Webinars

Regional Lung Targeting with PreciseInhale® A Feasibility Study in Humans
Paolo and Eunice introduced a webinar session on regional long targeting with Precise Inhale, highlighting its advantages and efficiency in delivering aerosols to the lungs. The meeting also discussed the setup and execution of a clinical trial involving healthy volunteers, the importance of identifying and mitigating risks, and the challenges faced during the trial. Lastly, the team discussed the modality of inhalation with a precise inhale, the aerosol parameters, and the potential of using gamma sintigraphy imaging for precise quantification of regional deposition patterns within the lungs.

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Does My Drug Have a Chance for Inhaled Delivery?
The meeting focused on the potential of inhaled drug delivery, with discussions on APIs, the possibilities for success in inhalation as a delivery route, and a case study on isolated perfused lungs. The team also explored the use of non-clinical in vivo data, the precise inhaler generator, and the isolated perfused lung system in understanding drug behavior and metabolism in the lungs. The conversation ended with a discussion on the substances studied, the use of the Ipl system in toxicology practice, and the announcement of an upcoming webinar.

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Translation of Inhaled Exposures throughout Drug Development
In this webinar, ISAB CSO Per Gerde is joined by Rebecca Fransson (Principal Scientist in Biopharmaceutics at AstraZeneca), Steven Oag (Director of Animal Science and Technologies, AstraZeneca) and Pär Ewing (DMPK Design Lead, AstraZeneca) who discuss how to:

• usea large-lung preclinical model to generate preclinical in vivo data
• reduce translational errors through drug development using this method
• carry out single-animal Nose-only and intra-Tracheal exposures using one-animal-at-a-time precision dosing on the PreciseInhale system

(Recording not available)

Realization and Preclinical Testing of Dry Powder Formulations
In this webinar, Per Gerde and Paolo Raffaelli, CSO and CCO respectively of Inhalation Sciences, with Ann Gidner and Xavier Turon, CEO and COO respectively from Ziccum, will discuss how to:

• Turn your biologic therapy into a stable dry powder at room temperature
• Generate actionable preclinical data to calibrate successive steps and consolidate your investor pitch
• Get insight into lung retention and PK curves for your dry powder biologics

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Human and Nonclinical Translational Dose Implications in Respiratory Drug Development
In this webinar, Matt Reed, PhD, principal at Coelus Bio, and Per Gerde, founder at CSO at Inhalation Sciences discuss how to:

• Generate a clinical dose estimate on the basis of preclinical data.
• Describe a specific example of generating a clinical dose for an antibiotic delivered via a nebulizer.
• How the rodent models are accurate for tidal breathing preclinical exposures and clinical exposures through nebulizers.
• For bolus delivery, a large lung model is necessary for a smoother translational exercise.

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The DissolvIt Dissolution Method Case Study and Bioanalysis of Inhaled
In this webinar, Maria MaImlof, Ph.D., Director of Project and in vitro Specialist, Inhalation Sciences Sweden AB, and Prof. Hermann Mascher, Founder of pharm-analyt Labor GmbH and Bioanalytical Consultant, discuss the following:

• How the DissolvIt dissolution method can generate PK curves similar to in vivo or human studies.
• How the DissolvIt method provides strong discriminative power across APIs, formulations, physical forms, and physiologically relevant data.
• A case study on Glycopyrronium and Indacaterol using the DissolvIt® method.
• Bioanalysis of small-volume DissolvIt samples with low LLOQs.

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