The NC3Rs* and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to host a workshop to overcome barriers to the wider uptake of human tissue based approaches for safety assessment of new drugs.
The workshop is on 15 July 2014 in central London and follows an assessment of the current use of human tissue through a survey of the international safety pharmacology community. The survey highlighted the increasing interest in human tissue as a tool for safety assessment and identified a number of potential barriers to wider adoption, including regulatory and supply issues.
The workshop aims to galvanise the safety assessment community in addressing these barriers. The key objectives of the workshop are to:
- Share experiences and best practice in the use of human tissue for safety assessment, focussing particularly on safety pharmacology.
- Identify and address the barriers to uptake of human tissue-based approaches.
- Work as a community in developing a strategy for overcoming some of the barriers to wider uptake of human tissue-based approaches to benefit safety assessment and the 3Rs.
- Provide a forum for linking safety scientists with experts in the development and application of human tissue models in other disciplines to start to translate these approaches in to safety assessment.
The meeting will include opportunities for delegates to network during poster and exhibitor sessions and participants are encouraged to submit poster abstracts showcasing human tissue-based approaches they have adopted/are developing for safety assessment.
Registration is open to key influencers from the pharmaceutical industry, contract research organisations, regulatory bodies, researchers developing human tissue models applicable in this area, and companies providing human tissue services to the research community. The closing date for registration is 4pm on 1 July 2014.
*The NC3Rs supports the science base by driving and funding innovation and technological developments that replace or reduce the need for animals in research and testing, and lead to improvements in welfare where animals continue to be used. The Centre promotes robust and ethical scientific practice through collaborating with research funders, academia, industry, regulators and animal welfare organisations, both in the UK and internationally. The NC3Rs is supported primarily by UK Government, but also receives funding from the charitable and industrial sectors. It has an annual budget of approximately £6 million and is the UK’s major funder of 3Rs research.