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What does the FDA modernisation Act 2.0 mean for pharmaceutical research?

January 23, 2023

Since the introduction of the recent FDA framework nearly 70 years ago, animal testing has been mandatory for all FDA therapeutic applications, once in a mouse and once in another non-mouse model. The science however, is clear. Animal studies have multiple downsides including;

  1. Ethical concerns: Many people believe that it is morally wrong to use animals in research, particularly when the animals are subjected to pain, suffering, or death. Animal welfare concerns are also a downside, as many animals are subjected to inhumane conditions and treatments during testing.
  2. Limited applicability: Results from animal studies may not always be directly applicable to humans, as animals may react differently to substances than humans do. Some animal tests, such as the LD50 (lethal dose) test, are considered to be inaccurate, imprecise, and unreliable.
  3. Inefficiency: Animal testing can be time-consuming and expensive,
  4. Alternatives: There are alternatives to animal testing, such as in vitro methods and computer simulations, which can be more efficient, accurate, and ethical.

The key component of the new FDA modernisation act 2.0 is that regulators can now consider alternative models to animal testing when approving the use of a new drug to market. This is a huge step forward towards the limitation and eventual banning of animal use in pre-clinical research.

Alcyomics has developed several human in vitro alternatives to animal tests which provide clinically predictive data for a wide variety of toxicological and immunotoxicological readouts. We have published and validated our assays to be clinically predictive of Human outcomes rather than relying on animal data. What are the benefits of using an in vitro alternative to animal models at Alcyomics?

  1. Predictability – We generate a Human response to your test compounds. In particular, our Human tissue based assays produce a clinically relevant, highly predictive Human tissue based response that encompasses a wide range of Human cellular mechanisms.
  2. Cost – Animal studies are hugely expensive. Our human tissue assays at Alcyomics are order of magnitude cheaper than their in vivo model counterparts whilst being more clinically predictive for immune response.
  3. Time – in vivo studies generally need to be organised and booked months (if not years) in advance and come with a huge amount of paperwork justifying the ethical need and suitability of the chosen model. At Alcyomics we can turn around a human tissue based study in 6-8 weeks from initial consultation to final report generation.

We also have a range of 3D tissue models for research and development applications including our: 3D Skin models for toxicological applications, 3D Innervated Skin model for pain sensation, 3D Osteochondral model for cartilage damage assessment and our, in development, Innervated Osteochondral model for joint pain sensation.

We have a huge range of technical skill at Alcyomics and work with several partners to develop novel human in vitro assays for a wide range of applications!

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