Biosensor for vaccine monitoring (BEAM)

Biosensor for vaccine monitoring (BEAM)

Terrassa, SpainSpain
Organization type: 
nonprofit/ngo/citizen sector
Budget: 
$50,000 - $100,000
Project Summary
Elevator Pitch

Concise Summary: Help us pitch this solution! Provide an explanation within 3-4 short sentences.

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

Problem: What problem is this project trying to address?

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

Solution: What is the proposed solution? Please be specific!

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

Example: Walk us through a specific example(s) of how this solution makes a difference; include its primary activities.

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.

Impact: What is the impact of the work to date? Also describe the projected future impact for the coming years.

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.
Sustainability

Financial Sustainability Plan: What is this solution’s plan to ensure financial sustainability?

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.

Marketplace: Who else is addressing the problem outlined here? How does the proposed project differ from these approaches?

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.
Team

Founding Story

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.
Organization Name

Leitat, Technological Center

About You
Innovation
Explain what the "innovation" is about, e.g., is it the idea and/or the model you use to accomplish the idea, or your understanding of the target population, 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 how your innovation model is distinct from any other organization in your field?

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.

What type of operating environment and internal organizational factors make your innovation successful?

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).

How do you make sure you constantly innovate in light of (potential) external challenges, or your growth plan?

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.

Organization Country

, BA

Business Model
The systemic challenge you are trying to overcome (select one)

Realign the incentives in the public healthcare system in mature markets, or

Health area (target market) where the need is [select only one]

Primary healthcare services

Categories along the health continuum you are covering [select all that apply]

Prevention, Detection, Intervention, Follow-up, Long-term care.

Stage that best applies to your solution [select only one]

Piloting (a pilot that has just begun operating)

Core strategies of your business model [select all that apply]

Patient-centered design, Redesign of the public healthcare system for more efficiency (in terms of processes, structure etc.), New/redefined roles for healthcare service provision, New financing strategies for health.

If other, specify here:
Most relevant tools you are using to implement the strategies outlined above [select only two]

Technology, New skills.

If other, specify here:
What is your value proposition?

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.

Who is your customer(s)?

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

What approaches to you use to reach your customers?

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).

What are your primary activities?

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.

What other challenges - individual, organizational, or environmental – are you currently facing or might hinder future success of your business, and how do you plan to overcome those?

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.

Briefly describe your growth strategy going forward

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€

What dimensions for growth are you currently targeting for your innovation [select all that apply]

New customer group(s).

What makes your business "ready" for growth?

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.

What are your key growth objectives?

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.

Social Impact
What methods for quantification of social impact are you applying (if at all)?

N/A

Could your solution work in other geographies or regions? If so, where?

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

What is your projected impact over the next 1-3 years?

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

Organization's Country of Operation

, BA, Terrassa

Sustainability
Elaborate on your current financing strategy

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.

Share of revenue generation in total income of organization (in percent)

89% R&D / 11% Advanced technological solutions

Direct sales to patients or other beneficiaries (in percent)

N/A

Of the possible sources of these sales listed below, check all that apply to your current strategy

Patients, Caregivers, Private businesses.

Licensing fees, e.g., for technology/franchise model (in percent)

Upfront payment plus royalties on sales. Licensing by diseases.

Of the possible sources of these licensing opportunities listed below, check all that apply to your current strategy

Foundations, Regional government, National government.

Service contract with organizations, e.g., government, NGOs (in percent)
Of the possible sources of the service contracts listed below, check all that apply to your current strategy

Foundations, Regional government, National government.

Explain your revenue generation strategy in more detail

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.

Share of philanthropy in total income of organization (in percent)

89% R&D / 11% Advanced technological solutions

Philanthrophy strategies you are using

Diversified strategy.

Explain your philanthropic approach in more detail

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.

Expand on your selections; explain how you will sustain funding over the next 1-3 years.

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.

Years in Operation

Operating for more than 5 years

Has the organization received awards or honors? Please tell us about them

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+