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

Closed

Programme Category

EU Competitive Programmes

Programme Name

Horizon Europe (2021-2027)

Programme Description

Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.

Programme Details

Identifier Code

HORIZON-HLTH-2023-IND-06-05

Call

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

Summary

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.

Detailed Call Description

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.

Call Total Budget

€3,00 million

Financing percentage by EU or other bodies / Level of Subsidy or Loan

100%

Contribution per project: €3,00 million

Thematic Categories

  • Education and training
  • Health
  • Research, Technological Development and Innovation
  • Small-Medium Enterprises and Competitiveness

Eligibility for Participation

  • Associations
  • Central Government
  • Educational Institutions
  • Investment Funds
  • Local Authorities
  • NGOs
  • Non Profit Organisations
  • Other Beneficiaries
  • Private Bodies
  • Researchers/Research Centers/Institutions
  • Semi-governmental organisations
  • Small and Medium Enterprises (SMEs)
  • State-owned Enterprises
  • Training Centres

Eligibility For Participation Notes

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.

Call Opening Date

12/01/2023

Call Closing Date

13/04/2023

National Contact Point(s)

Research and Innovation Foundation
29a Andrea Michalakopoulou, 1075 Nicosia
P.O.Box 23422, 1683 Nicosia

Telephone: +357 22205000
Email Address: support@research.org.cy
Website: https://www.research.org.cy/en/

Contact Persons:
George Christou

Scientific Officer
Email: gchristou@research.org.cy

Ioannis Theodorou
Scientific Officer
Telephone: +357 22 205 038
Contact Email: itheodorou@research.org.cy

(Publish Date: 07/02/2023-for internal use only)

EU Contact Point

European Commission, Directorate-General for Research and Innovation

https://ec.europa.eu/info/departments/research-and-innovation_en#contact