The key goals of the “TherGeLFas” project are: (a) the training of a talented experienced researcher in the fast growing field of innovative biomaterials for medical applications where the host and partner institutions have a critical knowledge and expertise; and, (b) the design and development of cost- efficient polymer materials in order to develop a new medicinal product for post-operative acute pain treatment and prevention of chronification. The aim of the research project and the main scientific challenge is thereby to develop a ‘therapeutically effective’ hydrogel based injectable product to be applied during and post-surgery in the fascial tissue that protects the nerves where the pain originates and chronifies. TherGelFas expects to create the proof of concept of a new medicinal product by combining advanced materials (a biodegradable, antiseptic and biocompatible carrier, made of porous nanostructured hydrogel based on hyaluronic acid) with the ability to load and release non-steroidal antiinflamatory drugs in a controlled manner. It is aimed for the improvement of the current multimodal strategies of peripheral nerve blockade injections used during and post-surgery in acute pain treatment to prevent it from becoming chronic and that unfortunately are unsuccessful many times. The first achievement will be that of the training of the experienced researcher in new areas of knowledge such as business development from original concept stages to production scale-up, manufacturing and marketing stages. The second achievement will be to scientifically assess whether these hydrogels can improve and replace currently used therapies, to develop a proof-of-concept scalable product. The third achievement will be to learn how to perform correctly the necessary steps needed to launch a product of this kind, such as record and prepare all the documentation needed to present the product to the corresponding regulatory agencies.

Worldwide chronic pain conditions are by far the greatest cause of disability. It has an enormous negative impact on quality of life and on personal and professional plane. Chronic pain is an important cause of depression, more sickness absences at work, productivity losses, unemployment, etc.). Chronic pain is one of the major reasons (30%) why people exit the labour market prematurely. 20% of current population in Europe suffers from chronic pain (102 mill.) and up to 50 % of that pain comes from wrongly treated acute post-operative pain. The total direct and indirect healthcare costs for chronic pain disorders in Member States have an EU average of 2.4 % of GDP and a cost of 271 billion euros per year. When acute pain is not properly treated in the first few days, it can become chronic. About 40-60% of patients report pain chronification after surgery. Current medicines do not prevent chronic pain from the start and have side effects. “Fast track” approaches have started to take the lead in pain management policies. Based on these approaches I +Med´s team works since 2014 in the development of FasNaGel, a new nanomedicinal product, unique in the world. It consists of a biocompatible and biodegradable injectable carrier, made of porous nanostructured hyaluronic acid hydrogel containing a non-steroidal anti-inflammatory drug that i) efficiently, provides a 100% of functional recovery after surgery in one third of the time, ii) is easy-to-use by medical staff, and the most important iii) increases by 80% the treatment effectiveness. FasNaGel will reduce the overall treatment costs in Europe, deducting indirect costs coming from acute pain up to €149 billion. The objective of this proposal is to be able to perform a thorough feasibility study for the validation of the production and commercialization of this novel product. FasNaGel marketing will have a huge of a SME such as i+Med, who estimates to multiply the team size by 8 in 7 years.

MEDIPOL (“Molecular Design of Polymers for Biomedical Applications”) is an interdisciplinary, international and intersectoral collaborative effort that utilises the mechanism of personnel exchange between partners located in the EU and Asia to address key aspects of problems of huge international socioeconomic importance. Through carefully planned and integrated secondments MEDIPOL will use knowledge transfer to train 29 ESRs and 20 ERs to be future leaders in both academia and industry. The specific major problems that we shall tackle affect vision and mobility, which are becoming increasingly critical issues in healthcare systems across the world, where the growing socio-economic difficulties of ageing populations are evident at both individual and governmental levels. MEDIPOL is designed to identify, design, develop and disseminate understanding of materials and technologies for systems that will aid and augment the healthy ageing of ocular and dermal tissue. Key to achieving this lies in harnessing the understanding of the moist ocular surface and its relevance to compromised dermal tissue. There are clear links between ocular and dermal sites. Importantly, understanding these analogies facilitates the design of contact lenses especially for use as corneal bandages, of ophthalmic dry eye therapies and of successful burn and wound dressings. These issues are international, they affect quality of life and they are of very significant social and economic importance in both developing and developed economies. MEDIPOL is an integrated 4-year program of knowledge transfer and networking between Aston University, UK (Aston), i+Med S. Coop, Spain (i+Med), Technical University of Liberec, Czech republic (TUL), Chiang Mai University, Thailand (CMU), Naresuan University, Thailand (NU) and Mae Fah Luang, Thailand (MFU). The overarching objective of the proposed joint exchange programme is to establish long-term stable research cooperation between all partners.

The launch of a novel drug to the market is preceded by clinical testing and validation both on animal in vitro and in vivo models. Animal models used in drug development have known methodological drawbacks leading to the failure of drugs. Further, animal tests are associated with ethical issues. Moreover, a strong bias in in-human testing still overlooks major population groups e.g. children, women, different ethical groups. It is estimated that 197,000 deaths per year in the EU are caused by Adverse Drug Reactions (ADRs) and the total cost to society of ADRs is €79 billion. The emerging Organ-on-Chip (OOC) field, an alternative to animal test, brings great potential for safe testing and validation: An OOC-systems consists of a 3D-microstructured channel network embedded on a small plastic device that simulates the mechanics and physiological response of an entire organ or organs. Project UNLOOC will develop, optimize, and validate a multitude of ECS-based tools to build OOC-models to replace animal and in-human testing. UNLOOC aims to combine three important characteristics for routine use of OOC models, i.e platforms that combine ECS-based technologies with established biological material, capitalize on AI, parallelized test set-ups allowing efficient high-throughput demands, and standardized procedures enabling reliable results. UNLOOC will develop ECS-based hardware and software tools and validate them in five Use Cases (UCs) performed in 10 European countries. The applications developed and validated will be used by academia and pharma industry to drive drug development, create cosmetics without animal test, personalized medicine and gain new insights into disease. Given the large OOC market, these solutions have great economic value, on average it would result in cost reduction of up to $169M and $706M per new drug reaching the market and will put Europe at the forefront of this booming research field (see impact section for details).