Executive Summary
Neurodegenerative and cardiovascular diseases, along with cancer and early feasibility studies, are among the topics to be addressed by consortia interested in taking part in the EU’s latest research partnership.
Source: Shutterstock/Vladimir SukhachevTHE EU’S IHI IS SEEKING NEW APPROACHES TO INNOVATIVE TREATMENTS
Europe’s public-private partnership, the Innovative Health Initiative, has launched its first calls for research proposals. They include a project on personalized therapeutic approaches for improving outcomes in cancer patients, and one on integrating data from diverse sources to support diagnosis, treatment and research in areas of high unmet need.
The IHI is a partnership between the EU and associations representing the pharmaceutical, vaccine, biotechnology, medical technology and digital health industries, namely EFPIA, EuropaBio, Vaccines Europe, MedTech Europe and COCIR.
Like its predecessor, the Innovative Medicines Initiative, it involves the formation of consortia that bid to carry out specific research projects outlined in the calls.
“These new calls for proposals are a fantastic opportunity for health researchers and stakeholders to work together on some of the most pressing issues in health research – issues that we believe can only be addressed by a cross-sector, multi-stakeholder partnership like IHI,” said the initiative’s executive director, Pierre Meulien.
“The calls also contribute directly to key EU policies including the Horizon Europe mission on cancer and the European Health Data Space,” he added.
Two Calls
There are two IHI calls in this first round. Call one, which comprises four topics on cancer, neurodegenerative diseases and health data, is a single-stage call. Applicant consortia must include industry/contributing partners that will bring financial or in-kind contributions, and a full proposal must be submitted by the deadline of 20 September.
Call two, which has two topics, on cardiovascular disease and early feasibility studies, is a two-stage call where applicant consortia should not include industry/contributing partners. Bidders should submit a short proposal by the 20 September deadline, after which the winning consortium will work with the industry partners that designed the call topic, with a view to submitting a full proposal by 28 February 2023.
Multi-Modal Cancer Therapies
One of the oncology projects in call one will aim to develop, test and validate personalized therapeutic approaches to cancer. It will involve “biomarker-guided, multi-modal precision oncology based on imaging, phenotype, genomics, in vitro diagnostics, co-morbidities, clinical and real-world data,” the IHI notes.
Patient-specific approaches are required because of the differing biology of cancers and different efficacy of treatments, and because multi-modal therapies “have been shown to be of high value in this respect,” it says.
Applicant consortia should pursue a number of therapeutic strategies and combine at least two cancer treatment modalities including pharmaceutical, nanotechnology, small molecules, hormone therapy, cell therapy or immunotherapy, drug delivery systems, theranostics and radiopharmaceuticals.
The project should include the evaluation of aspects such as the sequencing, timing and dosing of therapies to maximize treatment effects. “It is expected that the use of prognostic and predictive biomarkers and the combination of diagnostic tools to plan and adapt treatment and evaluate treatment and the follow up of patients will be a key component.”
Cancer Diagnosis And Therapy
The second oncology topic in call one is on image-based cancer diagnosis, prognosis and treatment. “The specific challenge to be solved by this call topic is to provide early evidence of improved cancer patient care when using next-generation imaging technologies and image-guided solutions as part of combined cancer therapies,” the IHI says.
“The driving principle must be improving and enhancing image-based diagnosis and therapy, eg, through automated image interpretation and segmentation, quantitative disease assessment, intuitive treatment planning and smart guidance both during treatment itself and in post-treatment monitoring of response to therapy, to enable more efficient patient-centric diagnosis/therapies/interventions and better patient outcomes.”
Among other things, this project should allow the development of improved artificial intelligence (AI) and machine learning (ML) validation and evaluation methodologies for imaging and image-guided diagnosis and therapy for cancer, the IHI says. It should also result in “better informed decision-making at different levels of the healthcare system that will in turn contribute to a better allocation of resources towards cost-effective innovations.”
Neurodegenerative Disease Pathways
Many people with neurodegenerative disorders such as dementia also have at least one other disease, and managing multiple health problems is challenging for patients and healthcare systems alike, according to the IHI.
“Recent developments give grounds for cautious optimism that a disease-modifying therapy is on the horizon,” it says. “However, the high disease prevalence, and the complex evaluation process when such a therapy becomes available, will create challenges for already over-burdened healthcare systems.”
The aim of this topic is to develop a decision-support system to enhance medical decisions with targeted clinical knowledge, patient information, and other health information. It should offer a more holistic approach in terms of better integration of diagnosis, treatment and care, and breaking existing data silos across medical specialities to allow the “dynamic flow of information”.
These data “may include medical/laboratory data, automatically collected data, omics data, medical device data, treatment modality/intervention-type data, real-world evidence, including medical condition and lifestyle-related data collected via e-health solutions, smart devices, wearables, medical grade sensors and other patient self-reported data.”
Unlocking The Potential Of Health Data
“Recent years have seen an explosion in the generation of data from sources as diverse as digital technologies, patient-reported outcome measures, clinical trials, and routine clinical care,” the IHI says. But while these data could potentially help to advance both research and patient care, accessing, integrating and analysing the data is “extremely challenging,” it adds.
The aim of this topic is to develop a scalable platform for the “seamless integration or linkage of these data at scale.”
Researchers, including industry stakeholders, have long-term access to diverse data, enabled by the linkage and integration of novel and cross-sectoral sources, including within industry, the IHI notes. “If possible, some of these data should be able to be used for providing evidence to support regulatory decision-making.”
Data sources used in the project should “as a minimum” include all of the following: clinical trials, registries, patient safety data, routine clinical care, publicly available health insurance data, patient reported outcome and experience measures, and data generated by digital technologies such as sensors, wearables and mobile health apps.
Cardiovascular Diseases
The aim of the first topic in call two is to develop tools for the earlier identification of people at risk of cardiovascular disease (CVD), the earlier diagnosis of CVD, and a more personalized approach to treatment.
“It will do this by analysing data from diverse sources,” such as transcriptomic, proteomic and multimodality imaging studies, combined with data from electronic interventions via CE-certified wearables such as smartwatches or activity trackers, as well as routine clinical data from medical devices, the IHI says.
“Accuracy of diagnosis and efficacy of treatment will increase thanks to an individualised sub-phenotype-risk approach which will allow for risk-focused targeted therapy.”
Early diagnosis of CVDs, combined with better understanding of the mechanisms involved, will “lead to the development of more cost-effective strategies, and the identification of new care pathways.”
Early Feasibility Studies
The second call two topic will aim to deliver a “tried and tested methodology” for the performance of early feasibility studies in the EU, which will include guidelines, templates and a stakeholder network, as well as use cases for testing the methodology.
“Early feasibility studies provide the opportunity to capture relevant additional information for the intended use from the real-world setting that would not be possible in non-clinical studies (ie, bench testing and animal studies) at a very early stage,” the IHI notes.
However, even though it is legally possible to undertake EFS in the EU, “such studies are not yet widely used,” it observes. “Indeed, most EFS are run today outside of the EU, and primarily in the US. This means that the EU may be at risk of losing out on an important opportunity to attract clinical research and further investments in innovation development to the region.”
Applicants will be expected to develop and validate a methodology for EFS that is compliant with EU regulations, including information on how to undertake EFS and the requirements that must be met.
The outcome should be to increase the attractiveness of conducting clinical research on health care technologies in the EU, including for small and medium-sized firms, spin-offs and start-ups.
The project should also allow faster translation of health technology innovation into practice, “with increased access to treatment for patients, especially those with medical conditions that have limited or no alternative therapeutic options.”
IHI Budget
IHI’s total budget is €2.4bn ($2.5bn), half of which comes from Horizon Europe, the EU’s research and innovation program. The IHI industry partners have committed €1bn to IHI, and a further €200m can be committed by other organizations that decide to become contributing partners.
Source: https://pink.pharmaintelligence.informa.com/PS146431/Major-EU-Research-Project-Targets-Personalized-Medicine-Unlocking-Of-Health-Data