Transmed Research s.r.l. is a social enterprise based in Ozzano dell’Emilia (BO) whose profits are entirely re-invested in scientific equipment and research activities. It operates as part of the Bologna-Ozzano Science Park, together with a few laboratories of the High Tech Regional Network focused on the life sciences.
TransMed Research - TMR conducts research, development, and technological transfer for health products in the pharmaceutical biotechnology sector, in cell therapies, and regenerative medicine. The company specializes in applied research (TRL4-5) with procedures implemented to reduce the translational development chain, from product to patient. The company therefore also conduct studies in safety and effectiveness of systems in vitro and in vivo.
TransMed Research also offer certified services in line with the standards of Good Laboratory Practice as defined by the OCSE (Organisation for Economic Co-operation and Development), and the ISO 10993 Standards (biological evaluation of medical devices). The studies satisfy the requirements of the regulatory authorities including the AIFA (Italian Pharmaceutical Agency), EMA (European Medicines Agency), and FDA (Food and Drug Administration) for the marketing of health products.
Research areas and relative innovations.
Improvement of the translational development chain for the life sciences.
- The business models in the new therapies sector are undergoing radical revision. In particular, there is an acknowledged need for a new alliance between the public and private sectors, with the primary aim of reducing research costs while developing and ensuring more rapid market release of products, save testing for non harmfulness. The current translational model underlying the procedures approved by the regulatory agents (AIFA, EMA, FDA) requires an effort to innovate and optimize the preclinical toxicological test phase, the analysis of effectiveness of animal models, and for innovating phases I, II, and III of clinical studies. TMR intends to renew preclinical and clinical toxicological testing, and specifically:
- Develop 2D and 3D cell systems on stem cells for in vitro toxicity studies (animals and adult humans), in order to ensure the most suitable cellular system for the drug in question, using cellular systems for customized medicines.
- Develop the application of “high yield” technologies (high-throughput analysis/screening - HCS) for toxicity studies on cell systems derived from stem cells.
- Develop “Standard Operating Procedures” for in vitro toxicity studies with cell systems derived from stem cells and analysed applying HCS techniques.
- Develop new statistical models to analyse effectiveness of new compounds on animal disease models, based on analysis principles of phenotypic “big data” (behavioural, anatomic, and molecular data).
- Fine tune multi-parameter tests for analysing biomarkers in biological fluids for use in clinical studies (phase I, II, III), including the development of new algorithms for statistical analysis, with the aim of also developing “multi-target analysis”.
- Develop “Standard Operating Procedures” (SOPs) for multi-parameter tests to analyse biomarkers in biological fluids for use in clinical studies (phase I, II, III), including the development of new statistical analysis algorithms.
New materials for regenerative medicine.
"Materials" are indicated as a "key technology" in the near future of biomedical science. TMR intends to develop and test new materials as a new way of administering pharmaceuticals and for regenerative medicine, in the light of the indications of point 1. Considering the provisions 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 analysing toxicity in vitro and in vivo of new materials, and specifically:
- Develop in vitro systems for testing toxicity and effectiveness of new scaffolds (from electrospinning and 3D printing), nanomaterials and nanoparticles for regenerative medicine, functioning by controlled release of proteins and drugs, also for analysis in HCS.
- Develop in vivo systems for testing toxicity, biocompatibility, biodegradability, and effectiveness of new scaffolds (from electrospinning and 3D printing), along with nanomaterials and nanoparticles for regenerative medicine.
- Develop “Standard Operating Procedures” (SOPs) for testing toxicity, biocompatibility, biodegradability, and effectiveness of new nanomaterial and nanoparticle scaffolds for regenerative medicine.
Services
Transmed Research is approved for conducting tests in compliance with the principles of Good Laboratory Practice in the following areas of competence:
- Cytotoxicity studies.
- In vivo studies of acute and repeat (chronic) toxicity.
- Studies in pharmacodynamics/pharmacological safety limited to studies of neurobehavioral activity in different animal species.
- Studies in biotechnology and molecular biology (biomarker dosages in biological fluids).
TMR are participating in the renewal of the public-private business model intended to support innovation in the human health sector, ensuring the development of new potentially innovative therapies, including customized and regenerative medicine. To this end, the provision of certified services, again innovative for technological content and design ideas, for proposed approval by regulatory bodies will be a fundamental component in TMR’s business strategy.
TMR delivers consultancy and research services in outsourcing throughout Italy, supporting companies in the relevant sectors (biomedical and pharmaceutical sectors, biomaterial manufacturers, and Contract Research Organizations). Some activity is also dedicated to accompanying companies taking part in competitive tenders within the EU.
