On 20th October a conference was hosted by Prof the Lord McColl FRCS in the House of Lords to discuss the barriers to using human tissues in research, and ways of overcoming them. Pathologists, researchers from academia and big Pharma as well as tissue supply or assay companies and of course, tissue banks, attended.

Although there was a strong UK emphasis, Dolores Baldasare from the US International Institute for the Advancement of Medicine gave a fascinating presentation on how her organisation manages to coordinate the collection and distribution of non-transplantable organs throughout the USA (as well as distribution abroad), and provided delegates with a pack containing all of the information and consent forms which they use, information which is bound to be of great interest, particularly to those currently engaged in establishing tissue collections. The presence of the French Science Attaché in London, as well as a senior scientist from French CRO PelviPharm, ensured that the European perspective was represented.

The meeting was called due to widespread anecdotal evidence that researchers find it increasingly difficult to obtain access to the human tissues they need in order to carry out their research. This assessment was borne out in the run-up to the meeting by the publication of three reports into the issue (Human Tissue Authority 2009; National Cancer Research Institute 2009; onCore UK 2009).

The opening presentation by Dr Bob Coleman (independent consultant to the pharmaceutical industry and science advisor to Safer Medicines Trust), emphasised the importance of human tissues in research, as results from studies using other species simply do not necessarily translate to the clinic, as indicated by the 92% failure rate of potential new drugs in clinical trials (FDA 2004). He pointed out the serious gaps in the supply of certain types of fresh tissue in particular, such as nerve tissues, and posited that, as these are not generally removed surgically, a system to obtain non-transplantable organs from heart-beating donors is necessary. This theme was followed up later on by Dolores Baldasare. Bob also discussed Safer Medicines Trust’s initiative to conduct a comparison of drug safety testing methods which emphasise human biology versus the animal-based systems that are currently required.

Dr David Bunton, CEO of Biopta Ltd, introduced the vital role that human tissues play in drug development, and elaborated on some of the remarkable ways in which even minute skin biopsies can be put to good use evaluating the impact of new compounds on blood pressure, for example.

Two speakers focused on the role of human tissues in respiratory medicine. Dr Kelly BéruBé, who heads the Lung and Particle research group at Cardiff University, gave an eye-opening presentation on the development of physiologically representative micro-lungs and how these are already being used to inform drug development, as well as to assess environmental hazards. Iain Dougall from AstraZeneca elaborated further on the use of human tissues in drug development for respiratory disorders, where they play an essential role. It was clear from his presentation, as well as comments from the floor, that human tissue use by pharmaceutical companies is highly regarded but would become more widespread as soon as supply issues are resolved. It was acknowledged that it was not feasible for pharmaceutical companies to stall their drug discovery pipelines for months at a time because a certain tissue was simply unavailable.

The critical role of pathologists in clinical research, and the problems, both financial and regulatory, they experience was the focus of two recent reports (NCRI 2009; onCore UK 2009), and this theme was elaborated by Prof Chris Foster of the University of Liverpool. His explanation of the need for improved recognition and funding of pathology departments, which collectively constitute the largest human tissue repositories and a tremendous but under-appreciated and utilised resource, clearly resonated with the hospital-based delegates present.

Prof Foster illustrated the value of such tissues in translating lab research into direct patient benefits using his group’s discovery of a biomarker, the measurement of which enables two-thirds of men with prostate cancer to be safely monitored, even for many years, rather than undergoing hormone treatment which can negatively impact quality of life relatively soon (Foster et al. 2009). His alarming assessment was that as this study required a very large number of samples, it would be “impossible” to carry out today. The decline in core pathology provision was also lamented, while Prof Barry Gusterson from the Glasgow Biorepository cautioned that autopsy numbers have also plummeted, partly due to a reluctance to engage with complex paperwork and particularly to approach relatives at such a traumatic time, leading to a severe reduction in expertise—both in terms of understanding the effects of disease at a systemic level and learning how to approach relatives.

Jane Hair, also from Glasgow, was the first of two speakers from tissue banks, while other banks from across the UK were represented in the audience. She gave a valuable insight into the challenges of setting up and running a biobank from the the National Health Service’s perspective, and the need to recoup costs while ensuring that all researchers with worthy projects have access to the necessary tissues. The cost implications relating to obtaining informed consent are not always appreciated, but at Glasgow these are minimised by ensuring that surgical patients receive an explanatory sheet alongside the other patient information issued by post prior to a procedure. Despite efforts to include research as “just another part of the work that hospitals do”, a recent survey uncovered that still, only 5% of surgical patients in Glasgow were being asked to consent to the use of their surplus tissues in research. They are now testing whether the use of IT to ensure that consent is requested and electronically recorded at admission, rather than being written in case notes, will improve this figure.

Prof Gerry Thomas of Imperial College London, who was instrumental in setting up the Wales Cancer Bank, of which she is now Scientific Director, found that patient power was the key in overcoming political and funding obstacles, commenting that “We did it from the bottom up… If you get the patients behind you, everything becomes possible, because they elect the politicians.” Encouragingly, delegates found patients to be overwhelmingly keen for their tissues to be used in medical research, making no distinction between academic and pharmaceutical research. There was some discussion as to whether this was more straightforward when dealing with patients who are ill and therefore highly motivated to assist with research, compared with having to ask traumatised relatives to give consent for brain-stem dead potential donors.

Both Gerry and Prof Barbara Pierscionek, who is setting up the Northern Ireland Eye Bank, felt that misinformation or over-interpretation amongst institutional ethical review committees frequently hampered efforts to engage in research. The role of tissue banks with “Ethical Approval Status” in minimizing paperwork by obviating the need for scientists to obtain individual project approval was highlighted by Sandie Martin of Ethical Tissue, Bradford. Based on her extensive experience, Sandie took us through the trials and tribulations of establishing a tissue bank, and outlined steps that she had found helpful.

If you are interested in getting involved with the Working Party established to tackle these and other issues identified, viewing speaker’s presentations or listening to the discussion sessions, please contact me at Margaret@safermedicines.org or on +44 (0)1223 863 651, or see www.safermedicines.org/humantissues.

The meeting was co-sponsored by charity Safer Medicines Trust, and specialist human tissue companies Biopta and Asterand.