Advanced Therapies (Advanced Therapies Medicinal Products and Biologised Medical Devices – ATMP/bio-MD) are a potential game changer in health care: They aim to transform the current focus on “treatment of disease” into one that concentrates on “regeneration of health”. The unifying goal of RESTORE is the implementation of newly developed Advanced Therapies in clinical routine to improve patients´ outcome with high impact on Europe´s society and economy.
To create a European ecosystem that will accelerate translation and commercialization of Advanced Therapies in Europe with a significant benefit for patients:
- Link technology and biology for the development pipeline of a new emerging class of Advanced Therapies aiming to shift the paradigm of medicine from treating to curing progressive diseases.
- Form academic translational hubs for Advanced Therapies that closely interact with industry, regulatory authorities, health insurances, and patient organizations.
- Move Advanced Therapies from early developments and studies driven by unmet medical need and science towards approved and marketable products that achieve adequate reimbursement.
- Advance the basic science on ATMP/bio-MD development, in order to continuously refine product prototypes and refill the pipeline by finding better solutions for solving further scientific, technology and challenges.
- Deliver knowledge, cutting-edge technologies, development strategies, infrastructures and educational pathways necessary for the sustainable development of European ATMP/bio-MD industry partners to top players in the world league achieving long-term health, economic, scientific and social benefits for the European community.
RESTORE will be structured in five Research and Innovation Action (RIA) modules to address these major challenges:
- Basic Science and Early Development
- Manufacturing of ATMPs and bio-MD, including product characterization
- Advanced Preclinical Models
- Biomarker for in-depth analysis of patients´ response to Advanced Therapies
- Clinical Research and Implementation
The Large scale Research Initiative RIAs will be supported by four Coordination and Support Action (CSA) modules targeting coordination, education & training, alignment to national programs and global networking.
Here it’s possible to download RESTORE documents for supporting actions