EATRIS focuses on preclinical and early clinical development of drugs, vaccines and diagnostics. Solutions are provided in the fields of advanced therapy medicinal products, biomarkers, imaging and tracing, small molecules and vaccines. The wide-ranging services portfolio focuses on supporting early decision-making and de-risking of projects with a focus on safe and efficient progression into clinical development.
Examples include validation and development of in vitro and in vivo biomarkers for patient stratification, molecular imaging tracers for drug development programs, GMP manufacturing of cellular therapy products, patient-derived xenograft models and many more highly specialized services.
Advanced Therapy Medicinal Products represent a new category of medicines with a wide therapeutic potential for treating different types of diseases such as cancer, neurodegenerative and cardiovascular diseases. They include Gene Therapy Medicinal Products, Cell Therapy Medicinal Products, and Tissue Engineered Products. Clinical application of the two latter types is frequently referred to as ‘Regenerative Medicine’. The platform provides the most qualified and state-of-the-art technologies for the critical issues in this development area, such as specialized GMP facilities, imaging facilities for in vivo animal studies, availability of dedicated/tailored animal models, clinical expertise and access to patients for high prevalence and/or rare diseases, as well as to clinical facilities. The platform includes a network of experts for regulatory affairs specialized in the ATMP field to ensure compliance with the preclinical and clinical development guidelines within Europe.
EATRIS-CZ participation: IEM, ICRC
Major technologies/infrastructures: GMP production plants, clinical trial units, animal facilities, imaging
Small molecules platform:
The EATRIS Small Molecules platform supports the pre-clinical and clinical development of drug candidates, utilizing academic expertise around novel targets and molecular scaffolds. The platform offers expert translational medicine institutions and has access to advanced screening facilities with innovative cell-based assays as well as integrated use of the latest biomarker techniques. Tailored animal models help shorten the time to in vivo proof of concept and study the mode of action of novel drug candidates and targets, supported by experts in pharmacology, medicinal chemistry, analytical chemistry and toxicology. In addition, crossover synergy is provided by the EATRIS Imaging & Tracing and Biomarker platforms to speed up small molecules development programmes to achieve early proof of concept all within one infrastructure.
EATRIS-CZ participation: IMTM, UCT Prague, IOCB Prague, IMC
Major technologies/infrastructures: uHTS/HCA analysis, medicinal chemistry, scale-up synthesis, analytical chemistry, drug formulation, GMP production plants, clinical trial unit, animal facilities, imaging
The EATRIS Vaccines platform covers the entire vaccine development and production pipeline ranging from late-phase pre-clinical development to clinical trials. Partnering with most advanced development centers, the Vaccines platform offers proven state-of-the-art resources for all critical issues related to vaccine development. They include specialized GMP provision with accompanying formulation and adjuvantation; disease specific animal models with facilities up to BSL3 containment; immunomonitoring, and access to clinical facilities with relevant patient groups up to phase IIa trials. The EATRIS Vaccines platform also provides a network of experts on regulatory affairs specialized in vaccines, to ensure compliance with all pre-clinical and clinical development guidelines within Europe. This allows us to bring projects forward in the minimum of time and with the most efficient use of resources, while ensuring high levels of scientific discipline and regulatory compliance.
EATRIS-CZ participation: IM
Major technologies/infrastructures: flow cytometry, BSL2/3 labs, animal facilities, imaging, specialized cell culture and modification techniques
In the era of personalized medicine, biomarkers play a crucial role in diagnostic and treatment decisions. Biomarkers also represent a key strategy for innovative clinical trials (e.g. patient stratification) that will facilitate cost-effective and speedy assessment of new drugs for efficacy and marketing approval. EATRIS Biomarkers Product Platform facilitates the validation and development of biomarkers for the prevention, diagnosis and prognostic assessment of disease as well as for the prediction of therapy response. EATRIS biomarker institutions utilize cutting edge infrastructures as well as a range of scientific, technological, clinical and regulatory expertise to operate professional and high-quality standardized services in biomarker development.
EATRIS-CZ participation: IMTM, CEITEC-MU, 1.FM CU
Major technologies/infrastructures: PCR techniques, NGS, DNA hybridization and sequencing, flow cytometry, imaging, specialized cell culture and modification techniques, cell and molecules purification techniques, proteomics, genomics, metabolomics, mass spectrometry
Imaging & Tracing platform:
The EATRIS Imaging and Tracing Platform provides a single point of entry to high-end expertise and cutting-edge translational imaging facilities, defragmenting the scattered nature of technical know-how and making optimal use of resources to improve R&D output.
EATRIS-CZ participation: IMTM, NPI
Major technologies/infrastructures: cyclotrons, in vivo imaging, animal facility, (GMP) production plants for tracers, radiochemistry.