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HESI & SPS virtual training opportunity

June 21, 2022 – December 31, 2022

On Demand Training, HESI & SPS

The Health and Environmental Sciences Institute (HESI) & Safety Pharmacology Society (SPS) present a new, on-demand training opportunity: A closer look at the new ICH E14/S7B Q&A's and Training Materials.

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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

December 3, 2020

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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PATB Committee Protein Toxins Workshop

October 21, 2020 – October 22, 2020

Virtual workshop, hosted by the HESI PATB Committee

The HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is hosting a virtual workshop focusing on the state of the science for a wide array of protein toxins classes, MOAs, structures, activity, and general biology. Additionally, the workshop will cover the bioinformatics analysis of protein toxins and how ...

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THRIVE Letters of Intent: Submission Now Open!

October 17, 2020 – December 31, 2020

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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eSTAR Committee and AAPS Webinar Series

October 15, 2020

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

Development and Regulatory Approval for Toxicogenomics Biomarker to Detect DNA Damage-Inducing Agents

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CT-TRACS Committee and NIH/NHLBI PACT Program Joint Webinar

September 3, 2020

Webinar, hosted by the National Heart, Lung, and Blood Institute (NHLBI) PACT Program

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Tracking Cells In Vivo and Following Biodistribtion" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program. Cell therapies show great ...

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The HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is hosting a virtual workshop focusing on the state of the science for a wide array of protein toxins classes, MOAs, structures, activity, and general biology. Additionally, the workshop will cover the bioinformatics analysis of protein toxins and how to leverage computational biology for protein toxins identification/characterization, with in silico approaches. 


The Protein Toxins Workshop will serve the dual purpose of learning from the experts in the field about the state of the science as well as assessing the translation of knowledge to practical applications, e.g., into weight-of-evidence approaches for the safety assessment of biotechnology products. The workshop aims to gain insight into how feasible/useful (or not) a protein toxin database could be in risk assessment/product development. This meeting will serve as an informational platform about HESI and will demonstrate the advances in protein toxins research, presented by international experts, and will help inform the development of novel approaches for the identification and classification of potential toxicity risk in novel proteins.


Details


    

  • Date: Wednesday, 21 October 2020 - Thursday, 22 October 2020
    • 

  • Time: 9:00 AM - 12:00 PM EST
    • 

  • Registration: Details coming soon
    • 


				PATC_resize
	
Workshop Program Outline (subject to change)


Wednesday, 21 October 2020


    

  • 9:00 AM - Opening Remarks (Dr. Laura Privalle, BASF Corporation)

      

    • From protein toxins to biotechnology products
      • 

    • Setting the stage; considerations for publication of meeting report
      • 

    

    • 

  • 9:30 AM - Brief Codex Discussion

      

    • Allergenicity assessment vs. toxins/toxicity assessment
      • 

    

    • 

  • 10:00 AM - Terrestrial Toxins
    • 

  • 11:30 AM - Marine Toxins
    • 



 


Thursday, 22 October 2020


    

  • 9:00 AM - Bacterial Toxins
    • 

  • 10:30 AM - Bioinformatics & Computational Biology in Protein Toxins Research
    • 



 


For more information, please contact the PATB Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.


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	Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients

What are your cells doing? Where do they go?

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program.


 


Details:


    

  • Date: Thursday, 3 September 2020
    • 

  • Time: 12:00 PM - 1:00 PM EST
    • 

  • Registration: Click here to register.
    • 


				CT-TRACS Web Seminar Image v2
	
 


Speakers:


    

  • Bill Shingleton, PhD, Alliances Manager at Cytiva
    • 

  • Brooke Helfer, PhD, Director of Research and Development at Celsense, Inc.
    • 

  • David Morrow, PhD, MBA, ATMP and Vaccine Scientific Program Manager at EATRIS
    • 


	
Cell therapies show great therapeutic promise in the fields of regenerative medicine and immunotherapy. To realize their full clinical potential, there is a need for greater understanding of their mode of action, how they migrate after administration to deliver their therapeutic benefits, their persistence at sites of action, and whether their properties, localization, or distribution may cause safety issues. Currently, there are several existing and many emerging tools available to develop pharmacokinetic data on these cell-derived therapies to improve our understanding of the mechanism of action and demonstrate on-target delivery, but adoption by clinical investigators has been limited.


In this web seminar, the CT-TRACS Committee speakers will provide an overview of technologies currently available for use in patients, how these are relevant to evaluate safety and efficacy aspects of cellular therapies, and the importance of collaboration to address challenges and needs facing the translation of cell therapies into the clinic​.


The CT-TRACS Committee provides a neutral platform for cell therapy developers, researchers, regulators, imaging specialists, and other stakeholders to interact, discuss current challenges, and identify best practices to improve confidence in the safety and efficacy of these therapies.


 


Webinar Objectives:


    

  • To learn about available and emerging noninvasive cell tracking modalities and their value in assessing cell fate and safety in vivo
    • 

  • To bring awareness on how the application of existing cell tracking technologies, methods, and best practices can benefit the clinical translation of cell therapies
    • 

  • To emphasize the need for dialogue with the international community and discuss opportunities to address the challenges facing the translation of cell therapies into the clinic
    • 

  • To understand the importance of therapy developers communicating practical challenges and needs to aid the development of enabling technologies and tools addressing those needs
    • 



 


Additional details can be found via the webinar e-flyer here. For more information, please contact the CT-TRACS Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.


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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

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