ATS 2019 Virtual Final Program

Target Audience Clinicians, clinician scientists, basic research scientists, fellows and residents Objectives At the conclusion of this session, the participant will be able to: • expand their knowledge on the environmental impacts on pulmonary health; • gain new knowledge on the state of science in metabolomics technologies; • understand Metabolomics profiles from body fluids and exhaled breath condensate and novel biomarkers evaluation. Humans are exposed to multiple environmental agents simultaneously, this recognition led to developing a conceptual framework of “exposome” to define totality of environmental exposures throughout the life from conception. Exposomics assess the external and internal exposome through targeted and untargeted analyses. To gain comprehensive understanding on the impacts of exposure to environmental agents at the cellular level, i.e., Responsomics needs integration of diverse omics technologies- metabolomics, adductomics, genomics and epigenomics, etc. The research program supported by NIEHS over the past few years in these programs is providing a wholistic understanding that might have been not realized by following a set of targeted analysis or tools or exposure to one agent at a time. In this presentation, the concept of Exposome will be introduced and this will be followed by presentations that are utilizing metabolomics approaches to gain understanding in environmental pulmonary health - new players involved in the inflammatory response in adult asthmatics and risk prediction for lung cancer in current and prior smokers; and novel markers in the exhaled breath to detecting risk of new-onset asthma from air pollution exposures. Chairing: G. Collman, PhD, Research Triangle Park , NC 12:15 Introduction G. Collman, PhD, Research Triangle Park , NC 12:20 The Exposome G. Collman, PhD, Research Triangle Park , NC 12:37 Applications of Metabolomics in Respiratory Health S. Sumner, PhD, Chapel Hill, NC 12:54 CawNO and CANO as Novel Exhaled Breath Markers for Detecting Respiratory Effects of Air Pollution Exposure S.P. Eckel, PhD, Los Angeles, CA PATIENT CENTERED OUTCOME RESEARCH INSTITUTE L2 PCORI: EVIDENCE TO ACTION NETWORKS: UPDATE OF PATIENT CENTERED OUTCOME RESEARCH RESULTS 12:15 p.m. - 1:15 p.m. KBHCCD Room C147/C148/C154 (Level 1) Target Audience Clinicians (physicians, nurses, fellows, residents), researchers, administrators and policymakers: anyone involved in delivery of care and the science of patient-centered research Objectives At the conclusion of this session, the participant will be able to: • understand the role of the Patient-Centered Outcomes Research Institute in funding comparative effectiveness research ; • understand collaborative activities taking place through the Transitional Care and Asthma Evidence to Action Networks; • learn about research results and interventions that improve patient health outcomes. A PCORI official will introduce summaries of PCORI funded PCOR (patient-centered outcome research) projects in pulmonary, critical care and sleep disorders. PCORI officials will update attendees on the unique evidence to action network activities in asthma and transition of care and discuss the potential implications of the results of the funded studies on research and practice. PCORI funded researcher will give researcher perspective for their experience. The purpose of the session will be to raise awareness of PCORI activities and results relevant to patient-centered care for patients with pulmonary, critical care, and sleep disorders. Chairing: A. Anise, MHS, Washington, DC K. Sumino, MD, MPH, Saint Louis, MO 12:15 Addressing Asthma Disparities: Research Results and Potential Impact from the Asthma Evidence to Action Network A. Anise, MHS, Washington, DC 12:30 Researcher Perspective on Collaboration in the Asthma Evidence to Action Network K. Sumino, MD, MPH, Saint Louis, MO 12:45 Transitional Care Evidence to Action Network: Approaches, Accomplishments, Opportunities in Transitional Care Research S. Clauser, PhD, MPS, Washington, DC 1:00 Panel Discussion A. Anise, MHS, Washington, DC U.S. FOOD AND DRUG ADMINISTRATION L3 GENERIC DRUG DEVELOPMENT FOR RESPIRATORY PRODUCTS: U.S. FOOD AND DRUG ADMINISTRATION UPDATE 12:15 p.m. - 1:15 p.m. KBHCCD Room C155-C156 (Level 1) Target Audience Clinicians in practice, researchers, pharmaceutical industry representatives, international drug regulators Objectives At the conclusion of this session, the participant will be able to: • recognize key aspects of the generic drug regulatory approval process, and how the Office of Generic Drugs (OGD) evaluates bioequivalence for complex inhaled generic drug products, using a weight-of-evidence approach; • describe product-specific recommendations and guidances for generic drug products recently posted by the Office of Generic Drugs (OGD), with a focus on how these can inform complex orally inhaled and nasal generic drug development; ATS 2019 • Dallas, TX 94 SUNDAY • MAY 19