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

Contact Tracing Apps Unlikely to Contain…

Contract tracing apps used to reduce the spread of COVID-19 are unlikely to be effective without proper uptake and support from concurrent control measures, finds a new study by UCL...

Philips Launches New Innovations to Help…

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today presented new approaches to health and healthcare, and the shift to health-at-home, at its virtual consumer health...

Internet Searches for Anxiety Attacks Ta…

Many health experts are concerned that the COVID-19 pandemic could be having widespread effects on people's mental health, but assessing these concerns is difficult without data. "Traditional public health surveillance lacks...

Orion Health Secures Place on Emerging T…

Remote Patient Monitoring solution included on Crown Commercial Services Spark: Technology Innovation Marketplace. Healthcare organisations now have a simple route to procure personalised monitoring for people living with chronic conditions to...

Scientists Develop Low-Cost Chip to Dete…

Robust and widespread antibody testing has emerged as a key strategy in the fight against SARS-CoV-2, the virus responsible for the COVID-19 pandemic. However current testing methods are too inaccurate...

Newly Merged CCG Expands Tech Support to…

Norfolk and Waveney Clinical Commissioning Group to support prescribers to improve the quality and safety of prescribing through deploying prescribing decision technology FDB OptimiseRx. A newly merged clinical commissioning group...

Anonymized Cell Phone Location Data can …

In March 2020, federal officials declared the COVID-19 outbreak a national emergency. Around the same time, most states implemented stay-at-home advisories - to different degrees and at different times. Publicly...

Designed Antiviral Proteins Inhibit SARS…

Computer-designed small proteins have now been shown to protect lab-grown human cells from SARS-CoV-2, the coronavirus that causes COVID-19. The findings are reported today in Science. In the experiments, the lead...

Telehealth Scales Up During the Pandemic…

Hailed for its ability to erase distance between health care providers in cities and patients in rural areas, telehealth has ironically enabled medical care to continue in a time when...

Fitbit Receives Regulatory Clearance in …

Fitbit (NYSE:FIT) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union, for its electrocardiogram (ECG) app...

Don't Fall for the 'Next Best Action' Tr…

15 September, 2020. London, UK. OKRA has announced a new, free webinar called 'Why Next Best Action is not enough', a panel will discuss the urgent need to move beyond the...

Cerner Chosen to Support Population Heal…

Cerner Corporation is pleased to announce a new relationship with Hampshire and Isle of Wight (HIOW) health and care system to enable their population health management journey to transform the...