Severe ocular disorders are affecting the lives of more than 100Mill people world-wide and at least 25% of the population above 70 years of age, a growing demographic group in EU. More than 8 million people lose their lives to cancer every year, making cancer a leading cause of pre-mature mortality in the world. The main hallmarks of severe eye conditions (i.e angiogenesis, inflammation and vascular permeability) play also pivotal roles in cancer, being therapeutic targets to treat both kind of diseases. The overall goal of 3D-NEONET is the improvement of available treatments for cancer and ocular disease by enhancing drug discovery-development and delivery to targeted tissues, through advanced international co-operation between academic and non-academic partners. The interdisciplinary expertise provided by 18 partners in 7 countries encompasses among others: drug screens, ADME, toxicology, preclinical models, nanotechnology, biomaterials and clinical trials. After the success with ongoing FP7-IAPP project 3D-NET (Drug Discovery and Development of Novel Eye Therapeutics; (www.ucd.ie/3dnet), we are assembling 3D-NEONET, this enlarged European interdisciplinary consortium that will join forces and exchange skills to enhance current therapies in oncology and ophthalmology. The 3 global objectives of 3D-NEONET are: 1- Enhance the discovery and development of novel drugs, targets and biomarkers for ophthalmology and oncology. 2- Improve the Delivery of Therapeutics for Oncology and Ophthalmology 3- Enhancement of Research, Commercial and Clinical Trial Project Management Practices in these fields. Through participation in the program, 3D-NEONET is the vehicle for driving synergies between academic and non-academic participants leading to increased scientific and technological excellence as well as tangible innovative outputs that will strengthen the competitiveness of both the researchers and industries of the network even beyond the lifetime of the network.

Aim of the HIPGEN project is to develop the first cell therapy to improve functional recovery following hip fracture arthroplasty. Hip fractures are a major public health concern in the EU with an increasing incidence of 1 million patients per year, high direct and indirect costs and high mortality. Conventional therapies are not able to address the main medical problems of hip fracture in these elderly patients, being the impairment of mobility and the stress imposed as a combined result of injury, surgery and immobilisation. PLX-PAD are an allogeneic, placental-derived, stromal cell product and currently the only Advanced Therapy Medicinal Product (ATMP) in phase III in this indication. Based on comprehensive preclinical work on the effect of PLX-PAD on muscle regeneration after injury, a phase I/II study under the collaboration of Pluristem and Charité demonstrated an increase in muscle force and volume in hip arthroplasty patients and a reduction of early postoperative stress. We plan to conduct a multicentre, randomised, double blind, placebo controlled phase III clinical trial evaluating the efficacy of intraoperative intramuscular injections of PLX-PAD for the recovery of hip fracture patients. The clinical study will include biomechanical analyses and in-depth biomarker studies of treated patients analysing the effects of the cells on the immune system and individual stress reactions aiming at stratifying patients in future therapies. Further preclinical characterisation of the mechanisms of action of PLX-PAD in injured patients will be conducted. The “Be the Partner” platform will be used to improve patient experience in the trial, and create a strategic patient engagement beyond the trial. In addition to renown experts in hip fracture, cell therapy and immunology, our consortium includes the main organisation for osteoporosis, IOF, who will help disseminate and communicate the results of the phase III study among clinicians and patient organisations.

Optimal treatment of the impaired mobility resulting from ageing and chronic disease is one of the 21st century's greatest challenges facing patients, society, governments, healthcare services, and science. New interventions are a key focus. However, to accelerate their development, we need better ways to detect and measure mobility loss. Digital technology, including body worn sensors, has the potential to revolutionise mobility assessment. The overarching objectives of MOBILISE-D are threefold: to deliver a valid solution (consisting of sensor, algorithms, data analytics, outcomes) for real-world digital mobility assessment; to validate digital outcomes in predicting clinical outcome in chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, proximal femoral fracture recovery and congestive heart failure; and, to obtain key regulatory and health stakeholder approval for digital mobility assessment. The objectives address the call directly by linking digital assessment of mobility to clinical endpoints to support regulatory acceptance and clinical practice. MOBILISE-D consists of 35 partners from 13 countries with long, successful collaboration, combining the requisite expertise to address the technical and clinical challenges. To achieve the objectives, partners will jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes can successfully predict relevant clinical outcomes and provide a better, safer and quicker way to arrive at the development of innovative medicines. MOBILISE-D's results will directly facilitate drug development, and establish the roadmap for clinical implementation of new, complementary tools to identify, stratify and monitor disability, so enabling widespread, cost-effective access to optimal clinical mobility management through personalised healthcare.

Amyotrophic Lateral Sclerosis (ALS) is a fatal degenerative disorder of the brain and spinal cord affecting some 40,000 individuals in Europe, causing 11,000 deaths each year. Our pioneering work on riluzole showed that it is possible to modify ALS progression but all subsequent trials of potential neuroprotective agents have failed. Thus, drug development in ALS, including trial design, patient selection, and outcome measures must be re-engineered to break the current impasse. Nerve cell death in ALS is associated with inflammation, which contributes to cell damage, and is a logical target for therapy. Although therapeutic attempts to modify this have failed so far, the discovery of regulatory T cells (Tregs) as key players in controlling inflammatory processes opens new possibilities since defective Treg function is important in ALS. In fact, Treg numbers and function predict rates of disease progression and survival. Low-dose interleukin-2 (ld IL-2) safely and specifically increases and activates Tregs in conditions such as type 1 diabetes, HBc-vasculitis and chronic graft-versus-host disease, so ld IL-2 has the potential to significantly improve survival and deliver a therapeutic breakthrough in ALS. We also integrate biomarkers for nerve cell damage into the trial design to provide proof of concept/mechanism. “Modifying Immune Response and OutComes in ALS” (MIROCALS) will test the hypothesis that ld IL-2-induced increases in Tregs result in decreased rates of nerve cell damage and that this effect can be detected early in the course of the disease using a range of blood and cerebrospinal fluid biomarkers. Our ambition is to develop a new therapy for ALS and through this novel trial design break the impasse in drug development of other disease-modifying agents in ALS. The impact will be to enhance quality of life and care for people with ALS, and provide a robust model for Industry to encourage investment in ALS and other neurodegenerative diseases.

HD is a monogentic disease, meaning modification in a single gene occurring in all cells of the body. In Western countries it is estimated that 5-7 people per 100,000 are affected by HD. Currently there is no cure for the disease and effective management is key to quality of life for those who are affected. Patients and families who are living with the disease face multiple social and self-management issues. For example, stigma of the disease alongside social isolation have been key drivers in terms of high levels of mental health difficulties. CH has the ability to assist with many of the difficulties faced by HD, RD and indeed other symptom related diseases. For example, CH can monitor and identify key intervention points along the disease progression pathway, it can inform and facilitate integrated care, it can assist with joining key stakeholders together in a shared ecosystem, and importantly it can assist patients and their families in terms of reducing isolation, optimising self-management and thus increasing empowerment and self-actualisation. Further, CH has the ability to optimise scarce resources in an over stretched health care system and thus produce effective and efficient outcomes. The primary aim of this RISE project is to establish an international and inter-sectoral network of organisations working in collaboration on a research project which seeks to design a technology enabled patient centred care pathway which will identify how to optimise Connected Health (CH) interventions at key points along Huntington’s Disease (HD) trajectory. This is an important project because patient centred care from a CH perspective in the area of HD is currently under developed. This project aims to develop a new pathway of patient care based upon a better understanding of what type of technology can assist patients with improving their quality of life at various key points along the care pathway.