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GAiTpost



Welcome to GAiTpost, the 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. GAiT's mission is to facilitate the development of, and access to, clinical-grade and HLA-haplotyped induced pluripotent stem cells for the manufacture of cell therapy products.
 
In this May 2018 issue of GAiTpost:
 
1. GAiT's Meeting Schedule for ISSCR/ISCBI in Melbourne
2. New GAiT website online
3. Industry Liaisons event in Miami
4. GAiT Quality Round 2018 - Call for Expressions of Interest
5. GAiT Quality Guidelines  Manuscript Update
6.  Strengthening Registry Relationships with WMDA
7. World Stem Cell Summit  & Upcoming Conferences
8. Acknowledgements
9. Coming in the next GAiTpost newsletter

GAiT Annual General Meeting
(ISSCR & ISCBI, Melbourne. June 2018) 

Access the detailed schedule here

Keeping the newsletter short

As our professional new website www.gait.global is now online, we have linked pages with extra detail on the events and items mentioned here so GAiTpost remains is clear and concise. To access the website, you will need a username and password, which you can receive by clicking here and inserting your name and email into the pre-written email text before clicking 'send'.

Engaging Industry at Phaciliate


Dr. Michael May, CEO of CCRM and GAiT Director, hosted a GAiT Industry Liaisons Event at the Phacilitate Cell & Gene Therapy World conference. Thanks to all those how attended. More industry engagement is planned for forthcoming IABS/CIRM and ISSCR conferences in June 2018. Such interactions raise awareness of GAiT's activity to industry in the iPSC translation space, and allows GAiT to understand the perspectives and requirements of Industry stakeholders when developing the haplobank network system.

GAiT QUALITY ROUND 2018:
Call for Expressions of Interest Now Open

Some of the mandatory quality tests agreed at the  5th GAiT Quality Standards and Controls Workshop are not standardised. Consequently, a validation process known as a 'Quality Round' has now been suggested. GAiT invites members to review details of the proposed Quality Round and consider giving an expression of interest in participating by clicking here and filling in your details. The closing date for expressions of interest is Monday 23 JULY 2018.

Quality Guidelines manuscript under review


In October 2017, GAiT hosted its 5th Quality Standards and Controls Workshop. We discussed Critical Quality Attributes for clinical-grade iPSC lines and agreed release criteria for lines to be included in the GAiT haplobank network. Now we have described these decisions, and their importance, in a new manuscript.

The manuscript has been reviewed by workshop delegates and the draft is being updated in response to the comments made. The manuscript will be submitted to Regenerative Medicine for peer review this Tuesday 22nd May 2018.

Updates on the manuscript are available on the website here.

Strengthening Registry Relationships with the help of the WMDA

 

The challenges facing iPSC  groups wishing to access donor material from haematopoietic stem cell registries were discussed at a Virtual Workshop in January 2018, hosted at the Cell and Gene Therapy Catapult in London.
Since hosting the workshop in January 2018, GAiT  has sought to deepen its relationship with the
World Marrow Donor Association (WMDA), an expert organisation, which like GAiT, promotes global collaboration and best practice in stem cell transplantation
. Through such interaction, GAiT seeks to highlight its mission to registries worldwide, making it easier for the individual efforts of GAiT members to be understood by registries, and consequently facilitating effective collaboration between GAiT members and their local WMDA affiliated registries. 

Thanks to the support of Dr. 
Carlheinz Mueller, WMDA President, GAiT 's Dr. David Turner has been invited to speak at the International Donor Registry Conference (IDRC), June 26-30, 2018 in Munich. It is our hope GAiT members can build trust by highlight this talk to their local WMDA affiliated registries when engaging with them.


Identify your local WMDA affiliated registry by clicking here.

Slides from the Registry Relationships virtual workshop on how to approach registries are available
here.

Additionally, efforts are also ongoing to access high resolution HLA genotype data from the WMDA, in order to understand the worldwide HLA haplotype coverage. The Research Committee of WBMA have agreed in principle to share these data, although consent from each individual registry will be required before the data can be released to GAiT. We hope this analysis will allow a targeted approach to the collection of relevant HLA haplotype homozygous donors by different groups.

World Stem Cell Summit

The rationale for GAiT was discussed with a general audience at the World Stem Cell Summit, Miami in January 2018. The GAiT talk can be accessed here and scrolling to 32 minutes into the recording. The Session which was chaired by Prof. Jeanne Loring and was entitled 'Enhancements in Pluripotency'. The Session finished with a Roundtable discussion which dealt with topics as diverse as transplantation strategies, clinical trials, and medical tourism.

 

Upcoming conferences


NIBSC GMP-compliant iPSC reprogramming workshop 21-23 May 2018
21-23 May 2018, London

IABS/CIRM Manufacturing and Testing of Pluripotent Stem Cells Conference
5-6 June 2018, Los Angeles

ISSCR Annual Conference
22-23 June 2018, Melbourne

International Donor Registry Conference (IDRC)
26-30 June 2018, Munich

KSSCR Annual Conference
15-18 August 2018, Seoul

Cell and Gene Meeting on the Mesa
3-5 October 2018, La Jolla

NYSCF Annual Conference
23-24 October 2018, New York

Informa Cell Therapy Manufacturing and Gene Therapy Congress
4-5 December 2018, Amsterdam

ECI Scale Up and Manufacturing of Cell  Based Therapies V
15-19 January 2019, Coronado

Acknowledgements


 Carlheinz Mueller, Anna FalkTerri Gaskell, Taadaki Hanatani, Chihiro Akazawa, Denis Gauvreau, Peter Andrews, Lygia da Veiga Pereira Carramaschi, Annelise Bennaceur-Griscelli, Maurice CanhamTamara Malygina, Leonid Torchinskiy, Veronika Rechkina, Ekaterina Kutuzova, Elena SergunovaKilian KellyAmanda Mack, Ngaire Elwood,  Hidetoshi Hoshiya, Patrick Bedford, Steven Keizer, Ian WilmutChaten ParmarAbbie CharletNuno Madeira do ÓRicardo BaptistaMichaela SharpeKevin McCormackBernard SiegelYoji Sato, Lucilia Mouries,  Kristina RunebergTakuji YamamotoDavid McKeonNatalie NaJung Kim, Michael Sheldon, Tenneille Ludwig, Juan Dominguez-BendalaJeff Wallerstein; Jean Hart, Liz Schwarzbach, Natalie WardWataru Fujibuchi, Elisa Manzotti,  Akira ChibaKeren Abberton, Karin Hoogendoorn, Martin McGlynn, Rui Shuhama, Outi Hovatta, Kevin McCormack, Scott Noogle, Pierre-Antoine Gourraud, and Stephen Lin. 
 

Coming in the Next GAiTpost newsletter


Official launch of website
Updates on ISSCR/ISCBI and other conferences
Update on clinical-grade iPSC database build
Update on QC guidelines publication
Upcoming GAiT Workshops

 
And finally....

The 2nd Quality Standards Survey for GAiT Stem Cell Centres (2018) is now online. We request each GAiT affiliated institution fill this out - the deadline for completion is 31st October 2018. The questions are identical to last year's survey and allow GAiT to assess how newcomers are assessing quality as well as tracking the progress of long standing GAiT affiliated centres in generating clinical-grade iPSC lines.
Data from the GAiT Quality Standards surveys will be summarised during the GAiT update 24th June 2018 at ISCBI.
Copyright © 2018 Global Alliance for iPSC Therapies, All rights reserved.


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