SESSION 5: Inhalation Innovation:
Regulatory Initiatives to Expand the Generic Marketplace
Tuesday • May 7, 2024 • 10:00–12:00 Noon • Arizona Ballroom
Moderator: Martin Oliver, B.Pharm
FDA’s Orange Book and ANDAs: Questioning the Policies and Precedents—and Recent Enforcement Actions—Surrounding RLD Patent Listings (2024 Update)
Kurt Karst
Hyman, Phelps & McNamara
Hyman, Phelps & McNamara
FDA Recommendations for the Design and Implementation of In Vitro and In Vivo Alternative Bioequivalence Approaches
Elizabeth Bielski and Susan Boc
U.S. Food & Drug Administration
U.S. Food & Drug Administration
FDA Recommendations for Alternative Bioequivalence Approaches: Design, Validation, and Use Case for In Silico Studies
Ross Walenga
U.S. Food & Drug Administration
U.S. Food & Drug Administration
An Industry Perspective on FDA's Alternative Approaches to Comparative Clinical End Point Studies for Generic Inhalation Products
Stephen Devereux
Teva Pharmaceuticals
Teva Pharmaceuticals
Discover More
Empowering the Path to Clinical: Innovative Strategies for De-Risking Product Development
Will Ganley, Jonathan Mulpas and Sara Pinto
Aptar Pharma
Aptar Pharma
Automating Inhaled and Nasal Product Testing: Lower Variability, Higher Productivity
Clair Brooks and Matthew Fenn
Copley Scientific
Copley Scientific
Electronic Facemask to Enhance Patient Compliance
Anthony Hickey
Astartein
Astartein
Differential Permeability of Dry Solid and Aqueous Suspensions of Fluticasone Propionate Through A549 Alveolar Epithelial Cells
Alexandre Ribeiro
Hovione
Hovione
Practical Considerations for Conducting Successful In Vitro Bioequivalence Studies on Inhalers
James Drake
Kindeva Drug Delivery
Kindeva Drug Delivery
Validation of the RS01X™ Smart Inhaler in a Clinical Setting
Dumiana Chamaon and Martijn F. Grinovero
Medisch Spectrum Twente
Medisch Spectrum Twente
Utilizing Physiologically-based Modeling for the Design of an Inhaled Powder Formulation of Imipenem Aimed at Maximizing the Dose Delivered to the Lung Lining Fluid
Will Ganley
Nanopharm
Nanopharm
Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate
Ross Walenga
U.S. Food & Drug Administration
U.S. Food & Drug Administration
Tandem Aerodynamic Particle Sizers Method for the Characterization of Aerosol Dynamics at Different Relative Humidities
Yiliang Jiang
University of Bristol
University of Bristol
Exploration of Alternative Methodologies for Spray Pattern Evaluation in a Budesonide/Formoterol Fumarate Dihydrate pMDI
Fraser Carr
Vectura
Vectura
Advancements in Complete-Airway Modeling of Pharmaceutical Aerosols: Implementation of a Tracheobronchial Voluming-Filling Algorithm
Morgan Thomas
Virginia Commonwealth University
Virginia Commonwealth University
Pharmaceutical Aerosol Deposition in a Stainless-Steel Version of the VCU Mouth-Throat Models
Caleb Dalton
Virginia Commonwealth University
Virginia Commonwealth University
CONFERENCE SUPPORTERS
WORKSHOP PRESENTERS
EXHIBITORS
ORGANIZATIONS
Exhibitors
