The strategic goal of IRMI is to create an infrastructure that will facilitate the exchange of knowledge between the different disciplines that underlie regenerative medicine products. Thank to this strategy, will be encouraged the development of new products on the territory for the advanced therapy; consequently increasing the international competitiveness of Italian Biotechnology sector for products derived from human tissues and cells.
This strategy will allow Italian companies to follow the enormous possibilities offered by European and other markets, thus ensuring even direct income, such as income from patents and from the creation of an industrial market of related products. Looking ahead, the IRMI can create, in future years, the conditions for scientific and industrial applications in order to achieve real savings for the Italian Health Service (SSN) and a reduction in social costs.In addition to it the IRMI, will contribute to the comprehension of biological mechanism and of cell interaction underlying tissue re generation, tank to the continous introduction of regenerative medicine products in pre clinical trial. Such tests will still be conducted in order to promote the adoption of discoveries in therapeutic practice.
More specifically, the IRMI will support the growth in the scientific-industrial sector producing:
1) the strengthening of existing biobanking structures at the Niguarda Hospital and at the LABORATORY PROMETEO BCTM IOR in Bologna, offering new opportunities for storage of both autologous and allogeneic cells and tissues, with the exception of cord blood. As of today, Italy lacks an appropriate infrastructure in terms of space and personnel able to manipulate, store and distribute the new tissues such as fat from liposuction or deciduous tooth; The banking must be executed according to Italian and international laws and authorized by the CNT. The strengthening of existing two banks already in operation and approved by the CNT and the respective regions allows to implement the project within 12 months.
2) the strengthening and rationalization of cell manipulation structures; The structures for cell manipulation (relevant= cell factory and not relevant= cell and tissue banks) require an investment more important for the normal operation than for the design and construction of structures. The achievement and the maintenance of GMP by AIFA for experimental production not of products advanced therapies represent a high cost depreciable only against a sufficient
production of drugs. The current structures belonging to IRMI approved by AIFA are 3 and 2 are under construction and in authorization phase. The IRMI proposal is that the structures are coordinated and operate collaboratively; following the example of the PACT created in the USA by National Lung, Heart and Blood Institute, also providing all the necessary services for the organization, management and analysis of clinical trials and the ‘interface with authorities, both for clinical trials and for the marketing authorization ofdrigs.
3) the strengthening of support structures for research and industrial development of advanced therapy products, including translational clinical research; It is needed to overcome the fragmentation and distance between academia and business: IRMI represents the physical location of that virtouos meeting. IRMI, due to the coexistence in the organization of academic research centers and companies will reach the target of an continuous technology transfer for a development technologically competitive. ChiesiFarmaceutici, with his vast experience and an organization aimed at both clinical research and relations with authoritieswill allow IRMI to have a decisive operational tool
4) research and development of new decellularized human tissues, osteo-inductive malleable thermoplastic pastes, bone tissue with automated cut and sizing, electro-spun biological membranes, biomatrices and biocompatible polymers. Bone tissues thermoplastic and malleable based on DBM, as of todayaare almost exclusively imported from the USA, due to the reduced production in Europe: the PROMETHEUS LAB BCTM IOR is currently the only European manufacturer of osteoinductive paste , but requires a substantial expansion of its capacity The problem lies in the ability to dispose of medical devices biologically compatible and effective in achieving the stated goals, at an acceptable cost. IRMI has in his team research groups both academic and industria, engaged in the creation of innovative biomaterials, which will be tested and used in combination in prototype.
5) experimental research and development aimed at the characterization of stem cells and their quality control, the implementation of a cellular product based on progenitors with high differentiation capabilities derived from iPS and active molecules able to regulate the proliferation and differentiation of stem cells. The main issues of R & D and descriptions of the solutions that we intend to study in respect of such products or processes are indicated in OR1) GENOMNIA and CNR, CNR and nell’OR2 in ‘OR3 GENOMNIA and CNR on page 140-142-145
6) research and experimental development of an innovative system of polymers capable of controlling the “homing and migration” of cells in order to encourage the regeneration of cells and tissues, experimenting and finalizing the innovative technology of Degrapol
7) Research and development of at least one cellular product based on mesenchymal stem cells from adipose tissue , obtained with technology Lipostem, that guarantees high and unique cellular quality thanks to its isolation exclusively physical. At the international level there are other methods of manipulation of adipose tissue, but all are using enzymatic or ultrasound methods, entailing an alteration of the regenerative capacity of the cells and their biological modification, which led to an identification of the final product by FDA as “biologics”. Main problem is the classification of the product and therefore, the regulatory process that must be submitted before release. The proposed solution is a request for advice to AIFA and EMA prior to clinical use.
8) research and experimental development of a product of advanced therapies based on autologous cultures of corneal epithelium, containing limbal stem cells, for the treatment of corneal opacity and the loss of visual capacity (total unilateral or bilateral partial) due to chemical or thermal burns of ocular surface.
9) Research and experimental development of stem cells for clinical trials, (with relevant manipulation as well as with not relevant manipulation), in orphan diseases (scleroderma, epidermolysis bullosa) and in chronic diseases with high incidence, currently treatable but not curable. The vast majority of clinical trials on advanced therapies are currently underway in the Usa, Australia and Japan. In Europe, only a few trials are currently underway.
10) new professionals figures for biobanking, the manipulation of cells and tissues, the research and development of biomaterials, the application of converging technologies, the management of clinical trials and regulatory aspects of advanced therapies. IRMI also aims to train new professionals for the for the care of patients treated with products and procedures aimed at tissue regeneration. Today in Italy there are professionals with general training, but not specific for Advanced Therapies.
The IRMI aims to promote, after the process of research and experimental development, the translation to the clinic of two types of products for regenerative medicine: products with manipulation not relevant and with relevant manipulation. The products with manipulation not relevant have a process more facilitated for their use in therapy compared to those with manipulation relevant. Thanks to these two different types of products, the IRMI intend to activate, mainly at the end of the project, a program of continuous introduction on the market of new derivatives for advanced therapies. In fact, products with manipulation not relevant will be introduced on the market during the third year of the project, allowing products with relevant manipulation to have enough time to terminate the acquisition of all necessary certifications for their therapeutic use.