Respiratory Drug Development: Comprehensive Strategies to Improve Data Quality
This webinar will explore how these principles apply specifically to respiratory clinical trials, an area where data variability and test-dependent reliability are critical for optimal study outcomes. The featured speakers will share study‑level and site‑level strategies for ensuring superior data quality, including centralized review models that enable standards‑based feedback, early and ongoing quality assessments, proper training and contemporaneous data quality review activities that offer deeper insight into data validity beyond ATS/ERS criteria alone. They will emphasize test-level spirometry performance characteristics that are critical in assuring that test results accurately reflect your study participants’ physiologic state. These processes not only support trial performance in real time but also strengthen confidence that the collected pulmonary function data accurately represent true physiological status.
Register for this webinar to learn how respiratory drug development teams can strengthen spirometry oversight and improve respiratory endpoint data quality.
Register for this webinar to learn how respiratory drug development teams can strengthen spirometry oversight and improve respiratory endpoint data quality.
Attendees will:
- Understand the key elements that affect data quality for respiratory endpoints, and why high data quality is essential
- Learn techniques to monitor for data quality issues
- Increase awareness of key requirements at spirometry test acquisition to assure clinical trial-ready data quality and accuracy
- Review key elements of proper training to reduce variability from the start across diverse testing sites
Speakers
Todd Lustine, M.D., MS, FCCP
Vice President, Medical Science, Respiratory at Clario
Todd Lustine has over 25 years of clinical leadership and pharmaceutical industry /medical safety experience. Prior to joining 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 9 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 customer support.
Todd holds BA degrees in Biology and Philosophy from Emory University, a Master’s degree (MS) in Human Physiology from Georgetown University and a Medical Doctorate (MD) from Georgetown University School of Medicine. He completed his residency, served as Chief Medical Resident (Internal Medicine) and completed a fellowship in Pulmonary and Critical Care Medicine at Thomas Jefferson University Hospital.
Kevin McCarthy, RPFT, ATSF, FAARC
Senior Director, Scientific Affairs, Respiratory Science at Clario
Kevin McCarthy has worked in lung function testing for 50+ years, with 40 years as 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 pulmonary function quality control in two NIH-funded registries: patients with severe A1AT deficiency and Registry of patients with lymphangioleiomyomatosis (LAM). He has published extensively on pulmonary function testing and is a former member of the ATS PFT Committee and ATS/ERS Task Forces that updated the standards for Spirometry in 2019 and the standards for Lung Volume testing in 2023.
Sascha Huth, Ph.D., MBA
Vice President, Client Education and Customer Experience at Clario
More info coming soon.
Phil Lake, Ph.D.
Senior Director, Scientific Affairs, Respiratory Science at Clario
Philip Lake is a respiratory specialist at Clario. He has held various roles in drug development for 20 years, predominantly focused on respiratory drug development. He has led the respiratory strategy for a number of CROs and held positions as Head of European Project Management for two of these companies. In addition to classic regulatory indications his recent focus has been on the use of lung function endpoints as a biomarker in rare disease and neurodegenerative disorders. Phil was pivotal to some of the first centralized overread studies and is committed to driving improvements in lung function testing through a better understanding of data plausibility and variability to generate new data.