ATS 2020 Advance Program

• understand the regulatory considerations and framework for recent approvals/reviews in the past year; • receive an update on other hot topics of review within pulmonary drug review division at FDA, including important safety issues. The most recent regulatory FDA actions, including recent drug approvals for pulmonary diseases will be discussed. Safety issues, recent research endeavors, and other hot topics will be presented by the Division of Pulmonary, Allergy, and Rheumatology Products at FDA. Chairing: B. Karimi-Shah, MD, Silver Spring, MD 11:45 Introduction and Session Overview B. Karimi-Shah, MD, Silver Spring, MD 11:50 Pulmonary Update from the FDA S. Seymour, MD, Silver Spring, MD 12:05 Regualtory Consideration in Interstitial Lung Disease K. Puthawala, MD, Silver Spring, MD 12:25 Regulatory Considerations in Cystic Fibrosis: An Update R. Lim, MD, Silver Spring, MD 12:40 Question and Answer Period B. Karimi-Shah, MD, Silver Spring, MD NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES/ASTHMA L25 IMMUNOMODULATORY THERAPIES IN ASTHMA 11:45 a.m. - 12:45 p.m. Target Audience Providers of lung health such as physicians, nurse practitioners, nurses, clinical researchers and those needing instructions in areas of medicine outside of their specialty will benefit. Objectives At the conclusion of this session, the participant will be able to: • learn new findings about immunologic targets in asthma ranging from innate to adaptive immunity; • define new strategies to manage the care of asthma based on knowledge gained after the review of ongoing and recently completed trials of biologic therapy for asthma; • appropriately use immunotherapy in the prevention and treatment of asthma. This session will provide the attendee an overview of an immunomodulary approach to asthma. The first talk will provided an overview of the current and emerging immunologic targets ranging from innate to adaptive immunity. Next ongoing and recently completed human clinical trials using biologics directed will be described. Finally allergen immunotherapy will be reviewed focusing both on treatment and prevention of asthma. Chairing: P.J. Gergen, MD, MPH, Rockville, MD 12:45 Immunologic Targets in Asthma L. Borish, MD, Charlottesville, VA 12:05 Biologics in Asthma: Ongoing Research W. Phipatanakul, MD, Boston, MA 12:25 Allergen Immunotherapy for Asthma Treatment and Prevention S. Durham, MD, London, United Kingdom DIVISION OF LUNG DISEASES/NHLBI L26 THE MOLECULAR ATLAS OF LUNG DEVELOPMENT (LUNGMAP), PHASE 2 11:45 a.m. - 12:45 p.m. Target Audience Providers of lung health, medical fellows in training, and basic and clinical researchers interested in lung biology, developmental biology, chronic lung disease pathogenesis, pediatrics, bioinformatics, and systems biology. ATS 2020 • Philadelphia, PA WEDNESDAY • MAY 20 137