ISAM - The International Society for Aerosols in Medicine
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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
Ben Forbes
Jayne Hasted
Invited Speakers
TBA
TBA
Workshop 2: Cell- and tissue-based in vitro models for facilitating the translation of innovative aerosol medicines into the
clinic
Saturday 26 August 2023 13:30-16:30
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.
Workshop 3: Inhalation Toxicology, Dose Finding, etc.
Saturday 26 August 2023 09:00-12:00
The development of inhalation products continues to evolve and adapted as the range of diseases and drug classifications evaluate within respiratory drug delivery. This session will provide current state of the are in in
vitro / in vivo dose and concentrations scaling metrics. Additionally this workshop will cover some of the basics on (i) how to address in vitro-in vivo extrapolation (IVIVE) for predictive inhalation toxicology, (ii)
in the conduct of inhalation toxicology programs and (iii) provide examples of how to approach new therapeutic modalities like inhaled gene therapies.
Katharina Schwarz, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, DE
Invited Speakers
TBA
TBA
Workshop 4: Addressing CMC Questions for Development of Inhaled/Intranasal Biologic Products
Saturday 26 August 2023 13:30-16:30
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”.
This course will focus on practical aspects of clinical aerosol medicine. Speakers will discuss aerosol devices, selection for different patient groups (e.g., pediatrics), device interchangeability, common use errors and why patients
fail to adhere to prescribed therapy. Hands-on device demonstration 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.New devices and novel applications for aerosol medicine, such as inhaled vaccines will be presented. This workshop will enable a broad
range of clinicians and educators to better enable their patients to more effectively self-administer and adhere to therapies crucial to management of their respiratory disease, improving both patient health and quality of
life. This workshop will also be useful for scientists and researchers who are new to the aerosol research field, and who want to develop a better understanding of aerosol dosing and delivery characteristics
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, DE
TBA
Invited Speakers
TBA
Conference Opening by the Conference Organizers and Key Conference Note by Peter Gehr
Saturday 26 August 2023 17:00-17:45
Keynote Lecture
Chairs
Robert Bals, Saarland Universtiy Hospital, Homburg, DE
Claus-Michael Lehr, Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken, DE
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.
Chairs
TBA
TBA
Invited Speakers
Gerhard Scheuch GS BIO-INHALATION, Gemünden, Germany: Title TBA
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.
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.
Chairs
Brigitta Loretz, Helmholtz-Institute for Pharmaceutical Research Saarland/HIPS, Saarbruecken, DE
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.
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.
Lung Models - Where are We Now? Complex In-vitro Models
Monday 28 August 2023 13:30-15:00
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.
Lung models - Where are We Now? In-silico Models and Imaging
Monday 28 August 2023 15:30-17:00
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.
There is a steady progress in inhaler technology. Device design can be utilised to dramatically improve lung targeting, dose consistency and patient adherence. This session will provide an overview of the cosmos of inhalers and highlights
recent trends in smart device and liquid inhaler development.
Biotherapeutics are a group of medicines of biological origin, either purified or produced by a biological source, and include non-synthetic peptides, therapeutic proteins (antibodies, growth factors), nucleic acids (DNA, RNA), vaccines,
bacteriophages and exosomes/extracellular vesicles. They are an integral part of modern medicine and are increasingly used to treat and prevent serious lung diseases or infections. This session will address the challenges associated
with inhalation of biotherapeutics and inhaled biotherapeutics under development to treat respiratory diseases.
Biotherapeutics are a group of medicines of biological origin, either purified or produced by a biological source, and include non-synthetic peptides, therapeutic proteins (antibodies, growth factors), nucleic acids (DNA, RNA), vaccines,
bacteriophages and exosomes/extracellular vesicles. They are an integral part of modern medicine and are increasingly used to treat and prevent serious lung diseases or infections. This session will address the challenges associated
with inhalation of biotherapeutics and inhaled biotherapeutics under development to treat respiratory diseases.
