling Senior Director, Strategy & Planning, iGM Therapeutic Area, Fortrea
  • Veerle Van De Velde Senior Medical Director, MedSci & iiGM Therapeutic Area, Fortrea

Synopsis

  • Highlighting Fortrea’s experience in IPF trial design
  • Discussing the current landscape overview
  • Design considerations and frequently asked questions during protocol development

10:00 am Advancing Bexotegrast to Late-Stage Clinical Development for the Treatment of IPF

Synopsis

  • Understanding the mechanism of action and translational research data of bexotegrast
  • Discussing the INTEGRIS-IPF Phase 2a study results
  • Reviewing the phase 2b study design and next steps

10:30 am Speed Networking

Synopsis

Put a face to a name – this session is the perfect opportunity to get face-to face time with the key opinion leaders in the pulmonary fibrosis field. Establish meaningful connections to build upon for the rest of the conference and gain individual insight beyond the papers and press releases into the pioneering research and therapeutic development in the pulmonary fibrosis field.

11:15 am Morning Break

Emerging Biology & Early Translational Track

Harnessing Tools at the Pulmonary Fibrosis Field’s Fingertips to Make Precision Medicine a Reality

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

11:30 am Harnessing a Combination of in vivo & in vitro Models to Create an Effective Preclinical Package: An OGG1 Inhibitor for Clinical Translation

Synopsis

  • Evaluating the use of in vivo, in vitro and ex vivo models to assess therapeutic efficacy prior to the clinic
  • Practically using in vivo and in vitro models
  • Exploring the use of patient-derived, precision-cut lung slices (PCLs) to identify tissue-derived protein fingerprint biomarkers

12:00 pm In Matrico®: A 3D Assay Platform Based on Human IPF ECM for Predictive Drug Testing

Synopsis

  • Incorporating minimally-processed, human lung extracellular matrices (ECMs) to recapitulate the fibrotic disease environment in 3D cell-based assays.
  • Evaluating antifibrotic therapeutic candidates in robust, clinically-relevant assays that correlate results with patient-specific data.
  • Improving decision making in preclinical drug development by comparing cell viability, protein secretion, and gene expression analysis with standardof-care compounds.

12:30 pm Bleomycin-induced IPF in the DIO mouse: a New Translational Model to Evaluate Drugs Targeting IPF

Synopsis

Highlighting the rationale for using DIO mice instead of other mouse models for bleomycin induced IPF

  • Describing the better bleomycin induction of IPF and Alk5i efficacy in DIO mice
  • Demonstrating the high relevance of the model with AI-based digital pathology methods

12:45 pm Modelling Interstitial Lung Disease in Lung Organoids Derived from Human Pluripotent Stem Cells

Synopsis

  • Harnessing organoid modelling of familial IPF and interstitial lung disease
  • Exploring the discovery of new targets
  • Delving into the pathogenesis of IPF to understand the pathobiology and patient molecular journey

1:15 pm Lunch & Networking

Later Translational & Clinical Track

Capturing Innovative Endpoints in Clinical Trials: Measuring Biomarkers Beyond Lung Function

  • Cheryl Nickerson-Nutter Executive Vice President, Research & Development, Three Lakes Foundation
  • David Lederer Executive Medical Director, Early Clinical Development & Experimental Sciences, Regeneron

11:30 am Delving into the Current State of Play in Imaging Technologies: Reaching for Innovative Biomarkers to Illuminate Therapeutic Efficacy Beyond the Standard of Care

  • Toby Maher Professor of Clinical Medicine, University of Southern California

Synopsis

  • Correlating quality of life questionnaires, HRCT and FVC to measure progression in IPF to look beyond lung function
  • Helping to make clinical trials shorter and faster to accelerate effective therapeutics to patients in need

12:00 pm Brainomix e-Lung Biomarkers are Prognostic & Outperform FVC in the Serial Assessment of Patients with Fibrotic Lung Disease

  • Peter George Consultant Respiratory Physician & Clinical Lead | Senior Medical Director, Royal Brompton Hospital | Brainomix

Synopsis

  • FVC as the ‘gold’ standard clinical trial endpoint is variable and may in insensitive to treatment efficacy
  • Brainomix e-Lung biomarkers provide robust assessment of serial change and have been validated in both IPF and non-IPF cohorts
  • Imaging biomarkers may hold the key to successful delivery of the next generation of ILD clinical trial

12:15 pm Using AI to Deliver New Endpoints in IPF Clinical Trials

Synopsis

  • Discussing FVC and the need for new biomarkers
  • Exploring HRCT scans and the information they contain
  • Combining imaging, clinical and biomarker information to create new disease endpoints both for trials and in hospitals

12:30 pm Precision Medicine in IPF: How Do We Get There?

Synopsis

  • Application of minimally invasive sampling and analysis techniques to gain insights into diseased tissue biology
  • Biomarkers to enrich response and characterize likely responders
  • Precision medicine from the start; incorporating precision medicine from target through development

1:00 pm Lunch & Networking

Emerging Biology & Early Translational Track

Stopping Progression, Clearing Senescent Cells, Repairing & Regenerating Lung Tissue: What Can We Do & Where Do We Go?

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

2:00 pm What’s Really Driving Fibrosis? Stopping Progression & Understanding the Behind the Scenes of the Fibrotic Response

  • Naftali Kaminski Chief of Pulmonary, Critical Care, & Sleep Medicine, Yale School of Medicine

Synopsis

  • Reviewing the current landscape of cell types and the extracellular matrix that are thought to be involved in driving fibrosis for target understanding
  • Delving into cell type-specific mechanisms to halt progression at early and late-stage progression
  • Using data sets to understand cell cross talk and interaction to paint more of the pulmonary fibrosis picture

2:30 pm Exploring the Loss of Pro-Fibrotic Fibroblasts to Achieve Resolution & Mitigating Fibrotic Scarring

Synopsis

  • Promoting regeneration through the clearance ofdysfunctional senescent fibroblasts
  • Encouraging senescent cells to apoptosis andregenerating normal healthy stroll cells
  • Assays to assess lung regeneration

Later Translational & Clinical Track

Looking Ahead: Using Innovative Biomarkers as Diagnostic, Prognostic & Predictive Markers for Pulmonary Fibrosis

  • David Lederer Executive Medical Director, Early Clinical Development & Experimental Sciences, Regeneron
  • Cheryl Nickerson-Nutter Executive Vice President, Research & Development, Three Lakes Foundation

2:00 pm Bridging the Gap: Blood-Based Prognostic Biomarker Development in Patients with Idiopathic Pulmonary Fibrosis

  • Justin Oldham Clinical Associate Professor, University of Michigan

Synopsis

  • Reviewing prognostic biomarker characteristics andmeasures of performance
  • Evaluating gaps in knowledge and limitations preventingbiomarker implementation
  • Discussing strategies to overcome limitations in biomarkerdevelopment for IPF and other fibrotic ILDs

2:30 pm Roundtable Discussion: Assessing Imaging & Blood Biomarkers in Progressive Pulmonary Fibrosis & Learnings for Early Patient Identification

  • Sudha Visvanathan Vice President & Head of Global TMCP Inflammation, Boehringer Ingelheim
  • David Lederer Executive Medical Director, Early Clinical Development & Experimental Sciences, Regeneron
  • Cheryl Nickerson-Nutter Executive Vice President, Research & Development, Three Lakes Foundation

Synopsis

  • Using quantitative HRCT to understand the trajectory of progression
  • Comparing and correlating HRCT and blood biomarkers with lung function
  • Imaging as a screening tool to help predict early onsets of progressive pulmonary fibrosis (PPF) and select patients for international trials

3:00 pm Afternoon Break and Poster Session

Synopsis

Connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships

whilst exploring the latest pulmonary fibrosis therapeutic development and research advancements

To submit a poster, or to find out more, contact: info@hansonwade.com

Divulging the Latest Phase 2 & 3 Clinical Trial Journeys & Illuminating Dynamic Preclinical Platforms to Benchmark & Supercharge Pulmonary Fibrosis Pipelines

4:00 pm Dynamic Fibrogenesis in Human Precision-Cut Tissue Slices: An Unrivalled 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

4:30 pm Determining the Importance of Epithelial & Endothelial Cells in Driving Pulmonary Fibrosis

  • Andrew Thorley Director, Principal Scientist, & Group Leader, Genentech

Synopsis

  • Reviewing the role of epithelial and endothelial cells and senescence of these cells in promoting fibrosis
  • Exploring targeting epithelial and endothelial cells in preclinical models and clinical studies
  • Clearing the senescent cells and re-epithilialisation and revascularisation

5:00 pm Chair’s Closing Remarks for Day One

  • Fernando Martinez Chief of Pulmonary & Critical Care, Weill Cornell Medical College

Pulmonary Fibrosis Ambassador Evening

Synopsis

With September being Pulmonary Fibrosis Awareness Month, the ambassador evening presents the opportunity to connect with and the IPF community working to create life-changing, disease-modifying, therapies for pulmonary fibrosis patients in a relaxed atmosphere

5:15 pm Welcome to the Ambassador Evening

5:20 pm Pulmonary Fibrosis Leaders Fireside Chat: Looking to the Future of Therapeutic Development to Propel New Ideas & Thinking Forward

  • Andrew Thorley Director, Principal Scientist, & Group Leader, Genentech
  • Toby Maher Professor of Clinical Medicine, University of Southern California
  • Gisli Jenkins NIHR Research Professor & Margaret Turner Warwick Chair of Thoracic Medicine, Imperial College London
  • Eric White Clinical Program Lead, Boehringer Ingelheim
  • Caroline Owen Executive Director – Medical Early Clinical Development, Respiratory & Immunology, AstraZeneca
  • Sudha Visvanathan Vice President & Head of Global TMCP Inflammation, Boehringer Ingelheim
  • Fernando Martinez Chief of Pulmonary & Critical Care, Weill Cornell Medical College

Synopsis

This is a relaxed opportunity to hear from some of the key opinion leaders and decision makers from the

leading companies in the field and put your thoughts forward to shape the next era of therapeutics. Come with your questions ready!

  • Highlighting the latest thinking in the field – what should we think about ahead of time? What’s not in the papers?
  • Discussing the Progressive Pulmonary Fibrosis (PPF) definition and the impact on therapeutic development for IPF and ILDs
  • Looking from discovery, targets, genetics, novel therapies (cell therapy, mRNA, gene therapy etc), preclinical modelling, biomarkers, imaging, to trial design: debating the current state of play in the field to direct efforts and advance therapies forward to the patients

6:20 pm Enjoy Refreshments & Networking

7:00 pm Close of the Ambassador Evening – See you tomorrow!