June 24, 2025 – June 26, 2025
Durham, NC, USA
The HESI eSTAR Committee is holding a workshop to discuss research questions related to transcriptomic point of departures (tPODS), focusing on the bioinformatic differences. We will identify research gaps, present case studies, and dive into datasets.
March 16, 2025 – March 20, 2025
Orlando, Florida, USA
HESI will attend the 2025 Society of Toxicology Annual Meeting and Tox Expo in Orlando, Florida. Click for details.
February 13, 2025 – February 14, 2025
Virtual, Online
December 12, 2019
Virtual, Webinar
An overview presentation on RISK21 was given by Michelle Embry (HESI).
September 24, 2019 – September 25, 2019
Silver Spring, Maryland, USA
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.
June 30, 2019
Los Angeles, California, USA
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 (Abbot et al., 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the ...
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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.
[post_title] => FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T-Cell Therapies
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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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