3Rs Management and Consulting ApS

28/10/2022

https://toxgensolutions.eu/toxgensolutions-bv-identified-a-9-mir-periferal-profile-that-can-identify-individuals-at-risk-for-acquiring-late-onset-alzheimers-disease-years-in-advance/

This proposal addresses the objective to drive the development of cutting-edge biomarkers and to explore novel diagnostic technologies. The ultimate goal of our program is to make diagnosis of late-onset Alzheimer’s Disease (AD): faster by turning the months/years it takes for the current diagnost...

06/10/2017

The proposed for food sensitization is based on information on molecular and cellular mechanisms and pathways evidenced to be involved in sensitization by and food proteins and uses the for chemical and sensitization induction as templates. Available mechanistic data on were included to fill out gaps in the understanding of how proteins may affect cells, cell-cell interactions and tissue homeostasis. Analysis revealed several key events (KE) and that may have potential use in testing and assessment of proteins for their sensitizing potential.
(van Bilzen et al., Clinical and Translational Allergy, 2017)

06/10/2017

The proposed for food sensitization is based on information on molecular and cellular mechanisms and pathways evidenced to be involved in sensitization by
and food proteins and uses the for chemical and sensitization induction as templates. Available mechanistic data on
s were included to fill out gaps in the understanding of how proteins may affect cells, cell-cell interactions and tissue homeostasis. Analysis revealed several key events (KE) and biomarkers that may have potential use in testing and assessment of proteins for their sensitizing potential.
(van Bilzen et al., Clinical and Translational Allergy, 2017)

03/10/2017

Using the recently published for respiratory induction by small as template, a set of test methods can be identified, each addressing a specific key event of the . While some tools produced promising results, more data are required to build confidence in these tools.

02/10/2017

An Adverse Outcome Pathway ( ) for
of the tract by low-molecular-weight chemicals is proposed to build evidence to support the utility
of methods in a context (Sullivan et al., Applied In Vitro Toxicology, 2017)

02/10/2017

The concept was applied to structure the available mechanistic knowledge for the purpose of identifying a number of methods, each addressing a specific event (KE), that provide information about the allergenic potential of new proteins (van Bilzen et al., Clinical and Translational Allergy, 2017). When applied in the context of an integrated strategy, these methods may reduce, if not , current approaches. The proposed will be shared at the www.aopwiki.org platform to expand the mechanistic data, improve the confidence in each of the proposed KE and key event relations (KERs), and allow for the identification of new, or refinement of established KE and KERs.

The AOP-Wiki will be undergoing maintenance during the weekend of September 2-3. Impact to users should be minimal, but there will be short periods throughout the weekend where the wiki is unavailable. We apologize for the inconvenience.

21/02/2017

By combining physico-chemical/structural analysis [ ApS (DK)] and biological pathway analysis of exposed human cells and tissue [ BV (NL)], both companies are convinced that they can offer a novel quantitative systems biology approach for efficacy/toxicity assessment, and more accurate human health and safety, where current in vivo animal models fail.

01/12/2016

participated in the COST project (www.imparas.eu) working group (WG) meeting in Vienna, as chair for WG2 (mechanism-based methods for testing and assessment of novel proteins).
impARAS proudly announces that consensus was reached about a proposal for an (AOP) for food sensitization. This will be made available as manuscript and on the www.aopwiki.com. We are looking forward to a global discussion driving the proposed AOP to a level where it becomes an informative component of a yet to be established integrated approach for testing and asssessment ( ) providing confidence in the safety of novel food) proteins.

Improving Allergy Risk Assessment

03/08/2016

Acquiring mechanistic understanding of the cellular interactions resulting in functional networks, tissues and organs has been the red thread through my career as researcher. I feel privileged to have experienced the emergence of novel technologies that made this possible.
The recognition that information from animal studies often poorly translates to humans, and personal rather unpleasant experiences with animal experimentation, made me invest my expertise in the development and application of mechanism-based methods for testing and assessment of product safety and efficacy.
The obstacles for application of emerging methods are currently addressed by the European Commission, the European Partnership for Alternative Approaches to Animal Testing, the John Hopkins Centre for Alternatives to Animal Testing, the In Vitro Testing Industrial Platform and the European Chemical Industry Council.
Through 3Rs Management and Consulting ApS (www.3rsmc-aps.com) I offer assistance addressing identified obstacles: (i) identification of suitable methods, (ii) assessment and adaptation of these methods, (iii) application and data interpretation, (iv) establishment of suitable testing and assessment strategy.
In addition to the soft tools applied by , I invest in methods to provide mechanistic understanding of human and environmental health and safety. AB (www.senzagen.com) is specialized in genomics-based solutions to identify sensitizers. BV (www.toxgensolutions.eu) provides customized mechanism-based solutions in the areas of genotoxicity, direct immunotoxicity and developmental toxicity.
The resulting data should provide ‘sufficient confidence’ about the toxicity or efficacy (or lack there off) of a test substance. I endorse the vision that building ‘sufficient confidence’ should be science-driven, even when the science is provided by an adapted test guideline or well-documented non-test guideline methods.

03/08/2016

Acquiring mechanistic understanding of the cellular interactions resulting in functional networks, tissues and organs has been the red thread through my career as researcher. I feel privileged to have experienced the emergence of novel technologies that made this possible.
The recognition that information from animal studies often poorly translates to humans, and personal rather unpleasant experiences with animal experimentation, made me invest my expertise in the development and application of mechanism-based animal-free methods for testing and assessment of product safety and efficacy.
The obstacles for application of emerging methods are currently addressed by the European Commission, the European Partnership for Alternative Approaches to Animal Testing, the John Hopkins Centre for Alternatives to Animal Testing, the In Vitro Testing Industrial Platform and the European Chemical Industry Council.
Through 3Rs Management and Consulting ApS (www.3rsmc-aps.com) I offer assistance addressing identified obstacles: (i) identification of suitable methods, (ii) assessment and adaptation of these methods, (iii) application and data interpretation, (iv) establishment of suitable testing and assessment strategy.
In addition to the soft tools applied by 3RsMC, I invest in methods to provide mechanistic understanding of human and environmental health and safety. SenzaGen AB (www.senzagen.com) is specialized in genomics-based solutions to identify sensitizers. ToxGenSolutions BV (www.toxgensolutions.eu) provides customized mechanism-based solutions in the areas of genotoxicity, direct immunotoxicity and developmental toxicity.
The resulting data should provide ‘sufficient confidence’ about the toxicity or efficacy (or lack there off) of a test substance. I endorse the vision that building ‘sufficient confidence’ should be science-driven, even when the science is provided by an adapted test guideline or well-documented non-test guideline methods.

24/05/2016

For some a safety dossier of good quality is a dossier 'complying with current guidelines', while others will consider a dossier being of good quality when it contains 'sufficient confidence' about the toxicity (or lack there off) of a substance or product. While both are not mutaully exclusive per se industry too often finds itself in a dilemma. When 'sufficient confidence' is based on more expensive strategies the uncertainty about the acceptance of these data by regulatory authorities makes costs often the decisive factor.