7:00 am Check-In & Breakfast

8:00 am Chairs Opening Remarks

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

Synopsis

From Setbacks to Breakthroughs in the Battle Against Pulmonary Fibrosis in the Past Year Since the 7th IPF Summit: Where Are We Now?

Exploring the Current State of Play in the Progressive Pulmonary Fibrosis Field

8:30 am Examining the Phase 2b BEACON-IPF Trial of Bexotegrast for Patients with IPF

  • Bernard Coulie President & Chief Executive Officer, Pliant Therapeutics Inc.

Synopsis

• Exploring key study design and attributes of the phase 2b trial

• Exploring the selected clinical study design including patient populations, biomarker panel, endpoint selection and beyond

• Looking on to the phase 3 study, what is next? 

9:00 am Distilling Phase 3 Commencing of BMS’ LPA1 Antagonist for IPF & PPF

  • Aditya Patel Clinical Development Lead, Bristol Myers Squibb

Synopsis

• Investigating the current clinical development and progress of BMS’ lysophosphatidic acid receptor 1 (LPA1) antagonist

• Exploring phase 2 readouts implications on phase 3 study design and exploring the process of enrolling a large-scale phase 3 study

9:45 am Panel Discussion: Incorporating Industry Perspectives When Examining Existing & Evolving Endpoints – “Feels, Functions, Survives”

  • Amy Case Interim Chief Medical Officer, Pulmonary Fibrosis Foundation
  • Marilyn glassberg speaker, Loyola University
  • Eric White Senior Clinical Program Lead, ILD, Boehringer Ingelheim
  • Steven Greenberg Vice President, Disease Area Head, Pulmonology, Bristol Myers Squibb

Synopsis

• Exploring the industry’s interpretations of Feels, Functions, Survives and the practical considerations and implications on drug development

• What is it going to take for the regulators to see beyond FVC and how can we as the industry precompetitive and come together to action this

• What additional surrogates of mortality are available, can we infer these from other diseases?

• Highlighting the importance of collaboration between researchers, regulators, clinicians, and patient advocates to drive the adoption of patient-centred endpoints

10:30 am Speed Networking & Morning Break

Synopsis

This informal session provides the perfect opportunity to connect with the industry frontrunners and key opinion leaders in the pulmonary fibrosis field. Establish meaningful connections to build upon for the rest of the conference and gain exclusive first-hand insights into the latest research and developments driving progression in the pulmonary fibrosis field.

Track 1: Emerging Biology & Early Translation

Chair: Marilyn Glassberg, Professor & Chair, Department of Medicine, Loyola University

Leveraging the Latest Advancements in Pulmonary Fibrosis Recapitulation to Enhance Preclinical Modelling & Drive the Field Forward

11:15 am Leveraging Induced Pluripotent Stem Cells to Replicate Genetic & Cellular Characteristics of Individual Patient Biology

  • Darrell Kotton Professor - Pathology & Laboratory Medicine, Boston University Medical Center

Synopsis

• Utilizing iPSCs for improved testing of drug efficacy in preclinical models that more closely mimic human lung tissue • Examining the promise of personalized models to identify different IPF patient subtypes and improve patient segmentation for improved clinical trial design

11:45 am Modelling the Repair Mechanisms to Better Understand the Regeneration Pathway & Uncover Novel Effective Therapeutics

Synopsis

• Examining distinct aspects of repair, from epithelial regeneration, collagen deposition, and immune response

• Defining the critical need for mechanistic understanding of fibrosis reversal mechanisms to identify drug candidates • Need for reliable biomarkers for assessing patient response to treatment for fibrosis stabilization or reversal

12:15 pm Navigation the Limitations of Cellular Assays for Novel Target Identification & Validation

Synopsis

• Leveraging state of the art techniques to examine macrophage biology

• Exploring novel assays and methodologies to study complex biology through dimension reduction to screen in vivo relevant phenotype

Track 2: Late Translation & Clinical

Chair: Fernando Martinez, Chief of Pulmonary & Critical Care, Weill Cornell University

Harnessing the Latest Imaging Technologies for Earlier & Improved Diagnostics, Prognostication & Disease Progression Tracking

11:15 am Examining Molecular Imaging Probes for NonInvasive Visualization of Lung Microstructure for Diagnosis and Progression Tracking

  • Lida Hariri Associate Professor - Pathology, Cardiovasuclar Genetics

Synopsis

• How Probe-Based OCT can identify molecular signatures of patients and its promise in patient selection

• Exploring the potential OCT for differentiating fibrotic from non-fibrotic interstitial lung disease in patients with low confidence CT findings

• Investigating the emerging use of OCT for monitoring disease progression and response to treatment

11:45 am Brainomix e-Lung Biomarkers are Prognostic & Outperform FVC in the Serial Assessment of Patients with Fibrotic Lung Disease

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 nonIPF cohorts

• Imaging biomarkers may hold the key to successful delivery of the next generation of ILD clinical trial

12:15 pm Uncovering Minimally Invasive Biomarkers in the Extracellular Matrix That Accurately Reflect Pulmonary Conditions

  • Claire Emson Senior Director - Clinical Biomarkers & Diagnostics, Amgen

Synopsis

• Examining the desperate need for reliable biomarkers for assessing drug efficacy beyond just clinical endpoints like FVC decline

• Promise of AI for unbiased and quantitative measures of disease progression and the potential use as a surrogate endpoint

• Exploring multi-modal biomarkers, combining blood, imaging, and beyond to paint a more complete picture of disease progression

12:45 pm Lunch Break

Track 1: Emerging Biology & Early Translation

Uncovering a Translational Framework of Preclinical Modelling to Enhance the Predictive Power & Navigate from Bench to Bedside for the Next-Gen Therapeutics

1:45 pm Building an Eco-System of Translational Models to Provide Enhanced Confidence in Candidate Mechanism of Action

  • Katie McCauley Associate Director, Head of Fibrosis Research, Novartis AG

Synopsis

• Exploring a translational framework to cross-validate findings across models for enhanced confidence

• Exploring candidate selection profiles and the level of confidence needed for go-no-go decisions

• Establishing a standardized protocol of readouts across models to improve data consistency and translatability

2:15 pm Enhancing Modelling of PK/PD in Preclinical Models to Better Predict Dosing Strategies & Enhanced Mechanistic Insights

  • Tim Oldham Chief Executive Officer & Managing Director, AdAlta

Synopsis

• Divulging the intersection where pharmacology meets clinical trial design from optimal dosing regimes

• Exploring how modelling can uncovering limitations such as fast clearance and the importance of anticipating limitations to better prepare for clinical trials

• Utilizing data driven design for identifying optimal targets, refining treatment regimens to accelerate drug discovery

2:45 pm Leveraging Biomarkers to Unveil Mechanistic Insights in Early Translational Development to Decode Pulmonary Fibrosis

Synopsis

• Explore how biomarker analysis provides critical insights into the pathophysiology of IPF, shedding light on the key molecular pathways involved

• Discover how leveraging biomarkers enables the identification of targeted interventions like LTI-03 to protect lung epithelium and inhibit fibroblast-mediated fibrosis expansion in patients with IPF.

Track 2: Late Translation & Clinical

Evolving Measures of Progress: Surrogate, Exploratory, & Composite Endpoints for Earlier Detection of Clinical Benefit

1:45 pm Panel Discussion brought to you by Vitalograph

2:15 pm From Symptom to Surrogate Endpoint: Where Does Cough Fit in IPF Drug Development

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

Synopsis

• Despite the significance of cough to patients with IPF, there is limited understanding of cough mechanisms, whether inflammatory, fibrotic, sensory

• Investigating cough as a surrogate endpoint in clinical trials for disease progression and treatment efficacy

• Coverage of design and validation of cough specific clinical trial design 

2:45 pm Session Reserved for Fortrea

3:15 pm Afternoon Break & Poster Session

Synopsis

Immerse yourself in an engaging and informal session, join your peers in a relaxed atmosphere that encourages meaningful conversations and discussions. Explore a range of exciting poster presentations and showcase your own developments in the Pulmonary Fibrosis world. Don’t miss out on the chance to connect, learn, and present. Get ready to be impressed!

4:00 pm Session Reserved for MannKind

4:30 pm Human Precision-Cut Tissue Slices as a 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

5:00 pm Analyzing Design of a Phase 3 Trial for Inhaled Treprostinil

  • Peter Smith Vice President Product Development, United Therapeutics Corp.

Synopsis

• Exploring the scientific rationale behind inhaled Treprostinil

• Phase 3 trial design and special considerations of inhaled candidate for evaluating the long-term safety and tolerability of Treprostinil

5:30 pm Chairs Synopsis of Day One

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

5:45 pm Ambassador’s Evening & Drinks Reception

Forge the Future of Progressive Pulmonary Fibrosis Therapeutics with An Evening of Dialogue

What is in Store?

Synopsis

Engage with your IPF community’s foremost thought leaders and pioneering figures in a laid-back setting, fostering ongoing dialogues and delve deeper into the ground-breaking insights exchanged earlier in the day. Benefit from the perspectives of industry trailblazers, and fearlessly pose insightful questions to extract forward-thinking insights that will influence the future landscape of IPF treatments.

Panel Discussion: Interrogating Recent Phase 2 & Phase 3 Failures by Dissecting Targets & MOA & Chosen Biomarkers, Endpoints, Patient Populations & Beyond to Bridge the Late Translational Gap

The last 12 months have been a turbulent year with high profile and unexpected clinical failures whereby Galecto and FibroGen’s phase 2 and phase 3 trials both failed to meet their primary endpoint of lung function (FVC). Having both showed immense promise experts in the space really can’t place their bets as where the next approval is coming from when these candidates looked so promising until late-stage clinical trials. Therefore, there is the opportunity to double down on the challenges and learn from these clinical failures and take the lessons learned into current therapeutic development.