Respiratory Drug Development: Comprehensive Strategies to Improve Data Quality

Dr. Todd Lustine, MD, MS, FCCP, Vice President, Medical Science, Respiratory, 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, 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.

Martha Mathews Martin, MPH, PhD, Director, Training Delivery, Clario

Dr. Matthews Martin is an experienced education professional with a special interest in the design and implementation of novel training and workforce development strategies in the pharmaceutical, biomanufacturing, and clinical research space.

In her current role as Director of Training Delivery, Martha leads a global team of Client Education Trainers charged with delivering effective, scalable, custom training programs to meet unique client needs. She earned her PhD. in Workforce Development and Public Policy from North Carolina State University and an MPH from Boston University School of Public Health.

Phil Lake, PhD, Senior Director, Scientific Affairs, Respiratory Science, Clario

Phil Lake, PhD, is a Respiratory Specialist at ERT who supports clients worldwide. Phil has held a variety of roles in drug development for nearly 20 years, predominantly focused on respiratory trials.

Prior to ERT, Phil held positions at SmithKline Beecham and GlaxoSmithKline. There, he worked on a number of anti-inflammatory agents, dual- and triple-combination therapies, monoclonal antibody studies, anti-infectives and some of the largest mechanistic studies examining biomarkers in sputum and biopsy samples. He also has experience supporting a number of CROs as a Respiratory Specialist and as the head of project management. For the last ten years, he has focused extensively on rare respiratory diseases, including Cystic Fibrosis and Idiopathic Pulmonary Fibrosis and has covered a variety of drug mechanisms and medical devices. Phil was pivotal to some of the first centralised over read studies and is committed to driving improvements in lung function testing.

He completed his training at University College Cardiff and Southampton University.