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 | Welcome to GAiTpost, the new newsletter for the Global Alliance for iPSC Therapies (GAiT). The function of the newsletter is to inform on GAiT activity and to highlight forthcoming events as well as to share information about the GAiT community.
Global Alliance for iPSC Therapies,
21 Ellen's Glen Road, Edinburgh EH17 7QT, UK. Landline: ++ 44 (0) 131 463 5500
Email: stephen.sullivan@gait.global
GAiT's mission is to facilitate the development of, and access to, clinical-grade and haplotyped induced pluripotent stem cells for the manufacture of cell therapy products.
In this September 2017 Newsletter:
1. Upcoming Meetings & Agendas
2. Recent Meetings
3. Other News
4. Coming in the December Newsletter
5. Acknowledgements
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Quality Standards Meeting An important Working Group meeting will take place on the Thursday 5th October 2017 at Mercure Sheffield St. Paul's Hotel, Sheffield, UK 12.00-16.00 GMT. This meeting will be chaired by the Quality Standards visiting chair Prof. Glyn Stacey and will focus on agreeing MINIMUM QUALITY ATTRIBUTES for GMP iPSCs in the GAiT system.
AGENDA
Testing and control: - What are the crucial issues that need to be covered in assessment of lines to be included in the GAiT programme such as ethics, governance, characterisation and safety?
- Review GAiT table of cell bank testing against ISCBI notes (Boston June)
- Identify release tests and tests for information
- Consider types of assays to recommend for release tests to enable appropriate sensitivity, specificity and reliability
- Consider physical control materials needed for GAiT testing and possible sources such as NIBSC WHO and diagnostic standards
Consistency with regulatory requirements - Review applicable national and international standards for GAiT compliance (delegates to propose these prior to the meeting)
- Agree back ground documents and standards to be adopted and how to accommodate different jurisdictions
Application of manufacturing standards for cell banking - What is a GAiT cell line status in the manufacturing process? What is the appropriate standard?
- Traceability: agree what needs to be documented for donor selection, tissue harvesting/storage, cell line derivation and banking
How can one demonstrate characterisation is adequate? How is ‘comparability’ of a common product demonstrated from different cells lines? If you wish to attend in person, please email Stephen.Sullivan@gait.global. The meeting to be held at Mercure Sheffield St. Paul's Hotel, Sheffield, UK on the 5th October 12noon-4pm GMT. Also you can dial into the meeting using local or toll free numbers. Dial in details are available by emailing Stephen.Sullivan@gait.global. If you are also visiting GAiT's new Scottish office (@ The Jack Copland Centre), note there are direct trains between Sheffield and Edinburgh (train journey time is about 4.5 hours). |
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|  | | Upcoming meetings of interest to the GAiT community - if you have a meeting for inclusion in the December newsletter let us know. |
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 | GMP iPSC database development meeting
A GAiT meeting will take place in Berlin Wednesday 1st November 2017 to address the following for the GAiT database for clinical grade iPSC lines:
Develop GAiT specific data structure, use cases and interface structure; identify search requirements and filters
Define HLA and clinical grade PSC fields
Discuss usage of MIACARM
Define user management for GAiT
More details are available by emailing Working Group Lead Andreas Kurtz or ILO Stephen Sullivan.( We will have more on the GAiT website and Database development in the December newsletter.) |
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GAiT/ISCBI WorkshopThe Global Alliance for iPSC Therapies (GAiT) and the International Stem Cell Banking Initiative (ISCBI) held a workshop at the Harvard Stem Cell Institute, Cambridge, USA on 16th June 2017.
The meeting highlighted the growing interest in iPSC therapy and research and described efforts to standardise the field so that the discordance evident in MSC translation would not be repeated for iPSC (see more on Quality Standards below).
Attendees expressed the desire for more frequent communication regarding GAiT activities and events, which resulted in the creation of this quarterly newsletter.
Full minutes and a review of slides presented will be posted on the website in the coming weeks once we have the website developed. Alternatively, please send a request to Stephen.Sullivan@gait.global and we will email it to you.
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 | August Board of Directors MeetingGAiT held its August Board meeting in Seoul during the KSSCR - the Korean Society for Stem Cell Research. The meeting was hosted by Board Director Prof Jihwan Song. The Board meeting focused on the updated strategic plan, reviewing progress with the Working Groups, administrative consolidation, development of the website, and event planning.
Korea will host the annual ISSCR meeting in 2019. |
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Donor Selection Working Group MeetingDue to the retirement of Prof Craig Taylor, new histocompatibility expertise is required to develop the GAiT Donor Selection program.
A productive meeting was held with Histocompatability expert and Deputy director of the Anthony Nolan Research Institute Prof Steve Marsh and Dr James Robinson from his team and GAiT hopes to develop a relationship that will enable a comprehensive analysis of HLA haplotypes in the global population to better inform donor selection.
A proposal is being prepared by Prof Marsh and will be discussed at the New York Board meeting. The Donor Selection Working Group is chaired by Dr Dave Turner (Scottish National Blood Transfusion Service). |
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 | AppointmentGAiT hired its first full time employee, Dr Stephen Sullivan, as International Liaison Officer (ILO). Dr Sullivan is responsible for the day-to-day activity of GAiT including managing Working Group activity in collaboration with the Scientific Leads, as well as engaging associates of GAiT through publications, conferences, and indeed one-to-one communication. He is located at GAiT's Scottish office at 21 Ellen's Glen Road, Edinburgh.
Formally Dr Sullivan was Chief Scientific Officer of the Irish Stem Cell Foundation and has worked with human pluripotent stem cells at Harvard, Cambridge and Edinburgh. He also has clinical trial management experience at Novartis. More detail is available here. |
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And coming in the December Newsletter....
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Development of the GAiT website and database.
The Board and Industry Liaison meetings in New York.
GAiT's minimum quality attributes for clinical grade iPSCs.
GAiT's Regulatory Working Group. |  |
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Acknowledgements GAiT would like to thank Hadi Mirmalek-Sani, Samantha Barran, Daniel Surridge, Veena Bairoliya, and Bernard Johnson-Tackie at the Cell and Gene Therapy Catapult, London for their kind assistance on boarding the new ILO. We are also grateful for advice received from Stacey Johnson at CCRM regarding the software used to generate this newsletter.
Global Alliance for iPSC Therapies,
21 Ellen's Glen Road, Edinburgh EH17 7QT, UK. Landline: ++ 44 (0) 131 463 5500
Email: stephen.sullivan@gait.global |
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