RESEARCHERS

The Andalusian Initiative for Advanced Therapies, through its Coordination Unit, fosters translational research in the field of advanced therapies, by encouraging synergies between technologists, basic researchers and clinicians, and by promoting collaborative research between the different advanced therapy areas: cell therapy and regenerative medicine, clinical genetics and genomic medicine and nanomedicine. To achieve this, the Initiative cooperates with all agents involved, including those from the academic world, research institutions, health centres, patients’ associations, biotechnological SMEs and the pharmaceutical industry. The boost given to this research has required, among other things, the development of infrastructure and the supply of equipment needed for the research itself as well as that required for the manufacturing of clinical grade quality products, i.e GMP laboratories.

preclinicalThe Coordination Unit of the Initiative fosters progress in the field of advanced therapies by supporting all phases related to the development of these medicinal products. The pre-clinical or non-clinical (regulatory term) research is one such phase which precedes the design of a clinical trial in humans.

Pre-clinical research is of extreme importance to minimize the risks associated with clinical trials testing new drugs in humans. By means of in vitro and in vivo studies in animal models, it seeks to predict the safety and efficacy of medicinal products which must be later demonstrated through clinical research in patients.

Read more...

clinicalThere are nowadays many diseases for which there is still no effective treatment. In the case of certain of these, we are making some advances in the research to find a treatment using advanced therapy medicinal products (cell therapy, tissue engineering and gene therapy). The Andalusian Initiative for Advanced Therapies has, as one of its main objectives, to facilitate access to those therapies to the Andalusian population on an equitable basis whilst guaranteeing their administration under the strictest legal requirements and the highest safety.

In this regard, the work of the Andalusian Initiative for Advanced Therapies ranges from manufacturing advanced therapy products considered in most cases as medicinal products, to setting up and monitoring a range of clinical trials in phase I/II and III, to show their safety and efficacy and subsequently to incorporate these therapies into routine clinical practice in the near future.

Read more...

gmpThe treatment of patients with advanced therapy medicinal products demands that these medicinal products be manufactured in specially designed infrastructures under the strictest regulatory standards. These infrastructures are known as white rooms or Good Manufacturing Practice (GMP) laboratories.

The Coordination Unit of the Andalusian Initiative for Advanced Therapies coordinates a network of GMP laboratories which belong to the Andalusian Public Health System. They are for the most part located in hospital centres, regional blood transfusion centres or science parks.

Read more...

regulationAdvanced therapies comprise cell therapy, gene therapy and tissue engineering. For the most part, these are considered a special type of medicinal products. The only exception is the cell therapy which is considered as a cell transplant and not as a medicinal product when the cells are not subject to substantial manipulation and are used to carry out their normal function or essential functions.

Read more...

 
investigadores


"What I probably admire the most of Andalusian Initiative for Advanced Therapies is that it does not matter whether the solution to a genetic disorder or a traumatic injury is developed first in Andalucia or in India, or USA. What it matters to them is that it should be implemented in Andalucia, by Andalucian Scientists and Physicians, with no delays.

There is an incredible level of dedication in all members of Team, a contagious energy spirit headed by its director. As a consequence, this incredible talented group of scientists, administrators, and health care workers, are immune to those unwilling to recognize that new therapies for untreatable conditions can indeed be developed in Andalucian soil."

Prof Jose Cibelli
Professor of Animal Biotechnology
Head of Cellular Reprogramming Laboratory
Michigan State University, USA
Scientific Director -LARCel – Seville, SPAIN