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
How to achieve your sustainability goals in Medical Devices. Insights from a plastic material suplier perspective.
By Volker Dickfeld Sr. Marketing Manager HealthCare Global at Avient Colorants Germany GmbH
➡ In this presentation we will highlight, new material options to reduce the carbon footprint for healthcare application, while keeping the regulatory integrity.
➡ Learn more, on how to reduce the carbon footprint using color and additive solutions formulated with bio-based polymers. You will get insides on the concrete PCF Product carbon footprint savings of these solutions, that are of cause specially designed for the use in regulated healthcare applications with regulatory compliance support and comprehensive documentation.
➡ In addition, you will discover further option to save material, reducing weight of plastic article, using special Additive solutions.
➡ 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
11:30 - 12:00
Aiming to the balance point: thinking next generation DPIs
By Marco Franza Director Sales and Business Development at Global Inhalation & Medical Devices – Berry Healthcare
➡ Digital empowerment;
➡ Different approaches for sustainable development of generic DPI
12:00 - 12:30
Patient in-use factors decisive to the performance of dry powder inhalers
By Amrit Paudel Leader-Formulation and Drug Delivery at Research Center Pharmaceutical Engineering GmbH (RCPE)
12:30 - 13:00
Challanges of powder dosing in inhalation product manufacturing
By Marian Asch Senior Sales Manager at Harro Höfliger
➡ Powder properties and its impact on manufacturing processes;
➡ Considerations from lab to production during the develepment of Dry Powder Inhaler products;
➡ Two-stage filling for pMDI manufacturing.
DPI
Novel therapeutics
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
Topic to be announced
By Hugh Smyth Professor at The University of Texas at Austin
16:00 - 16:30
Afternoon Coffee Break & Sponsors Presentation
➡ 16:00 - Intertek Melbourn Presentation
Networking Activities
16:30 - 17:00
The risk of nebulizer treatments in the transmission of bacteria and viruses - A Systematic Review
By Israel Amirav Physician at Tel Aviv Medical Center
17:00 - 17:30
Panel Discussion: "The Future of Inhalation Therapy: Innovations and Challenges"
➡ Emerging technologies and innovations in inhalation therapy
➡ Challenges in developing inhalation therapy for different respiratory conditions
➡ Regulatory considerations for inhalation therapy products
➡ Patient-centered approach in inhalation therapy development
➡ Sustainability and environmental impact of inhalation therapy devices
➡ The role of digital health in improving inhalation therapy outcomes
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
09:00 - 09:30
Replacement Strategies for Animal Studies in Inhalation Testing
By Eleonore Fröhlich Director Core Facility Imaging, Center for Medical Research at Medical University of Graz
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
SmartTrack: An Alternative Pathway to the Approval of Generic Respiratory Products
By Jan De Backer CEO at Fluidda, Lucas Silva Head of Analytical Development and Life Cycle Management at Nanopharm, an Aptar Pharma Company
➡ Presentation of SmartTrack approach to derisk and accelerate generic product development as a biowaiver for clinical end point studies. Introduction of the in vitro and in silico tools comprising SmartTrack platform under the umbrella of bioequivalence studies for generic orally inhaled products.
➡ Presentation of SmartTrack in silico tools by Fluidda: Functional Respiratory Imagining and Rapid Deposition Analysis. Opportunities versus limitations and how, if combined together into the SmartTrack platform, they can make clinical trials shorter, faster and thus, more cost effective.
➡ Presentation of SmartTrack realistic in vitro tools by Nanopharm and their application in a regulatory submission of a dry powder inhaler bioequivalent product.
Connected Devices
DPI
In Vitro Testing/Inhalation
12:00 - 12:30
Inhaled New Modalities - from preclinical research to the clinic
By Lena Ripa Director, Medicinal Chemistry at AstraZeneca
12:30 - 13:00
Intertek Presentation (To be announced)
By Mark Parry Senior Scientific Director at Intertek Melbourn
➡ Topic to be announced
13:00 - 14:00
Business Lunch
14:00 - 14:30
Clinical Evaluations & Repiratory Devices
By Ortzi Olasolo Medical Device Consultant at Beyond Conception
➡ Overview of the regulatory landscape for respiratory devices
➡ Which respiratory devices mandate a Clinical Evaluation according to Regulation 2017/745
➡ Overview of the Clinical Evaluation Process
➡ When are Post-market Clinical Follow-up activities necessary?
Medical Devices
Regulatory challenges
14:30 - 15:00
Behavior design and connected devices. Simplifying the complex by identifying what matters
By Søren Skov Senior Human Factors Engineer at Roche
15:00 - 15:30
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
15:30 - 16:00
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
16:00 - 16:05
End of RESCON Europe & Chairperson Closing Remarks