ATS 2019 Virtual Final Program

• articulate how emerging technologies and innovative approaches are being utilized for FDA-funded research, FDA guidance development, and regulatory decision making. This session will describe respiratory product development of generic drugs within the US, focusing on paths forward to bring safe and effective generic respiratory products to the American public. A general overview will summarize the generic drug approval process, including demonstration of bioequivalence and therapeutic equivalence. Discussion of recent generic product approvals and posted regulatory guidance will provide the audience a greater understanding of the generic approval process, and how the use of emerging technologies and outcomes of research projects contribute to scientific understanding for these complex orally inhaled and nasal drug products to inform regulatory actions. Chairing: K.A. Witzmann, MD, Silver Spring, MD 12:15 Introduction K.A. Witzmann, MD, Silver Spring, MD 12:18 Overview of FDA Generic Inhaled Drug Approval Process M. Luke, MD, PhD, Silver Spring, MD 12:35 Update for Generic Orally Inhaled and Nasal Drug Products K.A. Witzmann, MD, Silver Spring, MD 12:52 Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products D.S. Conti, PhD, Silver Spring, MD 1:09 Questions and Answers K.A. Witzmann, MD, Silver Spring, MD NATIONAL AERONAUTICS AND SPACE ADMINISTRATION L4 NASA REMOTE SENSING SATELLITE OBSERVATIONS: APPLICATIONS FOR RESPIRATORY HEALTH 12:15 p.m. - 1:15 p.m. KBHCCD Room C146 (Level 1) Target Audience Air quality researchers, pulmonary physicians, researchers and clinicians Objectives At the conclusion of this session, the participant will be able to: • provide an overview of the NASA Health and Air Quality Program relating to public health applications that are of interest to pulmonary clinicians and researchers; • inform clinicians and researchers about ongoing NASA projects related to performance lung and cardiac disease; • provide update informations at a local, state, national and international levels on Air Quality and its effect on health outcomes. Satellite earth observations present a unique vantage point of the earth’s environment from space, which offers a wealth of health applications for researchers. The session shows results of the remote sensing observations of earth and health applications. This session will detail ongoing projects within NASA and specifically related to incorporating satellite remote sensing for studying city air pollution burden of disease, emissions control, and using chemical data assimilations to improve air quality and their relationship to diseases such as asthma, and other environmentally induced lung and cardiac diseases. Chairing: S. Estes, MS, Huntsville, AL J. Haynes, MS, BS, Washington, DC 12:15 NASA’s Public Health and Air Quality Program Helping Us Understand Satellite Remote Sensing and How it Can Improve Health Outcomes J. Haynes, MS, BS, Washington, DC 12:27 Improving the Representation of Physical Atmosphere in Air Quality Decision Support Systems Used for Emissions Control Strategy Development A.P. Biazar, PhD, Huntsville, AL 12:39 Using Satellite Derived PM 2.5 Exposure Estimates to Assess Neighborhood-Scale Health Impacts K. Cromar, PhD, New York, NY 12:51 Chemical Data Assimilation and Analog-Based Uncertainty Quantification to Improve Decision-Making in Public Health and Air Quality R. Kumar, PhD, Boulder, CO DIVISION OF LUNG DISEASES, NHLBI/NIH L5 RESULTS FROM NHLBI-FUNDED GENOMIC RESEARCH IN ALPHA-1 ANTITRYPSIN DEFICIENCY AND SARCOIDOSIS (GRADS) PROGRAM 12:15 p.m. - 1:15 p.m. KBHCCD Room D167/D174 (Level 1) Target Audience Physician scientists and health providers interested in Sarcoidosis including researchers, clinicians, nurses and educators. Students, Postdoc fellows, junior faculty who would like to hear advances in rare lung disease research like sarcoidosis Objectives At the conclusion of this session, the participant will be able to: • apply new technologies (transcriptomics and metagenomic analyses) to investigate the pathogenic mechanisms of AATD and sarcoidosis; • understand the pathogenesis of sarcoidosis and the role of Microbiome; • understand clinical phenotyping of Sarcoidosis to understand and improve outcomes. This session will present a brief overview of the GRADS Study, a description of the phenotypes in sarcoidosis, the proposed definitions of disease burden, and the apparent influence of the microbiome. It will also include updates on the data analyses of the RNA transcriptome of sarcoidosis patients, proposed environmental risk factors, and the association of clinical variables with specific microbiota. The session will conclude with discussions on suggested directions for the future of sarcoidosis research. Chairing: L.J. Vuga, MD, MPH, PhD, Bethesda, MD E.D. Crouser, MD, Columbus, OH ATS 2019 • Dallas, TX SUNDAY • MAY 19 95 SUNDAY MID-DAY