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The goal of this workshop is to discuss the preclinical and translational safety assessment of engineered T cell therapies. The workshop will focus on six topics, followed by an in-depth discussion:

Designing engineered T cells for optimal activity and safety
Target expression and associated liability assessment
In vivo models informing safety and activity
Safety of viral and non-viral gene delivery systems – utility, risk of genomic injury
Linking preclinical development with the clinical experience
Regulatory considerations

 
Agenda: Please find workshop agenda here.
Accommodations: Click here to find a list of nearby hotels. Please note that participants are responsible for their own transportation to and from the US FDA site.
Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).
Registration: Onsite registration is now closed. To attend the workshop virtually, please use the webinar link located below.
Webinar: Click here to join the webinar.

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	Date: June 30, 2019

Time: 13.00 - 18.00 PST

Location: Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC

First Floor, Seminar Room #101

1425 San Pablo Street, Los Angeles, CA 90033
 
After the success of the 2018 CIRM/IABS “4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells” and the associated HESI CT-TRACS tumorigenicity workshop (conference report: Abbot et al. 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the manufacturing and testing of pluripotent stem cell-based therapies.
 
The Pluripotent Stem Cells Manufacturing Meeting 2019 (PSCM2019) will be held on 30 June 2019 at the Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC (Los Angeles, California), following the International Society for Stem Cell Research (ISSCR) 2019 Annual Meeting. For more information, please contact Lucilia Mouriès (lmouries@hesiglobal.org).
 
This event is co-hosted by the following organizations:

 
Live-streaming information for the event and related materials will be available via GAiT’s website: http://www.gait.global/expert-panels-2019/
Start date in different time zones worldwide

See location on Google Maps
	
Agenda for the Expert Panels
 
13.00-13.25 Opening Panel: Review of takeaways from the June 2018 CIRM/IABS PSC Manufacturing, Standards, & Controls meeting; objectives and context for this year’s discussion.

Chair: Dr. Stephen Lin (CIRM)
Panel:




Assoc. Prof. Ngaire Elwood (ISCT)
Dr. Stephen Lin (CIRM)
Dr. Lucilia Mouriès (HESI CT-TRACS)
Dr. Yoji Sato (NIHS; HESI CT-TRACS)
Prof. Glyn Stacey (ISCBI)
Dr. Stephen Sullivan (GAiT)



 
13.30-13.55 Panel 2: Pluripotent stem cells as manufacturing cell substrates – challenges encountered and forecast

Chair: Dr. Wen Bo Wang (Fate Tx)

 
14.00-14.25 Panel 3: International standardization of human pluripotent stem cell manufacturing – rationale and review of current status

Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)

 
14.30-14.55 Panel 4: Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development 

Co-Chair: Assoc. Prof. Ngaire Elwood ((Murdoch’s Children’s Research Institute/ISCT/FACT/ BMDI Cord Blood Bank)
Co-Chair: Dr. Amanda Mack (Fujifilm Cellular Dynamics International)

 
15.00-15.25 Panel 5: Outlining a road map to cell therapy comparability

Chair: Prof. Jo Mountford (SNBTS/University of Glasgow)

 
16.00-16.25 Panel 6: Towards standardized tumorigenicity testing – challenges and the way forward

Chair: Dr. Yoji Sato (NIHS; CT-TRACS Tumorigenicity WG)

 
16.30-16.55 Panel 7: Towards automated and closed human Pluripotent Stem Cell Manufacture

Co-Chair: Dr. Elizabeth Schwarzbach (NYSCF)
Co-Chair: Dr. Mathilde Girard (YposKesi)

 
17.00-17.15 Panel 8: Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture

Co-Chair: Dr. Bill Shingleton, Assymtote
Co-Chair: Dr. Rajesh Ambasudhan (Allele Biotech)

 
17.20-17.35 Panel 9: Avoiding immunorejection and engraftment failure – challenges and the way forward

Chair: Dr. Stephen Sullivan (GAiT)

 
17.40-18.00 Closing Panel: Organizers summarizing and highlighting upcoming events

Co-Chair: Dr. Stephen Lin (CIRM)
Co-Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)

 
See more on the format and recommendations for participation here.

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                    [post_title] => 2019 HESI Annual Meeting
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