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Kingsbridge, United Kingdom

Clotworthy M.,Safer Medicines Trust
Cell and Tissue Banking | Year: 2011

The challenges to using human tissues in research are many and varied. However, there is little consensus on how concerns raised by researchers should be addressed, and who should be responsible for ensuring that patients continue to benefit from medical research carried out using human tissues which have been ethically donated or collected after surgery, or where organs donated for transplant are unsuitable for this purpose. A conference in the House of Lords sought to bring together stakeholders from all areas of human tissue research to discuss the problems experienced, share solutions, and form a Working Party to carry the conference momentum forward into action in the near future. © Springer Science+Business Media B.V. 2010.

Coleman R.A.,Safer Medicines Trust
Cell and Tissue Banking | Year: 2011

The introduction of safe and effective new medicines is proving ever more difficult, a problem arguably due at least in part to over-reliance on experimental animal-based test systems. In light of the increasing awareness of the lack of predictiveness of such non-human approaches, the necessity to focus on human-based test methods is clear. There has been considerable progress in human in vivo (microdosing) and in silico approaches, primarily to identify ADMET issues, however, in vitro functional studies using human tissues are receiving inadequate attention. The potential scope of human tissue-based research is considerable, but much methodological development is required, which necessitates an increased willingness on the part of the Pharma industry to support it. This approach also requires considerably improved access to the cells and tissues themselves. While current acquisition is almost exclusively from surgery and post mortem, the range of tissue types, the quantity, quality and frequency of supply will remain inadequate to support human tissue as a key component of pre-clinical efficacy and safety testing. Additional routine access to non-transplantable tissues from organ donors for research purposes would be of inestimable value, but in order to realise this, true collaboration will be required between NHS, the Pharma and biotech industries, and the general public. © 2010 Springer Science+Business Media B.V.

Clotworthy M.,Safer Medicines Trust
Cell and Tissue Banking | Year: 2011

On 20 October 2009, scientists and politicians gathered in the House of Lord to discuss the barriers medical researchers face when attempting to access surplus human tissues. Presently, such tissues, including those surplus to requirements for diagnosis after surgery, are all too often incinerated because patients' permission has not been sought for them to be used in medical research. A similar situation arises where organs which have been donated for transplant are unsuitable for donation. As a consequence of the conference, the Human Tissues Working Party was established to enable the discussions which began so fruitfully at the conference to continue, and to allow delegates, and participants who have joined subsequently, to present a unified case in submissions to public consultations, for example. © 2010 Springer Science+Business Media B.V.

Archibald K.,Safer Medicines Trust | Drake T.,Center for Responsible Science | Coleman R.,Safer Medicines Trust | Coleman R.,Center for Responsible Science
ATLA Alternatives to Laboratory Animals | Year: 2015

Although there is growing concern as to the questionable value of animal-based methods for determining the safety and efficacy of new medicines, which has in turn led to many groups developing innovative human-based methods, there are many barriers to their adoption for regulatory submissions. The reasons for this are various, and include a lack of confidence that the available human-based methods, be they in vivo, in silico or in vitro, can be sufficiently predictive of clinical outcomes. However, this is not the only problem: The issue of validation presents a serious impediment to progress, a particularly frustrating situation, in view of the fact that the existing animal-based methods have never themselves been formally validated. Superimposed upon this is the issue of regulatory requirements, where, although regulators may be willing to accept non-animal approaches in place of particular animal tests, nowhere is this explicitly stated in their guidelines. Such problems are far from trivial, and represent major hurdles to be overcome. In addition, there are a range of other barriers, real or self-imposed, that are hindering a more-predictive approach to establishing a new drug's clinical safety and efficacy profiles. Some of these barriers are identified, and ways forward are suggested.

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