Final-Program-ATS-2023-AP.vp

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WEDNESDAY • MAY 24

11:15 Identifying Novel Biomarkers for Elafin and other PAH Therapies A. Sweatt, MD, Stanford, CA

11:05 Markers of Lung Degradation and Emphysema: A Pilot Study J.M. Wells, MD, MSPH, Birmingham, AL 11:15 Questions R.A. Wise, MD, Baltimore, MD

U.S. FOOD AND DRUG ADMINISTRATION OUTSIDE ORGANIZATION SESSION

DIVISION OF LUNG DISEASES, NHLBI/NIH OUTSIDE ORGANIZATION SESSION

L26 PULMONARY UPDATE FROM THE US FOOD AND DRUG ADMINISTRATION 10:30 AM - 11:30 AM Walter E. Washington Convention Center Room 204 A-C (Level 2) Target Audience Clinicians in practice, academic researchers, pharmaceutical industry representatives, international regulators Objectives At the conclusion of this session, the participant will be able to: • to provide a better understanding of the regulatory considerations and lessons learned in review of immunomodulators for COVID-19 • to provide a better understanding of regulatory considerations regarding potential changes in asthma management and treatment paradigms • to provide an overview of recent approval actions, safety issues, and hot topics which arose over the past year in the pulmonary division at FDA. The most recent FDA actions, including recent drug approvals for pulmonary diseases will be discussed, recent research endeavors, safety issues, and other hot topics that we have navigated over the past year in the Division of Pulmonology, Allergy, and Critical Care in the Office of New Drugs at FDA. Chairing: B. Karimi-Shah, MD, Silver Spring, MD S. Seymour, MD, Silver Spring, MD 10:30 Regulatory Considerations in COVID-19 Development Programs: Lessons Learned K. Puthawala, MD, Silver Spring, MD 10:50 FDA Updates: Highlights From Recent Asthma Approvals E. Boulos, MD, MPhil, Silver Spring, MD 11:10 Pulmonary Update from the US FDAM R. Lim, MD, Silver Spring, MD 11:20 Question and Answers B. Karimi-Shah, MD, Silver Spring, United States

L25 ELAFIN: FROM TRANSLATIONAL PPG TO CLINICAL TRIAL 10:30 AM - 11:30 AM Walter E. Washington Convention Center Room 147 A-B (Street Level) Target Audience Clinicians, basic scientists, nurses, technologists and trainees interested in pulmonary vascular disease trials Objectives At the conclusion of this session, the participant will be able to: • learn about ways to successfully translate preclinical laboratory findings into IND-enabling work for the development of therapeutics to treat PAH • learn about Phase I and II clinical trial design for pulmonary arterial hypertension • learn about the importance of biomarker design and inclusion in clinical studies to monitor disease progression and treatment effects This session will discuss results derived from an NHLBI-funded Translational Program Project Grant (TPPG) that supported pre-clinical studies of elafin in chronic lung disease of infancy, lung transplant rejection, and pulmonary arterial hypertension, and successfully translated those findings into follow-on IND-enabling safety pharmacology and toxicology studies and a subsequent Phase I clinical trial of Elafin use in healthy subjects. Plans for a Phase II clinical trial in PAH patients will also be discussed, with a description of relevant biomarkers and planned endpoints. Chairing: L. Xiao, MD, PhD, Bethesda, MD A. Hemnes, MD, ATSF, Nashville, TN 10:30 The Role of Elastase and Elafin in PAH and Other Respiratory Diseases M. Rabinovitch, MD, Stanford, CA 10:45 High-Dimensional Single-Cell Imaging Maps Distinct Inflammatory Cell Subsets to PAH Vasculopathy S. Ferrian, PhD, Stanford, United States 11:00 Phase I and Phase II Clinical Trial Design and Implementation in PAH R.T. Zamanian, MD, FCCP, Stanford, CA

ATS 2023 • Washington, DC