Closed

Mapping the hurdles for the clinical applications of Advanced Therapy Medicinal Products (ATMPs)

HORIZON Coordination and Support Actions

Basic Information

Identifier
HORIZON-HLTH-2023-IND-06-05
Programme
A competitive health-related industry (Single stage - 2023)
Programme Period
2021 - 2027
Status
Closed (31094503)
Opening Date
January 11, 2023
Deadline
April 12, 2023
Deadline Model
single-stage
Budget
€25,000,000
Keywords
Clinical PharmacologyClinical researchClinical trialsDNA therapyDrug development, clinical phasesGene therapy, cell therapy, regenerative medicineHealth care sciences and services (including hospital administration, health care financing)Health policy and servicesMedical biotechnologyMedical ethicsMedical statisticsPharmacology, pharmacogenomics, drug discovery and design, drug therapyToxicology

Description

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed towards and contributing to all of the following expected outcomes:

  • Challenging aspects of regulation, policy, safety, efficacy, manufacturing, organisation, infrastructure, decision-making, and commercialisation are identified for speeding up the equitable clinical applications of ATMPs.
  • European regulatory frameworks are adapted to novel scientific progress, especially those related to platform approaches, genome editing, interface with medical devices, artificial intelligence.
  • Competent authorities in the Member States can propose adapted pricing and reimbursement schemes that allow European citizens to benefit from novel ATMPs.
  • Academic and SME developers and manufacturers of ATMPs have an increased knowledge of the regulatory aspects.
  • The decentralised manufacturing of ATMPs is consistent across health care centres.
Scope:

New pioneering treatments called Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, have the potential to bring new cures to patients affected by diseases with limited or no available treatments. However, several hurdles impede or slow down the access of ATMPs to patients in the EU and Associated Countries. These include e.g. regulatory challenges, underlying scientific uncertainties, differences in assessing the values of ATMPs by the various Health Technology Agencies (HTA), difficulties to perform randomised-controlled clinical trials or to obtain long-term safety and effectiveness data, the lack of harmonised approaches to the reimbursement of the high upfront costs by health systems, manufacturing processes, etc.

The proposals should address all of the following activities:

  • Map the regulatory, safety and efficacy assessment, manufacturing, organisational and infrastructural needs to improve the translation of ATMPs from preclinical development to clinical use.
  • Address the gaps and uncertainties in regulatory and policy aspects pertinent to complex innovative ATMPs.
  • Address predictivity of preclinical data for safety and efficacy testing of ATMPs. Improved novel models could be proposed.
  • Tackle decision-making processes relating to ATMPs, such as for instance the assessment of their values, the demonstration of the long-term safety and effectiveness, or new pricing and reimbursement frameworks.
  • Propose opportunities for an improved knowledge of the regulatory processes among academic ATMP developers.
  • Involve regulatory authorities, Health Technology Agencies (HTA), clinicians, ethics committees, and patients, with the aim to ensure higher clinical use of ATMPs. The findings of the project will be available to competent authorities, ATMP developers and manufacturers as well as to national/regional funding agencies.

Destination & Scope

Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘A competitive and secure data-economy’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is innovative, sustainable and globally competitive thanks to improved up-take of breakthrough technologies and innovations, which makes the EU with its Member States more resilient and less dependent from imports with regard to the access to and supply of critical health technologies’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘Industrial leadership in key and emerging technologies that work for people’, ‘High quality digital services for all’, and ‘Good health and high-quality accessible health care’.

The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of health care services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. high attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for research and innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).

In order to address these challenges, in particular green and digital transitions and proper supply of health technologies and products, destination 6 will focus on research and innovation activities that aim at:

  • Facilitating the production of pharmaceuticals in compliance with the objectives of the European Green Deal.
  • Developing methodologies, guidelines and standards, assessment studies, and structuring activities adapted to digital solutions and interventions for GDPR compliant translation into health care practice, including inter-operability, cyber-security and data confidentiality.
  • Supporting public authorities with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive manufacturing and other production technologies (incl. bio manufacturing); safe, smart and sustainable materials.

Expected Impacts:

Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and globally competitive health industry, and more specifically to one or several of the following expected impacts:

  • Health industry in the EU is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and digital technologies, contributing to job creation and economic growth, in particular with small- and medium-sized enterprises (SMEs).
  • Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, health care providers, health authorities and regulators ensuring suitability and acceptance of solutions.
  • European standards, including for operations involving health data, ensure patient safety and quality of healthcare services as well as effectiveness and interoperability of health innovation and productivity of innovators.
  • Citizens, health care providers and health systems benefit from a swift uptake of innovative health technologies and services offering significant improvements in health outcomes, while health industry in the EU benefits from decreased time-to-market.
  • Health security in the EU benefits from reliable access to key manufacturing capacity, including timely provision of essential medical supplies of particularly complex or critical supply and distribution chains, such as regards vaccines or medical radioisotopes.

Eligibility & Conditions

General conditions

General conditions

1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.

 

2. Eligible countries: described in Annex B of the Work Programme General Annexes.

A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.

Coordinators of projects must be legal entities established in an EU Member State or Associated Country.

 

3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.

 

4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.

Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.

Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.

 

6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.

 

Specific conditions

7. Specific conditions: described in the specific topic of the Work Programme.

Support & Resources

Online Manual is your guide on the procedures from proposal submission to managing your grant.

Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.

Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.

Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.

National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).

Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.

IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.

European IPR Helpdesk assists you on intellectual property issues.

CEN-CENELEC Research Helpdesk and  ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.

The European Charter for Researchers and the Code of Conduct for their recruitment consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.

Partner Search Services help you find a partner organisation for your proposal.

Latest Updates

Last Changed: August 9, 2023

Call HORIZON-HLTH-2023-IND-06

We recently informed the applicants about the evaluation results for their proposals.

The results of the evaluation are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 17

Number of inadmissible proposals: 0

Number of ineligible proposals: 1

Number of above-threshold proposals: 8

Total budget requested for above-threshold proposals: EUR 50,650,760.

Last Changed: August 9, 2023

Call HORIZON-HLTH-2023-IND-06

We recently informed the applicants about the evaluation results for their proposals.

The results of the evaluation are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 17

Number of inadmissible proposals: 0

Number of ineligible proposals: 1

Number of above-threshold proposals: 8

Total budget requested for above-threshold proposals: EUR 50,650,760.

Last Changed: April 13, 2023

Call HORIZON-HLTH-2023-IND-06 closed on 13 April 2023. 17 proposals were submitted. The breakdown per topic is:

  • HORIZON-HLTH-2023-IND-06-01: 1 proposals
  • HORIZON-HLTH-2023-IND-06-02: 3 proposals
  • HORIZON-HLTH-2023-IND-06-04: 3 proposals
  • HORIZON-HLTH-2023-IND-06-05: 2 proposals
  • HORIZON-HLTH-2023-IND-06-07: 8 proposals

Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.

Last Changed: January 12, 2023
The submission session is now available for: HORIZON-HLTH-2023-IND-06-02(HORIZON-RIA), HORIZON-HLTH-2023-IND-06-05(HORIZON-CSA), HORIZON-HLTH-2023-IND-06-01(HORIZON-CSA), HORIZON-HLTH-2023-IND-06-07(HORIZON-RIA), HORIZON-HLTH-2023-IND-06-04(HORIZON-RIA)
Mapping the hurdles for the clinical applications of Advanced Therapy Medicinal Products (ATMPs) | Grantalist