Past Events

FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop

Silver Spring, Maryland, USA

The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by longer in-depth discussion within each session, the goal ...

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				ITC Workshop Image_April 2020
	

THIS EVENT HAS BEEN POSTPONED IN RESPONSE TO COVID-19. PLEASE STAY TUNED FOR UPDATED DATE, TIME, AND OTHER MEETING DETAILS.

 

Background

The field of immuno-safety is a dynamic one in which changing public health concerns, novel biomedical research advances, and innovative technological developments constantly change the landscape and the way in which work is carried out and utilized. As this field requires combined expertise in both immunology and toxicology, the need for continued training and interdisciplinary interactions are critical for those who work within this field. This is essential both for those with an immunology background who seek to apply this expertise to drug development and safety, as well as those who wish to enhance their current drug safety expertise with a deeper understanding of immunology.

 

Objectives

-Review the background science of the immune system in both normal and diseased state
-Enhance awareness of toxicities associated with modulation of the immune system
-Provide a training mechanism that incorporates the latest science into preexisting drug development methodologies

 

Output

Beyond the dialogue that will be generated on the latest science, this training course will provide the opportunity to apply it to a drug development setting through the following means:

-Engagement and discussion with experts in the field will enable participants to see how the science translates to applicability in drug development
-The use of specific case studies will engage and illustrate to participants how they can systematically progress on a sample task [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-2 [to_ping] => [pinged] => [post_modified] => 2020-10-28 14:59:49 [post_modified_gmt] => 2020-10-28 14:59:49 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21939 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 22078 [post_author] => 14 [post_date] => 2020-01-02 13:06:03 [post_date_gmt] => 2020-01-02 18:06:03 [post_content] => FDA CDER Immunomodulators and Pregnancy Workshop

ABOUT THE EVENT

The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by a longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.

 

The  workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss:

  1. The current state of reproductive immunology
  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
  3. What additional tools/methods are currently being developed that could address gaps
  4. Global regulatory considerations across various immunomodulatory modalities

 

Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).

 

Registration: Up-to-date information and registration can be found here. Registration will close on February 5, 2020. Due to the format and structure of this workshop, attendance is restricted to in-person attendees only.

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THIS EVENT HAS BEEN POSTPONED IN RESPONSE TO COVID-19. PLEASE STAY TUNED FOR UPDATED DATE, TIME, AND OTHER MEETING DETAILS.

 

Background

The field of immuno-safety is a dynamic one in which changing public health concerns, novel biomedical research advances, and innovative technological developments constantly change the landscape and the way in which work is carried out and utilized. As this field requires combined expertise in both immunology and toxicology, the need for continued training and interdisciplinary interactions are critical for those who work within this field. This is essential both for those with an immunology background who seek to apply this expertise to drug development and safety, as well as those who wish to enhance their current drug safety expertise with a deeper understanding of immunology.

 

Objectives

-Review the background science of the immune system in both normal and diseased state
-Enhance awareness of toxicities associated with modulation of the immune system
-Provide a training mechanism that incorporates the latest science into preexisting drug development methodologies

 

Output

Beyond the dialogue that will be generated on the latest science, this training course will provide the opportunity to apply it to a drug development setting through the following means:

-Engagement and discussion with experts in the field will enable participants to see how the science translates to applicability in drug development
-The use of specific case studies will engage and illustrate to participants how they can systematically progress on a sample task [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-2 [to_ping] => [pinged] => [post_modified] => 2020-10-28 14:59:49 [post_modified_gmt] => 2020-10-28 14:59:49 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=21939 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 8 [max_num_pages] => 2 [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] => aefa9c2e9007f1b57f4180e1e8365d7e [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 ) )

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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