Upcoming Events

Development of Next-Generation Biomarkers for Detecting Kidney Toxicity

Webinar, hosted by HESI and the American Association of Pharmaceutical Scientists (AAPS)

Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum creatinine, and urinary markers, such as urinary volume, specific gravity, or osmolality, protein, fractional electrolyte excretion, or sediment examination). ...

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HESI Board of Trustees Meeting

Virtual meeting, hosted by HESI Board of Trustees

The HESI Board of Trustees will meet to review 2020 achievements and challenges, approve a 2021 organizational budget, progress the strategic plan, and refine Board priorities for 2021. This is a closed meeting for HESI staff and the HESI Board of Trustees.

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Quantitative Interpretation of Genetic Toxicity Dose Response Data for Risk Assessment and Regulatory Decision-Making: Current Status, Persistent Challenges, and Emerging Priorities

Virtual workshop, hosted by HESI and the Environmental Mutagenesis and Genomics Society (EMGS)

The workshop will (1) provide a brief overview of the state of the science regarding quantitative interpretation of genetic toxicity dose-response data, including a brief overview of the BMD combined covariate approach for potency ranking and MOA investigation, (2) a summary of recent genotoxicity risk assessment case ...

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THRIVE Letters of Intent: Submission Now Open!

Online submission, via HESI THRIVE

HESI THRIVE is a seed grant program that is innovating translational research and improving quality of life after cancer. By providing researchers with both seed funding and access to critical networks, THRIVE enhances the visibility of the patient need, the value of the research, and the reasons that larger funding entities ...

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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 ...

Read more

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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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