2011

January 2011

REMEDiE Co-ordinator invited to Oslo to present findings to the Research Council of Norway (RCN)

Andrew Webster was invited by Dr Helge Rynning, senior scientific officer at the RCN, to present emerging results of the project to key civil servant, clinical and commercial stakeholders based in Oslo. This was an extremely valuable meeting and one that provided very fruitful discussion about the field, its position with Norway and how this relates to changes elsewhere in Europe.

March 2011 

Regenerative Medicine Call for Evidence from UK Government

The Department for Business, Innovation and Skills (BIS) launched a Call (PDF , 33kb) requesting evidence relating to regenerative medicine in regard to ‘perspectives on the opportunities and needs of the area, as well as barriers to progress, from which Government can identify policy gaps’. On behalf of the REMEDiE project, SATSU provided a detailed response to the Call for evidence on 9 March 2011. As this is evidence made to government, details of our response are not yet publicly available. They will be published later this spring.

REMEDiE members visit the Commission’s DG Research and Innovation

On 28 March REMEDiE members, Stuart Hogarth, Michael Morrison and Andrew Webster visited the offices of Dr Arnd Hoeveler, Director of Health Biotechnology in the commission, to present some of the emergent findings from WP1 and 6. A report on this meeting will appear here soon.

April 2011

European Court ruling on patenting of embryo-derived tissue

The commercial, regulatory and scientific communities are awaiting the outcome of deliberations, due shortly, within the European Court of Justice as to whether it is legal to patent embryo-derived tissue. If the ruling finds against patenting this could lead major problems in respect to translating research from the lab to the bench. A recent letter in Nature by leading UK scientists explains their concerns: see link www.nature.com/nature/journal/v472/n7344/full/472418a.html

REMEDiE researchers Morrison and Stuart have explored the commercial activity in the field in great detail. While the question of patenting-or not – of embryonic tissue is important, they point out that those in the field stress that patenting in the RM field is difficult not because of EU blocks on embryonic-based stem cell patents, but because of the amount of prior art. Data show that many see IP as “a minefield” because of the lack of certainty about who owns what and about which IP is going to be most important, and that twenty-year life of a patent was too short for cell therapies because of the much lengthier R&D process left companies insufficient time on the market to recoup their investment before the entry of competitors. The relative importance of alternative forms of IP such as trade secrets and know-how were emphasised by a number of interviewees, again suggesting a marked difference between the RM sector and the wider biopharmaceutical industry.

A full report on this work will be appearing very soon on the REMEDiE website.

October 2011

European Court of Justice Ruling on Patenting of Human Embryonic Tissue

On 18 October the ECJ handed down its final judgement on the Brüstle versus Greenpeace hESC patenting case yesterday, and found in favour of the previously published Advocate General’s Opinion, that is that such tissue was not patentable.

See the link to the full Opinion at:

http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=EN&Submit=rechercher&numaff=C-34/10

The key decision is as follows:

The Court rule that an invention must be excluded from patentability in accordance with Article 6(2)(c) of Directive 98/44 where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos’.

The decision will generate considerable debate and controversy and hostility in the stem cell field, though in respect to research and commercial development of new products (especially among SMEs) there may be some freeing up of development work. For smaller companies, REMEDiE found that patenting was not so important as access to finance and clinical trials infrastructure.

On the other hand, firms such as ReNeuron whose trial study of a neural stem cell therapy for disabled stroke patients has not involved hESC-derived tissue and has secured patentable IP, so its market position may by default be even stronger.

More on this will appear as the debate develops.

November 2011

Andrew Webster, Christian Haddad and Catherine Waldby have recently published a jointly-authored paper on clinical trials in the field of regenerative medicine. See:

Webster, A. et al. (2011) Experimental heterogeneity and standardisation: Stem cell products and the clinical trial process, BioSocieties, vol 6: 401-419.

Abstract: This paper examines developments in the field of regenerative medicine with respect to two quite distinct models of therapeutic development, a medical innovation model and a ‘cells-as-drugs’ model. It seeks to contribute to our understanding of regenerative medicine clinical trials, by exploring the ways in which the contingencies that shape all trial processes are given particular expression in stem cell trials. Drawing on both primary and secondary data, the paper examines the two main trajectories taken by biomedical innovation, one based on patient-specific therapies, the other more akin to the innovation path seen in the pharmaceutical sector. Each path raises distinct scientific, regulatory and commercial challenges and uncertainties for those involved. We analyse the implications of these two paths for our understandings of regenerative medicine and the innovation process more generally.

Journal link: http://www.palgrave-journals.com/biosoc/index.html

Geron Pulls out of embryonic stem cell clinical trial

Geron has announced it will be discontinuing its clinical trial using  embryonic stem cells for spinal cord injury. Four out of a planned 11 patients have been treated thus far. The firm intends to devote its  resources primarily to cancer therapies. The CEO John Scarlett said,"By  narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important [targets] without the necessity of raising additional capital.This would not be possible if we continue to fund the stem cell programmes at the current levels."

This is a serious setback for the hESC field given the leading role the firm has played in securing regulatory approval for this type of trial (there is now only one other registered trial by the New York firm ACT using hESC derived products).

December 2011

More comment on the European Court of Justice Ruling on Patenting of Human Embryonic Tissue

Michael Morrison, a former Research Fellow at SATSU, now based at Egenis, has provided a sensible and robust commentary on the court ruling: see the link to this at:

http://www.genomicsnetwork.ac.uk/egenis/news/comment/title,25326,en.html

2010

November 2010

REMEDiE team attend the ‘Making perfect Life’ Conference, Brussels, and meet with MEPs and EC officials

The project partners attended the Making Perfect Life conference organised by the Science and Technology Options Assessment office in the European Parliament, and led by the Rathenau Institute. Members presented to the meeting via a panel and special presentation on the interim findings from the project. The conference explored the argument that there is a convergence between a range of contemporary innovative technologies – artificial intelligence nanotech, regenerative medicine, synthetic biology, robotics etc – that are breaking down the boundaries between biology and technology, each of these two feeding into each other in novel ways that pose regulatory and governance challenges at national and international levels. This broad theme fitted well with REMEDiE’s own agenda but we are cautious about accepting the ‘convergence’ argument given that these different domains have quite distinct regulatory and commercial paths.

REMEDiE’s coordinator, Andrew Webster, gave a brief presentation (MS PowerPoint , 3,695kb)  on the project at the meeting.

While in Brussels, the project team also met with MEPs and members of the Commission, to discuss the emerging findings and their implications for legislation and policy. An overview (PDF , 470kb)  formed the basis of the discussion. Some of the issues that emerged from these discussions were concerns over:

• Clinical trials and their organisation and potential modification to respond to the specific challenges found in the regenerative medicine field

• Cord blood banking (an area that we are doing some very detailed work on in York parallel to the REMEDiE project)

• The oversight and control of egg donation/procurement across Europe

• Stem cell tourism

• Global developments – especially in Asia – and their implications for governance and innovation

August 2010

New York Judge rules against Obama’s stem cell policy

While most if not all US scientists thought that Obama’s change of government position on use of embryonic stem cells research last year was now water long-gone under the policy bridge, it came as something of a shock to the stem cell network across the US when a judge in a New York ruled in favour of the conservative Alliance Defense Fund and against Obama’s executive order, saying it violated a ban on federal money being used to destroy embryos. The full story can be found at:

http://www.nytimes.com/2010/08/24/health/policy/24stem.html?_r=1

http://www.nature.com/news/2010/100824/full/news.2010.428.html

The implications of the ruling are yet to be determined and no doubt there will be appeals made against this decision. Whether it will slow down hESC research in the US is debatable as state-based, private funding will continue, and in a global context, research collaborations and networks can be used to work around this type of legal constraint.

UK government announces key regulatory changes

The UK government has announced the closure of two of the key agencies overseeing parts of the RM regulatory regime: the HFEA (Human Fertilisation and Embryology Authority) and the HTA (Human Tissue Authority) are to go over the next 12 months or so. Their functions are likely to be merged. There was talk of this in 2004 with the idea of an agency called ‘RAFT’ (see an example).
 
Though the regulatory elements may well be covered in the future, it will be interesting to see whether the new agency retains the political capital that the HFEA has enjoyed in the UK and which has to some extent helped manage the public face of embryo research, and whether UK clinical researchers/bioscientists see the new body as a reduction in the regulatory hurdles they confront.

Successful COST bid

Linked to our REMEDiE work has been  a successful bid to the European Commission’s ‘COST’ programme with a bid (one of only 3 out of 80 that were funded) relating to the challenges posed by new ‘bio-objects’. The bid builds on longstanding links among the proposers who were all members of a Marie Curie Training Site based in SATSU at York between 2000-5. The members have remained in contact since then, developing their independent research and yet retained links through self-funded annual meetings we have organized. The disciplinary range includes political science, sociology, philosophy, law, economics and bioethics, and all have substantial experience examining the bioscience field.
 
This research network develops novel interdisciplinary tools based on a range of evidence that will improve our understanding of bio-objects, their production and governance. The core questions answered through this COST Action are: how are the boundaries between human and animal, organic and non-organic, living and the non-living opened up?; how do bio-objects change social relations?; how does the public-private interface shape the making of bio-objects?; and finally, how does the governance of bio-objects perform at different levels, from the level of the European Union and its Member States to the sub-political level, and finally in clinics and laboratories?
 
The work begins in November 2010 and will last for four years. For further information go to our Marie Curie Network pages.

February 2010

One of the REMEDiE partners, Professor Judit Sandor, has just published a new book that explores the legal and ethical dimensions of regenerative medicine. The text includes nine chapters ranging over topics such as cloning, the Hwang scandal in South Korea, stem cell research in Japan, Germany and the US, and broader bio-political concerns shaping the field.

The full details are:

Sandor, J. (ed.) Perfect Copy: Law and the Ethics of Reproductive Medicine, Centre for Ethics in Law and Biomedicine, Central European University, 2010. ISBN: 978=963-9776-75-3

Contents: Introduction / Judit Sándor - Nuclear transfer cloning : the state of the art / András Dinnyés - Cloning and research misconduct : the Woo-Suk-Hwang case / Péter Kakuk - Rhetorical speech and argumentation in the public debate on stem cell research ... / Knut W. Ruyter - Legal, ethical and cultural aspects of regulations on human embryo research in Japan / Orio Ikebe - Stem cell research from the perspective of German law / Tade Matthias Spranger - Unlocking human cloning : does a constitution help? / Violeta Besirevic - "Human dignity" and "humanity" in stem cell politics : EU stem cell reports compared to the report of the US President's Council on Bioethics / Hanne Maaria Rentola - Human embryonic stem cell research : ethics and bio-politics / Maurizio Salvi.

2009

August 2009

2nd TERMIS World Congress: Science and Technology for Patients (Seoul, South Korea)

Tissue engineering and regenerative medicine is an emerging multifaceted field involving biology, medicine, engineering and many other related disciplines. It can revolutionize the ways that we improve the health and quality of life by replacement, repair, maintenance and enhancement of tissue function for either therapeutic or diagnostic applications.

The main theme of this congress is entitled "Science and Technology for Patients".

Andrew Webster, REMEDiE project co-ordinator, will be presenting a paper that discusses the regulatory and governance aspects of stem cell research as they relate to patients. Details of his paper appear in the Conference Programme.

10 June 2009

Joint meeting report

A joint meeting between REMEDiE and the UK Social Science Stem Cell Initiative was held in June 2009 at the Wellcome Trust in London.

• Report and photos of the meeting, in addition to PDFs of conference presentations