Upcoming Events

HESI DART Committee 2021 Spring Meeting

Virtual meeting, hosted by the HESI DART Committee

The HESI DART Committee 2021 Spring Meeting will take place on April 20-21, 2021 from 9am-1pm EST. The virtual meeting is open to DART Committee participants only.

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Stanford 2021 Drug Discovery Symposium

Virtual symposium, hosted by Stanford University

Advances in research and technology now afford us the unique opportunity to develop and test novel diagnostics and therapeutics. This conference takes advantage of the collective experience and expertise of our participants to cover a broad range of policy, research, and venture topics. This symposium provides an invaluable ...

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ITC Humanized Mouse Model Working Group Seminar Series

Virtual seminar series, hosted by the HESI ITC Committee

This ITC working group seminar series aims to provide informational background on existing or newly emerging case studies of humanized mouse models from various organizations, including The Jackson Laboratory, Taconic Biosciences, AstraZeneca, and the US Food and Drug Administration. The working group seeks to better ...

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Pluripotent Stem Cell Manufacturing Expert Panels 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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				ITC Workshop Image_September 2019
	

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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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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Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859

740 15th Street NW, Suite 600
Washington, DC 20005

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