1. Providing guidance, technology transfer and training

3RSMC has established an extensive network spanning academia and the 7 industrial sectors which makes it a good mediator between test developers with test users.

An extensive academic network provides a ‘life catalogue' of in vitro assays, in silico tools and NAMs with various degrees of maturity.

By understanding the needs of industry 3RsMC can provide guidance and advice with respect to the industrial applicability of methods and how to get there.

To gain industrial acceptance for non-regulatory purpose 3RsMC assists with finding mature ‘fit-for-purpose’ methods or approaches that fill out customer needs and expectations. Providing technology transfer and training by the test developers is in this context an important activity.

To acquire regulatory acceptance 3RsMC assists the customer in complying with relevant OECD test guidelines. The regulatory network of 3RSMC is instrumental in the dialog with regulators and risk assessors which is crucial for acquiring regulatory acceptance of the methods and eventually of the products assessed by these methods for safety or efficacy.

2. Building confidence through ab initio studies

Mature fit-for-purpose in vitro assays, in silico tools and NAMs, defined by a detailed standard procedure supporting reproducibility, are transferred to the customer to drive the implementation of the methods.

The strategy:

  1. Building confidence by generating data in real-life settings that eventually contribute to validation in regulatory and non-regulatory settings,
  2. Addressing drivers and barriers experienced by stakeholders in a multilevel perspective.

Implementation for non-regulatory purposes by industry, such as during screening and preclinical testing, is preferably in parallel with already applied in-house testing and assessment approaches.

The customer is requested to add difficult ‘data-poor’ in-house chemicals to further challenge the chemical applicability domain of the methods serving as ab initio studies.

3. From validation to business development

Small ab initio studies with industry including well-characterised chemicals and chemicals of direct relevance to the customer provide real-life data and are highly relevant for the acquisition of regulatory acceptance.
Once industrial acceptance (for non-regulatory purpose) is established, 3RsMC capable of managing and coordinating validation studies demonstrating reproducibility, reliability and predictivity of in vitro assays, in silico tools and NAMs in compliance with the OECD guidelines.
- Track record: GARDTMskin, GARDTMpotency, GARDTMair, RHE IL-18 -
3RsMC delivers for the customer validation study reports and eventually validated in vitro assays, in silico tools and NAMs that are in line with the principles of the 21st Century Toxicity Testing vision and the next generation risk assessment.
While regulatory acceptance of the validated methods is pending, 3RsMC can provide business development expertise aiming at the introduction of the methods to the market.
- Track record: SenzaGen, ToxGenSolutions, PreMeDia - 

4. From business development to Start-up and SME

3RsMC is co-owner of SenzaGen (https://senzagen.com) and ToxGenSolutions (https://toxgensolutions.eu).

Currently, 3RsMC is negotiating with the Hangzhou government and local venture capitalists how, when and where to set-up a new company specialized in diagnostics in the area of preventive medicine.

Due to the current economic situation, no additional investments can be considered

3Rs Management and Consulting ApS

3RsMC is a non-profit initiative with the objective to bridge the gap between test developers (often academia and small enterprises) and test users (industry and regulatory authorities). Its main focus is therefore on replacement strategies, and on refinement and/or reduction strategies but only as far as relevant for the development and improvement of replacement approaches.

Contact info

  • Erwin L Roggen
  • Asavænget 14
    2800 Kongens Lyngby
  • Phone: +45 3153 8020
  • Email: 3RsMC.eu@gmail.com

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