Sunday, April 22, 2018

  • 3:00 p.m. - 7:00 p.m.
    Central Registration

    Registration

  • 7:30 p.m. - 9:30 p.m.
    Meecha Lawn

    Welcome Reception

    Sponsored by Our Platinum and Gold Sponsors

Monday, April 23, 2018

SESSION 1: Frontiers in Lung Biology

  • 12:15 p.m.

    Lunchtime

SESSION 2: Exploring the Targeting Offered by Inhalation and Molecular Design

  • 3:00 p.m.
    Arizona Ballroom
    Refreshments

SESSION 3: Posters on the Podium

Tuesday April 24, 2018

  • 7:00 a.m.
    Ania Terrace

    Continental Breakfast

    Central Registration

    Registration

SESSION 4: Platinum Sponsor Seminars

  • 8:00 a.m. - 9:30 a.m.

    Our Platinum Sponsors will host 30-minute presentations on new technologies related to aerosol drug delivery. Meeting participants may select and attend TWO of these sessions.

  • 8:00 a.m.

    Platinum Sponsor Seminar #1

  • 8:45 a.m.

    Platinum Sponsor Seminar #2

  • Tucson Ballroom G/H

    3M Drug Delivery Systems
    The 3M Intelligent Control Inhaler™ Platform and the Challenges of Incorporating Existing Molecules into Pressurized Metered Dose Inhalers (pMDIs)

    Introduction: This presentation will review the need for improved pMDI delivery devices like the 3M Intelligent Control Inhaler™ platform and the challenges associated with designing a pressurized metered dose inhaler (pMDI) which matches the performance of an existing inhalation product.

    Description: Many of the best-selling inhalation products deliver drugs that have been available for decades, yet regulatory uncertainty has resulted in very few generic inhalers reaching the market. Those which have reached the patient have usually been “branded generics,” where the brand and generic share a common drug substance, formulation and hardware. An alternative approach is to incorporate existing inhaled drug substances currently available in a dry powder or soft mist inhaler into a new pMDI. Depending on client needs, this approach may result in a more favorable intellectual property situation, serve as a valuable lifecycle management strategy or be a tool for achieving market differentiation. This presentation will illustrate the challenges associated with developing existing drug substances into pMDIs, considering complex in vitro and in vivo relationships that can exist. Additionally, it will expand on the advances made to the Intelligent Control Inhaler platform and the advantages of using the inhaler for product differentiation.

    Outcome for Participants: Attendees will leave the presentation with a better understanding of the challenges associated with formulating and commercializing old drugs into the pMDI format, and knowledge of the benefits of switching platforms aided by the latest version of the 3M Intelligent Control Inhaler platform.


     

    Tucson Ballroom I/J

    Aptar Pharma
    Decoding FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs, and Nasal Sprays

    Introduction: The finalized FDA Guidance for Combination Products issued in January 2017 defines a Combination Product as a product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another). There are three types of combinations products: single entity, co-packaged, or cross-labeled. The drug applicant, therefore, needs to demonstrate compliance with all cGMP regulations applicable to each of the constituent parts included in the Combination Product.

    Description: This presentation will provide an overview on the most recent FDA guidance on Combination Products focusing on respiratory and nasal drug products, specifically DPIs, pMDIs, and Nasal Sprays. In addition, insights on optimal approaches to help secure approval in this changing and challenging regulatory landscape, will be discussed.

    Specifically, the following topics will be reviewed:

    • The Basics – medical device, combination product, and packaging components
    • NDA/ANDA submissions: regulatory pathway review for combination products
    • Human Factor studies in the context of combination product
    • Clarify expectations: Sponsor, device supplier, and regulators

    Outcome for Participants: Attendees will gain practical insights to navigate FDA expectations for device information in NDA and ANDA submissions for combination products, in the context of the current guidance.


    San Pedro 1/2

    Lonza Pharma & Biotech
    Expanding the Orally Inhaled and Nasal Drug Product (OINDP) Portfolio Through Particle Engineering

    Introduction: The majority of inhalation drug research is currently centered around existing and new therapies for diseases such as asthma and COPD. Treatments for other disease states are emerging, some of which may require particle engineering techniques to overcome dose, solubility or other unique challenges.

    Description: This presentation will discuss the wide range of molecules currently in a particle engineering portfolio for inhaled delivery. Insight will be provided on the circumstances where particle engineering is applicable, and how to use the technology to incorporate compounds with unique properties ranging from biologics, high dose insoluble compounds, and new chemical entities (NCEs). Representative case studies with representative molecules and scale-up best practices will also be presented.

    Outcome for Participants: Participants will gain insights and case studies on how spray drying can be utilized to target various indications through respiratory drug delivery.

  • 9:30 a.m.
    Arizona Ballroom
    Refreshments

SESSION 5: Exploring the Benefits of Smart Inhalers on Public Health

  • 12:00 noon

    Lunchtime

SESSION 6: Deposition Modelling for Pharmaceutical Aerosols - Dealing with Dynamic Change

  • Arizona Ballroom
    3:30 p.m.
    Refreshments

SESSION 7: Optimizing Aerosol Delivery with Respiratory Support Devices

Wednesday, April 25, 2018

  • Ania Terrace
    7:15 a.m.

    Continental Breakfast

Meeting Break for Recreation

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

SESSION 8: Strategies for Regional Nasal Targeting

  • Foyer
    2:30 p.m.
    Refreshments

SESSION 9: Innovations in Pharmaceutical Engineering

  • 4:30 p.m.
    Late Breaking Presentation

    Highlights of the April 2018 Draft FDA Guidance on Quality Considerations for MDI and DPI Drug Products
    Richard T. Lostritto, Ph.D., U.S. Food and Drug Administration, Silver Spring, Maryland, USA (Delivered via Teleconference)

Thursday, April 26, 2018

  • 7:15 a.m.
    Ania Terrace

    Continental Breakfast

    Central Registration

    Registration

SESSION 10: Expanding the Marketplace for Generic Inhalers via Improved Testing & Regulatory Guidance

Excursions

  • 2:00 p.m.
    Crafted Brewery Tour: $90 per person; Leaves JW Marriott at 2:00 p.m.

    Experience the uniqueness of Tucson while enjoying tastings of craft-brewed beer and snacks at three of the city's great watering holes.

  • 2:00 p.m.
    Autobahn Speedway: $150 per person; Leaves JW Marriott at 2:00 p.m.

    Experience an Italian-made speed kart on an indoor Grand Prix Style track for 50-mph driving thrills in the comfort of the indoors.

  • 2:00 p.m.
    Glassblowing Art: $175 per person; Leaves JW Marriott at 2:00 p.m.

    Create a one-of-a-kind art piece in this glassblowing studio partaking in either 'Hot Shop' glassblowing or "Warm Shop" fusion to create your own handmade souvenir.

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