Basic and Preclinical Development

The Coordination Unit of the Andalusian Network for the design and translation of Advanced Therapies comprises a multidisciplinary group of professionals who are able to focus their combined experience on the development of advanced therapy medicinal products, giving strategic and regulatory support to the different projects in research and development.

This activity ranges from the first phases in basic research, through its design as a possible therapeutic candidate, to its eventual development as a medicinal product in research and, consequently, the start of preparatory phase in which optimum safety levels have to be demonstrated as well as a specific level of efficacy. This is the compulsory prior phase to the subsequent start of the study in humans.

As Coordination Unit, we analyse research lines in this type of products, defining their translational potential, assessing their grade of adaptation to the existing regulation as well as giving support with the design of the experimentation which completes the data required by the Regulatory Agencies to authorize the clinic study.

We seek scientific advice on behalf of the researcher from the pertinent Regulatory Agencies (AEMPS, EMA) as well as preparing and updating all the documentation required by those agencies in the different phases of medicinal product development.

The development of an advanced therapy medicinal product implies the establishment of strict systems of quality throughout all the research phases. In this regard, we give support with the generation of quality assurance systems to those laboratories wanting to implement Good Laboratory Practice guidelines into their procedures.