New Frontiers in Respiratory Trials: AI, Lung Sounds, Remote Coaching and Alternate Endpoints

For decades, respiratory trials relied almost exclusively on large, site-based spirometer units and required protracted timelines for data analysis and overread. Achieving repeatable, high-quality forced spirometry maneuvers was challenging and required in-person coaching to ensure that maximal effort was achieved.

With the recent pandemic and the shift to a decentralized trial approach, trial participants are looking to test from home; however, without coaching and with standard overread timelines, there is a great risk of unusable data, retests and missed timepoints. In this webinar, Dr. Marko Topalović, co-founder of ArtiQ, will discuss new artificial intelligence approaches to spirometry data overread that enable instant feedback and make at-home, just as in-clinic, testing more robust and cost-effective. Clario’s Kevin McCarthy and Dr. Phil Lake will address new options for at-home spirometry that bring the clinician into the participant’s home, virtually, and the impact that has on data quality.

Respiratory endpoints have moved beyond standard spirometry metrics and sponsors now have more flexibility in demonstrating drug efficacy, and in ways that are more repeatable and less taxing on the trial participant. Dr. Adrian Marinovich of Strados Labs will discuss remote lung sound monitoring, the respiratory endpoints it provides, and how it fits into respiratory trials. Lastly, Dr. Kai-Michael Beeh of Clario will discuss additional respiratory endpoints that provide low-strain alternatives to forced spirometry as well as complementary endpoints that provide additional insight into lung health.

Join a cross-industry panel of experts as they examine new and upcoming developments in respiratory trials.

Attendees are encouraged to sign up early to get their question in the queue for the panel!

Speakers

Kevin McCarthy, RPFT, Director, Respiratory Science, 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 accurately answer questions. Kevin’s research experience includes managing pulmonary function quality control in two NIH-funded registries: patient 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 current member of the ATS PFT Committee and ATS/ERS Task Force to update the standards for Lung Volume testing in which he participated in 2019 to update the standards for Spirometry.

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Dr. Kai-Michael Beeh, MD, Founder and Medical Director, insaf Respiratory Research Institute

Dr. Kai-Michael Beeh was clinically trained at Mainz University Hospital where he received board certifications in internal medicine and pulmonary medicine. In 2004, he co-founded the insaf Respiratory Research Institute in Wiesbaden and is currently the Medical Director. In this position, he designed and conducted more than 100 clinical trials in asthma, COPD and allergies, acting as Principal or Coordinating Investigator. In 2009, he founded Aereon Consulting, a scientific consulting company, where the 1st edition of the “Respiratory Trials Masterclasses” was launched as a dedicated training program for clinical researchers. Dr. Beeh has received various accolades as a researcher and lecturer and has authored, co-authored and edited various industry publications contributing to advances in pulmonary medicine.

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Phil Lake, PhD, Senior Director, Respiratory Solutions, Clario

Phil Lake is a respiratory specialist at Clario who supports global clients. He has held various roles in drug development for 20 years, predominantly focused on respiratory trials. Prior to Clario, Phil worked on several anti-inflammatory agents, dual and triple combination therapy, monoclonal antibody studies, anti-infectives and some of the largest mechanistic studies looking at biomarkers within sputum and biopsy samples at SmithKline Beecham and GlaxoSmithKline. He has experience supporting CROs as a respiratory specialist and as the head of project management. Recently, his concentration has been extensively on rare respiratory diseases, including Cystic Fibrosis and Idiopathic Pulmonary Fibrosis, covering a variety of drug mechanisms and medical devices. Phil was pivotal to some of the first centralized overread studies and is committed to driving improvements in lung function testing.

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Marko Topalović, PhD, CEO & Co-Founder, ArtiQ

Marko Topalović is a CEO of ArtiQ (Leuven, Belgium), a company that aims to empower medical professionals with artificial intelligence to accurately and timely diagnose, treat and monitor patients with lung diseases. Formerly, as a postdoctoral researcher in the University Hospital in Leuven (Belgium), Marko worked on inventing algorithms for assessing lung disease. He obtained a PhD degree on the topic “Artificial intelligence for pulmonary function tests” at the KU Leuven. His scientific work has contributed to many peer-reviewed publications and numerous conference presentations. Moreover, he received several international awards.

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Dr. Adrian Marinovich, MD, MPH, Senior Machine Learning Engineer, Strados Labs

Dr. Adrian Marinovich has a background as an HIV epidemiologist, and as an attending forensic pathologist and pediatric surgical pathologist, including at St. Christopher’s Hospital for Children in Philadelphia. He has over 12 years of data and statistical programming experience, and has worked in data engineer, data scientist and machine learning engineer roles in the telecom industry, in pharmaceutical R&D consulting and at a computer vision startup.

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