Workshop 2:  Cell- and tissue-based in vitro models for facilitating the translation of innovative aerosol medicines into the clinic

Pulmonary in vitro and ex vivo models, particularly when of human origin, gain increasingly in importance. This is not only because they might reduce the number of animal experiments per se, but also because of the higher species relevance. Complex in vitro models have valuable potential not only for evaluating the safety, but also to demonstrate the efficacy of new pharmaceutical products and especially aerosol medicines. This workshop will cover basic principles, but also introduce more complex models and state-of-the-art techniques.

Chairs

• Carsten Ehrhardt, Trinity College Dublin, Ireland
• Claus-Michael Lehr, Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken,Germany
• Lucila Garcia-Contreras, The University of Oklahoma Health Sciences Center, United States of America
  
  

Speakers

• Josué Sznitman,Technion - Israel Institute of Technology, Haifa, Israel: 
  Reconstituting induced-pluripotent stem cell derived bronchial airways in advanced lung-on-chip models
• Nicole Schneider-Daum, HIPS – Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken, Germany:  
  Models for pulmonary infections and anti-infectives
• Armin Braun, ITEM - Fraunhofer, Hannover, Germany: 
  Slice technology to determine efficacy and safety of inhaled drugs
• Ruth Olmer, Medical University Hannover, Hannover, Germany: 
  In vitro modelling of the human lung using pluripotent stem cells
• Marius Hittinger,PharmBioTec Research and Development GmbH, Saarbrücken, Germany: 
  Industrial implementation of cell and tissue based in vitro models
  

Workshop 4:  Discussing Scientific Challenges for Development of Inhaled/Intranasal Biologic Products

For inhalation and nasal products, regulatory guidances around the world generally assume delivery of a small-molecule drug product. A multi-disciplinary discussion is therefore of interest, to develop “points to consider” and eventually “best practices” and guidelines for “orally inhaled and nasal biologics”. (Workshop Abstract)

 Chairs

• David Cipolla, Insmed Incorporated, United States of America
• Lana Lyapustina, IPAC-RS Secretariat, United States of America
  
• Franz-Josef Rehmann, AstraZeneca, Sweden
  
  

Speakers and Panellist

• David Cipolla, Insmed Incorporated, USA: 
  The first approved inhaled protein: Pulmozyme rhDNase
• Philip Kuehl, LOVELACE Biomedical, United States of America,
  Measuring/Controlling the impact of aerolisation on the structure and activity of inhaled biologics
• Mark Parry, Intertek Melbourn, United Kingdom:
  Establishing BSL safety approaches for OINDP evaluation of biologics
• Chris Gruenloh, PPD, United States of America:
  DDU and APSD testing: Alternatives for aerolisation and detection of biologics
• Nani Kadrichu, Consultant, United States of America:
  Phase-appropriate testing for development of inhaled biologics
• Lei Mao, Recipharm, United States of America:
  Nasal Biologics – formulation and analytical considerations
• Carina Simons, BfArM, Germany:
  Defining the regulatory landscape for inhaled biologics: work in progress
• Bing Li, FDA, United States of America: 
  Scientific and regulatory considerations on establishing bioequivalence for generic inhaled biologics
  

Workshop 6:  Clinical of Aerosolised Medicines in Respiratory Disease

Founding principles for an Inhalation Biopharmaceutics Classification System (iBCS) for inhaled drug products were published in 2022; This session will rationalise the scientific basis of the iBCS and consider the barriers to routine application of the framework with a focus on pulmonary drug solubility and dissolution.

Chairs

• Robert Bals, Saarland Universtiy Hospital, Homburg, Germany
• Omar Usmani, Imperial College London, United Kingdom
  
  

Speakers

• Gerhard Scheuch, GS BIO-INHALATION, Gemünden, Germany:
  The clinical use of complex inhalation devices
  
• Thomas Voshaar, Bethanien Hospital, Moers, Germany:
  Novel developments in inhaler therapies for asthma and COPD
  
• Thomas Hofmann, MannKind Corporation, Danbury, United States of America:
  Inhaled antibiotics
  
• Joseph Bain, CSL Behring Innovation, Marburg, Germany:
  Inhaled proteins as novel strategy
  
  

16:30-17:00

Get-together at the Foyer

17:00-18:00

Conference Opening by the Conference Organizers

• Claus-Michael Lehr, Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken, Germany
• Marc Schneider, Saarland University, Saarbruecken, Germany
• Robert Bals, Saarland Universtiy Hospital, Homburg, Germany

Conference Key Note by Peter Gehr

• Peter Gehr, University of Bern, Switzerland:
  A Journey through the Lungs - a Journey Through the World - an Experience Report of Aerosols in the Lungs

18:00-20:00

opening reception - industry exhibition and posters

ISAM Conference Scientific Sessions Overview

Sunday 27 August 2023

07:30

registration opening

08:30-10:00

Viral Infection and COVID: Transmission and Protection

SARS- CoV 2 as well as other respiratory viruses are transmitted via aerosols (aerogenic transmission). This session will discuss the scientific background on how the aerogenic transmission can happen and how the aerosol particle can be generated in the respiratory system. And the measures to protect infection will be highlighted.

Organizers

• Gerhard Scheuch, GS BIO-INHALATION, Gemünden,Germany
• Philip Kuehl, LOVELACE Biomedical, United States of America

Chairs

• William Bennett
  
• Bernhard Müllinger
  

Invited Speakers

• Gerhard Scheuch, GS BIO-INHALATION, Gemünden, Germany:
  SARS-CoV 2 transmission by breathing in children and adults 
• Christof Asbach Gesellschaft für Aerosolforschung e.V.o, Köln, Germany. Institut für Energie- und Umwelttechnik e.V. (IUTA), Duisburg, Germany: 
  Review of protective measures against direct and indirect infections
  

Contributed Talks

• Phil Kuehl , Lovelace Biomedical, United States of America:
  Non-Clinical Models of SARS-CoV-2 Transmission by Aerosol – What Are the Models and What Can We Learn From Them?
• Guy Barbin, Epithelix, Schwitzerland: 3D Human airway epithelial models to study SARS-CoV-2 pathogenesis and to discover antivirals
  
  

10:00-10:30

coffee break

10:30-12:00

Viral Infection and COVID: Therapy and Prevention

SARS-CoV 2 and other respiratory viruses will cause respiratory diseases. Is it possible to treat these diseases via aerosol medicines and can we also replace needle vaccination by an inhaled vaccine? This session will highlight novel programs for the treatment (prophylactic/therapeutic) and vaccination against obligate respiratory pathogens like SARS-CoV2.

Organizers

• Gerhard Scheuch, GS BIO-INHALATION, Gemünden,Germany
• Philip Kuehl, LOVELACE Biomedical, United States of America

Chairs

• Jens Hohlfeld,
• Gerhard Scheuch, GS BIO-INHALATION, Gemünden,Germany

Invited Speakers

• Thomas Voshaar, Bethanien Hospital, Moers, Germany:
  From Medication to Intubation: Therapy of COVID 19 in hospital Patients
• David A. Edwards, Harvard School of Engineering, Boston, United States of America: 
  Upper airway dehydration, rehydration and the management of respiratory health

Contributed Talks

• Rajiv Dhand, University of Tennessee, United States of Amercia: Does Pre-existing Severe Asthma Increase Risk of Morbidity and Mortality from COVID-19?
• Beatrice Tolksdorf, Technische Universität Berlin, Berlin, Germany RNA interference against SARS-CoV-2

  12:00-13:30

lunch break

Young Investigator / Early Career – Lunch Session

ISAM aims to support young group leaders and scientists working in aerosol medicine. The ISAM Congress 2023 in Saarbrücken is organizing a Lunch Session to bring together researchers who are in the early stage of their career and to provide contact to and a dialogue with already established senior group leaders. An open discussion will touch on how to overcome challenges of young scientists, when starting their independent research. The event is organized by Dr. Fabian Blank, University of Bern, Switzerland.

Chairs

• Fabian Blank, University of Bern, Switzerland
  

Young Researcher Lunch, sponsored by

  13:30-15:00

Best Oral Presentations

Organizers

• Jessica Oakes, Northeastern University, United States of America

Chairs

• Jessica Oakes, Northeastern University, United States of America
• Barbara Rothen-Rutishauser, Adolphe Merkle Institute, Université de Fribourg, Switzerland
  

Contributed Talks

• Philippe Vollmer-Barbosa,  Fraunhofer ITEM, Germany: Development of LNP formulations for RNAi inhalation
• Ron Bessler, Technion Israel institute of technology, Haifa, Israel: Exploring the role of electrostatic effects on inhaled aerosol deposition in alveolated in vitro airway models
• Arumina Sengupta, ARTORG Organs-on-Chip Technologies, University of Bern, Bern, Switzerland. A robust lung-on-chip inhalation platform for toxicity and therapy assessment
• Samy Aliyazdi, Helmholtz-Institute for Pharmaceutical Research Saarland, Saarbrücken, Germany: 3D-Bioprinting of Bacterial Biofilms on Human Lung Epithelial Cells for Building Complex In Vitro Infection Models
• Isobel Tetreau, University of Alberta, Edmonton, Canada: Spray-drying of anti-Tuberculosis phage Fionnbharth
• Alberto Baldelli, Vancouver, Vancouver, Canada: Nasal delivery of encapsulated recombinant ACE2 as a prophylactic drug for SARS-CoV-2
  
  

 15:30-17:00

Barriers to Pulmonary Drug Delivery

Besides epithelial cells and macrophages, pulmonary drug delivery must cope with non-cellular barriers, such as surfactant, mucus and bacterial biofilms, depending on the (patho)physiological situation. This session addresses challenges originating from barriers and novel approaches to overcome them.

Organizers

• Brigitta Loretz, Helmholtz-Institute for Pharmaceutical Research Saarland/HIPS, Saarbruecken,Germany
• Marc Schneider, Saarland University, Saarbruecken,Germany
  

Chairs

• Marc Schneider, Saarland University, Saarbruecken, Germany
• Brigitta Loretz, Helmholtz-Institute for Pharmaceutical Research Saarland/HIPS, Saarbruecken, DE
  

Invited Speakers

• Tom Coenye, Ghent University, Ghent, Belgium: 
  Microbial biofilms and the failure of antibiotic therapy in chronic infections
• Matthias Ochs, University Hospital Charité, Berlin, Germany: 
  A closer look at the alveolar epithelium of the lung

Contributed Talks

• Salma Mahmoud Abdel-Hafez, Saarland University, Germany: Extracellular matrix-modulating nano-structured microparticles for pulmonary inhalation as potential delivery system for lung cancer
• Gabriella Costabile, University of Napoli, Italy: Repurposing Gallium for local treatment of bacterial pneumonia through inhalable nano-embedded microparticles
  
  

17:00-20:00

The future of ISAM Networking Groups

17:00-18:00

reception, industry exhibition and poster presentations

08:15-08:30

Welcome Note

Speaker

• Jakob von Weizsäcker, Minister of Saarland, Finance and Science

 08:30-10:00

10:00-10:30

coffee break

10:30-12:00

Inhalation in Disease and Age : Chronic Diseases, COPD, Asthma

This session focuses on the translation of inhalation concepts into clinical application. The speakers will cover drug and inhaler development, formal approval and trials, as well as clinical application for infectious and non-infectious diseases.

Organizers

• Anthony Hickey, RTI International, United States of America
• Omar Usmani, Imperial College London, United Kindom
• Philip Kuehl, LOVELACE Biomedical, United States of America
• Robert Bals, Saarland Universtiy Hospital, Homburg,Germany
• Heidi Mansour, University of Arizona, United States of America
  

Chairs

• Robert Bals, Saarland Universtiy Hospital, Homburg, Germany
• Omar Usmani, Imperial College London, United Kingdom

Invited Speakers

• Robert Bals, Saarland University Hospital, Homburg, Germany: Has the time come to end use of the blue inhaler?
• Christopher O'Callaghan, University College London (ULC) Great Ormond Street Children’s Hospital Institute of Child Health, London, UK : Aerosol transmission of pathogens: hospital acquired infections in children and adults

Contributed Talks

• William Bennett, University of North Carolina at Chapel Hill, United States of America: The Effect Of Discontinuing Aerosolized Hypertonic Saline Or Dornase Alfa On Mucociliary Clearance In Trikafta-Treated CF
• Jessica Oakes, Northeastern University, United States of America: In Silico Modeling of Dosimetry in Sarcoidosis Patients with Airway Disease
  

12:00-13:30

lunch break

JAMPDD Lunch

Dear Editorial Board Member,
Thank you for serving the Editorial Board of the Journal Of Aerosol Medicine and Pulmonary Drug delivery
I will be hosting a lunch meeting on behalf of Mary Ann Liebert publications at the upcoming ISAM 2023 meeting in Saarbrucken, Germany. If you plan to attend ISAM 2023, we invite you to join us for the meeting for an update on the Journal.
Warm regards

Thomas O'Riordan, Editor -n-Chief

JAMPDD Lunch, sponsored by

13:30-15:00

Lung Models - Where are We Now?  Part A - Complex in vitro Models

Complex in vitro models comprise several cell types as well as non-cellular elements or even bacteria. Moreover, they allow for metered deposition of aerosolized drugs and disease-relevant readouts, hopefully leading to a better predictivity for clinical outcomes than currently used animal models.

Organizers

• Claus-Michael Lehr, Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken, Germany
• Otmar Schmid, Helmholtz Center Munich, Munich, Germany: 

Chairs

• Nicole Schneider-Daum, Helmholtz-Institute for Pharmaceutical Research Saarland/HIPS, Saarbruecken,Germany
• Fabian Blank, University of Bern, Switzerland

Invited Speakers

• Otmar Schmid, Helmholtz Center Munich, Munich, Germany: 
  An in vitro IPF mini-lung with real-time monitoring of cell mechanics for improved clinical relevance
• Claus-Michael Lehr, Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken, Germany: Complex in-vitro Models of the Human Air-Blood-Barrier for Developing Anti-Infective Aerosol Medicines
  

Contributed Talks

• Sandeep Keshavan, Adolphe Merkle Institute Université de Fribourg, Switzerland: Mitigation of quartz aerosol effects in reconstituted human airway epithelial models combined with primary macrophages
• Christopher Herbst, Charité, Germany: Human primary alveolar epithelial cells in air-liquid interface transdifferentiate into basal like intermediates
  

15:00-15:30

coffee break

15:30-17:00

Lung models - Where are We Now?   Part B - in silico Models and Imaging

Advances in in-silico modeling and in the development of virtual populations capturing intrasubject variability in lung morphometry open the way for in-silico clinical trials of new inhaled drugs. Talks on the latest technical developments will be followed by a roundtable discussion on challenges to overcome for in-silico trials to be accepted by the regulatory, pharmaceutical and medical communities.

Organizers

• Chantal Darquenne, UC San Diego, United States of America
• Katharina Schwarz, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany
• Omar Usmani, Imperial College London, United States of America:

Chairs

• Stavros Kassinos, University of Cyprus, Cyprus
• Katharina Schwarz, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany
  

Invited Speakers

• Yu Feng Oklahoma, State University, Stillwater, United States of America: 
  Build the Next-Generation Physiologically Realistic Human Respiratory Digital Twin System for Pulmonary Healthcare
• Stavros Kassinos, University of Cyprus, Nikosia, Cyprus: 
  Leveraging low-raditation imaging to inform computations in th e context o f in-silico population studies

Contributed Talks

• Chantal Darquenne, University of California, United States of Amcerica: Multiscale modeling of aerosol dosimetry: validation with subject-specific deposition data
• Théo Galland, Novadiscovery, Lyon, France: A PBPK model of intranasal administration with detailed compartment architecture for optimization of nasal drug delivery
  

Round Table Discussion

• Chantal Darquenne
• Stavros Kassinos
• Yu Feng Oklahoma
• Omar Usmani, Imperial College London, United States of America:
  Clinical Point of view
• David Cipolla, Chair of the ISAM:
  Regulatory and Standards WG

17:00-18:00

The future of ISAM Networking Groups

17:00-18:30

reception, industry exhibition and poster presentations

19:00-20:00

reception at the Saarbrücken Town Hall