FDA/CDER - HESI Immunomodulators and Pregnancy Risk Assessment Workshop

Tuesday, February 11 2020 8:00 AM - 5:00 PM [EST]

10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States

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Tuesday, February 11 2020 8:00 AM - 5:00 PM [EST]

US Food and Drug Administration: White Oak Campus, 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States.

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 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 immunodulatory therapies  

3) What additional tools/methods are currently being developed that could address gaps 

4) global regulatory considerations across various immunomodulatory modalities   

 

Event Registration

This workshop is a joint effort between the US Food and Drug Administration (FDA) and the Health and Environmental Science Institute (HESI) - FDA’s mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and the safety and security of our nation’s food supply, cosmetics, and products that emit radiation. FDA also advances the public health by helping to speed innovations that make medicines more effective and affordable and safe. As part of these goals, FDA’s CDER and CBER seeks to protect and enhance the public health through the regulation of drugs, biologicals, and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. -Health and Environmental Sciences Institute (HESI) was established in 1989 to provide an international forum to advance the understanding of scientific issues related to human health, toxicology, risk assessment, and the environment. In 2002, the U.S. Internal Revenue Service granted HESI tax-exempt status as a publicly supported, independently charted, charitable scientific organization pursuant to Section 501(c)(3) of the Internal Revenue Code. HESI’s scientific programs bring together scientists from around the world to address human and environmental health issues.

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09:00 AM

Welcome

09:00 AM - 09:15 AM
09:15 AM

Session 1: Background on basic biology and immune mechanisms/ immunoregulation that occurs during pregnancy to identify a hazard

09:15 AM - 10:30 AMGreat Room
11:00 AM

Session 2: Current safety assessment paradigm

11:00 AM - 12:00 PMGreat Room
01:00 PM

Session 3: Putting Science into Practice

01:00 PM - 04:30 PMGreat Room
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