Closing the gap – validating and implementing new approach methodologies in a regulatory context (ValNAM)

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Logo beauftragt vom Bundesministerium für Bildung und Forschung
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This calls aims for validation of new approach methods in a regulatory context, with the ultimate goal to implement new animal-free, human relevant methods as OECD guidelines or establish qualified models to be used in efficacy testings for new pharmaceuticals.

In this regard projects are expected to increase in technology readiness levels during the duration of the project, thus enabling them to prepare documentation for a timely (2-3 years post project finalisation) regulatory evaluation and approval, if feasible.

Documents

Documents to be offered for download in the final version 

Submission deadline: 28.04.2025

Webinar

We will host two digital webinars with the first one aiming to provide you with general information regarding the new funding call and set expectations regarding consortia assembly and the approval process. In addition, you may use this opportunity to network and exchange contact details with various other interested parties to establish your consortia. The first webinar will be hosted on 

Tuesday, January 28th from 1 pm to 2.30 pm. 

In addition, we will host a second webinar providing more detailed information on evaluation criteria and the proposal submission process. You may also use this opportunity to ask any remaining questions regarding the call.
The date and registration link will be published here soon.

For further information regarding the call please refer to the FAQ section below. We strongly encourage you to use the guidance provided by OECD, ECVAM and various other.

If you have an idea for a fitting project but you are currently lacking project partners to fulfill the calls’ requirements for the consortia composition please reach out to us, we may be able to assist you. You may also use the resources provided below in the FAQ section.

 

FAQ

What is the aim of the call?

This call aims to fund the validation of new approach methods in a regulatory context, with the ultimate goal to implement new animal-free, human relevant methods as OECD guidelines or establish qualified methods to be used in efficacy testings for new pharmaceuticals.

In this regard, projects are expected to increase in technology readiness level (TRL) during the duration of the project, thus enabling them to prepare documentation for a timely regulatory evaluation and approval, if feasible.

Who should apply?

Eligible projects should present a method with a technology readiness level of 3-7. The method described has to be human relevant. The project proposal involves at least one eligible research partner from each country participating in the call. 

Project partners should contain at least one partner from a research institute and at least one partner from a commercial organization. The consortium coordinator and each of the additional consortium partners asking to be financed are eligible to receive funding from the two funding organizations participating in the call.

Are you allowed to participate in multiple consortia?

Yes, applicants may contribute to multiple consortia, as long as there is a distinctive separation of work packages contributed to each consortia. However, please note, that applicants may not coordinate two different consortia.

Can international partners from outside The Netherlands and Germany be
included in the consortium?

International partners may contribute to the consortia, will however not be eligible for funding through the participating funding agencies and thus, will need to provide their own resources.

I have a great idea, but I am looking for a Dutch/German/ industry/ academia
partner to qualify for the call. What should I do?

If you are looking for a suiting project partner please reach out to the JCS as we may be able to assist you. You may also find the following websites useful for identifying potential collaborators.

How to assess technology readiness?

Please use the available online resources to assess your technology readiness, such as the ReadEDTest (https://readedtest.u-paris-sciences.fr/ ). In addition, you may find the following publications insightful:

Bal-Price, A. (2018) “Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity”, ALTEX - Alternatives to animal experimentation, 35(3), pp. 306–352. doi: 10.14573/altex.1712081.

https://www.altex.org/index.php/altex/article/view/353 

Crouzet, T. (2023) „ReadEDTest: A tool to assess the readiness of in vitro test methods under development for identifying endocrine disruptors“, Environment International, Volume 174, doi: 10.1016/j.envint.2023.107910.

https://www.sciencedirect.com/science/article/pii/S0160412023001836

Jacobs, M.N. (2020) „Chemical carcinogen safety testing: OECD expert group international consensus on the development of an integrated approach for the testing and assessment of chemical non-genotoxic carcinogens“, Arch Toxicol 94, 2899–2923, doi: 10.1007/s00204-020-02784-5

https://link.springer.com/article/10.1007/s00204-020-02784-5 

Krebs, A. (2019) “Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data”, ALTEX - Alternatives to animal experimentation, 36(4), pp. 682–699. doi: 10.14573/altex.1909271.

https://www.altex.org/index.php/altex/article/view/1433 

What is the available funding budget and are there any restrictions?

In this call, ZonMw aims to fund the Dutch partner(s) of four to eight research projects, each with a maximum of K€ 300-600 for the Dutch part of the budget. ZonMw will not be able to fund more than a total of M€ 2.5.

The BMBF aims to fund the German partner(s) of four to eight research projects, each with a maximum of K€ 600-1200 for the German part of the budget. The BMBF will not be able to fund more than a total of M€ 5.

Industrial research  Small enterprisesMedium-sized enterprises Large enterprises
Basis   50%   50%  50% 
Top-up   20%  10%  none
Knowledge dissemination  15%  15%  15%
TOTAL  80%  75%  65%

‘Industrial research’ means the planned research or critical investigation aimed at the acquisition of new knowledge and skills for developing new products, processes or services or for bringing about a significant improvement in existing products, processes or services. It comprises the creation of components parts of complex systems, and may include the construction of prototypes in a laboratory environment or in an environment with simulated interfaces to existing systems as well as of pilot lines, when necessary for the industrial research and notably for generic technology validation (taken from COMMUNICATION FROM THE COMMISSION Framework for State aid for research and development and innovation (2014/C 198/01)).

Experimental development Small enterprisesMedium-sized enterprises Large enterprises
Basis   25%   25%  25% 
Top-up   20%  10%  none
Knowledge dissemination  15%  15%  15%
TOTAL  60%  50%  40%

‘Experimental development’ means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services. 

Experimental development may comprise prototyping, demonstrating, piloting, testing and validation of new or improved products, processes or services in environments representative of real life operating conditions where the primary objective is to make further technical improvements on products, processes or services that are not substantially set. This may include the development of a commercially usable prototype or pilot which is necessarily the final commercial product and which is too expensive to produce for it to be used only for demonstration and validation purposes. 

Experimental development does not include routine or periodic changes made to existing products, production lines, manufacturing processes, services and other operations in progress, even if those changes may represent improvements (taken from COMMUNICATION FROM THE COMMISSION Framework for State aid for research and development and innovation (2014/C 198/01)).

Feasibility studiesSmall enterprisesMedium-sized enterprises Large enterprises
Basis   50%   50%  50% 
Top-up   20%  10%  none
TOTAL  70%  60%  50%

‘Feasibility study’ means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision making by objectively and rationally uncovering its strengths and weak nesses, opportunities and threats, as well as identifying the resources required to carry it through and ulti mately its prospects for success (taken from COMMUNICATION FROM THE COMMISSION Framework for State aid for research and development and innovation (2014/C 198/01)).

For further information regarding state aid regulations please refer to: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014XC0627(01)

In addition we recommend the following websites for further information regarding method validation, regulatory requirements, TRLs, NAMs etc.

If you are in need of an OECD contact person, please refer to the following website for your national coordinator of the OECD test guideline program: 
https://www.oecd.org/content/dam/oecd/en/topics/policy-sub-issues/testing-of-chemicals/National%20Coordinators%20of%20the%20Test%20Guideline%20Programme.pdf

Please indicate your interest in the bi-national ValNAM funding call, when contacting them prior to proposal submission. Contact points from Netherlands and Germany have been informed about the publication of this call.

Contact 

Email: mkmd@zonmw.nl