RDD 2016 - Program

Sunday, April 17, 2016

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

Registration
7:30 p.m. - 9:30 p.m.

Welcome Reception

Monday, April 18, 2016

7:15 a.m.

Continental Breakfast and Registration
8:30 a.m.

Welcome

Joseph T. DiPiro, Pharm.D.
Dean, School of Pharmacy,
Virginia Commonwealth University, Richmond, Virginia
8:35 a.m.

Introduction & Presentation of Charles G. Thiel Award

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

PLENARY LECTURE

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

Inhaled Calcilytics: Effects on Airway Inflammation and Remodeling
Daniela Riccardi, Ph.D.,
Professor, Deputy Head, School of Bioscience
University of Cardiff, Cardiff, United Kingdom
10:00 a.m.

Refreshments

SESSION 1: Frontiers in New Drug and Product Development

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

Reconstructing the Emphysematous Lung: A Critical Appraisal and Case Study with VCU-CDSO3
Masahiro Sakagami, Ph.D.,
Virginia Commonwealth University, Richmond, Virginia
11:00 a.m.

Asthma Rescue with Carbonated Perflubron: A Novel Biophysical Approach
John Dennis, Ph.D.,
SolAeroMed, Calgary, Canada
11:30 a.m.

Using Connected Devices to Monitor Inhaler Use in the Real World
David van Sickle, Ph.D.,
Propeller Health, Madison, Wisconsin

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

Scientific Poster Session & Technology Exhibition

"Grab and Go" Lunch

SESSION 2: Aerosol Drug Disposition

Sponsor: RPC Formatec
Moderator: Guenther Hochhaus, Ph.D.
2:00 p.m.

Tiotropium Pharmacokinetics and Pharmacodynamics - What are Drivers for Systemic Levels and Local Pulmonary Responses?
Benjamin Weber, Ph.D.,
Boehringer Ingelheim, Ridgefield, Connecticut
2:30 p.m.

Is Systemic PK really an Indicator of Pulmonary Deposition?
A Fluticasone Propionate Case Study
Philip Kuehl, Ph.D.
Lovelace Respiratory Research Institute,
Albuquerque, New Mexico

3:00 p.m.

Refreshments

SESSION 3: Posters on the Podium

3:30 p.m.

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

Poster authors have been selected to summarize their work and answer questions during a fast-paced interactive podium session.
3:35 p.m.

Sulfated Caffeic Acid Oligomer: Reversal of Functional and Morphological Impairment in Emphysema Induced with VEGF Receptor Blockade
Tien Truong
Virginia Commonwealth University, Richmond, Virginia
3:45 p.m.

Examining the Effect of Ambient Pressure on Dry Powder Inhaler Performance
Conor Ruzycki
University of Alberta, Alberta, Canada
3:55 p.m.

In Vitro Evaluation of Lysophosphatidic Acid for use in Perfluorocarbon-Based Pulmonary Delivery to Enhance Alveolar Repair Following Acute Lung Injury
Diane Nelson
Carnegie Mellon University, Pittsburgh, Pennsylvania
4:05 p.m.

Development of siRNA-loaded Chitosan Nanoparticles targeting Galectin-1 for the Treatment of Glioblastoma Multiforme via Intranasal Administration
Matthias Van Woensel
University of Leuven, Leuven, Belgium
4:15 p.m.

Using a Cell-Penetrating Peptide to Enhance pDNA Uptake in Lung Epithelial Cells
Larissa dos Reis Gomes
Woolcock Institute of Medical Research and Sydney Medical School, University of Sydney, Sydney, Australia
4:25 p.m.

Pulmonary Vascular Effects in COPD Subjects after Pulsed Inhaled Nitric Oxide Therapy Evaluated by Functional Respiratory Imaging (FRI)
Jan de Backer
FLUIDDA, Kontich, Belgium
4:35 p.m.

Novel High Efficiency Inhaler for PDE5i Lung Delivery
James Hannon
Respira Therapeutics, Albuquerque, New Mexico, USA
4:45 p.m.

USSC-03: A Modular Breath-Actuated Multidose Dry Powder Inhaler System With Telehealth Capability
Mark Glusker
Novartis, San Carlos, California, USA

Tuesday April 19, 2016

7:15 a.m.

Continental Breakfast and Registration

SESSION 4: Platinum Sponsor Seminars

Our Platinum Sponsors each sponsored 30-minute cutting edge presentations on new technologies and services related to nasal and pulmonary drug delivery. Meeting participants may select and attend TWO of these sessions.

3M Drug Delivery Systems
From Ancient Egypt to Smart Inhalers: The History of Respiratory Drug Delivery

Aptar Pharma
Cross-over Technologies and Innovations Between Respiratory, Nasal and Injectable Markets

AstraZeneca / Pearl Therapeutics
A New Era in Development of Inhaled Medicines and Combinations with MDIs

Catalent
Non-Invasive Macromolecule Delivery: Breathing Them In
8:00 a.m.

Platinum Sponsor Seminar #1
8:45 a.m.

Platinum Sponsor Seminar #2

9:30 a.m.

Refreshments

SESSION 5: MDI and DPI Theory and Practice

Sponsor: Chiesi Farmaceutici
Moderator: Stephen P. Stein, Ph.D.
10:00 a.m.

Advanced Microparticle Characterization Methods to Support Regulatory Product Development
David Lechuga, Ph.D.,
Pearl Therapeutics, Redwood City, California
10:30 a.m.

Extending MDI Valve Prime Theory: The Effects of Formulation and Temperature Shock
David A. Lewis, Ph.D.,
Chiesi Limited, Chippenham, United Kingdom
11:00 a.m.

Blending Pre-formulation Metrics with Molecular Calculations to Facilitate Aerosol Product Formulation
Darragh Murnane, Ph.D.,
University of Hertfordshire, Hatfield, United Kingdom
11:30 a.m.

Stretching the Boundaries of Computational Fluid Dynamics to Address Deaggregation in DPIs
Ralf Kroeger, Ph.D.,
Ansys, Darmstadt, Germany

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

Scientific Poster Session & Technology Exhibition

"Grab and Go" Lunch

SESSION 6: Dealing with the Variability of Pulmonary Drug Deposition

Sponsor: Philips Respironics
Moderator: Warren H. Finlay, Ph.D.
2:00 p.m.

Analyzing 20 Years of Clinical Studies on Inspiration through DPIs
Andrew R. Clark, Ph.D.,
Aerogen Pharma, San Mateo, California
2:30 p.m.

Estimating Aerosol Size Distributions and Doses Entering the Trachea
Peter R. Byron, Ph.D.,
Virginia Commonwealth University, Richmond, Virginia
3:00 p.m.

Airway Geometry Variations and Disease Effects on Regional Lung Deposition
Jan de Backer, Ph.D.,
FLUIDDA, Kontich, Belgium
3:30 p.m.

Refreshments
4:00 p.m.

Pitfalls in Predicting Local Exposure
Per Bäckman, Ph.D.,
Mylan Global Respiratory Group, Sandwich, United Kingdom
4:30 p.m.

Assessing In Vitro BE Using Realistic Inhalation Profiles for Regulatory Approval of Generic Inhalers
Dennis Sandell, Ph.D.,
S5 Consulting, Blentarp, Sweden

5.00 p.m.

Panel Discussion: Acknowledging Variability while Judging Bioequivalence
Chairperson and Advocate:
Andrew R. Clark, Ph.D., Aerogen Pharma, San Mateo, California

Panel:
Per Bäckman, Mylan Pharmaceuticals
Peter R. Byron, Virginia Commonwealth University
Jan de Backer, FLUIDDA
Renish Delvadia, Food and Drug Administration
Warren H. Finlay, University of Alberta
Dennis Sandell, S5 Consulting

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, April 20, 2016

7:15 a.m.

Continental Breakfast and Registration

Meeting Break for Recreation

Participants can take part in one or more of the resort's activities, take an excursion, or relax.

SESSION 7: Engineering and Controlling Surface Properties

Sponsor: H&T Presspart
Moderator: John N. Pritchard, Ph.D.
1:00 p.m.
Controlling Surface Performance Characteristics of Medical Devices: A Critical Review of the Latest Industrial Techniques

Paul Stevenson, Ph.D.,
Portal Medical, Cambridge, United Kingdom
1:30 p.m.

Reducing Demand for Formulation Additives through Surface Control: Controlling Bioadhesive Container Properties
Arnaud Ponche, Ph.D.,
Institut de Science des Materiaux de Mulhouse, Mulhouse, France
2:00 p.m.

Lactose Specifications: Supplier and Process Defined Properties vs. Surface Characteristics Controlled and Specified In-house
Paul M. Young, Ph.D.,
Woolcock Institute of Medical Research and University of Sydney, Sydney, Australia

2:30 p.m.

Refreshments

SESSION 8: Evaluating Nasal Corticosteroid Spray Characteristics

Sponsor: Proveris Scientific
Moderator: Regina Scherließ, Ph.D.
3:00 p.m.

Bioequivalence Testing: Can Systemic Pharmacokinetic Profiles from Corticosteriod Nasal Sprays be used to Elucidate Local Drug Deposition With the Nose?
P. Worth Longest, Ph.D.,
Virginia Commonwealth University, Richmond, VA
3:30 p.m.

Characterizing Nasal Suspensions for Regulatory and Scientific Purposes
Jag Shur, Ph.D.,
University of Bath, Bath, United Kingdom
4:30 p.m.

Human Clinical Nasal Deposition and Retention of Non-aqueous and Aqueous Steroid Inhalers
Chet Leach, Ph.D.,
Lovelace Respiratory Research Institute, Albuquerque, New Mexico

6:30 p.m.

Cocktail Reception

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

Banquet & Dancing

Sponsored by ‘Our Platinum Sponsors’

Thursday, April 21, 2016

7:15 a.m.

Continental Breakfast and Registration

SESSION 9: Building, Maintaining & Measuring Quality During the Product Lifecycle: Current Thinking and New Opportunities

Coordinated with International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)

Co-Chairs:
Jeremy Clarke, Ph.D., GlaxoSmithKline, Ware, United Kingdom
Andy Rignall, Ph.D., AstraZeneca, Gothenburg, Sweden
8:30 a.m.

Knowledge Gaps and Challenges Facing Development of Orally Inhaled Drug Products
Sau (Larry) Lee, Ph.D.,
Food and Drug Administration, Silver Spring, Maryland
9:00 a.m.

Establishing the Design Space for Composite Soft Agglomerates in a Multi-dose Dry Powder Inhaler
Balaji Bharatwaj, Ph.D.,
Merck, Summit, New Jersey
9:30 a.m.

Quality Metrics Industry Pilot: A Progress Report from ISPE
Diane Hagerty, Ph.D.,
Genentech, South San Francisco, California
10:00 a.m.

Refreshments
10:30 a.m.

Experiences of Lifecycle Changes: Site, Scale Up, Polymers and Suppliers
Stefan Leiner, Ph.D.,
Boehringer Ingelheim, Ingelheim am Rhein, Germany
11:00 a.m.

Looking at the FDA's 1998 Draft CMC Guidance for MDI and DPI Drug Products with a 2016 Combination Products Mindset
Robert Berger, B.Sc.,
Merck, Summit, New Jersey
11:30 a.m.

Panel Discussion:
Assuring Public Health via Globally Harmonized Quality Incentives and Regulatory Oversight

Co-Chairs:
Jeremy Clarke, Ph.D., GlaxoSmithKline
Andy Rignall, Ph.D., AstraZeneca

Panel:
Robert Berger, Merck
Sai Chamarthy, Merck
Diane Hagerty, Genentech
Sau (Larry) Lee, Food and Drug Administration
Stefan Leiner, Boehringer Ingelheim

12:30 p.m.

Luncheon

Sponsored by ‘Our Platinum Sponsors’
2:00 p.m.

End of Respiratory Drug Delivery 2016
2:00 p.m.

IPAC-RS Symposium followed RDD 2016 on the afternoon of Thursday April 21 and ran through Friday April 22. Sessions addressed:
- Building Quality During Development Through Improved Tools & Decision Making
- Quality - A Global Perspective: Advances in the Global Regulatory Framework
- Quality Innovations to Improve the Patient Experience