Past Events

Past Events

Pluripotent Stem Cell Manufacturing Expert Panels 2019

Los Angeles, CA, 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 (conference report: Abbot et al. 2018. Biologicals, 56: 67-83), five organizations have come together to continue the discussion and address bottlenecks associated with the manufacture 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.

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2019 HESI Annual Meeting

Alexandria, Virginia, USA

Register now to celebrate 30 years of HESI science! This year’s program will bridge our past achievements and future plans to generate science for improved decision-making, enhanced human health and safety, and protected environments.

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.

[post_title] => FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T Cell Therapies [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => fda-cber-hesi-workshop-on-the-safety-assessment-of-engineered-t-cell-therapies [to_ping] => [pinged] => [post_modified] => 2019-09-19 11:37:05 [post_modified_gmt] => 2019-09-19 16:37:05 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21355 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 21367 => 105 => 2019-06-24 13:14:22 [post_date_gmt] => 2019-06-24 18:14:22 [post_content] => PSCM2019_Comm Image 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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The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee will be hosting a webinar to discuss emerging opportunities and innovations in the biotechnology and food safety assessment arenas. See details below!

Details

  • Date: Wednesday, May 22, 2019
  • Time: 11 AM - 12:30 PM EST
  • Registration: Click here to register.
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Speakers:

  • Scott McClain, Regulatory Product Safety Scientist, Syngenta Crop Protection (USA), PATB Committee Co-Chair
  • Lars Poulsen, Head of Research, Allergy Clinic, Copenhagen University Hospital at Gentofte (Denmark), Member of the COMPARE Database Peer-Review Expert Panel

Advances in agricultural and food biotechnology bring the opportunity to improve the way we grow food and feed crops. As part of the requirements to ensure food safety, it is vital to mitigate potential risks of introducing new allergens or unintended components in the food chain that could induce adverse reactions in humans.

The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee engages international collaborative teams of academics, clinicians, regulators, and industry scientists who conduct research, design and populate public database resources, and convene trainings on the use and evaluation of biotechnology products.  The PATB oversees the creation, maintenance, and distribution of the Comprehensive Protein Allergen Resource (COMPARE) Database whose use in conjunction bioinformatic tools, offers an effective means for assessing allergenic potential of novel food proteins. 

Webinar attendees will:

  • Learn directly from experts in the committee about the nuts and bolts of food safety assessment of biotechnology products, the committee contributions to the field and new emerging issues
  • Engage in an interactive discussion about emerging opportunities, challenges, and innovations in the biotechnology and food safety assessment arenas
[post_title] => HESI PATB Public Webinar - Emerging Opportunities and Innovations in Biotechnology and Food Safety Assessment [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => hesi-patb-public-webinar-emerging-opportunities-and-innovations-in-biotechnology-and-food-safety-assessment [to_ping] => [pinged] => [post_modified] => 2019-05-03 09:30:15 [post_modified_gmt] => 2019-05-03 14:30:15 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21115 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 20795 => 105 => 2019-01-10 10:45:01 [post_date_gmt] => 2019-01-10 15:45:01 [post_content] => Thyroid Workshop_Logo1 (003)

Recent updates to OECD developmental/reproductive toxicology guidelines and other regulatory guidelines and guidance require the measurement of thyroid hormone levels in the blood of mammalian laboratory species during development.  Preliminary analyses indicate that there is a wide variability across laboratories in the methods being used to measure thyroid hormones in young rodents, as well as in the success of obtaining reliable data.  Even though publicly available regulatory guidelines and guidance address study design, they allow varied approaches to thyroid hormone measurement in rodents, and an optimal study design or logical approach to thyroid hormone testing in young rodents has not yet been established in a regulatory testing context.  Validity, accuracy, sensitivity and reproducibility of the assays are issues of concern.  It is not clear to what extent variability in the data can be attributed to methodological issues or to innate biological variability.

WORKSHOP AIMS

  1. Present the state-of-the-science on thyroid hormone assessments, specifically as it relates to preclinical methods and data collection, and identify gaps and knowledge as it relates to regulatory DART testing,
  2. Provide clarification and guidance regarding the collection (timing and methods), assessment (standardization and validation), and interpretation of thyroid hormone data (as it relates to adversity) for regulatory toxicology and risk assessment,
  3. Discuss and come to consensus on recommendations on how to improve data interpretation/understanding of thyroid changes and their relationship to adverse outcomes
dreamstime_s_127655942

WORKSHOP AGENDA

Click here to download the workshop agenda.

 

Session 1: Setting the Stage

The Thyroid Axis - Overview of Anatomy, Physiology, Regulation in Mammalian Systems
Mary Gilbert, U.S. EPA (Download presentation) An AOP Network for Thyroid Hormone Disruption and Adverse Outcomes
Kevin Crofton, R3Fellows, LLC (Download presentation) Mild Thyroid Dysfunction During Pregnancy; Consequences for Pregnancy Outcome and Fetal Development
Robin Peeters, Erasmus University (Download presentation)

 

Session 2: Methodologies & Interpretation

Regulatory Requirements for Evaluation of Thyroid Status
Sue Marty, Dow (Download presentation) Pathology Endpoints: Evaluation of Thyrotoxicants in Animal Studies
Brent Walling, Charles River (Download presentation) Overview of In Vitro Assays to Investigate Chemicals for Thyroid-Axis Disrupting Potential
Michael Hornung, U.S. EPA (Download presentation)

 

Session 3: Global Thyroid Activities

Overview of Ongoing Thyroid Activities in the European Union and United States
Manon Beekhuijzen, Charles River (Download presentation) HESI DART - ETS Thyroid Hormone Survey - Results & the Path Forward
Pragati Coder, Charles River (Download presentation) [post_title] => HESI DART Committee Thyroid Hormone Assessment Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => hesi-dart-committee-thyroid-hormone-assessment-workshop [to_ping] => [pinged] => [post_modified] => 2019-05-29 11:56:59 [post_modified_gmt] => 2019-05-29 16:56:59 [post_content_filtered] => [post_parent] => 0 [guid] => http://hesiglobal.org/?post_type=event&p=20795 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) ) [post_count] => 5 [current_post] => -1 [in_the_loop] => [post] => WP_Post Object ( [ID] => 21355 => 105 => 2019-06-20 12:21:14 [post_date_gmt] => 2019-06-20 17:21:14 [post_content] => 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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