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Bridging the gap between science and clinical efficacy: physiology, imaging, and modeling of aerosols in the lung

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Consensus Statement_ISAM workshop2015 V3.2.docxAccepted version1.81 MBMicrosoft WordView/Open
Title: Bridging the gap between science and clinical efficacy: physiology, imaging, and modeling of aerosols in the lung
Authors: Darquenne, C
Fleming, JS
Katz, I
Martin, AR
Schroeter, J
Usmani, OS
Venegas, J
Schmid, O
Item Type: Journal Article
Abstract: Development of a new drug for the treatment of lung disease is a complex and time consuming process involving numerous disciplines of basic and applied sciences. During the 2015 Congress of the International Society for Aerosols in Medicine, a group of experts including aerosol scientists, physiologists, modelers, imagers, and clinicians participated in a workshop aiming at bridging the gap between basic research and clinical efficacy of inhaled drugs. This publication summarizes the current consensus on the topic. It begins with a short description of basic concepts of aerosol transport and a discussion on targeting strategies of inhaled aerosols to the lungs. It is followed by a description of both computational and biological lung models, and the use of imaging techniques to determine aerosol deposition distribution (ADD) in the lung. Finally, the importance of ADD to clinical efficacy is discussed. Several gaps were identified between basic science and clinical efficacy. One gap between scientific research aimed at predicting, controlling, and measuring ADD and the clinical use of inhaled aerosols is the considerable challenge of obtaining, in a single study, accurate information describing the optimal lung regions to be targeted, the effectiveness of targeting determined from ADD, and some measure of the drug's effectiveness. Other identified gaps were the language and methodology barriers that exist among disciplines, along with the significant regulatory hurdles that need to be overcome for novel drugs and/or therapies to reach the marketplace and benefit the patient. Despite these gaps, much progress has been made in recent years to improve clinical efficacy of inhaled drugs. Also, the recent efforts by many funding agencies and industry to support multidisciplinary networks including basic science researchers, R&D scientists, and clinicians will go a long way to further reduce the gap between science and clinical efficacy.
Issue Date: 1-Feb-2016
Date of Acceptance: 8-Nov-2015
URI: http://hdl.handle.net/10044/1/46051
DOI: https://dx.doi.org/10.1089/jamp.2015.1270
ISSN: 1941-2711
Publisher: Mary Ann Liebert
Start Page: 107
End Page: 126
Journal / Book Title: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Volume: 29
Issue: 2
Copyright Statement: © Mary Ann Liebert, Inc. Final publication is available from Mary Ann Liebert, Inc., publishers https://dx.doi.org/10.1089/jamp.2015.1270
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: CDF-2011-04-053
Keywords: Science & Technology
Life Sciences & Biomedicine
Respiratory System
aerosol deposition distribution
biological lung models
in-silico lung modeling
PET
SPECT
OBSTRUCTIVE PULMONARY-DISEASE
HUMAN RESPIRATORY-TRACT
IN-VITRO
PARTICLE DEPOSITION
DRUG-DELIVERY
HELIUM-OXYGEN
REGIONAL DEPOSITION
GAMMA-SCINTIGRAPHY
INHALED PARTICLES
SMALL AIRWAYS
Administration, Inhalation
Aerosols
Biomedical Research
Consensus
Drug Compounding
Humans
Image Interpretation, Computer-Assisted
Lung
Models, Anatomic
Particle Size
Pharmaceutical Preparations
Respiration
1102 Cardiovascular Medicine And Haematology
1115 Pharmacology And Pharmaceutical Sciences
Publication Status: Published
Appears in Collections:National Heart and Lung Institute
Airway Disease
Faculty of Medicine



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