ATS 2020 Advance Program

12:52 Liposomal Preparations of Ciprofloxacin for the Inhalation Treatment of M avium and M abscessus: Assessment of Preclinical Efficacy and Safety I. Gonda, PhD, San Francisco, CA 1:02 Liposomal Amikacin for Inhalation in NTM K.N. Olivier, MD, MPH, ATSF, Bethesda, MD FDA CENTER FOR REAL WORLD EVIDENCE ANALYTICS L5 FDA REAL WORLD EVIDENCE PROGRAM UPDATE 12:15 p.m. - 1:15 p.m. Target Audience Practicing clinicians, researchers, pharmaceutical industry and payer representatives, international regulators Objectives At the conclusion of this session, the participant will be able to: • understand the framework for FDA’s Real World Evidence program; • review current FDA Real World Evidence demonstration projects with a focus on those potentially impacting the pulmonary disease space; • review resources, findings, and considerations stemming from FDA’s Real World Evidence Program. The FDA Real World Evidence Program will be outlined. Two pulmonary disease demonstration projects using Real World Data and their interim findings will be reviewed. Additional learnings from other FDA demonstration projects and submissions containing RWE will be described. Publicly available resources resulting from the FDA Real World Evidence Program will be shared. Chairing: D. Martin, MD, MPH, Silver Spring, MD 12:15 Introduction to the FDA RWE Program D. Martin, MD, MPH, Silver Spring, MD 12:25 Overview of the RELIANCE Real World Clinical Trial J.A. Krishnan, MD, PhD, ATSF, Chicago, IL 12:40 Overview of the COPD, Asthma, and Respiratory Disease Effectiveness Project R. Busch, MD, Silver Spring, MD 12:55 Learnings From Other FDA Demonstration Projects and Submissions Containing RWE K. Quinto, MD, MPH, Silver Spring, MD 1:10 Questions and Answers D. Martin, MD, MPH, Silver Spring, MD NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND HEALTH L6 UPDATE ON NON-INFECTIOUS RESPIRATORY HAZARDS IN HEALTH CARE 12:15 p.m. - 1:15 p.m. Target Audience Providers of lung health and those interested in identifying and controlling non-infectious respiratory hazards in health care settings. Objectives At the conclusion of this session, the participant will be able to: • learn new findings about exposures to non-infectious respiratory hazards in general health care settings and potential related health effects; • gain understanding and learn new findings about non-infectious respiratory disease, in particular occurrence of idiopathic pulmonary fibrosis, in dental personnel; • learn new findings about exposures to non-infectious respiratory hazards specifically in dental settings. The session will provide an update on the range of non-infectious respiratory hazards present in health care settings and recent NIOSH efforts to address them. After a brief discussion of general health care settings, presentations will focus in particular on dental settings, where there have been recent concerns about risk of interstitial lung disease in dental personnel. Chairing: D.N. Weissman, MD, ATSF, Morgantown, WV ATS 2020 • Philadelphia, PA 50 SUNDAY • MAY 17