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Validation of New Approaches in Genetic Toxicology

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 ...

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FDA Cardiac Safety Workshop

Silver Spring, Maryland, USA

FDA Workshop on Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities

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				PATB Webinar Header
			
						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

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

 

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] => 2020-10-28 15:18:01 [post_modified_gmt] => 2020-10-28 15:18:01 [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 ) [1] => WP_Post Object ( [ID] => 20795 [post_author] => 2 [post_date] => 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] => 2020-10-28 14:07:16 [post_modified_gmt] => 2020-10-28 14:07:16 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=20795 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 21067 [post_author] => 12 [post_date] => 2019-03-26 09:22:27 [post_date_gmt] => 2019-03-26 14:22:27 [post_content] => [post_title] => Validation of New Approaches in Genetic Toxicology [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => validation-of-new-approaches-in-genetic-toxicology [to_ping] => [pinged] => [post_modified] => 2020-10-28 14:42:06 [post_modified_gmt] => 2020-10-28 14:42:06 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21067 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 20922 [post_author] => 13 [post_date] => 2019-02-05 11:54:03 [post_date_gmt] => 2019-02-05 16:54:03 [post_content] => [post_title] => Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune-Related Safety Assessments [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => cancer-immunotherapies-biology-therapeutic-approaches-and-immune-related-safety-assessments [to_ping] => [pinged] => [post_modified] => 2020-10-28 15:01:04 [post_modified_gmt] => 2020-10-28 15:01:04 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=20922 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 20672 [post_author] => 8 [post_date] => 2018-11-07 15:50:28 [post_date_gmt] => 2018-11-07 20:50:28 [post_content] => [post_title] => FDA Cardiac Safety Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => hesi-cardiac-safety-fda-workshop [to_ping] => [pinged] => [post_modified] => 2020-10-28 13:29:18 [post_modified_gmt] => 2020-10-28 13:29:18 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=20672 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [5] => WP_Post Object ( [ID] => 7223 [post_author] => 12 [post_date] => 2018-07-23 16:18:23 [post_date_gmt] => 2018-07-23 21:18:23 [post_content] => FAAM Workshop Logo_revised large 4 REGISTRATION HERE MEETING AGENDA Details
Location: Tivoli Hotel and Congress Center - Copenhagen, Denmark
Dates: October 17 - 18, 2018

There will also be another meeting at the Tivoli Hotel and Congress Center in Copenhagen, Denmark, called FAAM 2018, a EAACI Focused Meeting. FAAM 2018 will take place from 18 -20 October 2018. Please consider attending both events! Find more information on the event here.

 

About
In the growing field of allergy research, scientists can approach protein characterization and allergy hazard assessment in diverse ways. The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee supports original basic research that seeks to uncover the interplay between protein allergenicity and the physicochemical properties of allergenic proteins. The PATB also 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.  PATB’s focus on basic allergy research, coupled with bioinformatic methods for allergenic hazard assessment is unique within the scientific community as it supports an ever-increasing awareness of allergenicity among consumers and regulators. Topics to be covered in this workshop will include historic aspects of food allergy assessment, the evolution of bioinformatics as it relates to allergy assessment, and recent changes in regulations regarding novel food proteins.

This educational workshop will cover advances in protein allergy research and inform the use of novel approaches for the identification of potential food allergens. This event will be of interest to government regulators, those involved in food allergy and celiac disease research, and scientists involved in food safety and risk assessment.

dreamstime_xl_71979237

 

Objectives

Evaluate bioinformatics approaches to characterize the allergenicity potential of novel proteins and inform allergy safety assessment.

Discuss real-world examples of: 1) a product development case-study describing the utility of bioinformatics in protein characterization, and 2) a practical application of the EFSA 2017 Guidance.

Provide insights from new research, ranging from modifications of allergen epitopes at the single amino-acid level, to using protein structural modeling for allergenicity prediction, to the relation between enzymes and allergenic activity.

Introduction

Overview of contributions and research of the HESI PATB to Bioinformatics Analysis of the Potential Allergenicity of Novel Proteins
Greg Ladics, Dupont (Download Presentation)

 

Session I: Bioinformatics Approaches to Protein Characterization and Allergy Safety Assessment
A history of bioinformatics: development of in silico approaches to evaluate food proteins 
Andre Silvanovich, Bayer Crop Science (Download Presentation) Protein sequence analysis tools and resources to detect potential allergens
Rob Finn, European Bioinformatics Institute (EBI) (Download Presentation) Case Study: Allergenic risk of insect proteins
Kitty Verhoeckx, TNO (Download Presentation) The COMPARE Allergen Database: a public, comprehensive protein allergen resource for allergenicity safety assessment
Lars Poulsen, University of Copenhagen (Download Presentation) Novel methods to identify allergenicity potential of proteins
Sebastian Maurer-Stroh, A*STAR Bioinformatics Institute (BII), Singapore (Download Presentation)

 

Session II: Other Considerations for Allergen Safety Assessment

The PATB “Allergen Rebuild Project”: can the conservative replacement of amino acids in an allergen epitope affect IgE binding and cross-reactivity?
Ronald van Ree, Academic Medical Center, University of Amsterdam Development of a Random Forest model for predicting allergenicity of new and modified proteins
Tanja Krone, TNO Cross-reactive carbohydrate determinants and allergenicity 
Edzard Spillner, Aarhus University (Download Presentation)

 

Session III: Non-IgE Mediated Allergy

Overview of known non-IgE mediated diseases and progress in immunology of non-IgE diseases
Antonella Cianferoni, Children’s Hospital of Philadelphia (Download Presentation) In silico tools to predict potential celiac disease toxicity 
Frits Koning, Leiden University (Download Presentation) Application of EFSA 2017 bioinformatic guidance for non-IgE mediated immune disease
Andre Silvanovich, Bayer Crop Science (Download Presentation) Considerations for small peptide analyses in SGF
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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.
dna

 

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
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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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