ATS 2019 Virtual Final Program

U.S. FOOD AND DRUG ADMINISTRATION L15 PULMONARY UPDATE FROM THE U.S. FOOD AND DRUG ADMINISTRATION 12:15 p.m. - 1:15 p.m. KBHCCD Room C147/C148/C154 (Level 1) Target Audience Clinicians in practice, researchers, pharmaceutical industry representatives, international regulators Objectives At the conclusion of this session, the participant will be able to: • understand the recent regulatory framework and approvals in the past year; • understand the current risk/benefit framework of several prominent safety reviews over the following year; • understand the regulatory considerations in reviewing eosinophil targeted therapies. The most recent regulatory FDA actions, including recent approvals for pulmonary diseases will be discussed. Safety issues, including the Agency’s decisions regarding the completed LABA safety studies, as well as other prominent safety issues will be discussed. Finally, the current regulatory considerations for eosinophil targeted drug therapies will be discussed. Chairing: B. Karimi-Shah, MD, Silver Spring, MD 12:15 Introduction B. Karimi-Shah, MD, Silver Spring, MD 12:20 Pulmonary Update from the FDA S. Seymour, MD, Silver Spring, MD 12:35 Important Safety Issues: Update from the FDA R. Lim, MD, Silver Spring, MD 12:50 Regulatory Considerations for Eosinophil Targeted Drug Therapies R. Busch, MD, MMSc, Silver Spring, MD 1:10 Question and Answer Period B. Karimi-Shah, MD, Silver Spring, MD DIVISION OF LUNG DISEASES, NHLBI/NIH L16 THE COPD NATIONAL ACTION PLAN: 2019 UPDATE 12:15 p.m. - 1:15 p.m. KBHCCD Room D163/D165/D170/D172 (Level 1) Target Audience COPD patients, COPD advocates, Pulmonologists, Industry representatives, Health Care providers, Payors Objectives At the conclusion of this session, the participant will be able to: • Increase awareness and knowledge about the COPD national Action Plan • Alert the audience on the CNAP and ways to contribute to its implementation • Improve on disease management The COPD National Action Plan, the first blue print for the Nation to be used as a guideline to tackle the disease, was launched during the 2017 ATS International Conference. This session will update ATS 2019 attendees on the progress made and future perspectives as related to the audience by three government agencies (NHLBI/NIH, CDC & HRSA) and two advocacy groups (ALA & COPD Foundation), all of which were among the instrumental contributors to the development of the plan. Chairing: A. Punturieri, MD, PhD, Bethesda, MD 12:15 NHLBI Update on the COPD National Action Plan A. Punturieri, MD, PhD, Bethesda, MD 12:20 CDC Update on the COPD National Action Plan J.B. Croft, PhD, Atlanta, GA 12:32 ALA Update on the COPD National Action Plan D.P. Brown, BS, MS, CHES, Washington, DC 12:44 HRSA update on the COPD National Action Plan P. Moore, MD, Rockville, MD 12:56 COPD Foundation Update on the COPD National Action Plan J.L. Sullivan, MPH, Washington, DC DIVISION OF LUNG DISEASES, NHLBI/NIH L17 NHLBI MACS/WIHS COMBINED COHORT: A RESOURCE FOR APPLIED RESEARCH ON HIV-RELATED PULMONARY COMPLICATIONS 12:15 p.m. - 1:15 p.m. KBHCCD Room D167/D174 (Level 1) Target Audience Providers of lung health, medical fellows in training, and clinical and basic researchers on lung biology, HIV researchers and clinicians, virologists, immunologists, microbial pathogenesis, and infectious disease doctors and scientists. Objectives At the conclusion of this session, the participant will be able to: • gain knowledge about the new combined cohorts and data available to perform HIV research; • learn about future opportunities and collaborations in HIV pulmonary research; • learn about advances in HIV-related pulmonary research and apply new knowledge to own research. This session will give an overview of the Multicenter AIDS Cohort Study (MACS) and Women’s Interagency HIV Study (WIHS), two very large comprehensive cohorts studies that are now under the direction and management of the National Heart, Lung and Blood Institute. Both previously independent studies have been combined in one comprehensive study and will provide an avenue to investigate questions at the forefront of HIV co-morbidities research, and continue to provide a wealth of data that can be leveraged to investigate the progression of HIV-associated disease in women, gay and bisexual men. The combined cohort will be composed of over ATS 2019 • Dallas, TX 194 MONDAY • MAY 20