Wednesday, November 14, 2018

  • 5:00 pm - 7:00 pm

    Registration

  • 6:00 pm - 7:30 pm

    Welcome Reception

Thursday, November 15, 2018

  • 7:30 am

    Registration

  • 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

    Challenging the Bioequivalence Hurdles for OINDPs: Achieving Q3 Structural Equivalence
    Robert Price, Ph.D.
    Professor, Department of Pharmacy and Pharmacology
    University of Bath, Bath, United Kingdom

  • 9:30 am

    Refreshments, Scientific Poster Session & Technology Exhibition

  • SESSION 1: Advancing Regulatory Science of Inhaled and Nasal Products

  • 10:00 am

    Demonstrating Q3 Structural Equivalence of Nasal Sprays: New Analytical Concepts and Techniques
    Julie Suman, Ph.D.
    Next Breath, Baltimore, MD, USA

  • 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, United Kingdom

  • 11:00 am

    Pharmacodynamic Determination of Inhaler Bioequivalence for Asthma and COPD
    Leslie Hendeles, Pharm.D.
    University of Florida, Gainesville, FL, USA

  • 11:30 am

    That Inhaler Can Tweet: Privacy and Cybersecurity for Connected Inhalers
    Mary Devlin Capizzi, J.D., M.B.A.
    Drinker Biddle & Reath, Washington, DC, USA

  • 12:00 pm

    Lunch, Scientific Poster Session & Technology Exhibition

  • SESSION 2: Workshops

  • 2:00 pm - 6:00 pm

    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 attend THREE sessions.

    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

  • 8:00 pm

    Gala Dinner

    The Gala Dinner will be held at Palm Lawns, Grand Hyatt and will feature international cuisine, entertainment, dancing and networking with other delegates. Dress is informal.

Friday November 16, 2018

  • 7:30 am

    Registration

  • SESSION 3: Predictive Models to Support Inhalation Science

  • 8:30 am

    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, United Kingdom

  • 9:30 am

    De-risking Inhalation Product Development Using Predictive Models
    Per Bäckman, Ph.D.
    Emmace Consulting, Lund, Sweden

  • 10:00 am

    Refreshments, Scientific Poster Session & Technology Exhibition

  • 10:30 am

    Overcoming the Challenges of Aerosol Delivery to Infants During Non-invasive Ventilation
    Sneha Dhapare, Ph.D.
    Virginia Commonwealth University, Richmond, VA, USA

  • 11:00 am

    Combining API and Carrier Engineering to Enable Downstream Processing and Performance in DPIs
    Amrit Paudel, Ph.D.
    Research Center Pharmaceutical Engineering, Austria

  • 11:30 am

    Exploring the Relationship between Suspension and Solution MDI Formulation Variables and Predicted Lung Deposition
    Jeffry Schroeter, Ph.D.
    Applied Research Associates, Raleigh, NC, USA

  • 12:00 pm

    Lunch, Scientific Poster Session & Technology Exhibition

  • SESSION 4: Satisfying Patient Needs in the Global Marketplace

  • 2:00 pm

    Balancing the Needs of Patients, Regulators and Industry to Satisfy the Global Demand for Inhaled Products
    David Howlett, B.A.
    PharmaDelivery Solutions, King's Lynn, United Kingdom

  • 2:30 pm

    Economic Burden of Respiratory Disease in India
    Raj B. Singh, M.D.
    Apollo Hospital, Annanagar, India

  • 3:00 pm

    Refreshments, Scientific Poster Session & Technology Exhibition

  • 3:30 pm

    Making Sense of Inhaler Monitoring Technologies: Can They Improve Respiratory Outcomes?
    Joanne Peart, Ph.D.
    Virginia Commonwealth University, Richmond, VA, USA

  • 4:00 pm

    Whistles and Apps: Enabling Low-cost Objective Feedback of Inhaler Use
    Mark Sanders, Ph.D.
    Clement Clarke International, Harlow, United Kingdom

  • 4:30 pm

    A Respiratory Revolution: Reducing the Burden of Chronic Respiratory Diseases in India
    Sundeep S. Salvi, M.D. Ph.D.
    Chest Research Foundation, Pune, India

  • 5:00 pm

    End of RDD Asia 2018

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