COMPANIES

The proper implementation of RESEARCH, DEVELOPMENT AND TRANSFER PROGRAMMES requires collaboration between public and private agencies. In this regard, the Andalusian Initiative for Advanced Therapies was set up with the clear commitment to act as link and activator driver of such public-private collaboration.

We have identified certain therapeutic candidates which could not come to maturity without the existence of public-private consortia collaborating in the development of medicinal products or therapies. It is for this reason that the Coordination Unit of the Andalusian Initiative for Advanced Therapies has established an extensive network of contacts and collaborative links with the business sector, giving rise to agreements for research and co-development covering all phases of medicinal products developments, from manufacture to marketing.

Within the new open innovation paradigm prevailing in the development of new medicinal products, the Andalusian Initiative for Advanced Therapies stands out as a privileged partner within the Andalusian Public Health System. Thus we are able to provide a platform for maturing technologies at the service of society.

clinical developmentsOur Coordination Unit has launched over twenty clinical trials and clinical validation programmes for technologies related to advanced therapies and regenerative medicine. Thanks to this consolidated experience, we have been able to optimize the planning and design processes associated with clinical developments in this area.

Our success is based not only on sound knowledge of the current regulations governing advanced therapies but also on continued dialogue with the regulatory agencies, guaranteeing both the strictest adherence to the applicable regulations as well as safeguarding patient safety.

We provide a maturing technological platform within the Andalusian Public Health System and we are in continuous contact with the Andalusian Health Biobank and the National Transplant Organization. This enables us to optimize both the development times as well as the costs of the clinical trials we promote, and, as a result, we are able not only to select the most appropriate hospitals and key opinion leaders but also to improve patient recruitment. + info at Clinical Trials completed or on-going


servicesThe team members of the Coordination Unit of the Andalusian Initiative for Advanced Therapies are experts in the different phases involved in the development of an advanced therapy medicinal product.

Our area of expertise ranges from the preparation of the preclinical evidence to justify the start of a clinical trial through the adaptation of the manufacturing the adaptation of the manufacturing process to comply with GMP regulation, the clinical trial design and monitoring, to the finding of strategic associates. We have proven experience providing consultancy services in the development and manufacture of advanced therapy medicinal products. + info at Services Portfolio


gmpAs a result of our experience coordinating the ten GMP laboratories belonging to the Andalusian Public Health System, we have been able to improve and shorten the timeframe required for the development and manufacture of advanced therapy medicinal products.

This proven experience has allowed us to develop more than ten products in advanced therapies according to the strictest national and international guidelines with the collaboration of experts in the establishment of appropriate quality systems.

The network of GMP laboratories coordinated by the Coordination Unit of the Andalusian Initiative for Advanced Therapies represents the most important network of public GMP laboratories in Spain. They are mostly located on hospital complexes allowing keeping all clinical aspects under one roof and enhancing profitability as a result of economies of scale. This network, open to collaboration with biotechnology and pharmaceutical companies, facilitate the development of different parallel projects and their localization in the most suitable hospital centres according to efficiency criteria. + info at Network of GMP Laboratories


Within the boost given by the Government of Andalusia to advanced therapies and regenerative medicine treatments and technologies, the mechanisms for the identification and protection of intellectual property belonging to Andalusian Public Health System have been put in place.

The Coordination Unit of the Andalusian Initiative for Advanced Therapies collaborates with the Andalusian Public Health System’s Technology Transfer Office in the protection and exploitation of research results. The system has an interesting portfolio of patents as well as numerous technological offers.

We are pioneers in the generation of strategic associations for the effective exploitation of licences and patents, collaborating at every phase of product development. + info at Catalogue of Technology Offers


 

The Coordination Unit of the Andalusian Initiative for Advanced Therapies is committed to fostering synergies. In this regard, we have developed several alliances with institutions, research groups and companies.

The areas of cooperation are wide ranging. They cover every step in the development of advanced therapy medicinal products including basic research, pre-clinical regulations, regulatory and scientific advice, and clinical development as well as the processes involved in patent licensing and know-how.

All these collaborations have been developed in a framework of mutual and strategic benefit striving to enhance the generation of an effective business hub in the field of advanced therapies and regenerative medicine.