Biosensor for vaccine monitoring (BEAM)

Biosensor for vaccine monitoring (BEAM)

Terrassa, SpainSpain
Tipo de organización: 
Sin fines de lucro / ONG / Sector Civil
Presupuesto: 
$50,000 - $100,000
Resumen del Proyecto
Presentación del Proyecto!

Resumen conciso: Ayúdenos a presentar esta solución! Proporcione una explicación en 3 o 4 frases cortas.

Simple things can have huge impact.To assess the immune level against disease clearly impact on people future health so does in health systems. Low cost and high flexibiilty are the drivers of this concept.

About Project

Problema: ¿Qué problema está tratando de abordar este proyecto?

Nowadays, the unique method to know if a vaccine has provided immunity to certain disease is based on epidemiological data or by blood analysis in specialized units. Both options have limitations in terms of generalization instead of personal medicine when referring to epidemiological data and cost and time for decision making when referring to blood analysis. BEAM project will contribute to quantify the response of the immune system after vaccination, provide information on the maintenance of immunogenicity induced, enabling the identification of people who present a pre-existing immunity, save vaccinations to people who do not require vaccination, change schedule for people who may require it, reduce vaccination costs maintaining its effectiveness and safety

Solución: cuál es la solución propuesta? Por favor sé específico!

BEAM aims to develop an impedimetric label-free biosensor platform able to assess and quantify the antibody response after any vaccination program. The biosensor, based on hybrids biomolecule-nanoparticle, will reach a minimum sensitivity at nanomolar range by impedance spectroscopy measurements performed with a low-cost portable device capable of providing real-time individualized profile of the antibody response from a small blood sample. A three-year program of research developing a biosensor platform to assess the antibody response to human papiloma virus (HPV) vaccination has delivered a biosensing platform able to measure IgG against HPV types 16 and 18 by impedance spectroscopy processes.Now, it's time to expand to all marketed and under research vaccines.
Impact: How does it Work

Ejemplo: Guíenos a través de un ejemplo/s específico/s de cómo esta solución hace la diferencia; incluya sus actividades principales.

The goal of this project is to develop a cheap portable device able to deliver a real-time and personalized measure of the success after vaccination. The strategy set for this project will be a systematic parallel approach for each selected disease thanks to the two-step fabrication process. The major need is in the development wordl where people die from measles or malaria. So the first objective is set on this need where the impact is bigger. In paralel, it aimed to develop the device to assess the immunity of HPV vaccines to move to another marketed vaccines or close to the market such as cytomegalovirus for instance or therapeutic vaccines for alzheimer or some types of cancer.

Impacto: ¿Cuál ha sido el impacto del trabajo hasta ahora? Asimismo, describa el impacto previsto en el futuro para los próximos años.

The concept and the prototype has been presented in: ImagineNanno 2011, 7th Cancer Scientific Forum of the Cancéropôle CLARA(2012) ,EPOSS Annual Forum 2012, BIO 2012, BioEurope 2013, SPIE Microtechnologies 2013.
Sustentabilidad

Plan de Sustentabilidad Financiera: ¿Cuál es el plan para asegurar la sostenibilidad financiera de esta solución?

The plan is that in two years the device will be ready to be commercialized. All partners are in place, the activities asigned and there's a commitment of all members. The plan project a paralel work in nanotechnology, microelectronics and microfluidics that will converge in 16-18 months after project start. Then a validation process will be started as well as the roadmap to obtain the CE mark for IVD. The long term objective is to create a start-up that will manag the device, steer the research and act as IPR holder to act as a licensor to third parties while creates new innovations oriented to decentralized health.

Mercado: ¿Quién mas está abordando el problema aquí descrito ? ¿Cómo difiere el proyecto propuesto de esos enfoques?

Current interdisciplinary team, 2 SME plus 2 research performers, holds the required skills to bring the platform to a reality. Each member contributes to the project in a complementary manner from several knwoledge areas: microfluidics, nanotechnology, biomedicine and microelectronics. From the competition side, there isn’t any patent application or granted patent registered in the main patent repositories(WIPO, EPO, USPTO and JPO) with comparable features as the biosensor proposed in the BEAM project however several solution can be adapted to have similar functionality. FInally, there's one US company, Diagnostics for All, which is developing low-cost point of care devices for the developing world. However, the solution proposed by this company is less flexible than the proposed here.
Equipo

Historia fundacional

To be honest, the idea came after being vaccinated against Hepatitis B and I didn't reach the needed titer for protection so revaccination was required. This was the starting point to extend this experience at all levels: children, novel vaccines, professionals and health system. Based on current state of the art to bring new and simple device that could contribute to change the wordl health.
Nombre de la organización

Leitat, Technological Center

Sobre ti
Sobre ti
Nombre

Marc

Apellido

Masa

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Innovación
Explica de qué se trata la “innovación”, por ej.: ¿es la idea y/o el modelo que utilizas para lograr tu misión, o tu comprensión sobre la población objetivo, etc.?

The project is devoted to detect the immune response to vaccination based on the global and local vaccination programmes ongoing and to be established as well as its impact on the public health and on the public concerns on the safety. The innovation is based on current scientific knowledge as starting point to extend the state of the art in order to obtain a disruptive technology able to cover a current need in developed countries (HPV vaccination, cancer vaccines or influenza) but also opening opportunities for developing countries vaccination programs such as malaria, measles, etc... and/or quick actions to response a vaccine preventable diseases breakouts. The BEAM platform consists of two parts: plastic-based disposable biosensor and a portable reader. The main features are 1) to provide real-time individualized profile of the immune response to a vaccine or an infection, 2) affordability 3)feasible for industrial scale-up. It’s a label-free biosensor, combining printed electrodes and a microfluidic platform, able to quantify (≤ng/mL) in real time the immune response to vaccines or infection in a single device from a blood drop. Currently, a prototype(biosensor and a reader) is being validated with human healthy samples in order to assess its specificity and sensitivity.

Describe cómo se diferencia tu modelo de innovación en el campo, respecto al de cualquier otra organización.

There's no equivalent device avalable in the market or under research so far. .
Several stakeholders will benefit from the BEAM project:
Patients, it will perceive an increased protection from novel vaccines as well as better perception of individualized follow-up with special focus on children.
Healthcare systems, the expenditure incurred due to massive vaccination programs could be rationally reduced and the surveillance of the public health will be improves to finally reach an evidence based rational use of economic health resources.
Healthcare professional, BEAM l will contribute to the patient follow up and the decision making on vaccine preventable diseases
Health industry viewpoint, BEAM will facilitate the assessment of marketed vaccines and those which under research.

¿Qué tipo de sistema operativo y factores internos de la organización hacen que tu innovación sea un éxito?

The project BEAM is under progress so all the required actors are already together to deliver the platform. Two research centers (Leitat and Fraunhofer) together with two companies are actively working on tihis project. Leitat has being recognized as innovation center by several national and international institutions and it holds in-house expertise and knowlledge to push this project forward as done before in several national and international (e.g.FP7 projects).

¿Cómo te aseguras que innovas constantemente a la luz de (potenciales) desafíos externos, o cuál es tu plan de crecimiento?

Taking into account information from: 1)Available project results 2)Evaluation of possible industrial outcome for the research “products” developed 3) Estimation of the economic impact of the processes developed under the project 4) Observation of market trends and positioning of the new product resulting from the project 5)Market analysis (actual market needs and size, EU/US and GAVI countries, 6) Identification of potential pharmaceutical/diagnostic companies .Additionally, specific actions to define the supply chain, key resources, customer segments, key activities and key partners required will also be done in order to develop a potential business model based on the biosensor platform.

País de la organización

, BA

Modelo de Negocios
Desafío sistémico que tratas de superar (selecciona sólo uno)

Desarrollar nuevos incentivos en los del sistema de salud para crear mayor valor hacia la sociedad o

Área de salud (mercado objetivo) donde se encuentra la necesidad (selecciona solo uno)

Servicios primarios de asistencia médica

Categorías de la atención medica que estés cubriendo [selecciona todas las que correspondan]

Prevención, Detección, Intervención, Seguimiento, Cuidado a largo plazo.

Etapa que mejor aplica para tu solución [selecciona sólo una]

Inicio (un piloto que recién ha comenzado a operar)

Estrategias centrales de tu modelo de negocios (selecciona todas las que correspondan]

Diseño centrado en el paciente, Re-diseño del sistema público de atención de la salud, para una mejor eficiencia (en términos de procesos, estructura, etc.), Nuevos/redefinición de roles de prestaciones de servicio de atención de la salud, Nuevas estrategias financieras para la salud.

Por favor especificar
Herramientas más relevantes que estés utilizando para implementar las estrategias destacadas arriba [selecciona sólo dos]

Tecnología, Nuevas habilidades.

Por favor especificar
¿Cuál es tu propuesta de valor?

The final product companion will be unique. Based on previous technological vigilance and competition analysis performed up to now, no similar sensor is available. This fact opens a big market opportunity. Moreover, the device concept is flexible enough to adapt to several types of vaccines becoming a platform technology approach where several options can be build up on top such as animal health. Based on the flexibility it can be adapted to particular needs according to country policies. From our perspective, there's different needs between developed countries in front of the requirements of GAVI countries.

¿Quiénes son los beneficiarios se los que se dirige tu trabajo?

several stakeholders will benefit from
Patients perspective, it will perceive an increased protection from novel vaccines as well as better perception of personalized follow-up with special focus on children (HPV vaccine target)
Healthcare systems, the expenditure incurred due to massive vaccination programs could be rationally reduced and the surveillance of the public health will be improves to finally reach an evidence based rational use of economic health resources.
Healthcare professional standpoint, it will enable the quick identification of infected vs. healthy individuals and also it will contribute to the patient follow up and the decision making on vaccine preventable diseases.
Health industry viewpoint, facilitate the assessment of marketed vaccines and under development

¿Qué enfoques utilizas para llegar a ellos?

A multitier approach will be adopted. Define a target product profile and target market profile to identify particularities for each disease and country regulations. Identify unmeet needs in the vaccine area as well as identify and interview KOL and decision makers. Perform dissemination activities in the scientific enviroment and promote the device in partnering events like BIO, Bio-Europe, Bio-Asia, etc...
Approach the World Bank and the Asian Bank of Development to introduce the proposal to contribute to solve some of the identified needs
Including the accomplishment of the directive 98/79/EC on in vitro diagnostic medical devices as framework for quality assessment and reliability and its counterpart for each country to enter in the market such as 510(k) for FDA (USA).

¿Cuáles son tus actividades principales?

My role was to generate the idea, define the project and obtain technical, human and finantial resources to develop the concept up to a prototype. I've been steering the project.

¿Qué otros desafíos – individuales, organizacionales o ambientales – estás actualmente enfrentando o que podrían impedir el éxito futuro de tu emprendimiento y cómo planeas superarlos?

The full project success will rely on the technological innovation and the growing biomedical knowledge corpus. Being carefully observant to the all technological areas involved in the project could probably avoid unexpected deviations. Finally, the current financial crisis and the uncertainty success from current actions taken are dramatically affecting the society, governments and all the industrial sectors.

Describe brevemente tu estrategia de crecimiento futura

Once the research period and the proof of concept accomplished will be finished, the IPR secured and CE mark obtained. All the the key actors are already together so the cost to be incurred after the project and before exploitation: as initial series of 10.000 units of biosensors plus 1000 units of readers,the cost to be incurred, including management and commercial activities would be 170K€

¿Qué dimensiones de crecimiento estás actualmente focalizando para tu innovación? [selecciona todas las que correspondan]

Nuevos clientes grupo/s.

¿Qué hace que tu negocio esté “listo” para crecer?

There's a prototype already in place. The biosensor performance has been tested under lab conditions so now it's time to identify the industrial partner, secure the supply chain, contrast the concept with KOL and raise finantial resources.

¿Cuáles son tus objetivos centrales de crecimiento?

The main objective is to obtain the clearance to market the device to then become a licensor of the IPR by disease or indication. Special treatment it's considered for diseases associated with poverty where special agreements must take place.

Impacto social
¿Qué métodos cuantitativos de impacto social estás aplicando (si estuvieras aplicando alguno)?

N/A

¿Tu solución podría operar en otros conextos o regiones? Si así fuera, ¿en dónde?

Yes. According to the vaccination program or outbreak for each region or country.

¿Cuál es tu impacto proyectado para los próximos 1-3 años?

The current project converge technologies with greatest expectations in the short future: nanotechnology, microfluidics and smart biosensors. Taken all together, the project outcome will be aligned with the new strategy set by Horizon 2020: strength Union’s excellence, tackle societal challenges linking research and market, and contribute to the so called bioeconomy part of the Europe’s global competitiveness.
The proposed platform will contribute to increase the capacity of surveillance and monitoring of vaccine-preventable diseases which will turn into a putative improvement and reinforcement of the current immunization programs

País/es en los que opera la organización

, BA, Terrassa

Sostenibilidad
Explica detalladamente tu estrategia financiera actual

The current finantial strategy is based on partnering with third parties to apply to Calls like FP7, Eurostars, Eurotransbio, World Bank and so on. Current economic dowtime impedes to my institution to commit with internal funding to push forward the project.

Reparto de la generación de ingresos del total de ingresos de la organización (en porcentaje)

89% R&D / 11% Advanced technological solutions

Ventas directas a pacientes u otros beneficiarios (en porcentaje)

N/A

De las posibles fuentes de estas ventas, en la siguiente lista, marca todas las que correspondan a tu estrategia actual

Pacientes, Profesionales de la salud, Empresas privadas.

Tarifas de licencia, por ej., por tecnología/ modelo de franquicia (en porcentaje)

Upfront payment plus royalties on sales. Licensing by diseases.

Abajo, marca todas las que correspondan a tu estrategia actual

Fundaciones, Gobierno regional, Gobierno nacional.

Contrato de servicio con organizaciones, por ej. gobierno, ONGs (en porcentaje)
De las posibles fuentes de contratos de servicios, en la siguiente lista, marca todas las que correspondan a tu estrategia actual

Fundaciones, Gobierno regional, Gobierno nacional.

Explica tu estrategia de generación de ingresos más detalladamente

Currently, the strategy adopted is to submit the project to open calls related with the proposal. At this time, no internal resources are available to push forward the concept.

Reparto de la generación de ingresos del total de ingresos de la organización (en porcentaje)

89% R&D / 11% Advanced technological solutions

Estrategias filantrópicas que estás utilizando

Estrategia diversificada.

Explica tu enfoque filantrópico con más detalle

Several project calls has been applied to obtain finantial resource to approach several diseases. The project has been proposed and approved by the Spanish government to bring the idea to a prototype which included a loan. After that, the project was submitted to Bill&Melinda Gates Foundation together with the unit of Poverty related diseases of the Centro de Investigación Biomédica Esther Koplowitz (CIBEK). We didn't succeed. Recently, the project has been submitted to the EuroTransBio call. We're waiting for the resolution.

Amplia tu selección; explica cómo mantendrás el financiamiento dentro de los próximos 1 a 3 años.

In addition to the potential success to obtain finantial support from Eurotransbio call, it's also under consideration to creat a spin-out of the technological center as a way to raise capital and bring the device to the validation phase.

Años de operación

Operando más de 5 años

¿Tu organización ha recibido premios y/u honores? Cuéntanos sobre ellos.

LEITAT is a Technological Center, member of TECNIO and recognized by the Ministry of Economy and Competitiveness, that aims to collaborate with companies and institutions by adding technological value both to products and processes, and focuses its activity on research, development and industrial innovation (R+D+2i).
As Technological Partner, the Center is clearly committed to adaptation to transform the technological challenges into economic and social value. Since its foundation in 1906, LEITAT has prioritized its vocation of proximity by strengthening the principles of professionalism and respect to people and environment at the same time.
Awards and certifications
Awards finalist on VI l international automobile fair in Barcelona
Presentation the new Leitat Technological Center headquarters in Terrassa
Prize CECOT the institution for the contribution to the country’s economic and business development
Recognition of the FIA (International Federation of Automobile)
Getting the RENAULT self validation for approval of its supplier components
Founder member of the ATIT (Association of technical the Indústria textile)
Quality management system (standard UNE EN ISO 9001: 2008)
Quality management system BIOINVITRO Division (standard UNE EN ISO 9001: 2008)
Environmental management system (standard UNE EN ISO 14001: 2004)
R&D management system (standard UNE 166002: 2006)
Collaboration to the Community system of management and environmental audit (EMAS)
Governed by Regulation EC Nº 731/2001
Recognised for Excellence 3 star. EFQM 300+