Wednesday, November 14, 2018

  • 5:00 p.m. - 7:00 p.m.

    Registration

  • 6:00 p.m. - 7:30 p.m.

    Welcome Reception

Thursday, November 15, 2018

  • 7:30 a.m.

    Registration

  • 8:30 a.m.

    Welcome Address & Introduction
    Richard N. Dalby, Ph.D.
    Professor, School of Pharmacy,
    University of Maryland, Baltimore, Maryland, USA

  • 8:45 a.m.

    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 a.m.

    Refreshments, Scientific Poster Session & Technology Exhibition

SESSION 1: Advancing Regulatory Science of Inhaled and Nasal Products

  • 10:00 a.m.

    Demonstrating Q3 Structural Equivalence of Nasal Sprays:
    New Analytical Concepts and Techniques

    Julie D. Suman, Ph.D.,
    Next Breath, Baltimore, Maryland, USA

  • 10:30 a.m.

    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 a.m.

    Pharmacodynamic Determination of Inhaler Bioequivalence for Asthma and COPD

    Leslie Hendeles, Pharm.D.,
    University of Florida, Gainesville, Florida, USA

  • 11:30 a.m.

    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 p.m.

    Lunch, Scientific Poster Session & Technology Exhibition

SESSION 2: Workshops

  • 2:00 p.m. - 6:00 p.m.

    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 p.m.

    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 a.m.

    Registration

SESSION 3: Predictive Models to Support Inhalation Science

  • 8:30 a.m.

    Functional Respiratory Imaging as a Tool to Optimize Regional Delivery of Nasal Aerosols

    Wim Vos, Ph.D.,
    FLUIDDA, Kontich, Belgium

  • 9:00 a.m.

    Addressing Inter-patient Variability in DPIs:
    Optimizing Powder Entrainment using CFD-guided DPI Design

    Darragh Murnane, Ph.D.,
    University of Hertfordshire, Hatfield, United Kingdom

  • 9:30 a.m.

    De-risking Inhalation Product Development using Predictive Models

    Per Bäckman, Ph.D.,
    Emmace Consulting, Lund, Sweden

  • 10:00 a.m.

    Refreshments, Scientific Poster Session & Technology Exhibition

  • 10:30 a.m.

    Overcoming the Challenges of Aerosol Delivery to Infants During Non-invasive Ventilation

    Sneha Dhapare, Ph.D.,
    Virginia Commonwealth University, Richmond, Virginia, USA

  • 11:00 a.m.

    Combining API and Carrier Engineering to Enable Downstream Processing and Performance in DPIs

    Amrit Paudel, Ph.D.,
    Research Center Pharmaceutical Engineering and Graz University of Technology,
    Graz, Austria

  • 11:30 a.m.

    Exploring the Relationship between Suspension and Solution MDI Formulation Variables and Predicted Lung Deposition

    Jeffry Schroeter, Ph.D.,
    Applied Research Associates, Raleigh, North Carolina, USA

  • 12:00 p.m.

    Lunch, Scientific Poster Session & Technology Exhibition 

SESSION 4: Satisfying Patient Needs in the Global Marketplace

  • 2:00 p.m.

    Balancing the Needs of Patients, Regulators and Industry to Satisfy the Global Demand for Inhaled Products

    David J. Howlett, B.A.,
    PharmaDelivery Systems, King’s Lynn, United Kingdom

  • 2:30 p.m.

    Economic Burden of Respiratory Disease in India

    Raj B. Singh, M.D.,
    Apollo Hospital, Chennai, Tamil Nadu, India

  • 3:00 p.m.

    Refreshments, Scientific Poster Session & Technology Exhibition

  • 3:30 p.m.

    Making Sense of Inhaler Monitoring Technologies:
    Can They Improve Respiratory Outcomes?

    Joanne Peart, Ph.D.,
    Virginia Commonwealth University, Richmond, Virginia, USA

  • 4:00 p.m.

    Whistles and Apps: Enabling Low-cost Objective Feedback of Inhaler Use

    Mark Sanders, Ph.D.,
    Clement Clarke International, Harlow, United Kingdom

  • 4:30 p.m.

    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 p.m.

    End of RDD Asia 2018

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