Transbiohope | WP´s
Transbio project, oriented to the development of an in vitro diagnostic kit for the treatment of chronic rejection with immunosuppressants. H2020 program of the European Union
"trasplante riñón” “diagnóstico in vitro” “in vitro diagnosis” “trasplante renal” “H2020” “European Commission project” “renal transplant” “kidney transplant” “start-up” “Tres Cantos” “biomedicina” “biomedicine” “biotechnology” “immunobiogram” “inmunobiograma” “tratamiento inmunosupresores” “Treatment with immunosuppressants”
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WP1: Pilot clinical study for prototype test kit tuning up

The objective of this WP1 is to optimize the prototype test kit already developed and patented by BioHope. This will be done by a pilot study involving 60 patients (study protocol already approved by the Ethics committee, see section 5) in collaboration with Hospital Puerta de Hierro (Madrid). This pilot study performed with real patients, will enable the selection of the most clinically relevant cellular/molecular markers from those currently integrating the test kit prototype developed and validated in vitro by BioHope. Therefore, the final objective we seek in this WP is to end up in an optimized prototype test kit for achieving a price reduction that will undergo a large scale clinical validation study in WP2.

WP2: Multicenter validation study for prototype validation

The objective of this WP2 is to validate the clinical and analytical utility of the prototype test kit optimized in WP1 as a tool for a double end: a) tool for the early identification of patients at risk of chronic rejection or showing a clinical operational tolerance (diagnostic tool) and b) tool for the selection of the optimal immunosuppressive therapy for patients diagnosed at risk of chronic rejection (companion diagnostic tool). This will be done by a transnational multicenter validation study involving 300 patients in collaboration with a network of 7 renowned Nephrologist of the following hospitals in Europe and 1 in USA: Hospital Puerta de Hierro (Spain), Hospital Vall d´Hebron (Spain), Hospital del Mar (Spain), Univesitätsklinikum Essen (Germany), Medica University Borowska (Poland),  Massachussets General Hospital (Boston, USA), University Hospital of Copenhagen (Denmark).

WP3: Biostatistics and software development

The objective of this WP3 is to perform a bio-statistical analysis (big data analysis) of all clinical (patient´s clinical history) and experimental (molecular/cellular markers measured in blood plasma measured by our prototype test kit by ELISA and flow cytometry and urine analysis performed by conventional clinical analysis) obtained in sample analysis. The bio-statistical analysis will enable the correlation of all clinical parameters involved in the immunological response profile for each of the patients recruited in the pilot study (WP1) and the multicenter validation study (WP2).

WP4: TRANSBIO Project Management

The objectives of the WP are as follows:

To ensure all legal, contractual and financial obligations are carried out in an appropriate manner.

To ensure that the technical developments of the project are carried out in accordance with the work plan and associated budget in order to achieve the milestones and objectives.

To supervise the whole project and keep optimal use of the resources.

To monitor aspects of ethical issues and regulatory aspects.

WP5: Plan for TRANSBIO commercialization

The main objectives of this WP4 are:

To prepare a communication strategy aimed to involve key stakeholders (key opinion leaders-KOLs, public health administration as payers, patient organizations, etc.).

To prepare and implement a Regulatory Affairs strategy with Public Administrations in TRANSBIO countries

To prepare a plan for commercialization of TRANSBIO.

To ensure an efficient existing IP management and the strategic protection of the new knowledge.

WP6: Ethics requirements

The objective is to ensure compliance with the ‘ethics requirements’ set out in this work package. This work package sets out the ‘ethics requirements’ that the project must comply with.

To ensure an efficient existing IP management and the strategic protection of the new knowledge.