GAiTpostWelcome 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 Therapies52 Research Avenue North, Heriot-Watt Research Park, Edinburgh, EH14 4BE, 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 December 2017 issue of GAiTpost:
1. Director Retires
2. Working Group Updates
3. Upcoming Meetings
4. Acknowledgements
5. Coming in the March Newsletter |
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Director Retires
At the most recent GAiT Board meeting, Director Prof Johan Hyllner retired. We thank him for all his hard work for GAiT and wish him all the best. On the 27th of November, we interviewed Prof Hyllner and you can read the interview here.
Prof Hyllner is replaced by his Catapult colleague Dr Jacqueline Barry. Dr Barry is the Chief Clinical Officer of the Cell and Gene Therapy Catapult (CGT) and former Lead of GAiT's Regulatory working group. We congratulate Dr Barry and wish her well in her new role.
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Working Group Updates
Quality Standards and Controls
One of the chief regulatory requirements of any cell therapy is to develop "release criteria" that define critical quality attributes of the final clinical product.
Visiting GAiT Quality Standards and Controls Chair and former Head of the UK Stem Cell Bank, Prof Glyn Stacey discussed and built consensus around release criteria for clinical grade iPSC lines at a workshop in Sheffield 5th September 2017. Such criteria need to be shown for inclusion of lines into the GAiT haplobank network.
The Minutes were circulated to Workshop Delegates and have now been approved.
Approved Minutes from GAiT Quality Standards Workshop 23 September 2017
Meeting delegates are reminded of two outstanding actions from this meeting:- All delegates to identify any further iPSC cell banking documents.
- Manufacturing centres to be invited to provide a map of their process.
Please send these to stephen.sullivan@gait.global.
A follow up GAiT comparability workshop will be scheduled after the Release Criteria manuscript has been written, edited following consultation, and published.
Donor Selection, Screening, and Consent
Establishing relationships with local blood and tissue registries is a key challenge for most in the GAiT community.
Prof Steve Marsh (Anthony Nolan Research Institute) and Dr Carlheinz Mueller (World Marrow Donor Association) will consider how to build and maintain good registry relationships at CGT headquarters at Guy’s Hospital, London on 30th January 2018 2-4pm GMT.
The start time in other time zones: 09.00 EST, 23.00 KST, 15.00 CET, 01.00 AEDT (12 NOV), 19.30 IST, and 06.00 PST. The dial in numbers will be same as the 2 previous GAiT meetings, and will be included in a reminder email nearer the time.
Topics will include: - Understanding the role of blood and tissue registries in the development of new therapies
- Understanding the risks registries face
- Understanding what are registries’ missions and motivations
- Understanding who registries want to engage with
(This meeting was originally scheduled for 12th December 2017 but has now been postponed until 30th January 2018 due to unavailability of key personnel. Apologies for any inconvenience caused by this rescheduling.)
Database
Prof Andreas Kurtz, Head of Stem Cell Research and Knowledge Management at BCRT, chaired a GAiT Website and Database Workshop in Berlin on the 1st November 2017. There he reviewed the rationale for a clinical grade iPSC database tailored to GAiT specifications, then reviewed how the hPSCreg database structure might be changed, augmented, and/or supplemented to meet the need of the GAiT community for a clinical grade iPSC database. Dr Dave Turner of SNBTS kindly led the discussion on immunogenetic fields to be included in the GAiT database.
Regulatory Compliance Dr Patrick Ginty (Head of Regulatory Affairs at CGT) was appointed to fill Dr Jacqueline Barry’s previous role as Regulatory working group Lead and Dr Patrick Bedford (Clinical Translation and Regulatory Affairs Manager at CCRM was appointed as deputy Lead. The Regulatory Compliance working group are currently working on the Governance & Regulatory Fields that will need to be included in the GAiT clinical grade iPSC database. More detail here.
Industry Liaison
GAiT will form relationships with Industry to incorporate relevant expertise, and to engage this stakeholder on GAiT activities. Industry sponsorship will not currently be sought to ensure all stakeholders have equivalent influence as standards and infrastructure are agreed by the GAiT community and put in place.
GAiT will host an Industry Consortia meeting at the Hyatt Regency in Miami 09.00 EST-12.00 EST on 26th January 2017, after the Phacilitate & WSCS conferences. The meeting will be chaired by GAiT Director & Industry Liaison Lead, and CCRM CEO Dr Michael May.
The start time in other time zones: 09.00 EST, 23.00 KST, 15.00 CET, 01.00 AEDT (27 NOV), 19.30 IST, and 06.00 PST. The dial in numbers will be same as the previous GAiT meetings, and will be included in a reminder email nearer the time.
The Agenda for this meeting includes:- The context for, and mission of, GAiT
- A description of GAiT strategy and the significance of Industry Stakeholders to fulfilling GAiT's objectives
- iPSC Therapy Regulatory round table
- iPSC Therapy Market round table
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Acknowledgements
GAiT would like to thank the following for their kind assistance over the past 3 months:
Hidetoshi Hoshiya, Daniel Paull, Joanne Mountford, Steven Keizer, Mary Babynbaena,Christine Wells, Amanda Mack, Tenneille Ludwig, Lydia Mailander Boisi, Alan Deegan,Jeff Wallerstein, Neil McGowan, Lisa Shapiro Strovink, Denis Gauvreau, Anna Williams and Tadaaki Hanatani. |
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The next GAiTpost newsletter will be sent on 1st March 2018.
Contents will include:
Update on the GAiT QC paper and 2nd Comparability workshop. Updates on GAiT website and clinical grade iPSC database development. |
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