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EOSC Beyond: advancing innovation and collaboration for research

EOSC Beyond overall objective is to advance Open Science and innovation in research in the context of the European Open Science Cloud (EOSC) by providing new EOSC Core capabilities allowing scientific applications to find, compose and access multiple Open Science resources and offer them as integrated capabilities to researchers. To do so, EOSC Beyond supports a new concept of EOSC: a federated and integrated network of Nodes operated at different levels, national, regional, international and thematic, to serve the specific scientific missions of their stakeholders. Further specific objectives of the project are to accelerate ‘time to product’ of new scientific applications with software adapters, enable Open Science with machine composability and dynamic deployment of shared resources, support innovation in EOSC with a testing and integration environment, and align the EOSC Core architecture and specifications to integrate with European dataspaces. The project extends the state of the art of the EOSC Core and adopts a co-design methodology, including requirements elicitation, software development and validation in collaboration with different use cases from EOSC national and regional initiatives (e-Infra CZ, Czechia, NFDI, Germany, and NI4OS, South East Europe region), thematic research infrastructures from Social Sciences and Humanities (CESSDA), Life Sciences (CNB-CSIC and Instruct-ERIC), Environmental Science (ENES and LifeWatch), and Health and Food (METROFood-RI). EOSC Beyond builds on the capacities of prospective EOSC Nodes and partners with multi-annual experience in developing solutions for large-scale federated digital infrastructures and aligns with the technical architecture and requirements of data spaces from different business sectors. Ultimately, EOSC Beyond supports Open Science in modern, data-intensive, and multidisciplinary research, facilitating resource discovery, access, and reuse across scientific communities, organisations, and countries. 

CULTUral heritage in RurAL remote areas for creative tourism and sustainabilITY

The main objective of the project is to contribute to the promotion of cultural and creative tourism activities, considering the different capacities, resources, and specificities (material, creative, human...) of the territories, as a mean to help with the sustainable development of peripheral rural areas, favoring job creation and population settlement. For this, the potential of its cultural heritage will be researched, taking into account both the artisan material culture (techniques, materials, patterns and decorative elements), as well as the intangible culture (music, oral knowledge and culinary traditions) as a resource.   To promote non-seasonal tourism as a form of sustainable development with a stable population settlement we are going to research the crafts linked to the territory and their implications, but we will also carry out a documentation of the productive processes. First and foremost, we are going to cater to the necessities of the local communities and pay attention to aspects related to societal groups at risk of exclusion, such as women, the elderly and the youth.  All this will be developed from a multidisciplinary perspective, for which we will count on the various teams —most of them linked to different countries— that will be part of the consortium. Each of these partners will contribute to the development, as well as to the final result of the project through input directly related to their area of ??expertise: for example, among the collaborators we have intellectual teams specialized in the digitalization of heritage, research, or communication and dissemination, as well as as various institutions that will act as a testing ground for the more practical parts of the proposal. However, if something will characterize our work, it will be the constant collaboration between all parties, as well as the exchange of advice and experiences that will help to enrich collective knowledge and guarantee optimal results.

AQUASERV – RESEARCH INFRASTRUCTURE SERVICES FOR SUSTAINABLE AQUACULTURE, FISHERIES AND THE BLUE ECONOMY

The overarching objectives of AQUASERV are to bring together, enhance, integrate and customise RI capacities (including facilities, instruments and expertise) and through the provision of transnational access (on-site or remote) and/or virtual access, to significantly further scientific advance and promote and facilitate the implementation of European Common Fisheries Policy, the Farm to Fork Strategy, the Sustainable Blue Economy and the European Green Deal.   AQUASERV will achieve these objectives by offering scientists from academia and business remote and on-site transnational (TA) and virtual (VA) access to an advanced set of European research infrastructures and its nodes related to research and management of marine and freshwater biological resources, food and biotechnology. These include the European Marine Biological Resource Centre ERIC (EMBRC), the Analysis and Experimentation on Ecosystems ERIC, The Aquaculture for Excellence for Aquaculture in Fish (Aquaexcel), and the Infrastructure for Promoting Metrology in Food and Nutrition (METROFOOD), as well as the International Council for Exploration of the Sea, both a service provider and stakeholder. It also includes the Research Infrastructure for Science and Innovation Policy Studies (RISIS) to bring contributions from the social sciences and to bring results nearer to policy makers ensuring societal impact.   To enhance, integrate and customise RI capacities, collaboration between partners and new pipelines to meet the objectives of the project will be developed during the first 3 years and will make available  to users.  To ensure these capacities will not be lost, a sustainability work package involving stakeholders will address the project legacy.    To maximize impact, AQUASERV will build a communication network among the partnership and develop a dissemination and outreach programme. Furthermore, an advanced training programme will be developed to capture future users and will be updated during the p

Harmonization of Advanced Materials Ecosystems serving strategic Innovation Markets to pave the way to a Digital Materials & Product Passport

The overarching objective of DigiPass is to enhance the digital maturity of the European communities that develop materials and intermediate products. The project will develop recommendations and clear routes toward digitalized circular business models. The overarching key result of DigiPass is to create a sustainable platform which includes support for Digital Materials & Product Passport and for collaborative innovation-by-design processes in a circular economy served by advanced materials. A business model for operating such a platform completes the overarching objective. DigiPass is harmonizing and synergizing collected materials data sources and digital infrastructures. This will enable interoperability of data exchange, and standardization of advanced materials knowledge representation at all maturity levels. Accelerating the design, development, and production of advanced, safe, and sustainable chemicals and materials, as they are necessary for innovative products, calls for a collaborative approach involving different stakeholders to support durability, repair and overhaul, reuse, and recyclability of products. DigiPass project impacts all materials development communities over the whole circular value chain.  

EOSC-ENTRUST: A European Network of TRUSTed research environments

The mission of EOSC-ENTRUST is to create a European network of trusted research environments for sensitive data and to drive European interoperability by joint development of a common blueprint for federated data access and analysis.  Countries and institutions have made significant investments in secure and trusted data environments to meet the need for research and policy-driven analysis of sensitive datasets such as people's health and socio-economic status, the habitats of vulnerable species and geo-spatial locations of protected sites. There are now a large number of such secure environments in operation - linked to national centres, individual organisations or specific research communities. This fragmented landscape poses challenges for both users and providers: researchers are faced with a large number of different systems and access procedures; providers need to manage federated access across multiple, potentially incompatible, technology and governance frameworks. EOSC-ENTRUST brings together providers of operational Trusted Research Environments from 15 European countries with a shared goal to implement, validate and promote their capabilities through a common European framework using shared standards and common legal, operational and technical language. This blueprint for interoperability is anchored in the EOSC Interoperability Framework spanning the four dimensions of Legal, Organisational, Technical and Semantic interoperability. EOSC-ENTRUST has identified four driver projects covering Genomics, Clinical trials, Social science, and public-private partnerships to benchmark capabilities, inform blueprint design and demonstrate secure  data analysis using federated workflows. Targeted outreach activities will expand this open network with further providers and develop policy papers and guidelines for the full range of stakeholders to create a long-term operational TRE framework within the European Open Science Cloud. 

IMProving User experience, Long-term sustainability and Services of EU-OPENSCREEN

EU-OPENSCREEN (EU-OS), the distributed European Research Infrastructure for Chemical Biology and early drug discovery, provides world-class services in high-throughput compound screening and medicinal chemistry to users from academia and industry. As one of the largest open-access initiative globally, EU-OPENSCREEN plays an increasingly important role in facilitating early stage drug discovery in Europe. It recently integrated fragment-based drug discovery and chemoproteomics as two new services, but the increasing complexity of modern drug discovery projects requires an even more comprehensive portfolio and integration of emerging technologies. To ensure that EU-OS continues to offer a comprehensive suite of relevant services and support a growing user community to conduct forefront research, IMPULSE will develop, validate and integrate new services in AI/ML, new chemical modalities, and innovative disease-relevant cell models combined with CRISPR-Cas9/RNAi-based genetic screening. IMPULSE will work towards the implementation of common operational and data standards to increase data reproducibility and FAIRness. Bespoke outreach and training activities will raise awareness among key user groups of its new services and advance operational excellence and reproducibility in pre-clinical drug discovery. New models for pre-competitive drug discovery with industry or charities, and growing ERIC member community will reinforce the sustainability and accessibility of EU-OPENSCREEN.

Strengthening resilience and mental wellbeing through the Support4Resilience toolbox for leaders in elderly care

European elderly care experiences labor shortages, lack of qualified workers and a mismatch between capacity and demands, causing stress, burnout, and reduced mental wellbeing among healthcare workers and informal caregivers. Leaders are crucial in promoting supportive working conditions but lack research-based measures to act upon these challenges.  Support4Resilience (S4R) will develop, implement, and evaluate a research-based Toolbox to support healthcare leaders in improving healthcare workers’ and informal caregivers’ resilience and mental wellbeing in elderly care. S4R will identify resilience and mental wellbeing factors among healthcare workers and informal caregivers; explore their perspectives and needs; develop new theory on the relationship between individual and organizational resilience, and mental wellbeing; and develop recommendations and cost-effective interventions. The Toolbox with tailormade resources for policy and practical use will be available through an open access S4R Resource Bank.  The S4R Toolbox includes three main tools: 1) Mapping and identification, 2) Reflection and education, and 3) Reorganization. Measures are initiated at the organizational level and effects on mental wellbeing and resilience transpire at the frontline of elderly care. The Toolbox covers different situational contexts, types of healthcare providers and health system levels. Elderly care settings in six European countries will implement and evaluate the Toolbox through a process evaluation, effectiveness evaluation, and cost-effectiveness evaluation.   S4R provides policymakers, decisions-makers and leaders with solutions for taking action to solve specific risks for healthcare workers’ and informal caregivers’ resilience and mental wellbeing. Thus, pertinent to the work programme, S4R will support the development of resilient health systems in European elderly care through improved leadership capabilities, governance structures, and adaptive capacities.

UNIVERSAL SENSOR BASED ON ELECTRICALLY-PUMPED MID-INFRARED SPECTROMETER ON SILICON CHIPS

High resolution optical spectroscopy in the mid-infrared (mid-IR) spectral range (3-12 µm wavelength) is an unambiguous way to detect and quantify small traces of greenhouse and toxic gases down to sensitivities of parts-per-billion. Such sensitivities are a prerequisite to safeguard low-pollution and toxic-free environment defined by the EU Action Plan: "Towards a Zero Pollution for Air, Water and Soil.” However, size, cost, and general complexity of the commercially available instruments limits their use to a small number of highly specialized applications, and prevents their deployment with sufficient coverage e.g. in networks, wearable electronics, etc. Particularly in the context of Internet of Things (IoT) devices, on chip integration of spectroscopic systems would constitute a game changer for mid-IR high-precision and portable sensors. The objective of UNISON is to address this challenge and demonstrate a highly scalable platform for infra-red spectroscopy that has both high-end performance and is compact. UNISON sensing scheme relies on dual comb spectrometers obtained by leveraging on electrically pumped cascade lasers (QCL and ICL) and on silicon-germanium (SiGe) mid-IR photonic circuits to surpass current spectroscopic systems in terms of detection bandwidth, point spacing and system compactness. UNISON is organized around 3 main cornerstones each of them relying on ambitious physical and technological challenges: (i) tunable large bandwidth frequency combs will be generated on SiGe photonics circuits  by combining electro-optical comb generation, non-linear effects and dispersion engineering ; (ii) the comb sources will be pumped by novel electrically-driven cascade laser sources integrated with the SiGe photonics circuits ; (iii) compact, broadband, and sensitive interaction region for trace gas detection, designed and optimized for the SiGe platform, will be integrated with the dual comb source to showcase the sensing capability of the spectrometer. 

Providing research infrastructure services to support Next Generation EU

This four-year project will harness outputs from key social science RIs in Europe and other reliable sources to support the aims of the ‘Next Generation EU’ programme and to inform EU youth policy. Virtual access will be provided to the outputs through special installations (portals) developed during the project. The core of the proposal is a set of existing research ‘services’, which will be re-purposed and customised to focus directly on the five themes: Make it Green; Make it Digital; Make it Healthy; Make it Strong; and Make it Equal.   For each area, the consortium will work collaboratively to produce seven sets of resources:  i)	A searchable inventory of relevant variables drawn from multiple cross-national datasets;   ii)	Analytical summaries, suitable for policy makers and analysts new to the field, as well as interactive resources available through the project portal;  iii)	Harmonised and merged extracts from these datasets that reduce the burden on analysts and increase sample sizes;  iv)	New data collected through the ESS’s established CRONOS web panel infrastructure. Eleven countries will field five waves of the panel, each one dedicated to a NextGenEU theme. Free and rapid access to the data will be available through the CRONOS portal alongside analytical summaries;  v)	In-person and virtual deliberative forums with young people (aged 18-34) in four countries covering the five Next Generation EU’ themes;  vi)	An educational tool (E-NextGen) channelling our data for use in classrooms and by the general public;  vii)	Comprehensive training materials related to all project outputs. 

Cooperation and AgReements enhancing Global interOperability for Aerosol, Cloud and Trace gas research infrastructures

The goal of CARGO-ACT is to deliver a clear roadmap for sustainable global cooperation between key ground-based aerosol, cloud and trace gas research infrastructures, each having invested in infrastructure and services to support their observing networks with a long-term perspective, with a view to consolidating into a sustainable global research infrastructure in the future. There is a strong desire for global integration from the research community, including weather, climate, and air quality monitoring and modelling,  and in particular from space agencies, since global networks of ground-based observations are an essential component complementing Earth Observation from space, providing calibration and validation of the remote sensing information collected by current and future satellite missions. The integration of the current ground-based networks, which may have different interests and priorities, requires cooperation and agreements at the global level, including engagement with relevant stakeholders. Their service provision is not limited to data services, but includes access to the measurement facilities, reference instruments, reference standards and laboratories, all of which are topics to be assessed in CARGO-ACT.    The specific objectives of CARGO-ACT are to, develop sustainable partnerships and decision making processes with relevant partners, demonstrate the benefits of converging interoperability and standards to stakeholders and the global research community, establish the mechanisms for providing  international access to distributed research infrastructures and develop a roadmap for upscaling towards an integrated global research infrastructure for aerosol, cloud and trace gases. 

Midlene fra RBGRUNSAMF-Res.bas.grunnbev.samf.v.inst fordelt på år

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Director

Grunnbevilgning - Frischsenteret

Resultatene fra hovedprosjektet tyder på at oxytocin levert med OptiNose-systemet fører til nese-til-hjerne (N2B) transport hos voksne. Det er ønskelig at fremtidige behandlingsregimer for lidelser som for eksempel for ASD også blir tilgjengelig for barn og unge. Det er imidlertid uvisst om leveringssystemet utviklet for voksne er egnet for bruk hos barn. Dessverre er ASD en kompleks og sammensatt lidelse og utviklingsprogrammet fram til markedet er tilsvarende utfordrende. Derfor vil vi heller gå for Prader Willy syndrom (PWS) som den første planlagte indikasjonen for oxytocin levert med OptiNose systemet. Nasal oxytocin har vist lovende effekter i PWS, en kompleks genetisk nevrologiske lidelse med kognitive/atferdsproblemer og fedme. PWS starter i tidlig barndom og det er et stort medisinsk behov for nye og bedre behandlingsalternativer. PWS er  klassifisert som en «sjelden sykdom» som gjør at det tilbys viktige fordeler hva angår utviklingstid, prising og markedseksklusivitet.
Ved denne forlengelsen av prosjektet har vi testet passform og brukervennlighet i individer under 18 år av et av leveringssystemene fra OptiNose utviklet for voksne og vi har dessuten samlet inn relevante antropometriske data hos ungdom og barn. Studien  begynte med den eldste aldersundergruppen (16-17 år) og fortsatte nedover mot den yngste aldersgruppen (6-7 år). Vi har fått svar på hvilke aldersgrupper som kan bruke leveringssystemet utviklet for voksne og i hvilke aldersgrupper det er nødvendig å gjøre tilpasninger av systemet. På bakgrunn av disse resultatene  har OptiNose utviklet prototyper som er spesielt tilpasset små barn og vi har testet funksjonaliteten av disse. 
Vi har dessuten laget nye  silikonmodeller av nese og bihuler som gjør det mulig å teste deponering av medikamener  hos pasineter som har gjennomgått operasjoner for kronisk biehulebetennelse. Vi har produsert avanserte og unike silikonmodeller som vi kan splitte  slik at vi kan pensle overflatene med en gele som simulerer den naturlige overflaten på slimhinneskifter.  Vi kan visualisere deponeringen i nesemoddellen ved at geleen skifter farge  når den kommer i kontakt med væske eller ved ved å bruke ulike fargestoffer.  Deponeringstudier i disse avanserte silikonmodellene  har gitt svært spennende og til dels uventede resultater som kan føre til nye patenter. Vi har presentert resultater fra disse studiene ved flere internasjonal vitenskapelig konferanser og resultatene kan også ha betyding kommersielt.
I forlengelsen av arbeidet med de beskrevne over har vi i samarbeid med norske firmaer også utviklet 3D-datamodeller av nese- og bihulegeometriene som muliggjør avanserte animajoner nesens og bihulenes anatomi og hvordan leveringsmetoden til OptiNose virker,  såkalt «utvidet/kunstig virkelighet» eller "augmented reality". Disse nye visualiseringsvertøyene er svært nyttig for instruksjon og opplæring av fagpersoner, patienter i alle aldre og deres omsorgspersoner og vi har vil også bruke dem kommersielt.

The primary objective of this project extension is to assess if an OptiNose exhalation delivery system used in adults is suitable for use in adolescents and children. 

Data suggest that oxytocin delivered with an OptiNose system may offer nose-to-brain (N2B) activity in adults.  It is desirable to make future treatment regimens also available, for example for autism spectrum disorder (ASD), to children and adolescents, but it is not known if the delivery system is suitable for pediatric use.  Unfortunately, ASD is a complex disorder, with a heterogeneous etiology, and the research program required is commensurately challenging.  It has been determined that Prader Willy syndrome (PWS) will be the first planned indication for an OptiNose exhalation delivery form of oxytocin. Nasal oxytocin has shown promising effects in PWS, a complex genetic neurodevelopmental disorder with cognitive/behavioral problems and obesity starting in early childhood where there is a high level of unsatisfied medical need for new treatment options.  PWS is also classified as an orphan indication, offering important advantages in development time and exclusivity. 

This extension project will test fit and usability in subjects under 18 of an exhalation delivery system known to be usable in an adult population and will collect anthropometric data. The study will begin with the oldest age sub-group (16-17 year old) and progress down towards the youngest (6-7 year old) until failure occurs.  Anthropometric data will help establish appropriate dimensions of an exhalation delivery system. If the fit or usability among age groups of subjects do not meet pre-defined levels, it may be determined that changes to the product design (for example, length of the flexible mouthpiece) may help subjects obtain an appropriate fit.  In that case, OptiNose may develop prototypes and test fit and usability in relevant age groups.

Usability assessment of an OptiNose exhalation delivery system in children

Narkolepsi er en kronisk søvnlidelse som skyldes tap av nerveceller i hjernen som produserer et viktig signalstoff, orexin-A (også kalt hypokretin-1). Narkolepsipasienter opplever skremmende nattlige hallusinasjoner og unormalt søvnbehov på dagtid med plutselige episoder med lammelse (katapleksi) utløst av følelser som latter og sinne. Narkolepsi er en nokså sjelden sykdom, men etter vaksinekampanjen i Norge for svineinfluensa i 2009/10 er det observert en mangedobling av antallet tilfeller hos vaksinerte barn og unge sammenliknet med jevnaldrende som ikke fikk vaksinen.  Tilgjengelige medikamenter har begrenset effekt og mange bivirkninger. Erstatning av signalstoffet orexin-A er ansett som den optimale terapi for denne tilstanden. Hjernen er et delikat organ og er ekstra godt beskyttet ved en barriere (blod-hjerne-barrieren) som hindrer de fleste stoffer å trenge inn i hjernen. Den nære forbindelsen mellom hjernen og nesen via luktenerven utgjør imidlertid en potensiell måte å omgå blod-hjerne-barrieren og dermed erstatte orexin-A mangelen hos narkolepsipasienter. 
OptiNose AS har utviklet en ny patentert metode for forbedret levering av medikamenter til nesen som har vist svært gode resultater i kliniske studier. En spesialvariant av leveringsmetoden for optimalisert "nese-til-hjerne" levering vil bli brukt i dette prosjektet. Hovione FarmaCiencia SA, Portugal vil utvikle og produsere en pulverformulering av orexin-A. De kliniske søvnstudiene vil bli gjennomført ved Nasjonalt kompetansesenter for nevroutviklingsforstyrrelser og hypersomnier (NevSom) ved Universitet i Oslo. Smerud Medical Research International AS vil overvåke planleggingen, gjennomføringen og analysene av de kliniske studiene og sørge for at disse oppfyller de regulatorisk krav som er nødvendig for å oppnå markedsføringstillatelse av en ny og bedre behandling for pasienter med narkolepsi og som også har med et stort markedspotensial. Den største utfordringen er formuleringsarbeidet som har tatt mer tid enn antatt. Problemene er identifisert og vi vurderer nye tilnærnimnger.Det har ikke vært mulig å løse problemene med formulering innenfor prosjektets tidsplan.

The aim is to develop an intranasal dry powder orexin-A formulation for the treatment of narcolepsy, a chronic sleep disorder caused by loss of nerve cells in the brain producing an important neurotransmitter orexin-A (also called hypocretin-1).Narcolepsy is a relatively rare disease, but following the vaccination campaign in Norway for swine-flu in 2009/10, it is observed a multiplication of the number of cases in vaccinated children and adolescents compared with their peers who did not receive the vaccine. Available drugs have limited efficacy and many side effects. Replacement of the neurotransmitter orexin-A is considered to be the optimal treatment for this condition. 

OptiNose has developed a new Breath Powered device technology for enhanced drug delivery into the brain along cranial nerve fibers innervating the upper part of the nose. This direct nose-to-brain circumvents the blood-brain barrier to offer better therapy also for other neurological and psychiatric disorders with great unmet needs. The innovative Breath Powered Bi-Directional nasal delivery system combined with a new dry powder formulation of orexin-A constitute the two underlying technological concepts in this proposal, whereas efficaciously treating narcolepsy with orexin-A is the third innovation. Partners include Hovione FarmaCiencia SA, Portugal; the National Centre for Neurodevelopmental Disorders and Hypersomnias (NevSom), University of Oslo and Smerud Medical Research International, Oslo, Norway. 

Work packages follow state-of-the-art methodology for drug development: drug formulation work, pharmacology and safety studies in rats and healthy volunteers, as well as two clinical proof-of-concept trials in patients.

The unmet therapeutic need, clear clinical endpoints and orphan status of narcolepsy make the OptiNose N2B orexin-A substitution an attractive product opportunity with high commercial potential and probability of success.

Nose-to-brain delivery of orexin-A - a novel therapy for narcolepsy.

BIA prosjektsammendrag 
Prosjektet arbeider med utvikling av en behandling for autisme ( ASD ) ved anvendelse av OptiNose teknologien for  levering av medisin direkte fra nesen til hjernen. En kjent substans med kjente positive effekter på evne  til sosialisering, vil bli testet med en OptiNose innretning som vil være optimalisert for «N2B» (nese-til-hjerne) levering. Høye doser som vanligvis brukes i dag i studier med substansen representerer en logistisk utfordring , og øker risikoen for uønsk ede bivirkninger ved lang tids bruk . Dette innebærer store utfordringer for den kliniske utvikling av denne svært lovende behandlingen til et kommersielt produkt . OptiNose i samarbeid med SINTEF , vil utvikle en optimalisert innretning for nese - til -  hjerne levering . SINTEF vil også være partner for optimalisering av  formuleringen.
Siden juni 2013 har vi , i samarbeid med Sintef , ferdigstilt design og produksjon av «N2B» innretningene  som vil  bli brukt i de kliniske studiene .  Vi har fullført pilotstudien og fase I klinisk studie - inkludert PK testing , fMRI og kognitiv testing av friske frivillige, i samarbeid med Smerud Clinical  Research( CRO ) og Oslo Universitetssykehus - ( Prof Andreassen og Assoc Prof Westlye .) Vi har analysert resultatene som er veldig lovende og den første artikkelen er publissert i et ledende psykiatrisk tidskrift.Vi har også presentert en poster med resultatene på  en prestigiøs psykiatri konferanse i Toronto. fMRI resultatene er akseptert for publikasjon i ledende tidskrift. Vi har fullført startet en fase 2a pilot studie på pasienter for å bekrefte funnene fra fase 1 før vi går igang med en full fase2 studie. Analysen av dataene viste positive resultater på enkelte parameter av kognitiv funksjon av ASD patienter. En vitenskapelig publikasjon er under utarbeidelse.

The project is pursuing the development of a treatment for Autism Spectrum Disorders (ASD) as a CNS therapy for the application of the OptiNose technology for nose-to-brain delivery.  A known compound with proven pro-social effects will be tested with an   OptiNose device that will be optimized for N2B delivery . High doses typically used today in studies with the compound represent a logistical challenge and increase the risk of adverse-events in long term use. These issues are major obstacles for the cli nical development of this very promising compound into a commercial product. OptiNose in collaboration with SINTEF, will develop a specific device customized for nose-to-brain delivery. SINTEF will also be the partner for the optimization of the formulati on.
In the clinical program OptiNose will collaborate with Oslo University Hospital and Smerud Clinical Research. The Phase 1 trial we l assess pharmacokinetics and explore the effects on brain activity and cognition by applying advanced fMRI in conjuncti on with validated cognitive tests. The Phase 2a trial will test the effect on cognitive and social symptoms in ASD patients. 
Positive outcome of these trials would make it possible to attract the funds for further development required for marketing appro val and commercialization, a major step towards a much needed therapy for ASD patients. The market potential of such product exceeds $1 Billion per year in sales. 
In addition, demonstration of N2B delivery in this project will represent a major breakthro ugh and will offer a new treatment modality in many other brain disorders.

Oxytocin delivered with the novel OptiNose nose-to-brain powder device - a novel therapy in Autism

Allergi og luftveissykdommer rammer 10-20% av verdens befolkning og er stigende i prevalens. Lokal medisinering er den foretrukne behandlingsmetode for disse gruppene av sykdommer. For systemiske medisiner (som skal virke i hele kroppen) og vaksiner har a dministrasjon via nesen svært mange fordeler. Markedet er i rask utvikling og kravene til nøyaktighet og reproduserbarhet av doseringen er svært strenge. Nesens slimhinne er, forutsatt optimal administrering, svært godt egnet til opptak av legemidler og a dministrering av vaksiner. Nye retningslinjer innen området (FDA i USA) setter strenge kriterier for medisinering og vaksinering via nesen. Problemstillingene beskrevet i denne sammenheng løses gjennom det patenterte behandlingsprinsippet til OptiNose.  Prosjektet det søkes om midler til er et forskningsamarbeid mellom OptiNose, Høgskolen i Telemark og Tel-Tek for doktorgradsarbeide innen numeriske simuleringer i avanserte geometriske strukturer. Doktorgradsarbeidet (dr.ing. grad avlagt ved NTNU) vil gi sentral forståelse og dokumentasjon over hvordan ulike leveringssystemer for medisiner kan optimaliseres. Bedre modeller for simulering av strømningsforhold i nesen vil også danne grunnlag for ny forståelse for liknende forhold i resten av respirasjonssys temet, samt øvrige deler av kroppen.

RBGRUNSAMF-Res.bas.grunnbev.samf.v.inst

Grunnbevilgning - Frischsenteret

Tildelt: kr 9,2 mill.

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RBGRUNSAMF-Res.bas.grunnbev.samf.v.inst

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