Tuesday, 18th July  2023, 8 am – 9 am (San Diego, CA); 11 am – 12 am (New York, NY); 5 pm – 6 pm (Paris, France)

Follow this link to register for the zoom webinar

Presenter: Dr. Katharina Schwarz and Msc. Norman Nowak

Dr. Katharina Schwarz leads the department of Aerosol Technology and Aerosol Biophysics at the Fraunhofer Institute for Toxicology and Experimental Medicine. ITEM, Hannover, Germany

MSc. Norman Nowak is a PhD student at the Fraunhofer Institute for Technology and Experimental Medicine. ITEM, Hannover, Germany

Facilitators:

• Jessica Oakes
• Carsten Ehrhardt
• Barbara Rothen-Rutishauser (ISAM president)

Webinar content

• Developing new (inhalational) anti-infective strategies for the clinical application is a very lengthy and difficult process. For a fast and predictive non-clinical development, we established an integrative platform aiming at an early assessment of efficacy, toxicity and respiratory pharmacokinetics of new inhalational drug candidates. Here, we used ciprofloxacin and tobramycin, two well-established antibiotic drugs for treatment of respiratory infections.  

• To define the local therapeutic window for ciprofloxacin and tobramycin in the lungs, a Precision Cut Lung Slice (PCLS) model was used as an immunocompetent ex vivo organotypic infection model for investigation of the host-pathogen interaction in situ.

• Besides knowledge of efficacy and toxicity, information on pharmacokinetics after inhalation, especially in the lung as site of the infection is crucial. Isolated Perfused Rat Lungs (IPL) providing a fully intact organ system was established to investigate respiratory pharmacokinetics.

• Data integration was conducted using the PBKit PBK model developed by the Fh ITEM, a new generic PBK model focused on the inhalational route. The new model divides the lung into several sub-compartments according to its heterogenic structure and different particle related clearance and uptake mechanisms determining the fate of inhaled pharmaceuticals.

• As shown for the two antibiotic agents and also for an anti-viral agent, application and combination of different methods can provide data, that can be incorporated into the non-clinical development of inhaled drug candidates. Therefore, newly developed platform can contribute to a faster and more effective early pre-clinical development and can help to refine regulatory studies.

About the presenters

Dr. Katharina Schwarz

• Leading the department “Aerosol Technology and Aerosol Biophysics” at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover

• Expert at the interface between aerosol/inhalation research, respiratory pharmacokinetics, toxicology/physiology, and inhalation exposure science with a special focus on particle lung dosimetry and biophysical particle-lung interactions

• Responsible for the aerosol aerosol/inhalation and dosimetry-related aspects in drug development programs and toxicological or inhalation exposure studies including GLP/GCP-compliance in her institutional role

• Interfacing with interdisciplinary teams from pre-clinical and clinical airway research as well as toxicology/risk assessment from Fraunhofer ITEM and the corresponding sponsors from chemical/pharmaceutical industry or governmental institutions to meet the sponsor’s needs

• In particular she has overlooked the development of the inhalation-focused “PBKit” PBK model as well as the derivation of quantitative in vitro to in vivo extrapolations (QIVIVE) resulting in powerful tools in in particular for respiratory toxicity and efficacy studies

• One of the chairs of the working group “Environmental/Occupational Health/Toxicology” of the International Society for Aerosols in Medicine (ISAM) and actively engaged in the working group “Respiratory Toxicology” of the German Society of Toxicology

• Member of the Scientific Program Committee for the 24th congress of the Society held in 2023

MSc. Norman Nowak

• Obtained master’s degree in material and nanochemistry at the Leibniz University in Hannover, GER

• It was during his master’s thesis working at the Fraunhofer Institute for Toxicology and Experimental Medicine that he was first introduced to PBK modelling

• Continuing his work at the Fraunhofer Institute, he now works on an inhalation-focused PBK model applicable to gases/vapours but also airborne particles or droplets

• Is part of various projects (Cefic LRI, Riskhunt3r (Horizon 2020), InhalAB/InhalPredict)

• He was awarded the “Best trainee abstract” in the biological modeling specialty section at Society of Toxicology meeting ’22 and

• He expects to finish his PhD this year

Thursday, 30th March  2023, 8 am – 9 am (San Diego, CA); 11 am – 12 am (New York, NY); 5 pm – 6 pm (Paris, France)

Follow this link to register for the zoom webinar

Presenter: Catherine Fromen Ph.D.

Facilitators:

• Jessica Oakes
• Carsten Ehrhardt
• Barbara Rothen-Rutishauser (ISAM president)

Webinar content

• Immunotherapies and immune engineering are approaches that have recently captivated the pharmaceutical industry, from the delivery of biologics that modulate immune checkpoints, adoptively transferred chimeric antigen receptor (CAR) T cells, or precision nanoparticles that direct immune responses for prophylactic or therapeutic immune responses. The potential to translate findings from other routes of administration into aerosol immunotherapies poses incredible potential for manipulating the local mucosal-specific microenvironment, engaging specialized pulmonary cellular defenders, and accessing lymphoid tissue to redirect systemic adaptive and memory responses. In this talk, I will provide my perspective on the outstanding needs and opportunities for thinking about aerosol immune engineering, while highlighting some recent advances in the area. I will also discuss some on-going efforts in my research group in the areas of nanoparticle immune engineering and preclinical model development that we hope will contribute to furthering this area of research. 

About the presenter

• Catherine Fromen is an Assistant Professor at the University of Delaware in the Department of Chemical and Biomolecular Engineering. She received her PhD in Chemical Engineering from North Carolina State University in 2014 and performed postdoctoral studies at the University of Michigan as a University of Michigan’s President’s Postdoctoral Fellow. She joined the University of Delaware in 2017, where her research group focuses on applying chemical engineering principles to challenges surrounding pulmonary drug delivery. Her research and publications have spanned the design of inhalable immune-modulatory formulations and the development of experimental dynamic, full volume approximations of the airways. Recent accolades include the AIChE’s 35 Under 35 Award, NSF CAREER Award, and NIH Early-Stage Investigator MIRA Award. She is a member of numerous professional societies, including ATS, AAPS, and of course ISAM, where she is currently serving as the Chair of the Awards Committee and a Women in ISAM Networking Group leader.

Title: ISAM Webinar: Time to revolutionise inhaler usage and provide better patient outcomes 

Monday, 21st November 2022

• Jessica Oakes
• Carsten Ehrhardt
• Barbara Rothen-Rutishauser (ISAM president)
  

Webinar content

The pressurized metered dose inhaler (pMDI) was introduced in 1956 and by the end of that year a report described the problems patients have using these inhalers. The first single dose dry powder inhaler (DPI) followed in 1967 and a multi-dose DPI in 1987. The drugs formulated in all the inhalers that are now available have revolutionized the management of patients but despite patient counseling sessions there are too many with inhaler technique and adherence problems leading to poor disease control. Electronic monitoring of how patients use their inhalers has the potential to provide objective information and feedback for self and clinical management. These electronic inhalers can measure inhalation parameters such as the peak inhalation flow (PIF), time to PIF, the duration of an inhalation and the inhaled volume so confirm that an inhalation was attempted. Hence, they monitor adherence, can give feedback about technique and disease deterioration if the parameters decline or rescue medicine use increases. This webinar will start with a review of past and present inhaler usage issues then describe how connected inhalers measuring inhalation parameters and attempted adherence, during real-life use, have the potential to individualize each patient’s management.

About the presenter

• Professor Chrystyn has published over 250 original research articles involving inhalers and supervised 53 PhD students. He is internationally recognized for his research on inhaled therapies, which has a strong emphasis on how patients use inhalers, and the integration of pharmaceutical sciences with routine patient care.
• Professor Chrystyn was lead author of the ERS Consensus Statement on the use of inhalers published in the European Respiratory Journal in 2011. He was is a member of the inhaler devices section of the British Thoracic Society (BTS) and the Scottish Intercollegiate Guidelines Network (SIGN) Guidelines on the Management of Asthma and, until his retirement, he was an Executive Editor of the British Journal of Clinical Pharmacology for approximately 20 years.
• For the past 6 European Respiratory Society annual meetings he has presented an invited plenary lecture on the problems patients have using their inhalers.

Title: ISAM Webinar: Strategies to Overcome the Physical and Biological Barriers Associated with Pulmonary Drug Delivery

Wednesday, 14th September 2022

Presenter: David Cipolla, PhD
David Cipolla is the VP of Research at Insmed Incorporated

Facilitators:

• Jessica Oakes
• CarstenEhrhardt
• Barbara Rothen-Rutishauser (ISAM president)

Webinar content

The past half-century has seen the emergence of sophisticated inhaled device technologies, including MDIs, DPIs, nebulizers and soft mist inhalers. When used properly, these technologies can facilitate delivery of therapeutics consistently and at high efficiency to the lung, bypassing oropharyngeal deposition. Novel chemistry or nanoparticle formulation technologies can be used in combination with these inhalation technologies to further improve treatment of lung disease. For example, strategies to overcome degradation and clearance mechanisms, or to reduce the rate of systemic absorption, can lead to prolonged retention of drug at the active site, which can extend duration of effect. Additionally, these technologies can improve tolerability of administration or facilitate uptake within cells to access intracellular targets. This paper describes the physical and biological barriers of pulmonary drug delivery and provides recent examples of formulation technologies or drug chemistry modifications to overcome those barriers.

About the presenter

David is the VP of Research at Insmed Incorporated, where he is part of a team developing novel, targeted therapies to help serve the critical unmet needs of patients battling serious rare diseases. Prior to joining Insmed in 2018, David worked at Aradigm (1996 to 2018) covering all phases of product development and led the development of preclinical research, CMC activities and intellectual property.  Prior to joining Aradigm, David worked at Genentech, Inc. (1988 to 1996) developing and characterizing the delivery of protein aerosols to the airways, culminating with the approval of Pulmozyme® rhDNase for the management of cystic fibrosis in 1993. David holds a chemical engineering degree from MIT (SB) and UC Davis (MS) and a pharmacy degree from the University of Sydney (PhD).

Title: ISAM Webinar: Immunemodulation in the respiratory tract: lung models to interact with nanoparticles

Thursday, 10th February 2022

• 8 am – 9 am (San Diego, CA); 11 am – 12 am (New York, NY); 5 pm – 6 pm (Paris, France)
• Follow this link to register for the zoom webinar: https://us06web.zoom.us/webinar/register/WN_pXKa7FQHROWXeJ9ZI_Olag

Facilitators:

• Jessica Oakes
• Carsten Ehrhardt
• Barbara Rothen-Rutishauser (ISAM president)
  

Webinar content

• Immune system of the respiratory tract: structural and functional barriers
• Nanocarriers as powerful immune modulators
• Opportunities and limitations of lung models in vitro and in vivo
• In vitro models of inhalation: quo vadis?

About the presenter

• PD Dr. Fabian Blank MSc in Cell Biology (2003) and PhD in Structural Biology (2006) at University of Bern. Postdocs at Institute of Anatomy, University of Bern (2007-2008) and Telethon Institute for Child Health Research, Perth (AU) (2008-2009).
• Since 2009, Senior Scientist, Pulmonary Medicine (Adults), DBMR; since 2010, Commission Member, Microscopy Imaging Centre.
• Since 2012, Head, Live Cell Imaging (LCI) Core Facility, DBMR. Venia docendi (2016). Since 2012, Fabian Blank is working as a group leader in the Pulmonary Medicine Research Laboratory (Berne University Hospital) which is part of the Department of BioMedical Research (DBMR).
• His research is focused on effects of biomedical and environmental nanoparticles on the pulmonary immune system. In particular, he is working with mouse models of allergic asthma, COPD idiopathic pulmonary fibrosis and with human in vitro models of the large airways. Since the start of his research career in the field of particle-lung interactions, Dr. Blank has been active in the community of ISAM.
• At the ISAM Conference 2005 in Perth (WA) he received the ISAM Student Research Award and between 2013 and 2015 he was member of the ISAM Student Committee. In addition, Dr. Blank was a co-chair organizing the ISAM Conference 2019, held in Montreux, Switzerland. Dr. Blank is currently a board member of the Society.

Carsten is Professor in Pharmaceutics and Biopharmaceutics and Fellow at Trinity College Dublin and Adjunct Professor at the University of Southern California.

• Barbara Rothen-Rutishauser (ISAM president)
• Jessica Oakes
• Fabian Blank

About the Presenter

• Carsten is Professor in Pharmaceutics and Biopharmaceutics and Fellow at Trinity College Dublin. He also holds an Adjunct Professorship at the University of Southern California.
• His research is focused on lung drug disposition, pulmonary epithelial transport and molecular origins of airways disease. Carsten has edited 1 book and (co-) authored 101 peer-reviewed publications and over 250 abstracts. He is the recipient of honours and awards from German Pharmaceutical Society (DPhG), American Physiological Society and Galenus Foundation.
• Carsten serves as Section Editor of European Journal of Pharmaceuticals Sciences and is a member of the Editorial Boards of American Journal of Physiology - Lung Cellular and Molecular Physiology, European Journal of Pharmaceutics and Biopharmaceutics, Journal of Aerosol Medicine and Pulmonary Drug Delivery, Journal of Pharmaceutical Sciences, Pharmaceutics, and Pharmaceutical Research.

Dr. sc. nat. Michael Riediker

Direktor at Swiss Centre for Occupational and Environmental Health (SCOEH),

CH-8404 Winterthur, Switzerland Facilitators Barbara Rothen Stephan Ehrmann Thursday, 29th of April 2021 8 am – 9 am (San Diego, CA); 11 am – 12 am (New York, NY); 5 pm – 6 pm (Paris, France) ZOOM Webinar Link: https://zoom.us/j/96678272823 Download invitation: ISAM Webinar April 29, 2021 Invitation ISAM Webinar April 29, 2021 Invitation (2 KB) Webinar Content Background on aerosol transmission An indoor simulator for estimation of potential exposure Risk scenarios: How can we stay safe? Guide towards healthy workspace or classrooms About Dr. Michael Riediker Dr. sc. nat. Michael Riediker is an environmental scientist and certified occupational hygienist SGAH. Since more than 20 years, he studies aerosols of all sizes from release over exposure to health impact as well as protection and intervention strategies. In 2018, he founded the Swiss Centre for Occupational and Environmental Health (SCOEH) in Winterthur, Switzerland, of which he is the director. At SCOEH he researches, advises and teaches on factors that make workplaces and the environment healthier. ISAM webinars are open to all ISAM members and are more specifically intended for early career / young researchers and clinicians in the field of aerosol medicine