2026 Presentations

The 1st Pulmonary Clinical Trials Workshop

  • Lessons Learned from Failed Phase 3 Trials - Kevin Brown (Denver, USA)

    Designing Pivotal Trials in the Era of Approved Therapies - Fernando Martinez (Boston, USA)

    Inhaled Therapy in Pulmonary Fibrosis - Jürgen Behr (Munich, GER)

    Are Head-to-Head Trials Feasible in Pulmonary Fibrosis? - Toby Maher (Los Angeles, USA)

    Is it Time to Combine IPF and PPF in Phase 3 Trials - Steven Nathan (Fairfax, USA)

    Patient Viewpoint - Gary Shuman (Pulmonary Fibrosis Foundation, USA)

    Methodology Viewpoint- Tom Jensen (Berry Consultants, USA)

    Industry Viewpoints - Camilla Graham (PureTech, USA), Melissa Rhodes (Avalyn, USA), Donald Zoz (Boehringer Ingelheim, USA)

    FDA Viewpoint - Khalid Puthawala (FDA, USA)

  • Repurposing Pulmonary Hypertension Drugs for Pulmonary Fibrosis – Steven Nathan (Fairfax, USA)

    Pulmonary Hypertension as a Treatable Trait in Pulmonary Fibrosis – Aaron Waxman (Boston, USA)

    Trial Design in Combined Pulmonary Fibrosis and Emphysema – Vincent Cottin (Lyon, FRA)

    Clinical Trials in Acute Exacerbations of Pulmonary Fibrosis – Steven Duncan (Birmingham, USA)

    Treating Cough in Pulmonary Fibrosis - Marlies Wijsenbeek (Rotterdam, NLD)

    Building the Neutral Infrastructure Needed for the Future of Clinical Trials - Carmela Wegworth (OSIC, USA)

    Patient Viewpoint - Karen Smoot (Pulmonary Fibrosis Foundation, USA)

    Industry Viewpoints - Bernt van den Blink (Vicore Pharma, SWE), Peter Smith (United Therapeutics, USA), David J. Zammit (BMS, USA)

    FDA Viewpoint - Andrew Clerman (FDA, USA)

  • Preclinical Studies in Pulmonary Fibrosis: When Is it Good Enough? – Elisabeth Redente (Denver, USA)

    Targeting TGF-β Signalling in Pulmonary Fibrosis – Greg Cosgrove (Centennial, USA)

    Biomarkers and Target Engagement in Pulmonary Fibrosis Trials – Deji Adegunsoye (Chicago, USA)

    Is HRCT a Valid Endpoint in Pulmonary Fibrosis? – Kevin Brown (Denver, USA)

    Is it Time for Trials of Upfront Antifibrotics in non-IPF Pulmonary Fibrosis? - Vincent Cottin (Lyon, FRA)

    Should We Use Digital Twins in Pulmonary Fibrosis Trials? - Toby Maher (Los Angeles, USA)

    Patient Viewpoint- Mark Cackler (Pulmonary Fibrosis Foundation, USA)

    Industry Viewpoints - Wouter Eijkelkamp (Chiesi, NLD), Carol Satler (Insilico, USA), Peter Schafer (PROLIFIC, USA)

  • Type-2 Molecular Phenotypes and Endotype of Asthma - Sally Wenzel (Pittsburgh, USA)

    Similarities and Differences in Anti-T2 Pathway Biologics - Praveen Akuthota (San Diego, USA)

    Remission (on or off Biologics) - Kaharu Sumino (St Louis, USA)

    Can We Cure Asthma or Does Asthma Cure Itself? - Ben Gaston (Indianapolis, USA)

    What Clinical Trial Designs Are Needed to Determine Whether T2 Biologics Remit or Cure Asthma Endotypes? - Michael E. Wechsler (Denver, USA) (virtual)

    Investigator Viewpoint - Marc Gauthier (New Castle, USA)

    NIH Viewpoint - Lisa Postow (NIH, USA)

    FDA Viewpoint - Ronald Rabin (FDA, USA)

    Industry Viewpoint - Thomas Corbridge (GSK, USA)

  • Problems with Current Asthma Severity Definitions and T2 Biomarkers - Eugene Bleecker (Phoenix, USA)

    Advantages and Disadvantages of Increasing Corticosteroid Doses - Stanley Szefler (Aurora, USA)

    Can AI Help Identify the Most at Risk Patients? - Joe Zein (Phoenix, USA)

    Should Prescribing Expand from Specialists to Primary Care? - David Price (Aberdeen, UK)

    Making Precision Medicine a Reality for All: As the Market Grows, How Do we Assure Equitable Care in Asthma? - Meredith McCormack (Baltimore, USA)

    Clinical Trial Designs to Address Earlier Interventions With Biologics - Malin Fagerås (AstraZeneca, SWE)

    Investigator Viewpoint - Dan Jackson (Madison, USA)

    Patient Viewpoint - Lindsay Cenname (Pittsburgh, USA)

    NIH Viewpoint - Patrice Becker (NIAID, USA)

    Industry Viewpoint - Yamo Deniz (Regeneron, NYC, USA)

  • How Should T2-Lo Asthma be Defined? - Steve Georas (Rochester, USA)

    Are There Clinical Phenotypes of T2-Lo Asthma? - Maarten van Deberge (Groeningen, NDL)

    Where Is the Overlap with COPD? - Nick Hanania (Houston, USA)

    Clinical Definitions vs Objective Physiologic/Biologic Markers - Monica Kraft (New York, USA)

    Clinical Trial Designs to Address the Challenges of T2-Lo Asthma and ACO? - Loren Denlinger (Madison, USA)

    Patient Viewpoint - Robin Rohrer (Pittsburgh, USA)

    Industry Viewpoint - Giovanni Piotti (Chiesi, ITA)

  • Pulmonary Hypertension ESC/ERS Guidelines: a Brief Summary on PAH– Marc Humbert (Paris, FRA)

    Pulmonary Hypertension World Symposium: PAH Treatment Algorithm – Vallerie McLaughlin (Ann Arbor, USA)

    Year in Review: PAH Clinical Trials – Victor Moles (Ann Arbor, USA)

    How to Develop a New Drug Targeting a Fifth Pathway in PAH? – Paul Yu (Boston, USA)

  • PAH Clinical Trials: a Focus on Phase 2 and Phase 3 RCTs – Kelly Chin (Dallas, USA)

    Is Mortality a Valid Endpoint in PAH RCTs? – Vallerie McLaughlin (Ann Arbor, USA)

    When an Independent DMC Should Stop a Trial in PAH? – Steve Kawut (Philadelphia, USA)

    Inhaled Drugs for PAH: Challenges and Opportunities - Sandeep Sahay (Houston, USA)

    Imaging of the pulmonary vasculature as a secondary endpoint - Nick Rahaghi (Los Angeles, USA)

    Investigator Viewpoint- Corey Ventetuolo (Providence, USA)

    Patient Viewpoint- Colleen Brunetti (Pulmonary Hypertension Association, USA)

    FDA Viewpoint- Mitch Psotka (FDA, USA)

    Industry Viewpoints - Chris Cabell (Inhibikase Therapeutics, USA), Rajeev Saggar (Liquidia, USA), Kate Steiner (Allrock Bio, USA)

  • Group 1 PH: Embracing Remission as a Goal in PAH – Sandeep Sahay (Houston, USA)

    Group 2 PH: RCT in Left-Heart Disease Associated PH – Failures and Promises – Mardi GombergMaitland (Washington, USA)

    Group 3 PH: RCT in Lung Diseases RCT – Failures and Promises – Vincent Cottin (Lyon, FRA)

    Group 4 PH: the Beauty of Multidisciplinary Approaches - Marc Humbert (Paris, FRA)

    Group 5 PH: Sickle Cell Disease and PH - Roberto Machado (Baltimore, USA)

    Investigator Viewpoint- Brad Maron (Baltimore, USA)

    Patient Viewpoint - Noemi Maldonado (Ashburn, USA)

    FDA Viewpoint- Mitch Psotka (FDA, USA)

    Industry Viewpoints - Franck Rahaghi (United Therapeutics, USA), Mahesh Patel (Merck, USA), Carlos Sanmarco (Pulmovant, USA)

  • Imaging the Vascular versus Parenchymal involvement in ILD – Simon Walsh (Queright, UK)

    What Hemodynamic Threshold for Enrollment in Group 3 Studies? – Sandeep Sahay (Houston, USA)

    How Best to Balance the Extent of Parenchymal Disease and Hemodynamic Impairment – Christopher King (Falls Church, USA)

    How Much Parenchyma Disease Is Permissible in Group 1 Studies? – Harrison Farber (Boston, USA)

    Sarcoid-Associated PH: a Different Entity or Bundle With Group 3? - Bob Baughman (Cincinnati, USA)

    Combined Pulmonary Fibrosis and Emphysema: Study Alone or Include With ILD-PH Studies? - Vincent Cottin (Lyon, FR)

    The Optimal Phenotype for COPD-PH Studies - Katarina Zeder (Washington, D.C., USA)

    NIH Viewpoint - Christian Gomez (NIH, USA)

    Patient Viewpoint - Lieutenant General Veralinn ‘Dash’ Jamieson (USA)

  • The Problem: We Are Late! What Is Early and/or Pre-COPD? - MeiLan Han (Ann Arbor, USA)

    Early Markers and Imaging – George Washko (Boston, USA)

    Applying Current Therapies at Earlier Stages: Is There Evidence? – Fernando Martinez (Boston, USA)

    Solution Provider Viewpoint – Ameera Patel (TidalSense, USA)

    Industry Viewpoint – David Lipson (GSK, USA)

  • Etiotypes, Phenotypes and Endotypes - Francesca Polverino (Houston, USA)

    Evidence for Inflammation – Maor Sauler (New Haven, USA)

    Evidence for Immune Dysregulation – Jeff Curtis (Ann Arbor, USA)

    Evidence of Accelerated Lung Aging – Miguel Divo (Boston, USA)

  • Dissecting the Event; the Need for Precision - Bartolome Celli (Boston, USA) (recorded)

    Assessing the Risk and Preventing Them Before Their Occurrence – Alver Agusti (Barcelona, ESP) (recorded)

    Is it the Lungs, the Heart or Something Else? – Leonardo Fabbri (Ferrara, ITA)

    Patient Viewpoint – Casey McPherson (AfPA, USA)

    Industry Viewpoint – Derek Daigle (Pfizer, USA)

  • Biologics in COPD: Where Are We? - Surya Bhatt (Birmingham, USA)

    Metformin: Is it an Option? - Jessica Bon (Winston-Salem, USA)

    Industry Viewpoint – Kate Knobil (Altesa, USA)

  • Measuring Disease Progression - Alver Agusti (Barcelona, ESP) (recorded)

    Patient Viewpoint – Jean Wright (COPD foundation, USA)

    Industry Viewpoint - Aubrey Kelly (AHIS, USA)

  • AI for Patient Care - George Washko (Boston, USA)

    AI for Disease Detection Using Imaging – Charles Hatt (Ann Arbor, USA)

    AI Approaches for Image Analysis – Raul San José Estépar (Boston, USA)

    Leveraging Foundational Models – Qazaleh Mirsharif (Genentech, USA) (virtual)

  • Industry Viewpoint- Robert Fogel (Astrazeneca, USA)

    GOLD-WHO Viewpoint – David Halpin (Exeter, UK)

  • The Multicenter Interventional LAM Early Disease (MILED) Trial of Sirolimus Treatment in Women with Mild LAM – Frank McCormack (Cincinnati, USA)

    The Future of Clinical Trials in LAM – Nishant Gupta (Cincinnati, USA)

    Targeting GM-CSF in Pulmonary Alveolar Proteinosis – Cormac McCarthy (Dublin, IRE)

    Cell Therapy Innovation in Pulmonary Alveolar Proteinosis – Bruce Trapnell (Cincinnati, USA)

    Pulmonary Langerhans Cell Histiocytosis: Is it Time to Treat? - Abdellatif Tazi (Paris, FRA)

    Clinical Trials in Sarcoidosis Daniel Culver (Cleveland, USA)

    Investigator Viewpoint Marlies Wijsenbeek (Rotterdam, NLD)

    Patient Viewpoint- Cindy Beasley (The LAM Foundation, USA)

    Industry Viewpoint - Raymond Pratt (Savara, USA)

  • Progressive Pulmonary Fibrosis: Does Progression Predict Progression or Is it the Burden of Disease? – Kevin Flaherty (Ann Arbor, USA)

    Beyond the FVC: How Best to Capture How Patients Feel and Function? – Jeff Swigris (Denver, USA)

    ILD Trials: Composing and Reporting Composites – Steven Nathan (Fairfax, USA)

    Clinical Trial Designs: Striking the Balance Between Quixotic and Pragmatic - Kevin Brown (Denver, USA)

    Innovative Trial Designs in ILD - Fernando Martinez (Boston, USA)

    The Role of Biomarkers as Endpoints in ILD Cinical Trials: Enrichment and/or Endpoint - Imre Noth (Charlottesville, USA)

    The Role of Imaging: Enrichment and/or Endpoint - George Washko (Boston, USA)

    Industry Viewpoints - Ines Macias-Perez (Cumberland, USA), Mudiaga Sowho (Contineum Therapeutics, USA)

  • The 6MWT: Is it All About the Distance?– Abhi Chandel (Falls Church, USA)

    How Best to Deploy Actigraphy in Pulmonary Clinical Trials – Steve Kawut (Philadelphia, USA)

    A “Utility” PRO: Can One Fit All Pulmonary Disease States? – Jeff Swigris (Denver, USA)

    Morphology Versus Physiology in ILD Clinical Trials - Athol Wells (London, UK)

    Clinical Trials: the Quest for Ethnic and Racial Equipoise - Yolanda Mageto (Dallas, USA)

    Cough: an Endpoint in IPF Studies, But an AE of Inhaled Therapies - Toby Maher (Los Angeles, USA)

    The Need for Greater Granularity in Adverse Event Reporting: Time to Resolution - Lisa Lancaster (Nashville, USA)

    What Are the Best Endpoints in Systemic Diseases? Sarcoid and Scleroderma Studies - Steve Mathai (Baltimore, USA)

    Patient Viewpoint - Kelly Andrews (Pulmonary Fibrosis Foundation, USA)

  • Dipeptidyl Peptidase-1 Inhibitors: Overview of Development and Data – James D. Chalmers (Dundee, UK)

    What Did We Learn About Endpoints: Exacerbations and Patient Reported Outcomes – Charles Daley (Denver, USA)

    Activity vs Damage: Are We Treating Too Late – Stefano Aliberti (Milan, ITA)

  • Patient Complexity and Heterogeneity in Bronchiectasis and How They Influence Treatment Response – Rebecca Hull (Dundee, UK)

    Dealing with Overlap Syndromes: COPD and Asthma – Eva Polverino (Barcelona, ESP)

    Co-development in CF and Bronchiectasis – David Nichols (Cystic Fibrosis Foundation, USA)

    Industry Viewpoint – Rod Hughes (MSD, USA)

  • Objectives of Therapy in Bronchiectasis Trials- Can We Do Better? – Anne O’Donnell (Washington, DC., USA)

    Lung Function Progression – Mark Metersky (Farmington, USA)

    Imaging in Bronchiectasis Trials – Harm Tiddens (Rotterdam, NL)

    Composite Endpoints and Future Technology- Solution or Mirage? – Raksha Jain (Dallas, USA)

  • Anti-Inflammatory Mechanisms, Biomarkers and Approaches – James D. Chalmers (Dundee, UK)

    Anti-Infectives: How Do We Set up for Success? – Tim Aksamit (Rochester, USA) (virtual)

    Mucociliary Clearance – George Solomon (Birmingham, USA)

    Targeted Therapies in Rare Endotypes: Lessons From the First Rrial of Gene Therapy for PCD – Michael Loebinger (London, UK)