Chemicals : Regulatory Compliance and R&D Costs Discover SAFETY BY DESIGN® : PREDICTIVE
TOXICOLOGY & ACTIVITY SOFTWARE BY HARMONIC PHARMA

SAFETY BY DESIGN® : Pretictive toxicology and activity software by Harmonic Pharma that integrate with :

  • Regulations in the pharmaceutical, cosmetic and specialty chemical fields. 
  • Alternative methods to animal experimentation (3 R’s ruleReduce, Refine, Replace :
    Reduce : limit as far as possible the number of animals used in experiments and avoid unnecessary suffering while ensuring the best possible welfare of the animals.
    Refine : ensure an optimal quality of life for the animals
    Replace : use alternative methods wherever possible
    ).
  • The Paris Climate AgreementParis Agreement for Climate Change (2015) : The aim is to contribute to reducing the environmental footprint of companies and to develop technological solutions to help them achieve this. In this context, the innovations promoted by SAFETY BY DESIGN® may and should bring an answer on these questions

To integrate a low-carbon and eco-responsible digital approach to meet the well-being of employees (operators), consumers and the environment.
To digitize and drastically reduce experimentation costs (substance synthesis, in vitro tests, in
vivo tests, development costs).

Strategic innovation for management, R&D (Research & Development), CSR (Corporate Social Responsibility) and HSE (Health, Safety and Environment) teams, with technologies that serve both humans and the environment, a key issue for the successful economic transition to a more sustainable world.

SAFETY BY DESIGN® : to face economic and energy challenges and the climate emergency, a historic opportunity to integrate innovative services based on artificial intelligence and 3D modeling.

The history of alternative methods in the field of animal experimentation goes back to 1850 in France with the  Grammont LawThe first regulation in France concerning animals was proposed to the National Assembly by Deputy Grammont, who implicitly admitted the specificity of the animal condition. It can be seen as a preliminary to the idea of animal protection, but was only intended to protect human sensitivity against the spectacle of animal suffering.

1959 PublicationAccording to FRANCOPA, « The recommendations in this book initially went unnoticed before serving as the basis for many regulatory texts. Today, they allow for the implementation of a reflection on animal experimentation and alternative methods ». of « The  principles  of  Humane  Experimental  Technique » by W.M.S Russell and R.L. Burch, which refers to a principle, today known as the three Rs rule for « Replace, Reduce, Refine ».

1976 (law of July 10, 1976) underlines the fact that animals are sentient beings undergoing constraints and suffering imposed by humans. The first two R’s, replacement and reduction, are included in the law of July 10, 1976 (article L214-3 of the French Rural Code).

1978 Alternatives  to  Animal  Experiments The term «  alternativeFRANCOPA : The word « alternative » is used to describe any modification to established scientific procedures that results in the replacement of animal use, reduction in the number of animals used, or refinement of techniques that can reduce pain/distress in animals.. Therefore, Smyth’s term, « alternative methods« , covers the same areas/topics as Russell and Burch’s « Three Rs »  » was coined in 1978 by the eminent physiologist David Smyth in his book.

1986 European Directive 86/609/EEC aims to regulate the protection of animals used in experiments. 

1999 ECOPA ECOPA’s main objective is to promote the « three Rs » (replacement, reduction and refinement) in the use of animals in research, testing, education and training in Europe.
(European COnsensus-Platform for Alternatives) https://ecopa.eu/ 

2005 Creation of the EPAACreated in partnership between the EC and industry to foster communication and technology transfer between different industrial sectors. (European Partnership for Alternative Approaches to Animal Testing) https://ec.europa.eu/growth/sectors/chemicals/european-partnership-alternative-approaches-animal-testing_fr 2006 Adoption of the REACH (Registration, Evaluation, Authorization and restriction of Chemicals) regulation and creation of the European Agency ECHA. REACH modernizes European legislation on chemicals and establishes a single integrated system for the registration, evaluation and authorization of chemicals in the European Union. The European Chemicals Agency (ECHA) has the role of regulator of chemical substances. https://echa.europa.eu/fr/regulations/reach/understanding-reach  2007 Creation of FRANCOPA, French platform for the development of alternative methods in animal experimentation, which allows France to join the European platform ECOPA. https://www.ineris.fr/fr/recherche-appui/focus/methodes-alternatives-experimentation-animale-francopa> Among the proposals : – To move from research to operational tools supported by a network of resources, – To acquire the means to have the quality of innovative methods recognised (standardisation, voluntary certification, other validation processes), – To structure the national contribution to regulatory validation, – To promote the 3Rs concern in the research process on living organisms, – To make known the actors and operational tools available, – To integrate the approach into national research strategies 2015 Adoption of the Paris climate agreement. The aim here is to contribute to reducing the environmental footprint of companies and to think of technological solutions to help them achieve this.

To meet regulatory requirements

For chemicals already on the market or in the research and development stage

Pharmaceutical

ICH M7

Cosmetics

CE n°1223/2009/EC

Specialty Chemistry

REACH 1907/2006 EC

Prediction and identification

Toxicological risk issues are becoming more complex with the new problems of endocrine disruption and cocktail effects. Civil society and regulations are organizing and tightening around these new health issues, which call for rapid and appropriate responses.

Predictive
toxicology

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Time Saving

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Efficiency gain

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Detailed report

  • The input data is the structure of the chemical substance (in sdf or other formats), the descriptors are generated from the structure.
  • QSAR computer models are recognized as alternative solutions to limit animal testing.

Identification of efficiency

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Creation of a polypharmacological profile with characterization of the mechanism of action based on the new targets identified

Implementation

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Toxicity alerts

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Toxic substances substitution

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Prioritizing the safest compounds

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