Sponsor: Chiesi Farmaceutici
Moderator: Sherri Biondi, Ph.D.

10:00 a.m.

Variation in Hospital Aerosol Delivery Practices:
Does it Matter?
Ariel Berlinski, M.D.,
University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA

Precision Sampling to Characterize Airway Inflammation in Asthma
Trevor T. Hansel, M.D. Ph.D.,
Imperial College, London, United Kingdom

Quantifying Monoclonal Antibody Disposition Following Aerosol Administration: Systemic and Airway Exposure in Non-human Primates
Masahiro Sakagami, Ph.D.,
Virginia Commonwealth University, Richmond, Virginia, USA

ALX-0171: Safety and Therapeutic Potential of an Inhaled Anti-RSV Nanobody
Erik Depla, Ph.D.,
Ablynx, Zwijnaarde, Belgium

Re-thinking Inhaled Insulin’s Role in the Global Challenge to Treat Diabetes
John S Patton, Ph.D.,
Dance Biopharm, Brisbane, California, USA

Sponsor: Aptar Pharma
Moderator: Gerallt Williams, Ph.D. 

2:00 p.m. - 6:00 p.m.

The following companies each sponsored 60-minute interactive presentations on new technologies and services. Participants could select and attend THREE of these sessions.

3M Drug Delivery Systems 
Evolving Regulatory Requirements for pMDI Registrations in the US

AstraZeneca 
Prediciting the Fate of Inhaled Molecules and Applying this Knowledge during Development

FluidDA
Demonstrating the Value of Regional Imaging Biomarkers in Respiratory Drug Development through Functional Respiratory Imaging (FRI)

Gateway Analytical
Assessing Aggregate Performance and the Presence of Foreign Particulate in OINDP's

Harro Höfliger Verpackungsmaschinen
The Challenge of Filling Dry Powder Inhalers including Injection Molded Disks

Hovione
Integrating DPI Development from Inhaler Design to Particle Engineering and Formulation Strategy

International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)
Abbreviated Impactor Measurement (AIM) and Effective Data Analysis (EDA) of Aerodynamic Particle Size Data from Orally Inhaled Products (OIP): How to Link with the Product Lifecycle

Nypro Healthcare
Integrating Predictive Design Tools to Achieve a Robust Inhalation Device Design

Proveris Scientific
Application of New Testing Technologies and Methods to Determine Critical Quality Attributes of pMDIs

Qualicaps
Inhaler Device Selection, Comparison of Capsule-based pMDIs and Mulit-dose DPIs

rap.ID  Particle Systems
Chemical Identification of Micro Particles from 2 µm and Up: Technology, Application and Validation

Toxikon Europe
Using Leachable Studies to Assist in Establishing an "Organic Impurity Profile" for Inhalation Drug Products

Sponsor: RPC Formatec
Moderator: Joanne Peart, Ph.D. & Paul Young, Ph.D.

Five poster authors have been selected to summarize their work and answer questions during a fast-paced interactive podium session.

Evaluation of Respimat^® Soft Mist^TM Inhaler Based on In Vitro Measurements and CFD Simulations
Anna-Maria Ciciliani, M.Sc.
Johannes Gutenberg University, Mainz, Germany

Guar Gum-Based Microparticles as Carriers for Lung Delivery of Anti-tubercular Drugs
Ana Grenha, Ph.D.
University of Algarve, Lisbon, Portugal

Brittle Matrices as a DPI Platform for Combination Therapies
Alan B. Watts, Ph.D.
University of Texas, Austin, Texas, USA

Novel DPI Formulation Based on Synergistic Combination of Salbutamol Hemisuccinate and Metatropium Iodide: Characterization, In Vitro and In Vivo Study
Tatiana N. Molostova, Ph.D.
Moscow City Hospital, Moscow, Russia

Chitosan Nanoparticulate Formulation for Pulmonary Vaccination – Formulation and In Vivo Proof of Concept
Regina Scherließ, Ph.D.
Christian Albrecht University, Kiel, Germany

Sponsor: 3M Drug Delivery Systems
Moderator: Richard N. Dalby, Ph.D

FDA’s Orange Book and ANDAs: Questioning the Policies and Precedents Surrounding RLD Patent Listings
Kurt Karst, J.D.,
Hyman, Phelps & McNamara, Washington DC, USA

Navigating Your Inhalation Patents through the European Patent Office
Richard J. Basile, J.D.,
St. Onge Steward Johnston & Reens, Stamford, CT, USA

Intellectual Property Protection and Enforcement for Pharmaceuticals in China: Status and Trends
Mr. Xiong Yu, M.B.A.,
Sinopharm VAC Biological Engineering, Yangzhou, P.R. China

Sponsor: Catalent
Moderator: Regina Scherließ , Ph.D.

Nose-to-Brain Drug Delivery: Opportunities and Challenges
Per G. Djupesland, M.D. Ph.D.,
Optinose, Oslo, Norway

Leveraging Old Drugs: A Critical Review of Delivery Systems and Lifecycle Management
Julie D. Suman, Ph.D.,
Next Breath, Baltimore, Maryland, USA

Towards Clinically Relevant In Vitro Testing of Locally Acting Nasal Spray Suspension Products
Michael Hindle, Ph.D.,
Virginia Commonwealth University, Richmond, Virginia, USA

Sponsor: Aptar Pharma
Moderator: John S. Patton, Ph.D. 

Platforms of the Future: Expanding the Route Map for Formulations and Devices
Richard N. Dalby, Ph.D.,
University of Maryland, Baltimore, Maryland, USA

Overcoming Critical Challenges in the Development of Needle-Free Delivery
John J. Turanin, M.B.A.,
Zogenix, Emeryville, California, USA

3D Printing and Beyond: Effective Use of Rapid Prototyping to Accelerate Medical Device Development
David S. Maltz, M.S. M.B.A.,
Novartis Pharmaceuticals Corporation, San Carlos, California, USA

Panel Discussion
Chairperson and Advocate: John S. Patton, Ph.D.
Dance Biopharm, Brisbane, California, USA

Panel:
Richard N. Dalby, University of Maryland
John J. Turanin, Zogenix
David S. Maltz, Novartis

Sponsor: MEGGLE
Moderator: Peter J Stewart, Ph.D.

Optimized Composite Particles for API-independent Formulations with Enhanced Performance
Eunice Costa, Ph.D.,
Hovione FarmaCiencia, Loures, Portugal

Solving the Particle Adhesion Paradox: Respirable Agglomerates of Micronized Drugs and Porous (Microcarrier) Particles
Jeffry Weers, Ph.D.,
Novartis Pharmaceuticals Corporation, San Carlos, California, USA

Theoretical Tools for Particle Engineers: Spray Drying Complex Formulations for Inhalation
Reinhard Vehring, Ph.D.,
University of Alberta, Edmonton, Canada

Sponsor: Our Diamond and Gold Sponsors
Moderator: Peter R. Byron, Ph.D. 

A Description and Appraisal of the New European Union (EU) Pharmacovigilance Legislation
John C.C. Talbot, Ph.D.,
University of Hertfordshire, Hatfield, United Kingdom

The Case For and Against Nonprescription Inhaled Short-Acting Bronchodilators
Leslie Hendeles, Pharm.D.,
University of Florida, Gainesville, Florida, USA

FDA’s Position on Over-the-Counter (OTC) Use of Drugs for Asthma and Allergies: Serving the Patient and Public Health
Badrul A. Chowdhury, M.D. Ph.D.,
Food and Drug Administration, Silver Spring, Maryland, USA

Expanding Access to Prescription SABA Inhalers: Rx to Over-the-Counter Switch and Alternative Models in Developed Countries
Natalie J. Gauld, Ph.D.,
Switch Specialist, Auckland, New Zealand

Panel Discussion
Chairperson and Advocate: Peter R. Byron, Ph.D.
Virginia Commonwealth University, Richmond, Virginia, USA

Panel:
Badrul Chowdhury, Food and Drug Administration
Natalie Gauld, Reclassification Consultant
Leslie Hendeles, University of Florida
John Talbot, University of Hertfordshire