ATS 2024 Final Program

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332

WEDNESDAY • MAY 22

12:16 Changes in Health Care Utilization with Adenotonsillectomy in children with mild Sleep Disordered Breathing 12:28 Social and Environmental Factors that Influence SDB Severity and Response to Treatment 12:40 Subgroup Differences in Response to Adenotonsillectomy and Implications for Clinical Management 12:54 Q&A

12:00 Measurement of Physical Activity by Actigraphy in Infants and Young Children with Pulmonary Arterial Hypertension 12:12 Repurposing a Histamine Antagonist to Benefit Patients with Pulmonary Hypertension 12:24 Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial (MILED) 12:36 Prenatal Vitamin C, In Utero Smoke Exposure, and Offspring Lung Function 12:48 Q & A MD31 GENERIC DRUG DEVELOPMENT FOR RESPIRATORY PRODUCTS, US FOOD AND DRUG ADMINISTRATION UPDATE 12:00 p.m. - 1:00 p.m. San Diego Convention Center Room 2 (Upper Level) 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 comparative clinical information to support bioequivalence for complex inhaled generic drug products. • describe product-specific 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 • articulate how emerging technologies and innovative approaches are being utilized for FDA-funded research, FDA guidance development, and regulatory decision-making This session will describe respiratory product development of generic drugs within the US, focusing on paths forward to bring safe and effective generic respiratory products to the American public. A general overview will summarize the generic drug approval process, including demonstration of bioequivalence and USDA MID-DAY SESSION

NHLBI, NIH MID-DAY SESSION

MD30 CLINICAL TRIAL STRATEGIES FOR RARE LUNG DISEASE AND DIFFICULT TO REACH POPULATIONS 12:00 p.m. - 1:00 p.m. Marriott Marquis San Diego Marina Pacific Ballroom 24-26 (Ground Floor, North Tower) Target Audience Fellow/Junior/Established Professional Objectives At the conclusion of this session, the participant will be able to: • define the safety and efficacy of low dose sirolimus in patients, and determine its useability to prevent disease progression • better understand histaminic signaling and blockade in pulmonary arterial hypertension.To increase awareness of drug repurposing in cardiopulmonary diseases. • evaluate the feasibility, tolerability, and adherence with wearable actigraphy devices in young children with/without PAH. Explore the ability of these devices to detect differences in activity intensity and heart.rate between the two groups. Clinical trials for rare diseases can present inherent challenges because of small participant pools, incomplete understanding of natural history, lack of sensitive biomarkers, and clinical outcome measures. This session will focus on challenges and innovations in drug development for three rare diseases and difficult to reach populations, and conclude with a discussion on future directions for conducting clinical trials. The MILED trial Team will present safety and efficacy of low dose sirolimus in patients with LAM to prevent disease progression. The other studies will address usage famotidine in a randomized placebo-controlled trial and actigraphy in children with pulmonary arterial hypertension

ATS 2024 • San Diego, CA