Open Call SC1-HCO-19-2020: Reliable and Accessible Information on Cell and Gene-Based Therapies

European CommissionCell and gene-based therapies have the potential to treat many debilitating diseases and conditions. However, the pace of their clinical development does not meet public expectations. They face difficulties reaching patients because inter alia the complexity and costs of product development, regulatory hurdles and the non-harmonized procedures for reimbursements. In addition, there are concerns over patient safety due to the use of unproven treatments.

Scope

Proposals should offer well-structured and detailed strategies to convey accurate and up-to-date information on cell and gene-based therapies using multiple contemporary modalities, including a website. The consortium should consist of diverse actors and could include experts in science communication, patients’ representatives, industry, SMEs, clinical and academic researchers as well as the major European learned societies in the field. They should provide expertise across the field of human stem cells, regenerative medicine, genome-editing and gene therapy. All communication material/information should be translated to English and proposals should provide a detailed strategy on the linguistic approach of dissemination in order to reach a large EU audience. The website should be user-friendly and should contain tailored sections dedicated to at least researchers, patients, and the public.

For broader audiences proposals should create a reliable, transparent, accessible resource for patients to make informed decisions and for citizens to have access to scientifically viable information on cell and gene-based therapies, including sex and gender aspects when relevant. Proposals should provide state-of-the-art strategies to engage the public and foresee regular evaluation of whether they reach the targeted audiences. In addition, a series of communication events should be organised, also open to the public, where innovative technologies could be presented and discussed.

For the research community, proposals should create an information source on the practical steps needed for cell and gene-based therapy development. Proposals should provide a one-stop shop on where to seek further information and guidance relating to manufacturing guidelines, regulatory requirements, intellectual property rights, market acceptability and ethical matters. Proposals should provide a strategy on how they will liaise with regulatory agencies (e.g. national agencies, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) network, EUnetHTA network). Finally, proposals should include a realistic sustainability plan which explores how the ownership of the information will be structured, and propose a defined organisation to take responsibility, manage and administer the information, and to which authorities/organisations the information will be delivered at the end of the project. Sustainability should be ensured for at least 5 years after the end of the project.

The Commission considers that proposals requesting a contribution from the EU between EUR 1.5 and 2 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected Impact

  • Better informed decision making by patients and the public, due to objective, accurate and transparent communications of the latest developments and actual treatments available in the field in order to avoid misconceptions
  • Better informed decision making by regulatory and healthcare authorities, due to better access to reliable and updated information, and to stronger synergies and knowledge sharing between decision-makers and other stakeholders including advanced therapies learned societies.
  • Improved products development, by providing the research community and patients with a high-quality information source.

Opening date: 04 July 2019

Deadline: 07 April 2020 17:00:00 Brussels time

Deadline Model: single-stage

Type of action: Coordination and Support Action (CSA)

For topic conditions, documents and submission service, please visit:
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/sc1-hco-19-2020

PS: Find your partners or consortia preparing a project proposal
If you need help to identify a potential partner with particular competences, facilities or experience, please join and explore (HEALTH IT) SPACE www.healthitspace.eu.

Most Popular Now

Open Call HORIZON-HLTH-2021-TOOL-06-03: …

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 "Unlocking the full potential of new tools, technologies and digital...

CSAM Acquires Optima - Further Boosts eH…

CSAM Health Group AS ("CSAM"), the leading provider of niche eHealth solutions in the Nordics, today announced it has signed a deal to acquire eHealth player Optima Corporation Ltd from...

Novartis and Hewlett Packard Enterprise …

Novartis and Hewlett Packard Enterprise (HPE)announced a collaboration that aims to accelerate the use of data and digital technologies within Novartis efforts to reimagine global health and improve access to...

COVID-19 Origins Still a Mystery

Scientists using computer modelling to study SARS-CoV-2, the virus that caused the COVID-19 pandemic, have discovered the virus is most ideally adapted to infect human cells - rather than bat...

Using Artificial Intelligence to Overcom…

Depression is a worldwide problem, with serious consequences for individual health and the economy, and rapid and effective screening tools are thus urgently needed to counteract its increasing prevalence. Now...

Deep Machine Learning Completes Informat…

The Structural Bioinformatics and Network Biology laboratory, led by ICREA Researcher Dr. Patrick Aloy, has completed the bioactivity information for a million molecules using deep machine-learning computational models. It has...

EU Digital COVID Certificate Enters into…

The EU Digital COVID Certificate Regulation enters into application. This means that EU citizens and residents will now be able to have their Digital COVID Certificates issued and verified across...

Philips and the Spanish National Center …

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, has participated in an important research project to develop a magnetic resonance (MR) imaging technique [1,2] that could...

Scottish Health and Care Professionals G…

Scottish health and care professionals across a wide range of clinical settings including NHS Scotland health boards are being given access to an individual's COVID-19 vaccine status through the Orion...

Ethics and Governance of Artificial Inte…

Artificial Intelligence (AI) refers to the ability of algorithms encoded in technology to learn from data so that they can perform automated tasks without every step in the process having...

It's Going to be Quite a Handover…

Health and social care secretary Matt Hancock has been abruptly replaced by Sajid Javid. The Highland Marketing advisory board consider the huge agenda he is now facing, and what it...

Philips Accelerates Stroke Diagnosis and…

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced a strategic partnership agreement with NICO.LAB, a MedTech stroke care company. Together with the recently expanded stroke...