RDD 2014 - Program

Sunday, May 4, 2014

3:00 p.m. - 7:00 p.m.

Registration
8:00 p.m. - 10:00 p.m.

Welcome Reception

Monday, May 5, 2014

7:30 a.m.

Continental Breakfast and Registration
8:30 a.m.

Welcome & Introduction

Peter R. Byron, Ph.D.
Professor, School of Pharmacy,
Virginia Commonwealth University, Richmond, Virginia
8:35 a.m.

Presentation of Charles G. Thiel Award

Peter R. Byron, Ph.D.
Professor, School of Pharmacy,
Virginia Commonwealth University, Richmond, Virginia
9:00 a.m.

PLENARY LECTURE

The Microbiome and Airway Disease: Role in Pathogenesis, Presentation and Response to Treatment

Sponsor: 'Our Platinum Sponsors'
Moderator: Peter R. Byron, Ph.D.

Yvonne Huang, M.D.
Associate Director, UCSF Adult Cystic Fibrosis Program
University of California, San Francisco, CA

10:00 a.m.

Refreshments

SESSION 1: Airway Pathogens, Aerosols & Immunologic Homeostasis

Sponsor: Aradigm Corporation
Moderator: Igor Gonda, Ph.D.
10:30 a.m.

Lower Airway Bacteria in COPD: Differentiating True Colonization, Chronic Infection and Acute Infectious Exacerbations
Sanjay Sethi, M.D.
State University of New York, Buffalo, NY
11:00 a.m.

Immunosuppressive and Anti-Inflammatory Consequences of ICS Therapy in COPD: The Epidemiology Perspective
Barbara P. Yawn, M.D. M.Sc.
Olmsted Medical Center, Rochester, MN
11:30 a.m.

Effective Steroid-free Therapies for Chronic Inflammatory Lung Diseases: Targeting Leukotriene B4
Norbert F. Voelkel, M.D.
Virginia Commonwealth University, Richmond, VA

11:30 p.m. - 2:30 p.m.

Scientific Poster Session & Technology Exhibition

"Grab and Go" Lunch

SESSION 2: Dealing with the Demand for Inhaled Product Safety

Sponsor: 'Our Platinum Sponsors'
Moderator: Peter R. Byron, Ph.D.
2:00 p.m.

LABA-ICS Safety Studies in Asthma: An Update
Carlos A. Camargo, M.D.
Harvard Medical School, Boston, MA
2:30 p.m.

The β2–Adrenergic Receptor Gene: Its Influence on Inhaled Beta Agonist Responsiveness
Eugene R. Bleecker, M.D.
Wake Forest Baptist Medical Center, Winston Salem, North Carolina

3:00 p.m.

Refreshments

SESSION 3: Posters on the Podium

Sponsor: Vectura
Moderator: Richard N. Dalby, Ph.D. and Joanne Peart, Ph.D.

Seven poster authors were selected to summarize their work and answer questions during a fast-paced interactive podium session.
3:30 p.m.

In Vitro Nasal Deposition in a Nasal Cast Model: A Useful Tool in Nasal Drug Product Development
Sabrina Trows, Ph.D.
Christian Albrecht University, Kiel, Germany
3:45 p.m.

More than Drug Delivery: A New Airway Clearance Therapy Evaluated Clinically Using MRI
Jason Suggett, Ph.D.
Trudell Medical International, Ontario, Canada
4:00 p.m.

Evaluation of Bioequivalence Criteria for Methacholine-Induced Bronchospasm: Bioequivalence Study of Albuterol Sulfate Metered Dose Inhalers
Bhawana Saluja, Ph.D.
Food and Drug Administration, Rockville, Maryland
4:15 p.m.

Flash Atomization in a Model System Representing Pressurized Metered Dose Inhaler Sprays
Reinhard Vehring, Ph.D.
University of Alberta, Alberta, Canada
4:30 p.m.

The Effect of Active Pharmaceutical Ingredients on Aerosol Electrostatic Charges for Pressurized Metered Dose Inhalers
Yang Chen, B.Pharm.
Woolcock Institute of Medical Research and Sydney Medical School, University of Sydney, Sydney, Australia
4:45 p.m.

Effervescent Aerosols: A Novel Formulation Technology for Pressurized Metered Dose Inhalers
Mukul Kelkar, B.Pharm.
University of Maryland, Baltimore, Maryland
5:00 p.m.

Use of Fluorescent Particles to Characterize Dose Release in Dry Powder Inhalers
Edward J. Long, Ph.D.
Loughborough University, Loughborough, United Kingdom

5:00 p.m. - 7:00 p.m.

Scientific Poster Session & Technology Exhibition
RDD Silver Anniversary Wine and Cheese Reception

Sponsor: Prosonix
Moderator: Richard N. Dalby, Ph.D.

Celebrating 25 Years of Bringing Science, Innovation and People Together

Tuesday May 6, 2014

7:30 a.m.

Continental Breakfast and Registration

SESSION 4: Optimizing Nasal and Pulmonary Formulations

Sponsor: 'Our Platinum & Gold Sponsors'
Moderator: Paul M. Young, Ph.D.
8:30 a.m.

Optimizing ICS Suspensions for Nasal Use: The Influence of Solubility, Stability, Spray Volume, Dose, Log P and Receptor Binding
Petra Högger, Ph.D.
Julius-Maximilians-Universität, Würzburg, Germany
9:00 a.m.

Powder Processing: Performance Improvements Through Co-milling
Hartwig Steckel, Ph.D.
Christian Albrecht University, Kiel, Germany

9:30 a.m.

Refreshments

SESSION 5: Gaining Access to Global Markets

Sponsor: Aptar Pharma
Moderator: David J. Howlett, B.A.
10:00 a.m.

Improving Access to Respiratory Medicines and Achieving Growth in Emerging Markets: Economics, Supply Chains and a Strategic Trajectory
Prashant Yadav, Ph.D.
University of Michigan, Ann Arbor, MI
10:30 a.m.

Addressing the Consequences of Delayed TB Treatment in Africa: Dry Powder Formulations of Drugs and Vaccines for Enhanced Efficacy
Bernard Fourie, Ph.D.
University of Pretoria, Pretoria, South Africa
11:00 a.m.

Inhaler Device Options in a Rapidly Changing World:
Addressing Physician and Patient Needs
Jaideep A. Gogtay, M.D.
Cipla, Mumbai, India
11:30 a.m.

Addressing China's Growing Need for Inhaled Drugs: Development Strategies for Marketing, Distribution and Regulation
Ying Li, Ph.D.
Merck, Summit, NJ

11:30 a.m. - 2:30 p.m.

Scientific Poster Session & Technology Exhibition

"Grab and Go" Lunch

SESSION 6: Questioning the Weight of PK and PD Evidence for Inhaled Corticosteroids

Sponsor: Boehringer Ingelheim
Moderator: Glyn Taylor, Ph.D.
2:00 p.m.

Fluticasone Pharmacokinetics: Meta-Analyses and Models
Masahiro Sakagami, Ph.D.
Virginia Commonwealth University, Richmond, VA
2:30 p.m.

Exploring Aerosol Absorption in Humans: Pharmacokinetics of Monodisperse Fluticasone Propionate
Omar S. Usmani, M.D., Ph.D.
Imperial College, London, United Kingdom
3:00 p.m.

Refreshments
3:30 p.m.

Relationship between Pharmacokinetic and Aerodynamic Particle Size Distribution Properties for Inhalers containing Corticosteroids
Peter Daley-Yates, Ph.D.
GlaxoSmithKline, London, United Kingdom
4:00 p.m.

Pharmacodynamic Evaluation of Inhaled Corticosteroids
Hartmut Derendorf, Ph.D.
University of Florida, Gainesville, FL
4:30 p.m.

Panel Discussion
Chairperson and Advocate:
Glyn Taylor, Ph.D., Cardiff University, Wales, United Kingdom

Panel:
Hartmut Derendorf, Ph.D., University of Florida
Peter Daley-Yates, Ph.D., GlaxoSmithKline
Petra Högger, Ph.D., Julius-Maximilians-Universität
Masahiro Sakagami, Ph.D., Virginia Commonwealth University
Omar S. Usmani, M.D., Ph.D., Imperial College, London

5:00 p.m. - 7:00 p.m.

Scientific Poster Session & Technology Exhibition
7:00 p.m. - 9:00 p.m.

AAPS Inhalation and Nasal Technology Focus Group

Wednesday, May 7, 2014

7:30 a.m.

Continental Breakfast and Registration

Meeting Break for Recreation

Participants could take advantage of the many hotel amenities at El Conquistador (golf, tennis, spa, water park, and many others), or book an excursion organized through Group Services, Inc.

SESSION 7: Improving Device Design to Meet New Technologic Challenges

Sponsor: Chiesi Farmaceutici
Moderator: Peter Villax, M.A.
1:30 p.m.

Beyond Small Particles: Development of DPIs that Target Small Airways and Alveoli
P. Worth Longest, Ph.D.
Virginia Commonwealth University, Richmond, Virginia
2:00 p.m.

Designing out the 'Load-Prime-Inhale-Empty-Load-Prime…' Routine for High Dose Formulations
Phil Seeney, M.Des.
PA Consulting Group, Melbourn, United Kingdom
2:30 p.m.

Device Design Development and Quality by Design
Andrew G. Dundon, B.Sc.
GlaxoSmithKline, Ware, United Kingdom

3:00 p.m.

Refreshments

SESSION 8: Improving Device Design to Satisfy Patients and Physicians

Sponsor: Philips Respironics
Moderator: M. Geraldine Venthoye, Ph.D.
3:30 p.m.

What are Meaningful Device Improvements for Patients, Providers and Payers?
John N. Pritchard, Ph.D.
Philips Respironics, Chichester, United Kingdom
4:00 p.m.

Ensuring Effective Lung Delivery with Vibrating Mesh Nebulizers: A Practical Approach
Gerald C. Smaldone, M.D. Ph.D.
State University of New York, Stony Brook, NY
4:30 p.m.

Manufacturing Considerations for Human Factors Engineering of MDIs: A Case Study using Integrated Dose Counters
Adam Stuart, B.Eng.
3M Drug Delivery Systems, Loughborough, United Kingdom
5:00 p.m.

NEXThaler^®: Patient Centric Inhaler Design
Alice Campanini, B.Sc.
Chiesi Farmaceutici, Parma, Italy

6:30 p.m.

Cocktail Reception

Sponsored by ‘Our Platinum Sponsors’
7:30 p.m.

Banquet & Dancing

Sponsored by ‘Our Platinum Sponsors’

Thursday, May 8, 2014

7:30 a.m.

Continental Breakfast and Registration

SESSION 9: Advances in Testing and Manufacturing Science

Sponsor: AstraZeneca
Moderator: Stephen W. Stein, Ph.D.
8:30 a.m.

Real-Time Inhalation Analytics using Single Particle Aerosol Mass Spectrometry (SPAMS)
David P. Fergenson, Ph.D.
Livermore Instruments, Oakland, CA
9:00 a.m.

Ensuring Scaleable Filling of Engineered Powders: Quality by Design
Andreas Boeckl
Flurry Powders, Tarpon Springs, Florida
9:30 a.m.

Production and Release in the 21st Century: Prizing the Fingers of cGMP from Respimat's Testing Robots in Early Development
Herbert Wachtel, Ph.D.
Boehringer Ingelheim, Ingelheim, Germany
10:00 a.m.

Refreshments

SESSION 10: In Vitro Testing for Future Regulatory Relief

Sponsor: Prosonix
Moderator: Andrew R. Clark, Ph.D.
10:30 a.m.

Mouth-Throat Models for Realistic In Vitro Testing - A Proposal for Debate
Bo L. Olsson, Ph.D.
AstraZeneca, Mölndal, Sweden
11:00 a.m.

Breath Profiles for Testing New DPI Devices in Development
Peter R. Byron, Ph.D.
Virginia Commonwealth University, Richmond, VA
11:30 a.m.

Validating and Scaling the Alberta Idealized Child Throat
Warren H. Finlay, Ph.D.
University of Alberta, Alberta, Canada
12:00 p.m.

Optimizing Indacaterol Formulations in Practice: In Vitro Testing and PK/PD Correlations
Jeffry Weers, Ph.D.
Novartis, San Carlos, CA
12:30 p.m.

Panel Discussion

Chairman & Advocate:
Andrew R. Clark, Novartis, San Carlos, CA

Panel:
Peter R. Byron, Ph.D., Virginia Commonwealth University
Warren H. Finlay, Ph.D., University of Alberta
Bo L. Olsson, Ph.D., AstraZeneca
Jeffry Weers, Ph.D., Novartis

1:00 p.m.

Luncheon

Sponsored by ‘Our Platinum Sponsors’
2:30 p.m.

End of Respiratory Drug Delivery 2014