Sponsor: Vectura
Moderator: Peter R. Byron, Ph.D. 

Mechanisms of Action of Inhaled Iloprost in Severe Pulmonary Hypertension - The Heart, not the Lungs
Jose Gomez-Arroyo, M.D.,
Virginia Commonwealth University, Richmond, Virginia, USA

Pharmaceutical Engineering of Fasudil, a Rho-kinase Inhibitor, for the Treatment of Pulmonary Arterial Hypertension (PAH)
Fakhrul Ahsan, Ph.D.,
Texas Tech University Health Sciences Center, Amarillo, Texas, USA

Dihydroergotamine Inhalation Aerosol for the Treatment of Migraine: Insights from Pharmaceutical and Clinical Development
Donald J. Kellerman, Pharm.D.,
MAP Pharmaceuticals, Mountain View, California, USA

Discovery of Muscarinic Acetylcholine Receptor Antagonist and Beta Adrenoceptor Agonist (MABA) Dual Pharmacology Molecules
Adam D. Hughes, Ph.D.,
Theravance, South San Francisco, California, USA

Intranasal Insulin Targeting to Brain and Cerebrospinal Fluid (CSF): A Review of its Clinical Effects and Mechanisms
Christian Benedict, Ph.D.,
Uppsala University, Uppsala, Sweden

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

The following companies each sponsored 60-minute interactive presentations on new technologies and services related to nasal and pulmonary drug delivery. Meeting participants could select and attend THREE of these sessions.

Charles River Laboratories
Preclinical Development for Inhalation Drugs

DH Industries / Pamasol Willi Mäder
pMDI Pressure Filling - Principles, Set-Up, Operation, Parameters Setting, and Monitoring

DPT Laboratories 
Formulation and Device - Critical Parameters for Development of OINDPs

Gateway Analytical
Automated Ingredient Specific Particle Sizing (ISPS)

Harro Höfliger Verpackungsmaschinen
Get It Right: 100% In-line Verification of Dosed Mass in Inhalation Blisters

Hovione 
Integrating DPI Development: Inhaler Design, Particle Engineering and Formulation Strategy

Malvern Instruments & Next Breath
Linking Dissolution and Particle Size via Raman Imaging

Oxford Lasers
Using High-Speed Laser Imaging to Aid Development of DPI Devices

Presspart
Plasma Coating of pMDI Containers: Meeting the HFA Challenge

Proveris Scientific
Understanding Factors Leading to Actuator Deposition in pMDIs: Exploring the Value of Spray Angle Measurements

rap.ID Particle Systems
Characterization of Foreign Particles and API Agglomerates by Image-Directed Raman Spectroscopy

Toxikon Europe
A Novel Comprehensive Approach towards Extractables/Leachables Testing for pMDIs and DPIs

Sponsor: Boehringer Ingelheim
Moderators: Richard N. Dalby, Ph.D., and Joanne Peart, Ph.D. 

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

Uptake of Salmeterol Xinafoate and Fluticasone Propionate from Single and Combination Dry Powder Inhalers After Deposition on Calu-3 Respiratory Epithelia
Mehra Haghi, Ph.D. University of Sydney, Sydney, Australia

Real-Time Determination of Aerodynamic Particle Size Profiles and the Presence/Co-Presence of Active Ingredients in Inhalational Pharmaceutical Products Using a SPAMS 3.0 
David Fergenson, Ph.D., Livermore Instruments, Oakland, California, USA

Salbutamol-Glycine Composite Microballs for Pulmonary Drug Delivery
Ekaterina G. Zevak, M.Sc., Novosibirsk State University, Novosibirsk, Russia

Dose Range of a Propellant Driven High-Dose Dry Powder Inhaler
Robert Winkler, Boehringer Ingelheim, Ingelheim, Germany

Evaluation of Impact of Nasal Dry Powder Vaccine Formulations on Uptake and Activation by Dendritic Cells
Regina Scherließ, Ph.D. Christian Albrecht University, Kiel, Germany

Sponsor: Prosonix
Moderator: Günther Hochhaus, Ph.D. 

An Assessment of the FDA's Dose-Scaling Approach to Evaluate Pharmacodynamic Bioequivalence
Stephanie H. Kim, Ph.D.,
Food and Drug Administration, Rockville, Maryland, USA

Inhaler Bioequivalence using Combined CT Imaging and FEV₁ - A Crossover Study Design to Demonstrate Improved Statistical Power in a Small Number of Subjects
Jan De Backer, Ph.D.,
FluidDA, Antwerp, Belgium

Standardizing In Vitro Test Methods to Support Aerosol Drug Evaluation in the Clinic
Peter R. Byron, Ph.D.,
Virginia Commonwealth University, Richmond, Virginia, USA

Sponsor: Chiesi Farmaceutici
Moderator: Andrew R. Clark, Ph.D. 

Orphan Drug Approval in the US (and some EU Comparisons): Regulatory Mechanisms for Rare Pulmonary Disorders
Kurt Karst, J.D.,
Hyman, Phelps & McNamara, Washington DC, USA

Clinical Trial Design for Orphan Indications - A Pilot Study of Aerosolized Liposomal Cyclosporine A for Chronic Rejection in Lung Transplant Patients
Aldo T. Iacono, M.D.,
University of Maryland, Baltimore, Maryland, USA

Sponsor: Novartis / Sandoz
Moderator: Leslie Hendeles, Pharm.D. 

Transatlantic Differences in Clinical Testing Requirements - Is There Room for Compromise?
Leslie Hendeles, Pharm.D.,
University of Florida, Gainesville, Florida, USA

Clinical Requirements for New LABA/ICS Combinations in the USA
Badrul A. Chowdhury, M.D., Ph.D.,
Food and Drug Administration, Silver Spring, Maryland, USA

What Do You Need to Measure to Establish Efficacy of New LABA/ICS Combinations for Submissions in the EU?
David Wright, Ph.D.,
Medicines and Healthcare Products Regulatory Agency (MHRA), London, United Kingdom

Clinical Demands for New LABA/ICS Combinations in Europe
David Lyons, M.D.,
Irish Medicines Board, Dublin, Ireland

Clinical Development to Satisfy all Stakeholders. Who Might Give Way and On What?
Sanjeeva Dissanayake, M.D.,
Mundipharma, Cambridge, United Kingdom

Panel Discussion

Chairperson and Advocate:
Leslie Hendeles, Pharm.D.,
University of Florida, Gainesville, Florida, USA.

Panel:
Badrul Chowdhury, Food and Drug Administration
Sanjeeva Dissanayke, Mundipharma
David Lyons, Irish Medicines Board
David Wright, Medicines and Healthcare Products Regulatory Agency (MHRA)

Sponsor: Molkerei MEGGLE Wasserburg
Moderator: Geraldine Venthoye, Ph.D.

Monitoring and Improving Compliance and Asthma Control: Mapping Inhaler Use for Feedback to Patients, Physicians and Payers
David van Sickle, Ph.D.,
Asthmapolis, Madison, Wisconsin, USA

Steering the Design, Manufacture and Control of Genuair^TM/Pressair^TM Through Regulatory Approval
Carsten Niederlaender, Ph.D.,
Almirall, Barcelona, Spain

Impact of Patient Needs on Design and Usage of an Inhalation Device in Respiratory Medicine
Petra Moroni-Zentgraf, M.D.,
Boehringer Ingelheim, Ingelheim, Germany

Identifying and Satisfying New Human Factors Requirements Through Good Study Design
Julian Dixon, M.A.,
Team Consulting, Cambridge, United Kingdom

Sponsor: Trudell Medical International
Moderator: Paul M. Young, Ph.D.

Meeting Formulation Challenges for Reproducible Delivery using eFlow^® Technology
Oliver M. Denk, Ph.D.,
PARI Pharma, Gräfelfing, Germany

Intrinsic Particle Size Distribution: A New Metric to Guide the Design of HFA Solution pMDIs
David A. Lewis, Ph.D.,
Chiesi Limited, Chippenham, United Kingdom

Physicochemical Evaluation of Powder Aggregates in Guiding Formulation Design
Robert Price, Ph.D.,
University of Bath, Bath, United Kingdom