TY - JOUR
KW - animal models
KW - Biobanking
KW - Human tissue
KW - induced pluripotent stem cells
KW - Methods
KW - microphysiological systems
KW - Predictivity
AU - Samuel J. Jackson
AU - Helen Prior
AU - Anthony Holmes
AB - Introduction
The safety-related failure of drugs during clinical phases of development is a significant contributor to drug attrition, wasting resources and preventing treatments from reaching patients. A lack of concordance between results from animal models and adverse events in the clinic has been identified as one potential cause of attrition. In vitro models using human tissue or cells have the potential to replace some animal models and improve predictivity to humans.
Methods
To gauge the current use of human tissue models in safety pharmacology and the barriers to greater uptake, an electronic survey of the international safety assessment community was carried out and a Safety Pharmacology Society European Regional Meeting was organised entitled ‘The Use of Human Tissue in Safety Assessment’.
Results
A greater range of human tissue models is in use in safety assessment now than four years ago, although data is still not routinely included in regulatory submissions. The barriers to increased uptake of the models have not changed over that time, with inadequate supply and characterisation of tissue being the most cited blocks.
Discussion
Supporting biobanking, the development of new human tissue modelling technology, and raising awareness in the scientific and regulatory communities are key ways in which the barriers to greater uptake of human tissue models can be overcome. The development of infrastructure and legislation in the UK to support the use of post-mortem or surgical discard tissue will allow scientists to locally source tissue for research.
BT - Journal of Pharmacological and Toxicological Methods
DA - 2018-09-01
DO - 10.1016/j.vascn.2018.05.003
N2 - Introduction
The safety-related failure of drugs during clinical phases of development is a significant contributor to drug attrition, wasting resources and preventing treatments from reaching patients. A lack of concordance between results from animal models and adverse events in the clinic has been identified as one potential cause of attrition. In vitro models using human tissue or cells have the potential to replace some animal models and improve predictivity to humans.
Methods
To gauge the current use of human tissue models in safety pharmacology and the barriers to greater uptake, an electronic survey of the international safety assessment community was carried out and a Safety Pharmacology Society European Regional Meeting was organised entitled ‘The Use of Human Tissue in Safety Assessment’.
Results
A greater range of human tissue models is in use in safety assessment now than four years ago, although data is still not routinely included in regulatory submissions. The barriers to increased uptake of the models have not changed over that time, with inadequate supply and characterisation of tissue being the most cited blocks.
Discussion
Supporting biobanking, the development of new human tissue modelling technology, and raising awareness in the scientific and regulatory communities are key ways in which the barriers to greater uptake of human tissue models can be overcome. The development of infrastructure and legislation in the UK to support the use of post-mortem or surgical discard tissue will allow scientists to locally source tissue for research.
PY - 2018
SP - 29
EP - 34
T2 - Journal of Pharmacological and Toxicological Methods
TI - The use of human tissue in safety assessment
UR - https://www.sciencedirect.com/science/article/pii/S1056871918305690
VL - 93
Y2 - 2024-07-16
SN - 1056-8719
ER -