News

Successful trade mission to Japan and Korea yields new business opportunities for Sistemic

2012-03-26T10:03:55Z

26 March 2012: Sistemic, UK: Sistemic Ltd, Glasgow, concluded a successful trade mission to Japan and Korea in February 2012. Verna McErlane, Director of Commercial Operations, presented the company’s miRNA-based approach to a receptive group of businesses and research institutions in Tokyo, Osaka, Kyoto, Seoul and Jeonju. The Japan portion of the trip was planned by the Scottish and Japanese offices of Scottish Development International (SDI).

During the visit, Sistemic met with both existing and potential clients, and participated in a number of seminars and partnering sessions. Verna McErlane, Director of Commercial Operations, Sistemic, explained: “As the trade mission progressed, it became clear that the partnership model for drug development features highly in the plans of the pharma industry there. It was exciting to have the chance to present how the world’s second largest pharma market will benefit from Sistemic’s unique miRNA profiling products and services.”

Sistemic is pursuing an active global expansion plan for the business. Jim Reid, Sistemic’s CEO commented: “Pharma companies are looking to access technologies on a global basis, so it’s important Sistemic is recognised at this level. We are proud to have customers all over the US and Europe, as well as in Australia and Asia Pacific and we look forward to working closely with a number of new partners in Japan and Korea as a result of the trade mission.”

During the visit, Sistemic presented its SistemQC product for use in cell characterisation and QC. This is of particular interest to anyone working on cell therapies, regenerative medicine and stem cells. SistemQC is a miRNA-based fingerprint approach that provides a powerful and informative way to characterise and monitor cells lines, including stem cells, for identity, purity, safety and differentiation staging. Sistemic also presented details of SistemRNA and how it is used in drug discovery and development. SistemRNA applies a compound-centric approach identifying drug effects by associative changes in miRNA express profiles and its analysis in context. The addition of SistemRNA to the drug discovery toolbox can support strategic decision-making at key stages and maximise asset value.

Verna McErlane added: “The people we met in both countries were very welcoming and interested in innovative tools that can help them in their work. We are following up with a number of companies and planning return visits in June and September.”

For more information about Sistemic and it's products and services, visit: www.sistemic.co.uk

FibromEd and Sistemic are engaged in a collaborative project to identify important micro RNA signatures, required for high fidelity human hepatocyte generation from pluripotent stem cells.

2012-03-20T11:34:01Z

FibromEd and Sistemic (www.sistemic.co.uk) are engaged in a collaborative project to identify important microRNA (miRNA) signatures, required for high fidelity human hepatocyte generation from pluripotent stem cells. The project is funded by the Scottish Stem Cell Network.

Please contact either Dr David Hay (david.hay@fibromed.co.uk) or Dr Verna McErlane (verna.mcerlane@sistemic.co.uk) if you require more details.

Sistemic to Work with TiGenix On Landmark EUR 5.9 Million, FP7 European Project Aiming at Developing an Innovative Rheumatoid Arthritis Cell Therapy Treatment Product

2012-02-07T15:25:27Z

Glasgow, UK, February 7, 2012 / B3C newswire / - Sistemic is delighted to announce that its proprietary technology (SistemQC™) has been chosen to form a key part of the research and production process for a landmark multinational collaborative project led by TiGenix, Belgium and including partners from Spain, France, the Netherlands as well as the UK and Belgium. The project, REGENER-AR, will bring the first stem cell therapy treatment product for rheumatoid arthritis, Cx611, through final research and clinical development.

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

END

Rapid growth continues for Sistemic

2012-01-12T12:44:17Z

"ON TOP OF THE WORLD"

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/

End

Maximise the potential of your stem cell applications

2011-11-29T22:52:16Z

Meet Sistemic experts at Stem Cell Meeting on the MESA

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

Sistemic presents the solution for broader stem cell therapy at AUSBiotech 2011

2011-10-18T11:52:07Z

18 October : Sistemic, UK: Verna McErlane, Director of Commercial Operations for miRNA specialist Sistemic, is attending AUSBiotech 2011 in Adelaide, South Australia, 16-19 October. At this event she presented a talk entitled ‘The Challenges of Advancing Stem Cell Therapies into the clinic; a Characterisation Perspective’. The presentation formed part of the ‘Human Health – Clever cell culture for the innovation of biologics’ session on 18October.

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

Ends

Sistemic highlights the need for better cell characterisation in regenerative medicine

2011-10-03T16:00:29Z

03 October 2011: Sistemic, UK: Sistemic, the cell characterisation problem-solving service provider that uses miRNA, is a strong advocate for the potential of regenerative medicine. Dr Verna McErlane, Sistemic’s Director of Commercial Operations, recently took part in a round-table discussion with leading stem cell researchers http://www.sistemic.co.uk/publications. The scientific, ethical and moral debate about the use of stem cells continues and will soon be taken up in earnest at the World Stem Cell Summit, taking place from 3-5 October in Pasadena, California, where Dr McErlane is a key participant.

“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

End

Sistemic supports TalentScotland

2011-09-21T14:27:33Z

21 September: Sistemic, UK: Sistemic, a growing and successful biotechnology company, recently recruited a new Senior Bioinformatician with TalentScotland’s help. Sistemic and TalentScotland share a mutual goal of attracting ‘new blood’ from the international life science market to Scotland.

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

Cell characterisation experts Sistemic join the Alliance for Regenerative Medicine

2011-09-08T13:08:43Z

08 September 2011: Sistemic, UK: Sistemic Ltd, a fast growing company focused on providing innovative microRNA-based (miRNA) problem-solving services to areas of unmet need within the Cell Therapy/Regenerative Medicine markets and pharmaceutical and biotechnology R&D, is delighted to announce they have joined the Alliance for Regenerative Medicine (ARM). Founded in 2009, the Alliance has more than 80 members, who span research institutes, foundations, companies and investor groups. Their aim is to advance regenerative medicine by representing and supporting members in front of government agencies and the general public.

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

End

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

Sistemic shares its views on the cell therapeutics industry

2011-07-27T10:59:56Z

27 July 2011: Sistemic: Dr Verna McErlane, Director of Operations at Sistemic Ltd., a leading miRNA-based product company, has recently shared her perspective of the Cell Therapy Industry (CTI) by writing an article for the European Biopharmaceutical Review (EBR), a noted publication supporting the biopharmaceutical industry.

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

End

For further information please contact:

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