Wednesday, November 14, 2018
5:00 pm - 7:00 pm
Registration
6:30 pm - 8:00 pm
Welcome Reception
Sponsored by Aptar Pharma
Thursday, November 15, 2018
7:30 am
Registration and Welcome Coffee
8:30 am
Welcome Address & Introduction
Richard N. Dalby, Ph.D. Professor, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
8:45 am
Plenary Lecture
Sponsor: Aptar Pharma Moderator: Richard N. Dalby, Ph.D.
Challenging the Bioequivalence Hurdles for OINDPs: Achieving Q3 Structural Equivalence Robert Price, Ph.D., University of Bath, Bath, Somerset, United Kingdom
9:30 am
SCIENTIFIC POSTER SESSION & TECHNOLOGY EXHIBITION
Light Refreshments Served
Moderator: Richard N. Dalby, Ph.D.
Scientific Posters & Exhibit Tables will be available for viewing between 9.30 a.m. and 6.00 p.m.
10:00 am - 12:00 pm
SESSION 1: Advancing Regulatory Science of Inhaled and Nasal Products
Moderator: Gur Jai Pal Singh, Ph.D.
10:00 am
Demonstrating Q3 Structural Equivalence of Nasal Sprays: New Analytical Concepts and Techniques Julie D. Suman, Ph.D., Next Breath, Baltimore, Maryland
10:30 am
Navigating the Challenges of Generic Device Design using an "Outside-In" and "Inside-Out" Approach Suresh Gupta, Ph.D., Cambridge Consultants, Cambridge, Cambridgeshire, United Kingdom
11:00 am
Pharmacodynamic Determination of Inhaler Bioequivalence for Asthma and COPD Leslie Hendeles, Pharm.D., University of Florida, Gainesville, Florida
11:30 am
That Inhaler Can Tweet! Privacy and Cybersecurity for Connected Inhalers Mary Devlin Capizzi, J.D., Drinker Biddle, Washington, Washington, D.C.
12:00 pm - 2:00 pm
SCIENTIFIC POSTER SESSION & TECHNOLOGY EXHIBITION continues
Buffet Lunch provided
2:00 pm - 6:00 pm
SESSION 2: WORKSHOPS
Sponsor: Aptar Pharma Moderator: Gerallt Williams, Ph.D.
2:00 pm
Workshop Selection #1
3:15 pm
Workshop Selection #2
4:30 pm
Workshop Selection #3
The following companies will each sponsor 60-minute interactive presentations on new technologies and services related to nasal and pulmonary drug delivery. Meeting participants may select and attend THREE of these sessions.
Refreshments will be available throughout the afternoon.
AIMIL Assessing Bioequivalence for Nasal Sprays and Dry Powder Inhalers: Application of Physicochemical Test Methods
Amcor Cooperation in the Qualification and Validation of Primary Packaging for Dry Powder Inhalers to Gain Generic Drug Registration
Aptar Pharma Decoding FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs, and Nasal Sprays
H&T Presspart Unit-dose Dry Powder Inhalers: Challenges and Opportunities to Meet Patient Needs
MEGGLE Get the Right Grade: An Inhaled Lactose Guide for Dry Powder Inhaler (DPI) Formulations
Proveris Scientific A Step-wise Guide to Orally Inhaled and Nasal Drug Product (OINDP) Development
7:00 pm
Friday, November 16, 2018
Scientific Posters & Exhibit Tables will be available for viewing between 8.30 a.m. and 5.00 p.m.
8:30 am - 12:00 pm
SESSION 3: Predictive Models to Support Inhalation Science
Moderator: Julie D. Suman, Ph.D.
Functional Respiratory Imaging as a Tool to Optimize Regional Delivery of Nasal Aerosols Wim Vos, Ph.D., FLUIDDA, Kontich, Belgium
9:00 am
Addressing Inter-patient Variability in Dry Powder Inhalers: Optimizing Powder Entrainment using CFD-guided DPI Design Darragh Murnane, Ph.D., University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom
De-risking Inhalation Product Development Using Predictive Models Per Bäckman, Ph.D., Emmace Consulting, Lund, Sweden
Overcoming the Challenges of Aerosol Delivery to Infants During Non-invasive Ventilation Sneha Dhapare, Ph.D., Virginia Commonwealth University, Richmond, Virginia
Combining API and Carrier Engineering to Enable Downstream Processing and Performance in DPIs Amrit Paudel, Ph.D., Research Center Pharmaceutical Engineering, Graz, Austria
Exploring the Relationship between Suspension and Solution MDI Formulation Variables and Predicted Lung Deposition Jeffry Schroeter, Ph.D., Applied Research Associates, Raleigh, North Carolina
2:00 pm - 4:30 pm
SESSION 4: Satisfying Patient Needs in the Global Marketplace
Balancing the Needs of Patients, Regulators and Industry to Satisfy the Global Demand for Inhaled Products David J. Howlett, Ph.D., PharmaDelivery Solutions, King's Lynn, Norfolk, United Kingdom
2:30 pm
Economic Burden of Respiratory Disease in India Raj B. Singh, M.D., Apollo Hospital, Annanagar, Chennai, India
3:00 pm
3:30 pm
Making Sense of Inhaler Monitoring Technologies: Can They Improve Respiratory Outcomes? Joanne Peart, Ph.D., Virginia Commonwealth University, Richmond, Virginia
4:00 pm
Whistles and Apps: Enabling Low-cost Objective Feedback of Inhaler Use Mark Sanders, Ph.D., Clement Clarke International, Harlow, Essex, United Kingdom
End of RDD Asia 2018
