Electronic submission systems of the Innovative Medicines Initiative (IMI) will open for biotech companies and research groups on 4 January 2017 to apply for collaborative projects with pharma partners under the IMI scheme.
Autism, diabetes, cancer, and pain are topics of a €348m funding call launched under the IMI2 programme. Other topics in the call focus on: the creation of a European network for clinical trials in children; biomanufacturing; the need to include the patient perspective in medicines development; and the contribution of certain genes to disease.
€174m of the call’s budget comes from the EU’s Horizon 2020 programme and will fund the participation of universities, biotech SMEs, and patient organisations. The other half comes from the member companies of the European pharma association EFPIA and IMI Associated Partners.
“The Associated Partners in this Call are all contributing their own funds and resources to IMI. Furthermore, their involvement allows IMI to link in with other international initiatives tackling shared challenges like diabetes and autism,” said IMI chief Pierre Meulien.
The topics in brief: Understanding hypoglycaemia: the underlying mechanisms and addressing clinical determinants as well as consequences for people with diabetes by combining databases from clinical trials • How big data could support better diagnosis and treatment outcomes for prostate cancer (part of the Big Data for Better Outcomes programme) • Improving the care of patients suffering from acute or chronic pain (this topic includes three subtopics on patient reported outcomes; biomarkers; and chronic pelvic pain) • Creation of a pan-European paediatric clinical trials network • Biomanufacturing 2020: development of innovative high throughput analytical tools and methods to characterize cell culture fluid during development and commercial cell culture processes • Unlocking the solute carrier gene-family for effective new therapies (unlock SLCs) • Patient perspectives in medicines lifecycle • Personalised medicine approaches in autism spectrum disorders. Details of the funding subjects are listed in a pdf file.
Diabetes and low blood sugar: Many diabetes patients experience hypoglycaemia, when their blood sugar levels become too low. Symptoms include behavioural changes, memory loss and confusion, which can result in accidents and falls and, in the worst cases, in hospitalisation or death. This topic aims to add to our understanding of hypoglycaemia, with the ultimate goal of making it easier for people with diabetes to manage their blood sugar levels.
Prostate cancer and big data: Prostate cancer is the second most common cancer in men, and accounts for 9% of all cancer deaths among men in the EU. The goal of this topic is to identify and use existing real-life patient data to improve outcomes for prostate cancer patients. This topic falls under the IMI Big Data for Better Outcomes (BD4BO) programme.
Pain: Patients with a wide range of conditions may experience pain in the short or long term, and all too often, painkillers prove ineffective. This topic is split into three complementary subtopics. These address the need for patient reported outcomes; the need for better biological markers to facilitate the research and development of treatments; and the challenge of understanding chronic pelvic pain.
Paediatric clinical trials network: Less than half of all authorised medicines commonly used in children have been properly tested in this group. Running clinical trials involving children is hard. There are many operational challenges, such as finding enough patients, and there is no organised, EU-wide clinical trial infrastructure. This topic aims to change that by creating a large, collaborative paediatric network to facilitate the development of drugs for the benefit of children, parents and society.
Biomanufacturing: Animal cell technology is now widely used in drug development, and key to the quality of the final product is the cell culture process. The objective of this topic is to develop high-throughput tools and methods to monitor and manage the cell culture processes during both drug development and manufacture.
Genes and disease: So-called transport proteins are the gate-keepers of our cells, effectively controlling the flow of nutrients and other molecules across the cell membrane. This topic focuses on the solute carriers, which are the largest class of transport proteins, counting over 400 members. The genes that encode solute carrier proteins have been implicated in a number of diseases, including diabetes and cancer, yet many remain to be studied in detail. This topic aims to deliver new tools and methods that will make it easier for scientists to study the solute carrier gene family and develop drugs that target them.
Patient perspectives in research: The goal of this topic is to provide a framework and guidance for all stakeholders on the best ways to meaningfully engage patients at different stages of the medicines lifecycle.
Autism: Autism spectrum disorders (ASD) affect around 1% of the population and are characterised by difficulties in social interactions and communication as well as repetitive behaviours. Efforts to develop effective treatments have so far been unsuccessful, partly because of differences between different groups of patients. This topic will consolidate European clinical research in this area by creating a Europe-wide infrastructure to accelerate and tailor the recruitment of patients for clinical trials, and by validating biomarkers.