From Symptoms to Solutions: Enhancing Interstitial Lung Disease (ILD) Trials with Next-Gen Assessments
Session introduction
Register for this webinar to learn about the latest advancements in ILD clinical trial design from endpoint selection and novel cough monitoring tech to patient-centric trial design and imaging solutions.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m.ET (NA-East)
- 15:00 – 16:00GMT (UK)
- 16:00 – 17:00CET (EU-Central)
Abstract:
Interstitial lung disease (ILD) represents a diverse group of disorders characterized by infiltration of lung parenchyma with extracellular matrix, leading to progressive respiratory impairment and respiratory failure over time.
Patients often experience debilitating symptoms such as breathlessness and chronic cough, significantly affecting their quality of life and limiting daily activities. Treatment options for ILD are limited and vary based on disease etiology and progression. While antifibrotic agents such as nintedanib and pirfenidone have shown efficacy in slowing disease progression, there remains a significant unmet need with novel therapies directed at both underlying pathophysiology and symptomatic relief under active clinical development.
The application of meaningful and measurable endpoints is essential for the success of ILD clinical trials. However, regulatory challenges persist, particularly in validating novel digital biomarkers and patient-reported outcomes (PROs). Regulatory agencies emphasize the need for standardized, reproducible measures that demonstrate clinical relevance, necessitating rigorous validation studies and alignment with evolving guidelines for digital health technologies (DHTs) in clinical trials.
Click the register button for more details and to join this webinar to learn about the latest advancements in ILD clinical trial design from endpoint selection and novel cough monitoring tech to patient-centric trial design and imaging solutions.
Speakers
Todd Lustine, M.D., M.S., FCCP
Vice President, Medical Science, Respiratory at Clario
Dr. Todd Lustine has over 25 years of clinical leadership and pharmaceutical industry / medical safety experience. Prior to joining the industry, he spent 17 years in clinical pulmonary / critical care medicine, serving in various leadership roles, including Co-Chair of the Division of Pulmonary/Critical Care Medicine, Medical Director of the Intensive Care Unit/Services and Medical Director of the Pulmonary Diagnostic and Wellness Programs.
Over the last nine years in the pharmaceutical industry, he has held medical safety leadership roles at large and mid-sized companies. In his current role at Clario, he leads Medical Science – Respiratory, emphasizing a “science-first” mentality in all aspects of our customer support. Todd holds BA in Biology and Philosophy from Emory University, a MS in Human Physiology from Georgetown University and a MD from Georgetown University School of Medicine.
He completed his residency, served as Chief Medical Resident (Internal Medicine) and completed fellowship in Pulmonary and Critical Care Medicine at Thomas Jefferson University Hospital.
Kevin McCarthy, RPFT
Director, Scientific Affairs at Clario
Kevin McCarthy has worked in the field of lung function testing for 50+ years with 40 years as the Manager of the Pulmonary Function Laboratories at the Cleveland Clinic Health System. He has always been passionate about the quality of pulmonary function measurements and has moved this passion to the clinical trial world where data quality is critical and where these measurements help accurately answer the questions we are asking.
Kevin’s research experience includes managing the pulmonary function quality control in two NIH-funded registries: patients with severe A1AT deficiency and LAM Registry and the Cleveland Clinic’s NETT study. He has published extensively on pulmonary function testing and is a former member of the ATS PFT Committee and ATS/ERS Task Force to update the standards for Spirometry in 2019 and the standards for Lung Volume testing in 2023.
Amit Vasanji, Ph.D.
Vice President, Medical & Scientific Affairs at Clario
Amit Vasanji has over 20 years of experience in basic and clinical research image acquisition, processing, analysis, visualization and biomedical software engineering across multiple modalities and therapeutic areas. His research has been published in a broad array of peer-reviewed journals and he is frequently invited to speak at international events on effective workflow design and algorithm-based biomarker development for imaging-based clinical trials.
In his current role at Clario, Amit oversees the scientific feasibility and design of Clario’s imaging platform and is responsible for the development and integration of customized image analysis algorithms into clinical trial workflows.
Dr. Peter Cho
Consultant in Respiratory Medicine and Adjunct Senior Lecturer at Kings College Hospital NHSFT
Dr. Peter Cho has an interest in the physiology and assessment of cough, and his work provided novel insights into the role of cough inhibition mechanisms in the pathogenesis of chronic cough. His latest work focused on improving the assessment of the severity and impact of cough. Peter is currently leading a scientific study utilising network analysis to define phenotypes of cough for NEuroCOUGH, an ERS CRC funded Europe-wide cough registry. Peter was also a member of the BTS Cough specialist advisory group and BTS Education and Training Committee.