gender balance contacts the action intends to: 1 2 · 2016-03-09 · to maximize the impact of...
TRANSCRIPT
COST is supported by the EU Framework ProgrammeHorizon 2020
CONTACTS
Project’s Websites
www.siminhale-cost.eu www.cost.eu/COST_Actions/mpns/MP1404
siminhale https://www.linkedin.com/groups/8421105
advance particle and compound design for improved deposition and therapeutic effect
promote integration of particle/formulation engineering with inhaler design for optimal lung delivery
promote drug-properties-aware and drug-target-aware design and development of pulmonary drug delivery systems
explore imaging technologies for patient monitoring, delivery verification and simulation validation
promote critical assessment of toxicity issues and related risks
identify new applications and needs, evaluate and explore innovative technologies relevant to the field and publish critical reviews
SimInhale aims at making a new generation of advanced inhaled pharmaceuticals (formulations and devices) available to the public in a shorter period of time, thus promoting the welfare of patients and making major contributions to the European scientific and technological excellence, wider society and the economy.
THE ACTION INTENDS TO:
12
34
56
Chair: Stavros KassinosCountry: CyprusInstitution: University of Cyprus (UCY-CompSci)Email: [email protected]
Vice-Chair: Gerrit BorchardCountry: Switzerland Institution: University of Geneva Email: [email protected]
WG1Leader: Elias FattalCountry: FranceInstitution: University of Paris-Sud Email: [email protected]
Vice-Leader: Alessandra RossiCountry: ItalyInstitution: University of ParmaEmail: [email protected]
WG2Leader: Anne Haaije de BoerCountry: Netherlands Institution: University of Groningen Email: [email protected]
Vice-Leader: Sitaram VelagaCountry: Sweden Institution: Lulea University of TechnologyEmail: [email protected]
WG3Leader: Martin SommerfeldCountry: GermanyInstitution: Martin Luther University Halle-Witten-berg (MLU)Email: [email protected]
Vice-Leader: Alessio Alexiadis Country: United Kingdom Institution: University of Birmingham Email: [email protected]
WG4Leader: Jan de BackerCountry: BelgiumInstitution: FLUIDDA NVEmail: [email protected]
Vice-Leader: Kaye Morgan Country: GermanyInstitution: Technische Universität MünchenEmail: [email protected]
WG5Leader: Maria Beatriz da Silva LimaCountry: Portugal Institution: iMED.Ulisboa, Faculdade de Farmácia Universidade de LisboaEmail: [email protected]
Vice-Leader: Carsten EhrhardtCountry: IrelandInstitution: Trinity College DublinEmail: [email protected]
Grant Holder:
To maximize the impact of SimInhale, a gender balance is sought amongst the participants. An effort is made to take into account gender effects when asking scientific questions, such as gender related anatomical variations of the airways.
ACTION’S DURATION AND PARTICIPANTS
The Action started on the 4th of May 2015 and it will run for four years. Twenty-two COST countries have already signed the Memorandum of Understanding (MoU) as follows:
AustriaBelgiumCyprus Czech Republic DenmarkFrance Germany GreeceIreland Israel Italy
Malta Netherlands Norway PortugalRomaniaSerbiaSlovakiaSpainSwedenSwitzerlandUnited Kingdom
SingaporeUnited States of America
GENDER BALANCE
This article is based upon work from COST Action (SimInhale, MP1404), supported by COST (European Cooperation in Science and Technology). COST is a pan - European intergovernmental framework.
Its mission is to enable break-through scientific and technological developments leading to new concepts and products and thereby contribute to strengthening Europe's research and innovation capacities.
SIMULATIONPHARMACEUTICAL &
TECHNOLOGIESFOR ADVANCED PATIENT-TAILORED INHALED MEDICINES
The National University of Singapore (Singapore) and Dance Biopharm Inc. (USA) are participating in this Action as Management Committee (MC) Observers from International Partner Countries.
WORK PLAN AND ORGANIZATION
Working Group 1
Working Group 3
Working Group 2
Working Group 4
Working Group 5
The work plan of the Action is organized into 5 Working Groups (WGs) with the following corresponding objectives:
One of the greatest challenges considering the aging of the world population in combination with the reduction of health budgets is to keep the costs of therapy low. This has the consequence that medication has to be cheap, but yet highly effective, and devices have to be easy to operate, so that patients are able to comply with correct inhaler use and adhere to the therapy. These are prerequisites for preventing periodic or permanent exacerbations of the disease that lead to a higher frequency of hospitalization (and thereby, increase the cost of the therapy), but may also cause, for instance, bacterial resistance development against antibiotics. Notably, multi drug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) due to inappropriate therapies are already a huge global concern. In this respect, the main challenge in relation to inhaled medicines is to overcome technological difficulties while keeping the manufacturing costs low, the drug administration techniques simple and the time needed for the administration short.
The benefits of the Action will be of scientific and technological, economical and of course societal character. Making a new generation of advanced inhaled pharmaceuticals available to patients in a shorter period of time will have enormous social benefits. It will also have significant economic benefits, since it will advance pharmaceuticals with higher effectiveness and fewer side effects, thus reducing health care costs in the long run, and will help sustain innovation in the industry of inhaled pharmaceuticalsand inhaler devices.
As a result of the culmination of several scientific and technological developments, we are on the verge of technological breakthroughs in the field of inhaled medicines
that could revolutionize the treatment of many acute or chronic respiratory and systemic illnesses. However, knowledge in the field is vertically
fragmented and compartmentalized in disciplines. SimInhale will integrate scientific knowledge across disciplines and
geographical boundaries in order to accelerate progress and promote synergies. It will enable the flow of information
among research groups that are separated by distance or level and area of experience, thus maximizing the
effective use of all available European resources in the field of inhaled medicines. It will disseminate state of the art information across Europe and it will bring into the mainstream knowhow from across Europe. SimInhale will aim in particular to enhance the interaction between academic research institutions on one hand and industrial counterparts and regulatory agencies on the other.
A scientific network of early-career investigators (ECIs) has been established under the name "Breath of Life” society. The Breath of Life society will be able to meet separately during the WGs meetings, have its own platform for discussions, table new ideas and suggestions for dedicated tasks, training events, workshops, short-term scientific missions, etc. Through the
Breath of Life society, ECIs will have their own voice in SimInhale and a structured platform to
promote their active participation in this COST Action. The Breath of Life society will serve as a "Think
Tank" for the ECIs.
Particle engineering/processing of inhaled medicines for local/systemic action
(i) identify optimal deposition sites for topical and systemic therapies, (ii) consolidate information on the effects of lung disease on the deposition - dissolution - absorption pathway, (iii) assess the effect of airway geometrical differences on regional deposition patterns and identify key effects to be included in Computational Fluid Particle Dynamics (CFPD) simulations, (iv) promote deeper understanding of dissolution and absorption in the alveolar region, (v) assess emerging nanomedicine and excipient technologies in terms of efficiency and safety.
Device engineering and formulation-aware inhaler design
(i) promote the integrated design of formulations and inhaler devices, (ii) consolidate understanding on the balance of interparticulate dispersion - deposition forces for various formulation-inhaler designs by leveraging ongoing research and CFPD simulations, (iii) identify best design practices for emerging formulation needs such as high-dose drugs and combination therapies, taking into account cost and safety, (iv) promote the development of customized formulation-inhaler designs for special patient groups, such as the elderly and young children.
Computer simulations as a horizontal enabling technology: delivery, deposition and lung-tissue/particles interaction (i) promote close interaction between medical imaging and pharmaceutics experts, (ii) establish best-practice guidelines for the current generation of CFPD simulations tools that will be accessible to non-CFPD experts, (iii) identify and prioritize
additional physical effects that must be included in CFPD tools to make simulations more realistic, (iv) establish a roadmap leading to
integrated multiscale simulations with the ability to track aerosols over the entire delivery pathway, (v) establish a roadmap leading
to patient-specific and patient-class-specific CFPD simulations, (vi) promote the utilization of emerging
functional pulmonary imaging technologies for the validation and verification of computational models.
Advanced imaging, patient monitoring and delivery verification
(i) assess the relative merits and challenges associated with emerging imaging technologies, (ii) establish realistic pathways for the leveraging of emerging imaging technologies in the their current state of development for simulation validation, R&D
enhancement and patient monitoring, (iii) promote deeper understanding of dissolution and absorption in
the alveolar region through the utilization of emerging functional imaging methods, (iv) promote deeper
understanding of regional deposition and clearance in the conducting airways through the utilization of emerging
functional imaging methods.
Toxicity, xenobiotics, risk assessment and policy development
(i) establish the factors that affect dosimetry in toxicity studies for inhaled medicines, (ii) identify test systems (in vitro, in vivo, in silico) to address the preclinical aspects of inhalational medicinal products [delivery, absorption distribution metabolism and excretion (ADME), activity, toxicity], (iii) promote the Risk-Based Approach to establish the safety testing programs of inhalational medicinal products, (iv) promote common analytical approaches in toxicity assessments of inhalational medicinal products and xenobiotics.
THE BREATH OF LIFE SOCIETY FOR EARLY-CAREER INVESTIGATORS
THE BENEFITS OF THE ACTION
SIMINHALE ACTION’S
OBJECTIVES The main objective of SimInhale
is to create and maintain a pan-European multidisciplinary scientific network that
will coordinate and enhance research and development (R&D) in the field of inhaled medicines with the aim to
improve efficiency, safety and convenience, as well as to reduce
the costs of pulmonary drug delivery.
CHALLENGES OF THE ACTION IMPACT OF THE ACTION