IHI – Innovative Health Initiative Opportunities

Four Innovative Health Initiative Opportunities. Deadline to aply: March 15th.

Strengthening the European translational research ecosystem for advanced therapy medicinal products (ATMPs) for rare diseases

Research and innovation (R&I) actions to be supported under this topic must work towards results that contribute to all the following expected outcomes.

• A sustainable network of centres of excellence, that should:

1. advance the most promising, impactful, translatable, quality-controlled technologies that address the bottlenecks in the development of ATMPs and other related innovative therapeutic modalities such as the use of messenger RNA (mRNA), or nucleic acids and nanoparticle (NPs) delivery for gene editing;
2. make these technologies accessible to all actors involved in the development of ATMPs and other related innovative therapeutic modalities, including the research community, academia, clinics, small to medium-sized enterprises (SMEs), healthcare professionals, biotech, medical technology and pharmaceutical companies, and patients;
3. share information, processes and methods, and build capacity in science and technology, and regulatory awareness of ATMPs, including the ability to assist industrial and academic developers of ATMPs in their translational research.

• Consensus reached on quality standards (e.g. of analytical methods) and translation process by the ATMP community at large that support the timely and robust development of ATMPs and other related innovative therapeutic modalities.
• Strengthened interactions with regulators to enable a more streamlined and transparent regulatory pathway that will optimise and speed up the development and delivery of ATMPs and other innovative therapeutic modalities for rare diseases for the benefit of patients, carers, healthcare systems and society.
• Improved technologies/processes, analytic tools, methods including non-clinical methods, and assays useful for the development of ATMPs and other related innovative therapeutic modalities, beyond those targeting rare and ultra-rare diseases.

Combining hospital interventional approaches to improve patient outcomes and increase hospital efficiency

Research and innovation (R&I) actions (projects) to be supported under this topic should aim to deliver results that contribute to all of the following expected outcomes:

• Patients will be offered improved, evidence-based, innovative hospital treatment combinations that lead to better outcomes.
• Healthcare professionals will have access to improved clinical decision support systems that will recommend personalised treatments using patient-specific datasets collected in the hospital setting.
• Healthcare systems will have better evidence on cost-effective combinations of interventions and how these combinations can increase hospital efficiency.
• Researchers will have improved information on treatment combinations to facilitate the development of improved interventions.

Patient-generated evidence to improve outcomes, support decision making, and accelerate innovation

Research and innovation (R&I) actions (projects) to be supported under this topic should aim to deliver results that contribute to all of the following expected outcomes for the use cases selected:

• Decision makers have new methods for the integration of PROMs, PPI, and PREMs and other people-generated information into regulatory and health technology assessment (HTA) evaluation processes for integrated healthcare solutions.
• Patients of all ages have access to novel integrated healthcare solutions¹ that are developed using structured patient input and better respond to their needs and preferences.
• Researchers have new methodological approaches to elicit and integrate patient preferences into the conception, development, and implementation of integrated healthcare solutions¹.
• Researchers have wider access to interoperable, quality patient input and patient-generated data, respecting the FAIR (findable, accessible, interoperable, reusable) principles, facilitating the research and development of integrated healthcare solutions.
• Researchers are provided with new outcomes, outcome measures and the time horizon over which value should be assessed to develop appropriate tools and methods for the collection and analysis of PROMs, PPI, and PREMs.

Screening platform and biomarkers for prediction and prevention of diseases of unmet public health need

R&I actions (projects) to be supported under this topic should aim to deliver results that contribute to all of the following expected outcomes for disease(s) of high unmet public health need selected by the applicants:

• Patients will receive more timely personalised interventions (prevention, early treatment to avoid complications, etc) to reduce morbidity and mortality from major diseases, improving the lives of citizens.
• Healthcare professionals have access to a screening platform and clinically validated biomarkers for identifying people at risk of disease to facilitate the selection of the most appropriate preventative action.
• Researchers have new biomarkers for prediction and prevention to allow for the development of safer and more effective personalised interventions tailored to the individual’s characteristics.
• Healthcare systems will benefit from reliable evidence to target effective, preventative therapeutic interventions to those citizens who will benefit most from them.