TransMed Research - TMR is dedicated to research, development and technology transfer for health products in the pharmaceutical, biotechnology, cell therapy and regenerative medicine sectors. In addition to its own research activities, TMR aims to develop services certified in accordance with the standards of Good Laboratory Practice, as defined by the Organisation for Economic Co-operation and Development.
It supplies studies and tests to regulatory agencies such as the AIFA (Italian Pharma Agency), the EMA (European Medicine Agency) and the FDA (Food and Drug Administration), to be included in the applications to market made by pharmaceutical health products, in order to help shorten the translational path from product to patient's bedside.
Areas of activity and related innovations:
1. Certificate Services and translational medicine. As a result of the near-unsustainable costs of health care, even in western countries, business models in the field of new drug therapies are undergoing thorough review. The need for a new alliance between public and private sector is clear, with the primary objective of reducing the costs of research and development and ensuring products are brought to market more rapidly, subject to safety controls. The translational model now the basis of the procedures approved by regulatory authorities (AIFA, EMA, FDA) requires effort to innovate and optimise the preclinical toxicology testing phase, analysis of efficacy in animal models, and to innovate Phase I, II and III clinical trials. TMR intend to renew toxicological preclinical and clinical testing, and in particular:
- to develop 2D and 3D cellular systems of stem cells for in vitro toxicity studies (animals and human adult), in order to ensure the most suitable cellular system for the test drug and cellular systems for personalised medicine;
- to develop the application of "high-yield" technology (high-throughput screening - HCS) for toxicity studies of cellular systems derived from stem cells;
- to develop "Standard Operating Procedures" to be proposed to the OECD for in vitro toxicity studies with cellular systems derived from stem cells and analysed using HCS techniques;
- to develop new statistical models of analysis of the efficacy of new compounds in animal models of disease, based on the principles of analysis of phenotypic ""big data"" (behavioural, anatomical, molecular);
- to refine tests for multiparameter analysis of biomarkers in biological fluids to be used in clinical trials (Phase I, II, III), including the development of new algorithms of statistical analysis, with the additional aim of developing a "multi-target analysis";
- to develop "Standard Operating Procedures""(SOPs) to be proposed to the OECD for multiparameter tests for the analysis of biomarkers in biological fluids to be used in clinical trials (phase I, II, III), including the development of new algorithms for statistical analysis.
2. New materials for regenerative medicine. "Materials" are referred to as a "key technology" for the foreseeable future in the Biomedical Sciences. TMR intends to develop and test new materials as a new mode of administration for drugs and regenerative medicine, in the light of what is stated in point 1. Given the requirements of the European Union for the sector (NANoREG – A common European approach to the regulatory testing of Manufactured Nanomaterials) TMR intends to develop and validate Standard Operating Procedures in GLP for in vitro and in vivo analysis of toxicity of new materials, and in particular:
- to develop systems for in vitro testing of toxicity and efficacy of new scaffolds (by electrospinning and 3D printing) , nanomaterials and nanoparticles for regenerative medicine, functionalised with proteins and drug controlled release, also to be analysed in HCS;
- to develop systems for testing in vivo toxicity, biocompatibility, biodegradability and effectiveness of new scaffolds (by electrospinning and 3D printing), nanomaterials and nanoparticles for regenerative medicine;
- to develop "Standard Operating Procedures" to propose to the OECD for toxicity tests, biocompatibility, biodegradability and effectiveness of new nanomaterials and nanoparticles scaffolds for regenerative medicine.
TMR intends to participate in the renewal of the business model of public-private partnerships that will support innovation in the field of human health, ensuring the development of new and innovative therapies, including personalised medicine and regenerative medicine. To this end, the supply of certified services, as well as innovative technology and design ideas proposed for approval of the regulatory agencies, will represent a major element in the business strategy of TMR.
TMR will provide consulting services and research outsourced throughout, in order to support companies in the relevant sectors (biomedical and pharmaceutical companies, manufacturers of biomaterials, Contract Research Organisations). A part of the activity will also be devoted to helping companies keen to participate in EU award schemes.