Introduction and Presentation of Charles G. Thiel Award
Peter R. Byron, Ph.D. Emeritus Professor, School of Pharmacy Virginia Commonwealth University, Richmond, Virginia
PLENARY LECTURE
Moderator: Peter R. Byron, Ph.D., Virginia Commonwealth University
The Etiology of Fibrotic Interstitial Lung Diseases: Diagnostic Challenges and Treatment Strategies Oliver Eickelberg, M.D., Head, Division of Pulmonary and Critical Care Medicine, University of Colorado, Aurora, Colorado
Scientific Poster Session & Technology Exhibition
SESSION 1: Advances in Difficult-to-Treat Pulmonary Infections
Moderator: Stephen J. Farr, Ph.D., Zogenix
Phage Therapy for Pulmonary Infections: The Challenges of Choosing, Growing, and Purifying Phage for Clinical Use Benjamin K. Chan, Ph.D., Yale University, New Haven, Connecticut
Tuberculosis Therapy and Prophylaxis: Conquering Formulation and Delivery Problems with Inhaled Vaccines and Phages Reinhard Vehring, Ph.D., University of Alberta, Edmonton, Alberta, Canada
Inhaled Antibiotics: Negotiating the Obstacles to Treat Mycobacterial Lung Disease Thomas Hofmann, M.D. Ph.D., Qrumpharma, Doylestown, Pennsylvania
Inhaled Delivery of Clofazimine: A High Efficiency, Flow Independent, Targeted System for Mycobacterial Infections Hugh Smyth, Ph.D., The University of Texas at Austin, Austin, Texas
SESSION 2: Airway Remodeling or Renovation?
Moderator: Alan Watts, Ph.D., Savara Pharmaceuticals
Airway Remodeling: A Review of its Pathophysiology and Drug Treatment Challenges Masahiro Sakagami, Ph.D., Virginia Commonwealth University, Richmond, Virginia
Developing Inhaled Peptide Treatments for Pulmonary Fibrosis: Experience with CSP7 Formulation and Processing Robert O Williams III, Ph.D., University of Texas at Austin, Austin, Texas Recorded Presentation Not Provided
Recorded Presentation Not Provided
SESSION 3: Posters on the Digital Podium
Moderators: Daniela Traini, Ph.D., and Paul M. Young, Ph.D., Woolcock Institute of Medical Research Poster authors have been selected to summarize their work in Posters on the Digital Podium.
The AOS DPI: A Capsule-based Dry Powder Inhaler With Four Distinct Dispersion Elements Jeffry Weers, Ph.D., Respira Therapeutics, Burlingame, California
Model-based Evaluation Of Pulmonary PK Selectivity – Towards A Feasibility Assessment Of Targeting The Lung By Oral Drug Inhalation Anneke Himstedt, M.S., University of Hamburg, Hamburg, Germany
In-vitro Dissolution Testing Of Aerosolized Powders Using The USP Dissolution Apparatus 7 Jan Olof Svensson, Ph.D., AstraZeneca, Mölndal, Gothenburg, Sweden
Use Of L-leucine And Trileucine As Dispersion Enhancers In Spray-dried Albuterol Sulfate Formulations Serena Bonasera, M.S., Virginia Commonwealth University, Richmond, Virginia
Aerosol Deposition Profiles In A Nasal Cast Model Using Three Methods Of Administration Alain Regard, B.Eng, Nemera, La Verpillière, Lyon, France
The Effects Of Formulation Factors And Actuator Design On Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance and Effects Of Formulation And Actuator Design On Spray Pattern And Plume Geometry Of Mometasone Furoate Metered Dose Inhalers Elizabeth Bielski, Ph.D. and Sneha Dhapare, Ph.D. U.S. Food & Drug Administration, Silver Spring, Maryland
Modeling Intermolecular Interactions Between Solid And Liquid Components Of pMDI Suspension Formulations Vivian W. Barron, M.Eng, University of Leeds, Leeds, United Kingdom
The Effects Of Charge Of Inhaled Rapamycin Solid Lipid Nanoparticles For Lymphatic Targeting Emelie Landh, Woolcock Institute of Medical Research, Glebe, NSW, Australia
Presentation of VCU RDD Peter R. Byron Graduate Student Award
SESSION 4: Platinum Sponsor Seminars
Moderator: Joanne Peart, Ph.D., Virginia Commonwealth University
Decoding Article 117 of Medical Device Regulation 2017/745: Known Information and Future Challenges for Drug-Device Combination Products Krystel Limouzin, Aptar Pharma, Le Vaudreuil, France
Introduction
Replacing Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) 2017/745 will come into force on May 26, 2020 with new provisions that provide enhanced patient safety and transparency for both the patient and Industry. All device manufacturers must apply this regulation to maintain or bring their technologies on the market, including manufacturers of drug delivery devices (where used in a drug-device combination product with a Principal Mode of Action (PMOA) linked to drug) according to Article 117. Article 117 introduces new requirements which include compliance to General Safety and Performance Requirements (GSPR) for the device part of a single integral drug-device combination product, and the involvement of a Notified Body (NB) as a new stakeholder in the EU Marketing Authorization Application (MAA) process.
Description
This presentation will focus on the challenges introduced by Article 117 as much from the Authorities’ point of view as from Industry. Due to the current low level of information available from EMA, several questions were raised by Industry, such as:
To delineate organization and help industry, EMA has published a draft Guideline (May 29, 2019) that provided an initial overview of proposed solutions to match the incoming regulatory requirements in a pragmatic industrial context. Within this scope, EMA currently proposes a collaborative workshop on March 31, 2020 between all stakeholders to eventually clarify requirements for Article 117 implementation, and establish clear guidance. Outcomes related to this work will be included in this presentation.
Outcome for Participants
Attendees will leave the presentation with a better understanding of the impact of MDR’s Article 117 on all stakeholders involved in the drug-device combination product development and approval process, and of the current situation in Europe from the perspectives of industry and regulatory authorities.
Balancing Patient Needs and Sustainability in Inhaled Therapies: Looking Forward to the Next Generation of pMDIs Mike Needham, Kindeva Drug Delivery, Loughborough, Leicestershire, United Kingdom Philip Cocks, Kindeva Drug Delivery, Loughborough, Leicestershire, United Kingdom
This presentation will review the need for more sustainable inhalers and the challenges associated with this aim, and present new options for novel propellants, devices, and components.
In 1956, 3M launched the first pressurized Metered Dose Inhaler (pMDI). Following the Montreal Protocol of 1987, 3M transitioned to HFA propellants, launching the first HFA-based pMDI in 1995. More recently, the drive to reduce the carbon footprint of inhalation products has led to the exploration of newer propellants, such as dimethyl ether, propane, butane, and HFA-152a, as well as other more novel approaches such as CO2. Significant resources are being invested in innovating next-generation pMDIs that will use novel propellants with a significantly lower Global Warming Potential (GWP). Well managed, stable patients should have a lower overall environmental impact, and to this end, other innovations in inhaled therapies, including enhanced digital devices, should also positively contribute to patient care and, thus, lower the carbon impact.
pMDIs continue to provide an efficacious and cost-effective treatment for pulmonary diseases. For many patients, there are clear clinical benefits of pMDIs over DPIs and SMIs, and disadvantages associated with switching devices. pMDIs, DPIs and SMIs all play an important role in patient care. A patient-centric approach is vital, including maintaining a diverse range of therapeutic choices. Hence it is imperative that the pMDI platform is taken forward with enhanced sustainability credentials in order to maintain patient choice and optimized clinical and health economic outcomes.
Attendees will leave the presentation with a better understanding of the challenges associated with formulating current and new APIs with novel propellants, and knowledge of the options available, along with ideas for more sustainable components and devices.
From Feasibility to Final Product: Delivering Success for an Inhaled Development Program Sandy J. Munro, Vectura, Chippenham, Wiltshire, United Kingdom
Selecting the most appropriate delivery platform technology is critical to the success of an inhaled drug product development program. Careful management of that platform at each development stage can have a huge impact on the timeline, cost and probability of success.
Inhaled product development is complex and decisions on the most appropriate delivery platform are based on many factors, including patient and disease-state needs, molecule-specific technical challenges, time, cost and commercial considerations. After reviewing the factors influencing delivery platform selection, the presentation will provide an overview of the options available and introduce case studies to exemplify the critical success factors at key stages of development:
SESSION 5: New DPI Theory and Practice
Moderator: Michael Hindle, Ph.D., Virginia Commonwealth University
Reviving Positive Pressure DPI Devices for Efficient and Reproducible Aerosol Delivery to Infants and Children Worth Longest, Ph.D., Virginia Commonwealth University, Richmond, Virginia
Liposomal Nanocrystalline Ciprofloxacin Powders: Manipulating Delivery and Release through Formulation and Processing Hak-Kim Chan, Ph.D., University of Sydney, Sydney, NSW, Australia
Advanced Surface Chemistry Characterization to Understand Physical Stability And Performance Of Dry Powder Inhalers Tony Zhou, Ph.D., Purdue University, West Lafayette, Indiana
Unlocking the Microstructure of Inhalation Blends Using X-Ray Microscopy Parmesh Gajjar, Ph.D., University of Manchester, Manchester, United Kingdom
SESSION 6: Clinically Relevant Testing in NDA and Lifecycle Submissions
Pulmonary Drug Dissolution, Regional Retention & Systemic Absorption: Understanding their Interactions through Mechanistic Modeling Per Bäckman, Ph.D., Emmace Consulting, Lund, Sweden
Clinically Relevant Specifications for Orally Inhaled Drug Products: Challenges and Opportunities Renish R. Delvadia, Ph.D., U.S. Food & Drug Administration, Silver Spring, Maryland
Use of Realistic Testing for Lifecycle Changes: A Proposal for Discussion and Possible Future Regulatory Guidance Dennis Sandell, Ph.D., S5 Consulting, Blentarp, Sweden
Unraveling the Pulmonary Fate of Fluticasone and Friends: Meeting the Physiologic and Pharmacokinetic Challenges Günther Hochhaus, Ph.D., University of Florida, Gainesville, Florida
Dissolution Tests for Oral Inhalers: Challenges with Method Development and Specifications Andreea Floroiu, M.Sc., PHAST Development, Konstanz, Germany and Saarland University, Saarbrücken, Germany
SESSION 7: Evaluating Nasal Drugs: Improving Topical and Nose-to-Brain Delivery
Moderator: Julie D. Suman, Ph.D., Next Breath
In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple Anatomically-Correct Nasal Airway Models Laleh Golshahi, Ph.D., Virginia Commonwealth University, Richmond, Virginia
Nasal Sumatriptan: Deposition and Pharmacokinetic Effects of an Absorption Enhancer in Non-Human Primates Philip Kuehl, Ph.D., Lovelace Biomedical, Albuquerque, New Mexico
Functional Magnetic Resonance Imaging: Measuring Drug-Induced Neuronal Activation Jed Wingrove, Ph.D., University College London, London, United Kingdom
SESSION 8: Reducing Our Carbon Footprint
Moderator: Richard N. Dalby, Ph.D., University of Maryland
F-Gas Regulations and Beyond: Clinical and Economic Factors that will Drive Propellant Transition John N. Pritchard, Ph.D., Inspiring Strategies, Newtown Linford, Leicestershire, United Kingdom
The Reusable Respimat SMI: An Effective Propellant-Free Inhaler Platform Herbert Wachtel, Ph.D., Boehringer Ingelheim, Ingelheim, Germany
The Sustainable Smart Inhaler Challenge: Learning from Non-Pharma Industry Trends and Drivers Greg Anderson, M.Sc., Pharmacentric Solutions, Graveley, Hertfordshire, United Kingdom
SESSION 9: The Impact of New Technology & Regulation on Inhaler Design, Development & Product Lifecycle
Sponsor: AstraZeneca Moderator: Joanne Peart, Ph.D., Virginia Commonwealth University
Coordinated with International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
Rethinking Inhaled Product Development in the Digital World Matthew Bonam, Ph.D., AstraZeneca, Macclesfield, Cheshire, United Kingdom
User-Centric Design to Identify the Baseline Requirements for a Connected Inhaler Alan Tweedie, B.Sc., Chiesi Limited, Chippenham, Wiltshire, United Kingdom
Connected Ellipta®: A Case Study of Improved Adherence in Uncontrolled Asthma Alison C. Moore, Ph.D., GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom Recorded Presentation Not Provided
The Digihaler™: A New Approach to Manage Asthma and COPD Mark Milton-Edwards, Teva Pharmaceuticals, Harlow, Essex, United Kingdom
Personalized Aerosol Therapies: Understanding The Data Privacy Barrier Mary Devlin Capizzi, J.D., Drinker Biddle, Washington, Washington, D.C.
Connected Inhalers and Digital Health in the USA: Regulatory Considerations James Lee, Ph.D., U.S. Food & Drug Administration, Silver Spring, Maryland Recorded Presentation Not Provided
The OINDP Science and Research Agenda
Moderators: Jeremy Clarke, Ph.D., GlaxoSmithKline, and Andrew Rignall, Ph.D., AstraZeneca This session will exemplify how the latest developments in modelling and predictive tools in the areas of manufacturability, product performance and characterization can enable improved product quality and process robustness of dry powder products.
Overview and Introduction to IPAC-RS Jeremy Clarke, Ph.D., GlaxoSmithKline, Ware, Hertfordshire, United Kingdom Andy Rignall, Ph.D., AstraZeneca, Macclesfield, United Kingdom
Predicting Manufacturability of Inhaled Powders Amrit Paudel, Ph.D., Research Center Pharmaceutical Engineering, Graz, Austria
Spray Dried Particles for Inhalation: Process Development Following a QbD Approach Joao Henriques, Ph.D., Hovione, Lisbon, Portugal
Deconstructing the Role of Powder Agglomerates in Inhaled Powders (INFORM 2020) Darragh Murnane, Ph.D., University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom
Measurement of Dry Powder Inhaler Performance by Cascade Impaction: Multi-laboratory Experimental Study of Flow Rate Rise Time Characteristics and Theoretical Verification Based on Underlying Physical Processes Jolyon Mitchell, Ph.D., Jolyon Mitchell Inhaler Consulting Services Inc, Canada Henk K. Versteeg, Ph.D., Loughborough University, Loughborough, Leicestershire, United Kingdom
