By Joana Roque Vice-president of Associação Nacional de Fibrose Quística (ANFQ)
Patients as Partners in Research & Development.
➡ The value of integrating patient experience and perspective since early stages of R&D.
➡ The Cystic Fibrosis experience in Europe.
Cystic Fibrosis
08:30 - 09:00
Emerging digital trends in drug delivery to the lungs
➡ Enhanced drug delivery.
➡ Market challenges in digitalisation strategies.
Digital trends
09:00 - 09:30
Grey Soft Mist Inhalers for a green environment
By Herbert Wachtel Innovation Scout at Boehringer Ingelheim Pharma
➡ Design features of a re-usable Inhaler:
- Multi-Dose cartridge
- Multi-cartridge device
➡ Performance characteristics:
- Slowly moving soft mist with long spray duration
- Delivered Dose
- Aerodynamic Particle Size Distribution
➡ The carbon footprint of Respimat SMI:
- Investigation of the life cycle from cradle to grave.
Sustainability
09:30 - 10:00
Avient Presentation (To be announced)
➡ Topic to be announced
Plastic Solutions
Sustainability
10:00 - 10:20
Speed Networking
10:20 - 11:00
Morning Coffee Break
11:00 - 11:30
Novel system for combined nasal and pulmonary drug delivery of vaccines
➡ Future pandemics are expected to be caused by airborne virus infecting the respiratory tract. Several studies have shown that Mucosal IgA can provide immunity against respiratory viruses. A future vaccine, treatment or prophylactic drug could therefore be more efficacious using combined nasal and pulmonary delivery to give maximal mucosal absorption in the entire respiratory tract.
➡ A non-invasive method to simultaneously administer drug or vaccine to both the nose and the lung could be an important first line of defense against the next pandemic. Several nasal spray vaccines are under development, but sprays have the inherent limitation in terms of short shelf-life and coordination issues. A passive dry powder delivery system would address the limitation of wet sprays. A nasal DPI is driven by the inspiratory flow, eliminating all coordination issues. A dry powder is stable in room temperature eliminating the need for expensive and complicated cold storage. The dry powder formulation can also be optimized to give a maximal pulmonary deposition.
➡ A platform for simple and cost-efficient delivery of vaccines and biomolecules via the nose has been developed and optimized. The dry powder inhalation platform includes a device and a family of dry powder formulations. The platform is developed to be ultra-low-cost and suitable for low-income countries and tropical conditions. The project is funded by Bill & Melinda Gates Foundation.
DPI
Vaccines
12:00 - 12:30
Nano-repurposing Strategies for developing novel therapeutics for respiratory disorders
By Vivek Gupta Associate Professor, and Scientific Founder at St. John
12:30 - 13:00
Interacting with FDA and Regulatory Bodies
By Deepika Lakhani Vice President of Regulatory & Quality at PAVmed Inc.
➡ Strategies and lessons of delivering and evaluating medical device submissions to FDA and other Regulatory bodies.
Medical Devices
Regulatory challenges
13:00 - 14:00
Business Lunch
14:00 - 14:30
Physiology Based Biopharmaceutical Modeling - Bridging from In Vitro to PK
By Per Bäckman Senior Adviser - Inhalation Science at Emmace Consulting AB
➡ The potential of PBBM modelling to understand and predict the pharmacokinetics of inhaled medicines will be discussed. This will include predictions of PK parameters such as AUC and Cmax based on critical product attributes such as dissolution, dose deposition and delivered dose in support of pivotal bioequvalence studies.
➡ From a biopharmaceutical standpoint, critical product and drug attributes describe the extent to which the dose reaches the lung, dose penetration into the distal parts of the lung, dissolution rate in situ, permeation through lung epithelium and diffusion through lung tissue into the systemic circulation
➡ PBBM models mechanistically describe the processes involved and allow for the prediction of systemic and local exposure following administration of an inhaled medicine. This provide opportunities to predict bioequivalence between products, define clinically relevant product design specifications, as well as the potential of novel and repurposed drugs for inhalation.
In Vitro Testing/Inhalation
14:30 - 15:00
Preclinical studies of factors that affect delivery of aerosolized medications within the intranasal airways using 3D models
By Beth Laube Professor Emerita at the Johns Hopkins School of Medicine
15:00 - 15:30
Optimizing Aerosol Drug Delivery via High Flow Nasal Cannula
By Arzu Ari Professor & Associate Dean for Research at Texas State University
➡ Overview of transnasal aerosol delivery via high flow nasal cannula (HFNC) application and its safety.
➡ Present the latest research on aerosol delivery via HFNC
➡ Provide strategies to optimize aerosol delivery during HFNC based on the best evidence
Aerosol delivery
15:30 - 16:00
Liquid Foams for efficient delivery of high-dose pulmonary therapies
By Josué Sznitman Associate Professor of Biomedical Engineering at Technion - Israel Institute of Technology
16:00 - 16:30
Afternoon Coffee Break
16:30 - 17:30
Panel Discussion
Topics & Speakers for the Panel discussion to be announced.
Aerosol delivery
Cystic Fibrosis
DPI
In Vitro Testing/Inhalation
Inhalation therapy
Novel therapeutics
Pulmonary delivery
Regulatory challenges
Sustainability
17:30 - 17:35
RESCON Europe 1st Day Closing Remarks
19:00 - 20:00
Networking Wine Experience
20:00 - 22:00
Gala Dinner With Live Fado Concert
08:00 - 08:30
Registration & Coffee
08:30 - 09:00
Aerosol delivery in ILD - breakthrough or lost cause?
By Carsten Ehrhardt Professor in Pharmaceutics and Biopharmaceutics at Trinity College Dublin
➡ Interstitial lung disease (ILD) is an umbrella term used for a large group of diseases that cause irreversible fibrosis of the lungs. In many cases, such as idiopathic pulmonary fibrosis (IPF), the causes may be unknown.
➡ There is currently no cure for IPF. Pirfenidone and nintedanib are used with the aim of relieving the symptoms as much as possible and slowing down its progression. Bot drugs, however, cause significant unwanted side effects when given orally.
➡ Inhalation therapy could potentially increase the local drug concentration while simultaneously decrease systemic exposure. This presentation will explore if it is possible and meaningful to deliver drug aerosols to fibrotic lungs.
Inhalation therapy
09:30 - 10:00
Nasally Inhaled Divalent Salts for Prophylaxis and Treatment of Upper Respiratory Illnesses such as Chronic Cough
➡ Analytical insights into dry powder formulations for inhalation.
➡ Characterizing aerosol dynamics
➡ Tests according to ISO 18562-2,-3,-4
Testing/Analytical Tools
11:30 - 12:00
Replacement Strategies for Animal Studies in Inhalation Testing
By Eleonore Fröhlich Director Core Facility Imaging, Center for Medical Research at Medical University of Graz
12:00 - 13:00
Panel Discussion
Topics & Speakers for the Panel discussion to be announced.
Aerosol delivery
Cystic Fibrosis
DPI
In Vitro Testing/Inhalation
Inhalation therapy
Novel therapeutics
Pulmonary delivery
Regulatory challenges
Sustainability
13:00 - 14:00
Business Lunch
14:00 - 14:30
Inhalation Drug Product Development and Commercialization
By Aditya Ranjan Das Founder and Principal at Pharmaceutical Consulting
➡ An overview of the Global Inhalation Market, Leading Brands Indication and Sales for both Asthma and COPD and non-Asthma and COPD indications, Current Market and Indication Trends including Generics and Products in Late Stage Development
➡ Respiratory and Non-Respiratory Indications, Disease States with Increasing Global Burden, Prioritization of Therapeutic Strategies (Relevant Examples); Lung Architecture and the Lungs as a portal for Systemic Delivery; Overview of Pulmonary Drug Delivery Technology (Nebulizers, pMDIs, DPIs)
➡ The Case for Respirable Engineered Spray Dried Dry Powder, Pulmonary Particle Deposition using Gamma Scintigraphy and Systemic PK, Local Lung Delivery (Tobi Podhaler), Platform Approach and the 505(b)(2) Regulatory Pathway
Development & Commercialization
14:30 - 15:00
The uncovered treasure of Post-Market Surveillance data
By Yvonne Limpens Managing Human Factors Specialist at Emergo by UL
➡ How to make the most of post-market data to develop safe and effective medical devices
Medical Devices
15:00 - 15:30
Inhaler technique errors impact the majority of patients - what strategies can change this?
By Mark Sanders Inventor and independent researcher
➡ Since initial reports of inhaler technique difficulties in 1965 over 14,000 publication have explored the subject but the problems continue to exist.
➡ Inhaler technique training is called for in GINA, GOLD and other reports and a plethora of tools exist to conduct inhaler training, and yet the problem persists...
➡ This presentation reviews what has been done and the potential for new technologies in future.
Medical Devices
RESCON EUROPE Official Agenda 2023 will be announced soon…