The EuroTech Universities Alliance endorse many of the opinions and proposals laid down in the Innovative Medicines Initiative consultation “Facilitating the translation of advanced therapies to patients in Europe”. The IMI Concept Paper on advanced therapies incorporates many aspects that would indeed contribute to a faster development in the complex field of Advanced Therapy Medicinal Products (ATMPs), reflecting clinical requirements, manufacturing capacities especially in hospitals and academic institutions, and the variability inherent in the nature of these innovative products and the biological materials used. As outlined in its reply to the consultation, the EuroTech Universities would further suggest to:
- promote the idea of developing the Hospital Exemption clause further, by establishing a registry and accessible database, for example together with the EU Clinical Trial Database and within a special section dedicated to ATMPs;
- foster the development of a pre-competitive IT environment within – or beyond – the EU CT Database for an exchange of pre-clinical, quality and clinical data across academic centres, hospitals and industry;
- use the hospital exemption clause to define the interface between the process and the product in Point of Care Devices;
- develop together new concepts of specificity testing in pre-clinical development, involving the use of biobanks established in Academia and Industry;
- promote the establishment of generic tools, vectors, platforms and processes in manufacture and quality control that can be used in a modular fashion and will speed up the developmental trajectory;
- establish a database of available materials, devices, active pharmaceutical ingredients and excipients with details on product information, sources of origin and quality, under the auspices for instance of the EQPA or similar institutions;
- encourage all stakeholders including health insurance providers to develop novel models for reimbursement in earlier stages of clinical use;
- establish joint training and career development opportunities in ATMP manufacture and GMP, involving both, Academia and Industry.
Most and above all, IMI’s proposal of responding to the plentitude of challenges in a pre-competitive fashion, i.e. joint platforms under the IMI umbrella, is strongly supported. Here, we recommend to build upon, encourage and supervise existing structures, regional clusters of certain capacities, topics, and existing collaborations between Academia and Industry, and also to expand the networks by identifying new relevant partners. A one stop-shop concept will not be useful; rather, networks are needed (and available in Academia) that maybe more appropriate to bring ATMPs faster and more efficiently to the patients in need.