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 ...
June 11, 2019 – June 12, 2019
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.
May 22, 2019
Virtual webinar, hosted by the HESI PATB Committee
The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is hosting a webinar to discuss emerging opportunities and innovations in the biotechnology and food safety assessment arenas.
May 9, 2019 – May 10, 2019
Washington, District of Columbia, USA
Save the date! HESI DART Committee and European Teratology Society Workshop on Thyroid Hormone Assessment: Implications for Developmental and Reproductive Toxicology
May 8, 2019
Newark, Delaware, USA
Novel in vitro and in vivo assays have been developed to improve the reliability of tools employed for identification of genotoxic hazard. Several of the new assays can provide insight into mode-of-action (MoA). As emerging technologies generally used for evaluating human hazard and/or risk, these novel ...
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
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
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.
13.30-13.55 Panel 2: Pluripotent stem cells as manufacturing cell substrates – challenges encountered and forecast
14.00-14.25 Panel 3: International standardization of human pluripotent stem cell manufacturing – rationale and review of current status
14.30-14.55 Panel 4: Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development
15.00-15.25 Panel 5: Outlining a road map to cell therapy comparability
16.00-16.25 Panel 6: Towards standardized tumorigenicity testing – challenges and the way forward
16.30-16.55 Panel 7: Towards automated and closed human Pluripotent Stem Cell Manufacture
17.00-17.15 Panel 8: Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture
17.20-17.35 Panel 9: Avoiding immunorejection and engraftment failure – challenges and the way forward
17.40-18.00 Closing Panel: Organizers summarizing and highlighting upcoming events
See more on the format and recommendations for participation here.
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REGISTER HERE
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
Speakers:
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:
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
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
Session 2: Methodologies & Interpretation
Regulatory Requirements for Evaluation of Thyroid Status
Session 3: Global Thyroid Activities
Overview of Ongoing Thyroid Activities in the European Union and United States
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:
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] => 2020-10-28 15:00:39 [post_modified_gmt] => 2020-10-28 15:00:39 [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 ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 158 [max_num_pages] => 27 [max_num_comment_pages] => 0 [is_single] => [is_preview] => [is_page] => [is_archive] => [is_date] => [is_year] => [is_month] => [is_day] => [is_time] => [is_author] => [is_category] => [is_tag] => [is_tax] => [is_search] => [is_feed] => [is_comment_feed] => [is_trackback] => [is_home] => 1 [is_privacy_policy] => [is_404] => [is_embed] => [is_paged] => 1 [is_admin] => [is_attachment] => [is_singular] => [is_robots] => [is_favicon] => [is_posts_page] => [is_post_type_archive] => [query_vars_hash:WP_Query:private] => 2084414a757bbb1efd7ca29fe3704327 [query_vars_changed:WP_Query:private] => 1 [thumbnails_cached] => [stopwords:WP_Query:private] => [compat_fields:WP_Query:private] => Array ( [0] => query_vars_hash [1] => query_vars_changed ) [compat_methods:WP_Query:private] => Array ( [0] => init_query_flags [1] => parse_tax_query ) )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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