ATS 2020 Advance Program

exposure to environmental triggers, which can be exacerbated after a natural disaster, are an important component of asthma control. Evidence-based interventions, such as guidelines-based medical management, smoking cessation, asthma self-management education, home visits, and asthma-friendly policies, support asthma control. A new CDC initiative, CCARE (Controlling Childhood Asthma Reducing Emergencies), aims to prevent a half-million pediatric asthma-related emergency department visits and hospitalizations in 5 years. To achieve this goal, CCARE will promote evidence-based interventions across sectors and linkages between programs and clinics. Chairing: J. Malilay, PhD, MPH, Atlanta, GA 12:15 Current Asthma Burden in the United States Speaker To Be Announced 12:30 Environmental Triggers of Asthma After Disasters K. Cowan, MPH, Atlanta, GA 12:45 Multisector Involvement in Reducing the Burden of Asthma J. Malilay, PhD, MPH, Atlanta, GA 1:00 Implementing CCARE Through State Partnerships K.D. Sircar, PhD, MPH, Atlanta, GA FDA/CENTER FOR DRUG EVALUATION AND RESEARCH L14 GENERIC DRUG DEVELOPMENT FOR RESPIRATORY PRODUCTS: U.S. FOOD AND DRUG ADMINISTRATION UPDATE 12:15 p.m. - 1:15 p.m. 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 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; • 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 U.S., 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 an 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.A. Witzmann, MD, Silver Spring, MD 12:15 Introduction K.A. Witzmann, MD, Silver Spring, MD 12:18 Update for Generic Orally Inhaled and Nasal Products K.A. Witzmann, MD, Silver Spring, MD 12:35 Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products D. Santos Conti, PhD, Silver Spring, MD 12:52 Comparative Clinical Considerations in the Determination of Bioequivalence M. Spagnola, MD, Silver Spring, MD 1:09 Questions and Answers K.A. Witzmann, MD, Silver Spring, MD ATS 2020 • Philadelphia, PA 80 MONDAY • MAY 18