The proprietary SistemQC™ miRNA-based stem cell characterization and quality control tool-kit will provide important insights into process optimization and QC testing of TiGenix’s pioneering cell therapy product. This work is part of a larger collaborative effort led by TiGenix and funded by a EUR 5.9 million European Seventh Framework Programme (FP7) grant under the topic “Regenerative medicine clinical trials” within the Health theme.

SistemQC™ combines robust miRNA profiling with superior statistical analytics and multi-layered contextual analysis to generate a fingerprint of key miRNAs (kmiR™s). This approach provides a succinct read out on the status of the cells, with the added benefit of being able to interpret the underlying biological effects associated with any change observed. Additionally, the kmiR™ fingerprints can be adapted to a QPCR method for ease of integration into laboratory routine, and provide rapid testing. They can be used as a cell phenotype characterization tool in combination with a qualitative assessment of product cell composition, or to monitor product quality during scale-up and aid the selection of manufacturing process improvements.

Dr Vincent O’Brien, Sistemic’s Chief Science Officer said, “We are honoured to be working with TiGenix and Cellerix, its Spanish subsidiary as well as partners from all over Europe. Sistemic will provide in-depth product characterization data during the clinical trial with Cx611. This will be a critical part of the development and subsequent production process. We look forward to collaborating with all of the consortium members on this important project as we are supportive of the potential of cell therapy products to bring real benefits to those patients suffering from rheumatoid arthritis.”

The collaborative project, referred to as the REGENER-AR consortium, brings together 10 top-level research institutes, medical entities and biotechnology companies from Spain, France, the UK, the Netherlands and Belgium. The consortium has defined a clinical translational project with the aim of developing a broadly available, clinically applicable treatment for rheumatoid arthritis by exploiting human allogeneic mesenchymnal adult stem cells extracted from adipose tissue (eASCs).

Sistemic provides innovative miRNA-based products to the cell therapy, drug development and bioprocessing markets. The company’s pioneering approach enables companies to accelerate drug discovery and development programmes whilst reducing development risk. For further information visit: www.sistemic.co.uk

Sistemic is a registered trademark of Sistemic UK
SistemQC™ and kmiR™ are trademarks of Sistemic UK

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12 January 2012: Sistemic, UK:  Sistemic, the stem cell and drug development technology company, has won a substantial Scottish Regional Selective Assistance (RSA) grant from Scottish Enterprise. The grant forms part of a £1M planned investment programme which, on the back of a very successful year for the company, will see Sistemic more than double the size of its operation. To accommodate the expanded  research team, the company is relocating to customised laboratories during the first half of 2012.

Jim Reid, Sistemic ‘s Chairman and CEO said, “Securing this support from Scottish Enterprise is a major achievement and shows great support by the Scottish Government for what we are doing. It adds to an already successful year for Sistemic, a year which has seen us grow sales dramatically and develop our customer base in Europe, USA, Japan and Australia. We truly have become a global company during 2011 and we look forward to relocating in the first half of 2012 to allow this success and growth to continue. It is always an exciting opportunity to be on the lookout for new employees and we are ideally placed to recruit top talent. This type of grant support is crucial to help grow successful research focused biotech companies such as ours and we will ensure we make the most of it!”

“We work very closely with some of the world’s leading stem cell and pharmaceutical companies and we need to continually review our operations to make sure that we have the best technology and services and we need a facility which suits our needs,” explains Reid. “The world is waking-up to the incredible opportunities offered by stem cell technology. Opportunities which show great promise to prolong healthy life and Sistemic is already a key part of this burgeoning worldwide industry.”

Sistemic‘s SistemRNA™, SistemQC™, SistemKB™  and SistemTOX™ products have brought new depth to miRNA analysis, which has been shown to add value to drug discovery, cell therapeutics and diagnostics.  For 2012 the company looks forward to increased business and growing their client network around the world.

For further information on Sistemic and Sistemic miRNA analysis products, please visit: www.sistemic.co.uk

Regional Selective Assistance (RSA) is the main investment grant scheme in areas of Scotland designated for regional aid under European Community law. RSA funding is available to create or safeguard jobs for both Scottish owned businesses and inward investors. For further information visit the Scottish Development International website: http://www.sdi.co.uk/

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29 November: Sistemic, UK: Dr Verna McErlane, Director of Commercial Operations, International at Sistemic, is scheduled to give her own special insight into advanced analytical models to support the stem cell therapy industry at this year’s Stem Cell Meeting on the MESA conference. Participants will have the opportunity to discuss miRNA profiling and learn how to maximise the potential of stem cell applications. The 2011 conference will be held in the Salk Institute for Biological Studies in La Jolla, California on November 30 and December 1. 

Acknowledged experts in cell characterization, Sistemic has recognized a need in the stem cell industry for improved miRNA profiling methodology. The company’s unique approach to miRNA analysis presents significant benefits to stem cell research by providing the tools needed for accurate and rapid cell characterization and an excellent platform for validation prior to commercialization.

Dr Verna McErlane said: “As members of the Alliance for Regenerative Medicine, who are co-organisers of this event, we are particularly delighted to be attending this meeting, which we believe is the premier event for those involved in the stem cell industry.”

 Stem Cell Meeting on the MESA is a two-day conference, which is aimed at bringing together the scientific research and business communities. Dr McErlane will be available throughout the two days to discuss your stem cell analysis objectives and how Sistemic can help you meet those objectives more easily. Sistemic looks forward to meeting you there and supporting the event organizers in their goal to facilitate a bridge between academia and industry and further the translation of clinical research.

For further information come along to the meeting or contact Sistemic directly www.sistemic.co.uk

Dr McErlane’s talk provided an intuitive overview of the cell therapy market including future promise, what has been achieved to date, followed by a review of some of the challenges in bringing a cell therapy to the clinic. She then focused on cell characterisation and the utility of using miRNA fingerprinting by showcasing recent case studies where Sistemic SistemQC technology has provided unique insight to assist stem cell developers produce better and more standardised cells.

“The stem cell sector has already shown its promise in producing effective treatments but these are just the tip of the iceberg and there is the potential for so much more,” said Dr McErlane. “The cell therapy industry is at a critical cross-roads during its evolution into the clinical environment and there are some real challenges ahead including a definite need for reliable standardisation and characterisation methodology.”

Jim Reid, CEO of Sistemic commented, “At Sistemic we are addressing key challenges and, in conjunction with our stem cell clients, coming up with practical solutions which will enhance the potential of these developments in safe and effective patient treatment.”

The translation of stem cell technology from the lab into the clinic requires reliable monitoring and characterisation methodology. Sistemics’ SistemRNA and SistemQC use a stem cell focused, miRNA-based approach which molecularly characterises cells and monitors their quality. Not only does it give a succinct read out on the status of the cells, but also provides an insight into the underlying biological effects associated with any change observed. This is being used by the stem cell community to optimise and guide the differentiation process, benchmark differentiated cells and, from a manufacturing perspective, provide identity markers, purity and potency control. Such innovative developments, together with other new tools and a consensus on the stardardisation process, are what will really drive this industry forward to reach its full potential.

 Sistemic looks forward to meeting old colleagues, new faces and learning about the most recent developments in the field at AUSBiotech 2011 . Visitors can meet the team at the Scottish Development International booth in the exhibition hall. In the meantime, anyone interested in Sistemic and its products should visit: www.sistemic.co.uk

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 “The future for regenerative medicine is huge, but there are issues to be faced on this road to success,” said Dr McErlane. “Firstly we need to establish reliable cell standards, and secondly these standards should inform the development of a validated and dependable toolbox for monitoring and characterising stem cells during research and manufacturing. Only through characterisation can this technology enter the mainstream clinical practice and provide the patient benefits we are all hoping for.”

 Sistemic has developed a stem cell focused miRNA-based approach called SistemQC™ which molecularly characterises cells and monitors their quality. Not only does it give a succinct read out on the status of the cells but also provides an insight into the underlying biological effects associated with any change observed. SistemQC™ is being used by the stem cell community to optimise and guide the differentiation process, benchmark differentiated cells and, from a manufacturing perspective, provide identity markers, purity and potency control. Innovative developments such as this, as well as other new tools and a consensus on the standardisation of the process, are that will really drive this industry forward to reach its full potential.

 Dr McErlane went on to say, “Without adequate control, this unique opportunity to positively impact on the treatment of many untreatable conditions will be lost. Standardisation is key and Sistemic are at the forefront of assisting in making Regenerative Medicine a reality for clinical practice.”

 Initiated in 2009, the World Stem Cell Summit (http://www.worldstemcellsummit.com/) has quickly become one of the largest interdisciplinary, networking meetings of stem cell stakeholders, which unites the regenerative medicine industry and biomedical research. For 2011, one of the industry key note addresses, given by Dr Gil Van Bokkelen co-founder and CEO of Athersys and Chairman of the Alliance for Regenerative Medicine, of which Sistemic is a key member , will be; ‘The transformational potential of regenerative medicine, and how it will change healthcare as we know it’.

 Sistemic looks forward to meeting old colleagues, new faces and learning about the most recent developments in the field at the upcoming World Stem Cell Summit. Visitors can meet the team at the Scottish Development International Booth in the exhibit hall. In the meantime, anyone interested in Sistemic and its products should visit: www.sistemic.co.uk

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The new recruit Max Bylesjo, originally from Sweden, moved to Scotland to work at Sistemic in bioinformatics and was grateful to TalentScotland for all the information they provided. Max was recently interviewed by TalentScotland and talked about his work at Sistemic, his perception about living in Scotland, and his future goals http://bit.ly/Maxinterview

Sistemic specialises in targeted miRNA profiling technology (SistemRNA™) for drug discovery and stem cell therapy development and its employees are very proud of their Scottish connections.  Jim Reid, CEO of Sistemic, is a Scot and talented businessman. He freely admits that in his view Scotland projects an “excellent business environment” for life sciences and a range of other modern industries.

Reid, who has many years experience of working for pharmaceutical and biotech companies across Europe and in Switzerland, said: “Scotland has a great deal to offer,  new  technologies and applied knowledge continue to emerge from our world-class universities, driving the development of spinoff companies”.

 Jim Reid recently gave an interview to TalentScotland about the origins of Sistemic and his hopes for the future of the company http://bit.ly/Jiminterview

Sistemic is committed to the regenerative medicine sector and believe ARM has a key role in this exciting area. Support from Sistemic will include access to their cell characterization knowledge, innovative tools and experience for ARM members and also the broader community. Sistemic is confident that their miRNA profiling technology will make a significant contribution to the advancement of cell and regenerative therapies as well as to those developing stem cell lines for drug discovery and development.

Verna McErlane, Director of Commercial Operations, International at Sistemic Ltd, comments: “The revolution promised by cell-based techniques and therapies that regenerate cells, organs and tissues is a key area where Sistemic is making a contribution. Our customers are looking for tools to help them overcome the challenges of commercialisation of cell-based or derived products – namely, the absence of robust and information-rich characterisation and QC methods to monitor cells easily and effectively. Sistemic’s core expertise, the SistemQC^TM product, reduces these hurdles, providing an approach that fits seamlessly within their current workflow.”

SistemQC^TM combines robust miRNA profiling with superior statistical analytics and multi-layered contextual analysis to generate a fingerprint of key miRNAs (kmiRs) providing a succinct read out on the status of the cells, with the added benefit of being able to interpret the underlying biological effects associated with any change observed. These kmiR fingerprints can be adapted to a QPCR method for ease of integration into laboratory routine, and provide rapid testing. The result? Global understanding of cell systems allowing informed decision making for companies, at critical points within their process workflows, allowing them to proceed confidently with their cell populations.

Morrie Ruffin, Managing Director of ARM, said: “We are delighted that Sistemic have joined ARM and look forward to sharing information and understanding as we work together towards advancing the field of regenerative medicine… we feel Sistemic has a great deal to offer the Alliance in helping to support and develop this sector .”

For more information about Sistemic products and services, visit: www.sistemic.com

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For press information, please contact:    

Sarah Lawton, Kapler Communications                      

Knowledge Centre, Wyboston Lakes, Great North Road,

Wyboston, Bedfordshire, MK44 3BY, UK

Tel: +44 (0)1480 479280; Fax: +44 (0)1480 470343 sarah@kapleronline.com

 Sistemic UK Ltd.

Thomson Building, Gilmorehill, Glasgow, UK, G12 8QQ

Tel: +44 (0) 141 330 1683 Fax: +44 (0) 141 330 2062 verna.mcerlane@sistemic.co.uk

 Sistemic US Ltd.

28 State Street, Suite 2300, Boston, USA, MA 02109

Tel: +1 (0) 617 523 3272 Fax: +1 (0) 617 725 2897 info@sistemic.co.uk

 Contact:

Dr Verna McErlane, Director of Commercial Operations, International, +44 7855376358

The article reviews the development of CTI up to the current time and examines how the industry can develop to meet the need of untreatable and poorly treated diseases. In addition the article:

• highlights the technology and investment required for CTI to become a major therapeutic industry
• examines current cell characterisation techniques 
• makes a call to action for improved cell characterisation to aid R&D and manufacturing in cell therapeutics
• suggests miRNA profiling as one of the standard methods for cell characterisation

The article is published in the July issue of European Biopharmaceutical Review and will be available on-line at http://www.samedanltd.com/magazine/12

Dr Verna McErlane is Director of Commercial Operations at Sistemic Ltd. and is well known in the cell therapy market. Dr McErlane gained her PhD in cancer drug development and spent time at the Gray Cancer Institute in London  and SPEAR Therapeutics Ltd before moving to the University of Dundee in her native Scotland. Dr McErlane was subsequently asked to take part in the Saltire Foundation Fellowship, a prestigious MBA  Programme, where she spent time working on commercial cell therapy projects with Genzyme and market entry strategies with Axis-Shield. During this time Verna has been able to further her passion for commercialising well founded science into potential therapeutic benefits.  For more information visit: www.sistemic.co.uk

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For further information please contact:

Dr Verna McErlane, Director of Commercial Operations, International, +44 7855376358

18^th July 2011: Sistemic, UK:  Sistemic believe cell characterisation is an essential element in progressing safe and effective cell therapies for mainstream clinical use.  They offer unique miRNA analytical services that provide reliable and cost-effective, characterisation and QC tools that are applicable to all cell systems. Toward this end, Dr Vincent O’Brien (Chief Scientific Officer) and Dr Verna McErlane (Director of Commercial Operations, International) will present data supporting the utility of miRNA in the provision of superior cell characterisation and QC methods at the forthcoming Stem Cells Europe conference (20-21 July 2011, Edinburgh). 

Dr. Vincent O’Brien will present a poster entitled; ‘A novel microRNA-based stem cell characterisation and monitoring tool’,and Verna McErlane will join: Marilyn Robertson, SSCN; Aidan Courtney, Roslin Cells; Dr. David Hay, Fibromed; and, Michael Leek, Immunosolv, at the Scottish Stem Cell Network (SSCN) Panel showcase, “Progress to Therapy and Market” on Wednesday 20 July at 5pm.

 Sistemic Ltd are a global company offering unique miRNA-based products and services such as SistemQC^TM, designed for the sophisticated molecular characterisation of cells, which combines robust miRNA profiling, statistical analysis and contextual analysis. Further information on all Sistemic’s proprietary services, including; SistemRNA^TM, SistemQC^TM, SistemTOX^TM and SistemKB^TM, can be found at: www.sistemic.co.uk

Please Contact:

Dr Verna McErlane, Director of Commercial Operations,  +44 7855376358

 MicroRNA profiling has rapidly become an indispensable technology with a whole catalogue of applications and new opportunities. Companion biomarkers are the most recent extension of the technology and are set to provide valuable clinical data to guide both pre-clinical and clinical studies. The system will use the robustness and specificity of miRNA to identify highly discriminatory biomarkers which, in turn, will guide patient prognosis, the selection of appropriate drug treatment, and monitoring of drug response. 

 For further information on Sistemic’s new Companion Biomarker program, SistemRNA suite, and other Sistemic products and services please visit: www.sistemic.co.uk

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