‘Five For Friday’; Starting 2022 with five examples of human-relevant science using new approach methodologies (NAMs)

By Rebecca Ram

Many research methods which focus on human-relevant biology (NAMs) are in use worldwide.

However, a co-ordinated analysis of all existing methods that could be harmonised for global regulatory approval, as well as diversion of funding to the development of new methods are both long overdue. Encouraging signs were seen in Europe towards the end of 2021, when Parliament voted in favour of an EU wide action plan to accelerate the development of NAMs to improve human safety prediction and phase out animal use, with strong support from scientific stakeholders. Follow up action is now awaited from the European Commission.

As 2022 begins, we continue our ‘Five for Friday’ theme with a summary of some examples of positive progress in human-relevant research…..

  1. There is inevitably a continued focus on COVID-19. A collaborative project using state- of- the- art in silico methods (computer simulations) has recently published its findings on the cause of blood clots in response to the AstraZeneca vaccine.
  2. Researchers at Hebrew University reported a complete elimination of animal use with their ‘organ on a chip’ technology to measure kidney injury (nephrotoxicity). The technology also predicted the effects found in earlier clinical trials of patients who had taken the same drug combinations. Approval of just one new drug takes on average 10 years, uses many thousands of animals and costs £2 billion. In contrast, the Hebrew University technology is reported to provide results ‘ in eight months, without a single animal, and at a fraction of the cost.” and is planned for a submission to the US FDA (Food & Drug Administration).
  3. Advances in artificial intelligence (AI) have been combined with stem cell technology to test thousands of potential new drugs on ‘miniaturized patients-on-a-chip’ devices, to rapidly predict clinical effects and overcome the inaccuracies of animal tests with focus on brain, liver disease and cancer as ‘three areas where safety and efficacy failures of drugs are especially high’. The first ‘AI drug’ is planned to start clinical trials this year, described by the research team at Quris AI as ‘a test case to demonstrate how our system can bring a drug to market in five years with millions of dollars, not 20 years with billions’.
  4. Published within the last few days, a new study has further developed the in vitro−in silico-based NAM safety testing strategy for prediction of human gut metabolism using PBPK modelling (Physiologically Based Pharmacokinetics) The results obtained also highlighted interspecies differences between traditionally used rodents (rats) and humans.
  5. With regard to chemical safety, last month the US Environmental Protection Agency (EPA)  updated its ongoingNew Approach Methods Work Plan’ which includes a number of key objectives including  ‘Establish Scientific Confidence in NAMs and Demonstrate Application to Regulatory Decisions’ and ‘Develop NAMs to Address Scientific Challenges and Fill Important Information Gaps’. This follows on from the earlier 2021 publication of its latest ‘ List of Alternative Test Methods to Animal Testing | ‘ in order to meet requirements of the TSCA (Toxic Substances Control Act) as part of the EPA ‘2035’ directive.

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