7:50 am Chair’s Opening Remarks

  • Fernando Martinez Chief, Division of Pulmonary & Critical Care Medicine, Weill Cornell Medicine

Reviewing the Last 12 Months of IPF Drug Development

8:00 am What Are the Clinical Issues & Developments in the Last 12 Months of IPF Drug Development?

  • Fernando Martinez Chief, Division of Pulmonary & Critical Care Medicine, Weill Cornell Medicine

Synopsis

• Highlighting progress form the IPF Summit 2017 and 2018
• Reviewing the IPF drug development landscape
• Outlining outcomes for the 3rd IPF Summit from the outset

8:30 am The Prognostic Lung Fibrosis Consortium (PROLIFIC)

  • Peter Schafer Executive Director, Translational Development, Celgene

Synopsis

• Developing well-qualified assays for important peripheral blood markers of pulmonary fibrosis, suitable for non-exclusive use as prognostic or predictive biomarkers within the context of clinical trials, and for potential commercial use
• Overviewing the most important pulmonary fibrosis serum or plasma biomarkers based on prognosis (progression-free survival and/or lung function), through a survey of the literature and relevant research

9:00 am How Much More Data has Been Generated to Support Imaging Modalities?

  • Neeraj Vij Chief Clinical Development Officer , 4Dx

Synopsis

• Talk details to be finalized by 4Dx

9:30 am Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the IPF field and establish meaningful business relationships.

10:15 am Morning Break & Networking

Preclinical Stream

Clinical Stream

Pulmonary Pathobiology for New Target Identification

Transforming Patient Data into Actionable Insights

Toll-Like Receptor 5 (TLR5) Agonism as a Novel Immunotherapy Modality in IPF

11:00 am

• Outlining the role of host defence and immune pathways (e.g. muc5b and TOLLIP) as risk factors on IPF pathogenesis and identification of TLR5 as a novel, druggable target in IPF
• Demonstrating TLR5 relationship with IPF in humans and in mice
• Analyzing human and murine data to hypothesize TLR5 agonism is effective in preventing and treating lung fibrosis

Stavros Garantziotis, Medical Director, Clinical Research Unit,
National Institute of Environmental Health Sciences

Optimal Design of Early & Late Phase IPF Studies

11:00 am

• Refining endpoints for early stage studies to reduce the attrition rate for clinical trials
• More talk details to follow

Toby Maher, Professor of Interstitial Lung Disease,
Imperial College London

Disruption of Oxylipin Metabolism using Designed Multiple Ligand (DML) Molecules to Treat IPF

11:30 am

Patient Engagement, Use of Mobile Devices in Clinical Research, & Decentralized Clinical Trials

11:30 am

• Discovery and development of small molecules with multiple ligands to treat IPF
• Sharing soluble epoxide hydrolase (sEH) as a target for IPF and secondary targets selected based on their potential role in alleviating fibrosis
• Presenting recently generated new pharmacology data in the Bleomycin mouse model for IPF

Mehran Moghaddam, Chief Executive Officer,
OROX BioSciences

• Decreasing the costs of clinical trials by increasing patient engagement meaning enhanced recruitment, fewer amendments, improved retention, and better patient experience
• Using mobile devices to improve the quality and efficiency of trials and reflect more accurately “real world data”
• Decentralizing trials to decrease the patient burden, enroll a more diverse, representative spectrum of patients, and address challenges for investigative sites

Dan Rose, Steering Committee,
Clinical Trials Transformative Initiative

Disease-Specific Extracellular Matrix Cell Culture Substrates to Improve Predictive in Vitro Models of Pulmonary Fibrosis

12:00 am

Real-World Data: Transforming Clinical Research in IPF

12:00 am

• Developing much-needed commercial research tools for IPF research in the form of a standardized, fully humanized 3D cell culture platform comprised of intact extracellular matrix (ECM) that recapitulates the human IPF disease environment in vitro
• Reducing dependence on animal models, and enabling more meaningful and relevant results

John O’Neill, Chief Executive Officer,
XYLYX

• Describing opportunities to utilize Real-World Data in IPF clinical research
• Exploring Real-World Data considerations unique to IPF
• Demonstrating approaches to Real-World Data to accelerate IPF research

Komathi Stem, Founder & Chief Executive Officer,
monARC Bionetworks

12:15 pm Lunch & Networking

Closing the Translational Gap

Translating Patient Activity into Endpoints

Drug Discovery in Lung Repair & Regeneration

1:15 pm

Six-Minute Walk as Secondary Endpoint in IPF

1:15 pm

• Looking beyond the fibroblast to assess the fibrotic niche
• Exploring ‘differential patient biology’ as a route to novel target validation

Matthew Thomas, Department Head, Immunology & Respiratory,
Boehringer Ingelheim

• Reviewing open label data
• Contextualizing data to 6 minute walk time distance (6MWTD)
• Moving forward in IPF clinical trials using 6MWTD

Rick Jack, President, Chief Operations Officer & Chief Scientific Officer,
Promedior

Looking at the Kinetics of Transcriptional &
Extracellular Matrix Responses to Bleomycin Induced
Lung Fibrosis

1:45 pm

Refractory Cough as Primary Endpoint in IPF: Update on Inhaled RVT-1601

1:45 pm

• Differentiating intratracheal versus systemic Bleomycin models through transcriptome changes
• Presenting sensitivity and clinical relevance of lung function measurements mice
• Using mass spectrometry analysis of extracellular matrix and lung imaging to quantify preclinical disease outcomes

Hans Brightbill, Scientific Manager, Translational Immunology,
Genentech

• Disucssing unmet need for symptom relief and quality of life improvement in IPF patients
• Bringing fresh life to an old drug
• Updating on Inhaled RVT-1601: from proof of concept to Phase 2b

Ahmet Tutuncu, Executive Vice President, Clinical & Regulatory,
Respivant

Can we Correlate Biochemical Measurements & Pulmonary Function?

2:15 pm

The Use of Active Indication (IPF) Management to Drive Higher Quality Outcomes Data

2:15 pm

• Analyzing preclinical lung mechanics and the future of drug development
• Presenting sensitivity and clinical relevance of lung function measurements mice
• Understanding lung function and imaging in mice as new requisites for drug development for pulmonary fibrosis

Harry Karmouty-Quintana, Assistant Professor, Department of Biochemistry & Molecular Biology,
UTHealth - McGovern Medical School

• Many studies fail to deliver optimal data due to a lack of focus on research grade data, enrolment of inappropriate patients, a reliance on secondary quality control measures and an inability to effectively intervene
to drive change.
• High levels of primary data quality are possible through focused site training, real time intervention to certify and remove inappropriate patients and active management of outliers

Philip Lake, Respiratory Solution Architect, ERT

Patient Perspective Panel

2:30 pm

2:45 pm Afternoon Break & Networking

Prognostic, Diagnostic, Therapeutic, Enrichment: Biomarker Updates in IPF

3:15 pm Clarifying Guidelines for Diagnosis of IPF

  • Ganesh Raghu Director, Interstitial Lung Disease/ Sarcoid, Pulmonary Fibrosis Program, University of Washington

Synopsis

• Bridging the evidence based guidelines and the Fleischner document
• Clarifying the role of surgical lung biopsy
• The importance of accurate diagnosis for IPF

 

3:45 pm The Intersection of Lung Cancer & Fibrosis – as Told Through Imaging

  • Mary Salvatore Associate Professor – Thoracic Radiology, Columbia University Medical Center

Synopsis

• Discussing overlap of lung fibrosis with fibrosis seen in lung cancer
• Mapping out how orphan lung cancer develops from fibrosis with CT scanning

4:15 pm Using Systemic Biomarkers in the Context of Clinical Trials to Give Mechanistic Understanding

  • Toby Maher Professor of Interstitial Lung Disease, Imperial College London

Synopsis

• Updates on the PROLIE Study: a biomarker cohort as a vehicle to discover and validate biomarkers including blood based measures
• Sharing efforts with AI to improve reading of CT scans and introduce as clinical trial endpoints
• Developing strategies to increase confidence that drugs are hitting mechanism and interfering with fibrotic pathways

Evaluating Partnership & Collaboration Opportunities in IPF

4:45 pm Perspectives for Partnerships Panel Discussion

  • Eric Nelson Biotechnology Business Development Consultancy Director, NCE Biotech
  • Moustapha El-Amine External Innovation, Search & Evaluate, AstraZeneca
  • Yves Wyckmans Senior Director, Corporate Business Development & Strategic Planning at Actelion, Janssen Pharmaceuticals

5:15 pm Chair’s Closing Remarks

  • Fernando Martinez Chief, Division of Pulmonary & Critical Care Medicine, Weill Cornell Medicine

5:20 pm Scientific Poster Session & Drinks Reception

Synopsis

After the formal presentations have finished, the learning and networking carries on. The Poster Session allows you to present your research, connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships.