Spain is represented in EPTRI project by “Fundació Sant Joan de Déu” (FSJD) and “Servicio Madrileno de Salud” (SERMAS) with “Hospital Universitario La Paz” (HULP).
FSJD is the leader of the work package of “Communication, networking and patients involvement” and SERMAS-HULP is co-leading the work package on the “Context Analysis”. They also collaborate in several other work packages including the thematic research platforms “paediatric medicines discovery” and “paediatric biomarkers and biosamples”.
The Spanish respondents of the EPTRI WP3 surveys show to have mainly expertise in “paediatric medicines discovery” (50%) in the fields of haematology, immunology and cardiology and “paediatric biomarkers and biosamples” (40%) in identifying and characterizing biomarker used as prognostic and diagnostic tools. A smaller group of respondents has expertise in “developmental pharmacology” (7%) and in “paediatric medicines formulation and medical devices” (3%).
The EPTRI initiative has also received the official support from the Spanish Government. On the 17th of March 2020, the Directorate-General of Public Health, Quality, and Innovation of the Spanish Ministry of Health has signed the Expression of Political Support letter to EPTRI. Moreover, the Spanish Government supports the inclusion of EPTRI in the European Strategic Forum for Research Infrastructures (ESFRI) Roadmap 2021.
To date, several Institutions among which, Universidad de la Laguna (ULL), the Health research Institute Foundation of Santiago de Compostela (FIDIS), the Servizo Galego de Saude (SERGAS) and Fundació Sant Joan de Déu, provided letters to express their interest and support to the EPTRI initiative recognising its relevance for the paediatric research.
In addition, the ULL, SERGAS, FSJD and “Fundacion para la investigation del Hospital Universitario de La Paz” (FIBHULP- SERMAS) signed the Memorandum of Understanding (MoU) to state the intent to develop the EPTRI Infrastructure and organise the main research institutes into a National Node (the Spanish Hub) to link the Spanish scientific community to EPTRI.
The Spanish Hub (EPTRI-ES) is coordinated by the Spanish Paediatric Clinical Trials Network (RECLIP) and will be constituted by the following Institutions:
- Servizo Galego de Saúde (SERGAS): It is the organism in the Xunta de Galicia in charge of the healthcare public assistance. It integrates all the regional healthcare centres and services.
- Spanish Paediatric Clinical Trials Network (RECLIP): It works as the national reference hub for all the international or national initiatives dealing with paediatric clinical trials. It ensures a safety and effective conduction of paediatric clinical trials in several therapeutic areas, as vaccines, infectious diseases, neonatology, and medical devices.
- Health research Institute Foundation of Santiago de Compostela: The research groups involved work on all paediatrics research area. They study the paediatric mechanism of development of allergy, and vaccines and collaborate in early drug discovery projects mainly in the discovery of new target, hit finding for new target modulators and biological evaluation of small molecules with therapeutic interest. Moreover, they perform in vitro/in vivo pre-clinical studies on biological evaluation of small molecules with therapeutic interest.
- Fundació Sant Joan de Déu: FSJD conducts research in several fields as health technologies, biological and psychological problems related to paediatric diseases, and paediatric cancer. The research groups study new treatments (pharmacological therapy, biological drugs and immunotherapy) on preclinical models of paediatric solid tumours. They perform identification, experimental validation and rational drug design applied to paediatric diseases, and study paediatric development mechanism in immunology, neurology and infection. Moreover, they apply stem cell biology, regenerative medicine, and tissue engineering approaches to cartilaginous regeneration.
- Servicio Madrileno de Salud (SERMAS) – Hospital Universitario La Paz – La Paz Institute for Biomedical Research (HULP-IdiPAZ) – Fundacion para la investigation del Hospital Universitario de La Paz (FIBHULP): The pediatric team at HULP is focused on infectious diseases in children, addressing epidemiology, clinics, diagnostics and new therapeutic approaches for some of the most frequent diseases during childhood. From congenital to emerging infections, including viral, bacterial and parasitic infections, the group is interested in host-pathogen immune interaction. Vaccine response in high risk populations, from neonates to oncology patients is also the focus of intense research by the group. Research on new diagnostic biomarkers for infectious diseases in children is ongoing and the group is involved in several clinical trials for developing new treatments. Other research interests include the role of the human microbiome in health and disease.
- Hospital Universitario La Fe – Instituto de Investigación Sanitaria La Fe: It works on several research areas as neonatology and neonatal/paediatric intensive care. They study the paediatric development mechanism which could influence the onset of diseases in the fields of immunology, neurology, oncology, infection (eg encephalopathy), hormonal research and other as cystic fibrosis, celiac disease and cardiac congenital diseases. The research groups work on stem cell from umbilical cord blood and mesenchyma, Induced Pluripotent Stem cells, neonatal cardiomyocytes, and regenerative medicine approaches for skin and heart diseases. Moreover, they use biomarkers as diagnostic and prognostic tools for paediatrics radiomics in neuroblastoma and pontine glioma.
- Hospital Universitario Ramón y Cajal – Instituto Ramón y Cajal de Investigación Sanitaria: They perform clinical research in the fields of stem cell biology and regenerative medicine for the treatment of bronchopulmonary fibro dysplasia. They works to identify novel drugs targets in foetal, neonatal, and paediatric population, and biomarkers (miRNAs) to diagnose, prognosticate and predict bronchopulmonary fibro dysplasia and Acute Kidney Injury (AKI) in cardiac surgery in children. In addition, they study the paediatric development mechanisms in the onset of immunological diseases (paediatric systemic lupus erythematosus), infection (vasculitis), inflammatory diseases and other rare diseases. Furthermore, they perform dosage calculation for first in child pharmacokinetics.
- Hospital Clínico San Carlos – Instituto de Investigación Sanitaria Clínico San Carlos: It promotes research and provides methodological support for clinical trials. Their research groups perform activities in different research areas that include experimental validation of novel paediatric drug targets, development of the molecular and experimental pharmacology, and stem cell biology (eg iPSC). In particular, they are active in cardiovascular diseases and neurosciences working on a comprehensive preclinical study on cerebral and extracerebral protective effects of cannabidiol in acute newborn piglets brain damage.
- Hospital Universitatio Vall d’Hebron – Vall d’Hebron Institute of Research: The institution promotes biomedical research in several research areas as immune-mediated diseases and innovative therapies, obstetrics, paediatric and genetics. They study paediatric development mechanism which could be relevant in the fields of immunology, oncology, neurology and infection. They develop new models’ platforms from placental, umbilical cord and 3D organoid cell cultures by paediatric samples. Their expertise include identification and experimental validation of novel paediatric drug targets as the identification of new drugs in the treatment of rhabdomyosarcoma by targeting embryonal signaling pathways (Notch, Hedgehog, Wnt) and neuroblastoma (epigenetic drugs), the development of molecular and experimental pharmacology (Genomics, Metabolomics). The biomedical research works on human and animal embryonic stem cells.
- Hospital Infantil Universitario Niño Jesús: It is dedicated exclusively to paediatric pathology with several medical specialties areas as Paediatric Palliative Care, Growth and Metabolism, and General Paediatrics. The research groups study the paediatric development mechanism in the fields of oncology and haematology. Their mainly works on advanced therapy medicines, but they are also leader in the field of stem cell biology and its application in gene therapy. As other institutions, they perform identification of novel drug targets of foetal, neonatal and paediatric populations and drug design applied to paediatric diseases (eg neuroblastoma). Moreover, several research groups are focused also on acute leukaemia in children.
- Hospital General Universitario Gregorio Marañón – Instituto de Investigacion Sanitaria Gregorio Marañón: Several research are covered at this Institute. In particular, some research units work on biomarkers used for surfactant protein B (SPB) deficit diagnosis, HIV paediatric vaccines and specific miRNA in HIV development, determinate immune profile by flow cytometry, and use Interleukins as predictive markers in response to therapy. Moreover the Stem Cell Therapy and Regenerative Medicine Unit studies paediatric developmental mechanism for osteogenesis imperfecta and epidermolysis bullosa, and works on the production of mesenchymal stem cells from fat and bone marrow, T-reg cells, and NKs cells, but also on experimental validation of novel paediatric drug targets. Moreover, they have a well-established Biobank with a collection of paediatric donors of HIV, tuberculosis, rare diseases, neutropenia, bronchiolitis, and pertussis.
- Hospital 12 de Octubre – Instituto de Investigación – Sanitaria Hospital 12 de Octubre: The Paediatric Infectious Diseases Unit studies biomarkers and therapeutic targets for pneumonia and Kawasaki disease. They also synthetize biomarkers of severe infections, pneumonias, and viral infections. Moreover, they started to collaborate for the creation of a new biobank that include Kawasaki and Tuberculosis (TB) samples.
- Barcelona Institute for Global health (ISGlobal): The main thematic area of research are viral and bacterial infections; maternal, child and reproductive health, and malaria. Its research groups work on biomarkers and therapeutic targets used as diagnostic and prognostic tools for differentiation of clinical pneumonia syndrome and malaria.
- HM Hospitales – Fundación de Investigación HM Hospitales (FiHM): It is committed to translational research as a strategic support area for healthcare activity. Their unit can identify molecular markers in paediatric brain tumours like rhabdomyosarcoma, Ewing sarcoma, Primitive Neuro-Ectodermal Tumors (PNET) tumours, diffuse intrinsic pontine glioma (DIPG), rhabdofibromatosis, histiocytic disorders and soft tissue sarcoma. They use biomarkers as diagnostic tool for paediatrics peripheral blood analysis to look for proteins, antibodies or DNA, and as prognostic tool for medulloblastoma, high grade glioma and rhabdomyosarcoma. Furthermore, they use biomarkers as drug target in paediatrics, and when possible, use targeted drugs. In addition, they conducted research projects with the aim of identify new molecular markers.
- Hospital universitario Reina Sofía de Córdoba – Instituto Maimonides de Investigación Biomédica de Cordoba (IMIBIC): It is a multidisciplinary research space where scientists from the academic and health care sectors work together. The Clinical Research Units study paediatric development mechanisms in oncology and hormonal research, and the effect of the drugs (metformin for obesity) in prepubertal and pubertal children. They also evaluate how to improve both the follow up and specialized care for children with deficits in growth hormone. They also perform study on animal models and develop new model platforms from placental and umbilical cord.
- Universidad de la Laguna (ULL): Its research projects cover all paediatric research areas. In the fields of paediatric medicines formulation and medical devices, its research groups works on the characterization and stability of macromolecules, drug release systems and development and validation of child-friendly medicines with active principles ingredients (API). They also perform design of paediatric oral formulation, and study of quality and stability of formulations for oral paediatric administration.