Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for regulators

0 Saves · 0 Shares · 0 Comments Discussion

Grant Name

Funder

Horizon Europe Framework Programme (HORIZON)

European Commission

Research Field

Translational medicine

Pharmacokinetics

Pharmacology, pharmacogenomics, drug discovery and

Toxicology

Medical biotechnology

Pharmacodynamics

Deadline

2024-04-11 (Expired)

Grant Size

€2000000

Eligibility

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.

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

The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.

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.

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

5. Evaluation and award:

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.

Documents

Call documents:

Standard application form (HE CSA) - call-specific application form is available in the Submission System

Standard evaluation form (HE CSA)

HE General MGA v1.0

Information on clinical studies (HE)

Additional documents:

HE Main Work Programme 2023–2024 – 1. General Introduction

HE Main Work Programme 2023–2024 – 4. Health

HE Main Work Programme 2023–2024 – 13. General Annexes

HE Programme Guide

HE Framework Programme and Rules for Participation Regulation 2021/695

HE Specific Programme Decision 2021/764

EU Financial Regulation

Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment

EU Grants AGA — Annotated Model Grant Agreement

Funding & Tenders Portal Online Manual

Funding & Tenders Portal Terms and Conditions

Funding & Tenders Portal Privacy Statement

Grant Number

HORIZON-HLTH-2024-IND-06-09

Description

ExpectedOutcome:

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, tailored towards and contributing to all of the following expected outcomes:

European regulators gain state-of-the-art knowledge on different NAMs that are being proposed for the assessment of the safety and efficacy of chemicals and pharmaceuticals;
European regulators understand better the shortcomings of the current tools based on animal procedures for the assessment of chemicals and pharmaceuticals;
European regulators collaborate on a framework on how to assess the safety of chemicals based on NAM-data and how to classify the hazardous properties based on such data;
European regulators collaborate on a similar framework for assessment of safety and efficacy of pharmaceuticals based on NAM-data;
Citizens benefit from the supply and use of chemicals and pharmaceuticals that have been assessed through NAMs that are better predicting potential effects in humans than the current assessment methods;
Industry has an improved competitive position with the availability of harmonised and standardised NAM-based assessment tools that are faster and more flexible;
European Commission and Member States regulators are responding to the societal demand to move away from animal testing.

Scope:

There is increasing scientific evidence pointing to the limitations of animal testing for safety and efficacy assessment of chemicals and pharmaceuticals. Europe is also experiencing a strong societal demand to move away from animal testing. Scientific progress of the past two decades has produced a number of animal-free New Approach Methodologies (NAMs) that have the potential to be used instead of the animal models that are currently employed for such testing. However, knowledge, experience and confidence on how results from the NAM assays could be used is still lacking among regulators, which could limit the industry’s use of NAMs because of lack of legal certainty when generating safety and health data requested by EU legislation.

The proposals should focus on alternatives to the use of animals for regulatory safety and efficacy testing. Applicants should propose activities that bring together NAM developers and NAM users with European regulators responsible for the safe use of chemicals (e.g. industrial chemicals, pesticides, biocides and cosmetics) and pharmaceuticals in order to inform on NAM solutions available and to encourage the building of a framework on how these NAMs could be most effectively used in the different decision-making contexts. For NAMs applicable to chemical risk assessment, collaboration with existing initiatives such as the Partnership for the Assessment of Risks from Chemicals (PARC) and the ASPIS cluster of projects (Animal-free Safety Assessment of chemicals: Project cluster for Implementation of novel Strategies) is encouraged.

To build such a framework the proposals should address all of the following:

develop technical and regulatory readiness criteria
reflect on how to provide mechanisms to support technology transfer, i.e. bringing promising NAMs to the market (including optimisation and transferability assessment)
discuss how to standardise NAMs and NAM-based strategies via OECD, CEN, ISO, ICH, VICH and other international organisations, as applicable
provide technical training for Contract Research Organisations (CROs) applying NAMs for regulatory purposes
promote dialogue (involving companies, regulatory bodies on EU level, including ECHA, EMA and EFSA and Member States authorities) on how to integrate and interpret data from NAMs and facilitate their uptake for safety and efficacy testing of chemicals (including pesticides) and pharmaceuticals, while addressing the lack of reliability and shortcomings of the current tools based on animal procedures
identify obstacles in EU legislation for the regulatory use of NAMs and propose options/changes in the EU regulatory framework which address these obstacles and facilitate the uptake and use of NAMs

Proposals should consider involving the JRC to take advantage of its expertise and relevant activities in bridging research and regulatory communities and facilitating uptake of NAMs for regulatory application. In that respect, the JRC is open to collaborate with any successful proposal after its approval.

Funding resources
Purdue Grant Writing Lab: Introduction to Grant Writing	Open Link
University of Wisconsin Writing Center: Planning and Writing a Grant Proposal	Open Link