This workshop will focus on practical aspects of clinical aerosol medicine. Speakers will discuss aerosol devices, selection for different patient groups (e.g. paediatrics), device interchangeability, common use errors and why patients fail to adhere to prescribed therapy. Hands-on device demonstrations and a practical session on how to teach correct use of inhaler devices will include strategies/resources available for teaching patients and healthcare workers. Special considerations and recent innovations in aerosol therapy will be explored.
Target audience: Providers of lung health, including clinicians, pediatricians, internists, nurses, pharmacists, respiratory therapists and asthma educators. Participants with clinical, administrative and teaching responsibilities to integrate program content in to practice and resource support.
Workshop Chairs: Sunalene Devadason, Arzu AriPreclinical advancement of orally inhaled drug products (OIDP) requires knowledge of respiratory physiology, lung anatomy, cell pathobiology, aerosol physics. Regulatory requirements will be reviewed and, to better understand the fate of OIDPs, a discussion of dose, particle deposition in laboratory animals and humans, and clearance of small and large molecules will be presented. Practical aspects of in vivo toxicology study design and endpoints, exposure methods, dose formulation and aerosol device considerations will be reviewed and state of the art technologies for inhalable drug delivery to cell culture systems will be explained.
Workshop Chairs: Jeff Tepper, Ron Wolf, Barbara Rothen-Rutishauser
Pulmonary product development involves multiple disciplines; regulatory, preclinical, formulation and device development, clinical studies and marketing. This session will review product development in the context of these development elements and will explain how choices of device types and formulations are made at various stages along the development pathway. The Industries perspective and the challenge of adoption of new formulation and device technologies will also be discussed.
Workshop Chairs: Andy Clarke, Jeffry Weers
With the impact of COVID-19 on all aspects of daily life, there are no better themes for the Regulatory and Standards Community to focus upon than; The standards that should be applied to help prevent transmission of virus via aerosol exposure during routine activities for the general public, workplace exposures and health care workers together with and the regulatory guidance and policies to accelerate development and approval of inhaled therapeutics to prevent and treat COVID-19.
Workshop Chairs: Plamena Entcheva-Dimitrov, David Cipolla
This session is aimed at helping participants review the inhaled medications that are currently utilized in ED and ICU, with focus on the evidence and the evaluation on the drug effects. It will introduce the features of available aerosol devices and their set-up for invasive and non-invasive routes in a hands-on practical manner. The influential factors and optimal methods to deliver aerosolized medication to critically ill patients in different situation will be discussed.
Workshop Chairs: Stephan Ehrmann, Jie Li, Ronan MacLoughlin
The session is a follow-on from Part 1 and is aimed to help participants learn how to design, implement and interpret in vitro and in vivo aerosol studies.
Workshop Chairs: Stephan Ehrmann, Jie Li, Ronan MacLoughlin
Session 1 – Pediatrics
This session will include; a review of surfactant therapy in preterm infants and discuss the latest developments in less and non-invasive delivery methods, the challenges of adherence in children with asthma and how extending patents to included children may breathe new life into existing combination product intellectual property.
Session Chair: Chris O'Callaghan
Session 2 – Adult Critical Care
Aerosol therapy among intubated patients is now standard of care and noninvasive ventilatory support and oxygen therapies are rapidly spreading in intensive care units. The challenges of daily implementation among critically ill patients will be discussed in this session. We will also cover inhaled anti-infectives, a topic which recently drove intense interest in the scientific community. Large phase III clinical trials have been completed and the results need discussion to translate lessons learned into future research.
Session Chairs: Stephan Ehrmann, Rajiv Dhand, Jie Li, Jim Fink
Session 3 – Viral Pandemics, Transmission, Protection & Treatments (COVID-19)
The emergence of the family of SARS viruses has dramatically changed our daily lives. The world narrowly missed two pandemics from the first human infections, the third, caused by SARS-CoV-2, has resulted in widespread global infection and high mortality. This session will discuss viral infectivity, aerosol transmission and strategies to reduce infection rates in healthcare professionals.
Session Chair: Jie Li
Session Co-chair: Gerhard Scheuch
Session 4 – Special Topics in Inhalation Toxicology
Non-animal testing of inhaled drugs has rapidly progressed over recent years. Progress and challenges, as well as advantages and limitations associated with non-animal approaches using human cell culture systems, 3D tissue models, microfluidic airway organ-on-a-chip preparations and precision-cut lung slices from normal and diseased patients will be presented. Current advances in the use and validation of in vitro exposure devices for determining dose and providing realistic exposures to in vitro/ex vivo models, the rapid development of cell/organ-based techniques for understanding respiratory safety and in silico prediction of lung and systemic exposure using user friendly computational models as GastroPlus PBPK modeling and validation of these models under real-life scenarios for regulatory use will be discussed.
Session Chairs: Jeff Tepper, Ron Wolf, Barbara Rothen-Rutishauser
Session 5 – Utilization of Fluorinated Materials in Respiratory Drug Delivery
Fluorinated materials that exist as liquids at standard temperature and pressure have unique physicochemical properties including low surface tension, high densities, and a remarkable capacity for dissolving respiratory gases. These materials have been studied as synthetic oxygen carriers (i.e., blood substitutes) and as a ventilatory medium in the lungs (i.e. liquid breathing) for the treatment of respiratory distress syndrome and acute lung injury. In this session we will explore the potential for fluorinated liquids to be a carrier for drug delivery to the lungs.
Session Chair: Jeff Weers
Session Co-chair: Sabine Häußermann
Session 6 – Inhalation Therapy For Asthma & COPD
This session will focus on practical aspects of clinical aerosol medicine related to inhalation therapy for patients with asthma and COPD. Speakers will discuss new smart technology and its use in aerosol delivery devices (e.g. rescue inhalers), the role of measuring Peak Inspiratory Flow Rate (PIFR) for patents who are using Dry Powder Inhalers (DPIs) and the impact of COVID-19 on patients with asthma. The use of nebulizers during the COVID-19 pandemic is a matter of concern among clinicians. The evidence regarding risk of transmission of infections, including SARS-CoV-2, with nebulizer therapy will be reviewed.
Session Chair: Rajiv Dhand
Session 7 – Health Impact of Fire Smoke
Fire smoke inhalation has been linked to increased inflammatory response, dysfunction of multiple organs/systems in the body and has been shown to alter the body’s response to viral infections. The number and severity of wildfires is increasing and there is a need to understand the health consequences of fire smoke inhalation to inform and protect at risk populations. The goal of this session is to highlight the importance of smoke inhalation research and to promote a discussion regarding risk mitigation.
Session Chairs: Jessica Oakes
Session Co-chair: Bill Bennett
Session 8 – Current Trends in Cystic Fibrosis (CF), Pulmonary Hypertension (PAH), Idiopathic Fibrosis (IPF)
The session will cover each of the three clinical topics (CF, PAH and IPF) with up-to-date perspectives on the disease, biological rationales for pharmacological interventions, relevant therapies under development and approved treatment options.
Session Chairs: Tim Corcoran
Session Co-chair: Phil Kuehl
Session 9 – Aerosol Therapies for the Developing World
This session will cover the potential of aerosol products to improve healthcare outcomes in the developing world. The challenges around funding, regulatory approvals and performing trials will be discussed. Examples of products such as; inhaled vaccines, inhaled surfactant and inhaled drugs that could reduce mortality during childbirth will be presented.
Session Chair: Jim Fink
Session Co-chair: Farhad Imam
Session 10 – Bacteriophages and Respiratory Applications
Respiratory infections, including tuberculosis, are a leading cause of mortality and are increasingly difficult to treat due to the development of antimicrobial resistance. Bacteriophages have gained much attention as possible alternatives to antibiotics. This session will give an overview of phage selection for therapeutic purposes and provide a forum for discussion of the technical and regulatory steps necessary to develop a respiratory phage dosage form. Reports from efficacy studies in animal and human models will also be presented.
Session Chair: Reinhard Vehring
Session 11 – Scientific Basis for Dissolution Testing of Inhaled Products
Regulatory agencies have been keenly interested in the evaluation of dissolution testing of inhaled products and have been funding academic collaborations to investigate and develop test methodologies. This session will address important topics such as; Is there a scientific rationale for dissolution testing of inhaled aerosols, if so, which inhaled products should be tested? Should dissolution testing be applied as a characterization tool during development and product release, if so, which methodologies should be considered? Can in-silico simulations reliably predict exposures from inhaled products?
Session Chair: David Cipolla
Session 12 – Imaging and Deposition
The session will present; Pre-clinical models of aerosol drug deposition and efficacy, including in vivo and in-silico models of dosing, pharmacokinetics and therapeutic effects, clinical studies of deposited aerosol dose using scintigraphy techniques. Aerosol-based imaging techniques for quantifying lung physiology or evaluating therapeutic effect will also be included.
Session Chair: Tim Corcoran
Session 13 – Hot Topics
The hot topics session is designed to provide attendees with a glimpse of aerosol-related topics beyond those covered in the other congress sessions. It will also provide a forum for timely presentation of late- breaking science.
Session Chair: Chantal Darquenne
Details on registration fees are coming soon.
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The 23rd Congress of the International Society for Aerosols in Medicine
May 22-26, 2021
Boise, Idaho
Enjoy the 2021 ISAM Congress inspired by the natural beauty of Idaho combined with the intellectual rigor of scientists coming from all over the world.