ATS 2020 Advance Program

DIVISION OF LUNG DISEASES/NHLBI L10 A NEW APPROACH TO CLINICAL TRIALS FOR PRECISION INTERVENTIONS IN SEVERE ASTHMA 12:15 p.m. - 1:15 p.m. Target Audience Researchers and clinicians, particularly those with an interest in asthma management, clinical trials, phenotyping and biomarkers. Patient advocacy representatives, biotech/pharma representatives. Objectives At the conclusion of this session, the participant will be able to: • increase understanding of the design and implementation of adaptive, precision clinical trials protocols in targeted asthma phenotypes; • differentiate the roles of predictive and monitoring biomarkers in adaptive clinical trial designs; • increase understanding of how adaptive, precision medicine trials can be used to efficiently evaluate novel interventions in defined populations of severe asthma patients. This session will address the topic of using adaptive, precision clinical trial approaches in severe and/or exacerbation prone asthma patients. The rationale will be reviewed as well as the readiness of the field, specific interventions and biomarkers used by the NHLBI’s PrecISE (Precision Interventions in Severe and/or Exacerbation Prone Asthma) Network, and special considerations related to trial design and implementation. It is anticipated that there will be discussion on adaptive trial design, patient phenotypes, biomarkers, protocol implementation, regulatory considerations, and asthma pathobiology. Chairing: P. Noel, PhD, Bethesda, MD S.N. Georas, MD, Rochester, NY 12:15 Introduction to PrecISE P. Noel, PhD, Bethesda, MD 12:20 Precision Medicine in Asthma and the PrecISE Network R.J. Wright, MD, MPH, New York, NY 12:35 Statistical Considerations and Precision Adaptive Trials in Asthma L. LaVange, PhD, Chapel Hill, NC 12:50 Protocol Design and Implementation E. Israel, MD, Boston, MA 1:10 Discussion S.N. Georas, MD, Rochester, NY MEET THE PROFESSOR SEMINARS Registration Fee: $70.00 (includes box lunch.) Attendance is limited. Pre-registration is required . 12:15 p.m. - 1:15 p.m. MP401 PRIMARY IMMUNODEFICIENCY AND PULMONARY DISEASE A. Dosanjh, MD, San Diego, CA MP402 CYSTIC FIBROSIS THERAPEUTICS: GREAT STRIDES AND FUTURE DIRECTIONS J.L. Taylor-Cousar, MD, MSc, ATSF, Denver, CO MP403 ALPHA-1 ANTITRYPSIN DEFICIENCY: STATE OF THE ART J.K. Stoller, MD, ATSF, Cleveland, OH MP404 HOT CONTROVERSIES IN PLEURAL DISEASE: A RAPID-FIRE PRO/CON DEBATE O. Epelbaum, MD, ATSF, Valhalla, NY N. Rahman, BMBCH, MSc, Oxford, United Kingdom MP405 DRUG-INDUCED SARCOIDOSIS: CASES, QUERIES AND CONTROVERSIES A.S. Morgenthau, MD, New York, NY MP406 NEUROLOGIC DISASTERS IN THE ICU T.P. Bleck, MD, ATSF, Chicago, IL MP407 MENTORSHIP AND SPONSORSHIP: HOW DO I WORK WITH MENTORS AND SPONSORS TO FURTHER MY CAREER? M.A. Pisani, MD, MPH, New Haven, CT ATS 2020 • Philadelphia, PA SUNDAY • MAY 17 53