Final-Program-ATS-2023-AP.vp

MONDAY • MAY 22

191

U.S. FOOD AND DRUG ADMINISTRATION/FDA/CENTER FOR DRUG EVALUATION & RESEARCH (FDA/CDER) OUTSIDE ORGANIZATION SESSION GENERIC DRUG DEVELOPMENT FOR RESPIRATORY PRODUCTS, US FOOD AND DRUG ADMINISTRATION UPDATE 12:00 PM - 1:00 PM Walter E. Washington Convention Center Room 152 A-B (Street 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 therapeutic equivalence utilizing comparative clinical information. Discussion of recent generic product approvals and posted regulatory guidance will provide the audience a greater understanding of the generic approval process, and how the use of emerging technologies and outcomes of research projects contribute to scientific understanding for these complex orally inhaled and nasal drug products to inform regulatory actions. Chairing: K. Witzmann, MD, Silver Spring, MD 12:00 Update for Generic Orally Inhaled and Nasal Drug Products K. Witzmann, MD, Silver Spring, MD 12:20 Comparative Clinical Considerations in the Determination of Bioequivalence D. Santos Conti, PhD, Silver Spring, MD 12:37 Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products E. Bielski, PhD, Silver Spring, MD 12:54 Question and Answer K. Witzmann, MD, Silver Spring, MD L9

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NIH OUTSIDE ORGANIZATION SESSION

L10 NEW FINDINGS ON ASTHMA AND ALLERGIC DISEASE IN URBAN ENVIRONMENTS 12:00 PM - 1:00 PM Walter E. Washington Convention Center Room 150 A-B (Street Level) Target Audience Healthcare providers, clinical researchers, individuals working with disadvantaged populations Objectives At the conclusion of this session, the participant will be able to: • be able to describe early life lung function interacts with allergic sensitization to influence the risk for recurrent wheezing episodes in children and be able to apply this knowledge to improve his/her practice • describe the utility of airway transcriptome profiling in defining inflammatory pathways driving alterations in lung function at baseline and during respiratory illnesses in exacerbation-prone urban children • understand the role of DNA methylation in mediating environmental effects of risk for asthma and allergic sensitization in children This session will provide the listener insights into mechanisms of lung function development, lung function trajectories over childhood, and responses to respiratory infections among urban inner-city children and adolescents. The first talk will utilize the repeated pulmonary function measurements taken during the longitudinal follow-up of the URECA birth cohort to demonstrate how atopy and environmental factors influence lung function trajectories and the development of asthma. The second talk with elucidate transcriptomic pathways which are activate or suppressed during a viral respiratory infection and the impact on lung function. The third talk will present data on epigenetics role in asthma and allergic sensitizations. Chairing: A. Coleman, MD, Bethesda, MD 12:00 Interactions Between Allergic Sensitization and Lung Function on Wheezing Illnesses in Urban Children J.E. Gern, MD, Madison, WI 12:20 Airway Transcriptome Patterns Relate to Lung Function in Urban Children with Exacerbation-Prone Asthma M.C. Altman, MD, MPhil, Seattle, WA 12:40 Epigenetic Contributions to Understanding Asthma and Allergic Sensitization in Urban Children C. Ober, PhD, Chicago, IL

ATS 2023 • Washington, DC