Tuesday, February 11 2020, 8:00 AM - 5:00 PM [EST]
10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States
This registration is reserved for attendees who serve academic institutions or government organizations
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   Â
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.? Â
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The  workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss: Â
1)Â The current state of reproductive immunologyÂ
2) How adequate are the current set of tools/methodologies to address pregnancy risk under immunodulatory therapies Â
3)Â What additional tools/methods are currently being developed that could address gapsÂ
4) global regulatory considerations across various immunomodulatory modalities  Â
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.
This section seeks to describe the landscape as it relates to the current methods used to access pregnancy risk for immunomodulators. This session is intended to address the following questions: How current safety assessments are carried out? How adequate are the current set of tools? What worked? What did not work? What are the regulatory considerations that have surfaced?
Breakout sessions will enable workshop participants to engage in detailed discussions and facilitate the exchange of ideas or approaches to address (1) the Integration of knowledge in biology, (2) current tools and assessment, and (3) the potential incorporation of any emerging technologies to address gaps. In order to balance numbers and expertise across the breakout groups, participants will be pre-assigned to clusters and tasked to walk through and provide feedback on 2 unique scenarios. Breakout groups will report back to identify consensus on thoughts and approaches and to highlight unique perspectives on the same issue. Registrants will be notified of their breakout assignments prior to the workshop.
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