About the event:
The Food and Drug Administration (FDA, the Agency, or we) annouced the following public workshop entitled " Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products." The purpose of the public workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data.
Topics for Discussion
The main objectives of the “Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products” workshop are to:
— Discuss the available data on the placental transfer of drug and biological products with immunosuppressive effects.
— Discuss the potential clinical impact on infants exposed in utero.
— Identify gaps in knowledge.
— Explore innovative and practical approaches for collection of relevant data.
— Allow an open dialogue amongst regulators, academia, industry, and patient organizations regarding the potential safety concerns and approaches to data collection.
About The Co-Sponsor
M-CERSI is an FDA-sponsored center at the Baltimore and College Park campuses of the University of Maryland, under the coordination of FDA Office of Regulatory Science and Innovation (ORSI). The mission of the center is to foster the development of regulatory science—the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $30,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
FDA-University of Maryland CERSI Public Workshop:
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
Thursday, July 11, 2024 Day 1: Video Recordings
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Session 1: Opening and Overview
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| 9:00 a.m. - 9:10 a.m. |
Welcome and Overview
Tamara Johnson, FDA
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| 9:10 a.m. - 9:15 a.m. |
Introductory Remarks
Robert M. Califf, Commissioner of the FDA
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| 9:15 a.m. - 9:35 a.m. |
In Utero Exposure to Drug and Biologic Products: Regulatory Considerations
Katie Kratz, FDA Sonaly McClymont, FDA
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Presentation
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Background Session: Background and Current Landscape
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| 9:35 a.m. - 9:50 a.m. |
Mechanisms of Placental Transfer for Small Molecules and Biologics
Leslie Myatt, Oregon Health & Science University
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Presentation |
| 9:50 a.m. - 10:10 a.m. |
Fetal Transfer of Small Molecules
Raman Venkataramanan, University of Pittsburgh
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Presentation |
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| 10:10 a.m. - 10:30 a.m. |
Placental Transfer of Immunosuppressive Biologics: Current Clinical Pharmacology Landscape
Edwin Lam, Johnson & Johnson
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Presentation
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| 10:30 a.m. - 10:50 a.m. |
Current Clinical Landscape
Uma Mahadevan, University of California San Francisco
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Presentation
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| 10:50 a.m. - 11:05 a.m. |
Benefit-Risk Conceptual Framework for In Utero Exposure to Immunosuppressive Medications
Laura Bozzi, Johnson & Johnson
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Presentation |
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11:05 a.m. - 11:25 a.m.
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Break |
Break
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Session 1: : Current Clinical and Safety Considerations
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| 11:25 a.m. - 12:10 p.m. |
Panel discussion:
Moderator: Leyla Sahin
FDA Panelists:
- Kevin Ault, Western Michigan University
- L. Latéy Bradford, University of Maryland
- Maria Fernanda Scantamburlo Fernandes, Eli Lilly and Company
- Natalie Hayden, Patient Representative
- Uma Mahadevan, University of California San Francisco
- Vani Vannappagari, ViiV Healthcare
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| 12:10 p.m. - 1:10 p.m. |
Lunch
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Lunch
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Session 2: Nonclinical Evaluation of Placental Transfer and Immunotoxic Potential
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| 1:10 p.m. - 1:25 p.m. |
Relevant In Vitro and Ex Vivo Assessments for Small Molecules and Biologics
Nick Illsley, Placental Research Group LLC, Rutgers University
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Presentation
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| 1:25 p.m. - 1:40 p.m. |
In Silico Assessments for Small Molecules and Biologics
Rohan Lewis, University of Southampton
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Presentation
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| 1:40 p.m. - 2:00 p.m. |
In Vivo Animal Assessments
John M. DeSesso, Exponent
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Presentation
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| 2:00 p.m. - 2:15 p.m. |
Nonclinical Guidances Pertinent to Developmental Immunotoxicity
David McMillan, FDA
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Presentation
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| 2:15 p.m. - 2:55 p.m. |
Panel discussion
Moderator: Jashvant Unadkat, University of Washington
Panelists:
- John M. DeSesso, Exponent
- Nick Illsley, Placental Research Group LLC, Rutgers University
- Rohan Lewis, University of Southampton
- David McMillan, FDA
- Dinesh Stanislaus, GSK
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| 2:55 p.m. - 3:15 p.m. |
Break
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Break
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Session 3: Framing Concerns for In Utero Exposed Infants Based on Available Data
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| 3:15 p.m. - 4:00 p.m. |
Panel Discussion Moderator: Kelly Stone
FDA Panelists:
- Michael Keller, Children’s National/George Washington University
- Ofer Levy, Boston Children’s/Harvard University
- Jeff Roberts, Merck Research Laboratories
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| 4:00 p.m. - 4:15 p.m. |
Day 1 Closing Remarks
Tamara Johnson, FDA
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FDA-University of Maryland CERSI Public Workshop:
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
Friday, July 12, 2024 Day 2: Video Recordings
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Welcome and Introduction
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| 9:00 a.m. - 9:10 a.m. |
Welcome and Introductory Remarks
Tamara Johnson, FDA
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Session 4: Clinical Study Design Considerations
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| 9:10 a.m. - 9:20 a.m. |
Ethical Considerations for Clinical Investigations in Children to Assess the Impact of Placental Transfer of Drugs and Biologics with Immunosuppressive Properties
Melanie E. Bhatnagar, FDA
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Presentation |
| 9:20 a.m. - 9:40 a.m. |
How Can We Predict Fetal Drug Exposure Throughout Pregnancy To Inform Fetal Safety?
Jashvant Unadkat, University of Washington
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Presentation |
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| 9:40 a.m. - 10:00 a.m. |
Clinical Pharmacology and Modelling of Drug Transfer Across the Placenta and Fetal Exposures: Biologics
Ruth Oliver, Takeda
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Presentation
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| 10:00 a.m. - 11:05 a.m. |
Panel Discussion
Moderators: Lily Mulugeta, FDA & Sonaly McClymont, FDA
Panelists:
- Joseph Cafone, Johnson & Johnson
- Mona Khurana, FDA
- Elisa Ochfeld, Children’s Hospital of Philadelphia
- Ruth Oliver, Takeda
- Jashvant Unadkat, University of Washington
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11:05 a.m. - 11:25 a.m.
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Break |
Break
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Session 5 : Current Clinical and Safety Considerations
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| 11:25 a.m. - 12:10 p.m. |
Panel discussion:
Moderator: Lynne Yao, FDA
FDA Panelists:
- Kevin Ault, Western Michigan University
- Giorgia Berardi, EU Network – Italian Medicines Agency
- Natalie Hayden, Patient Representative
- Ofer Levy, Boston Children’s/Harvard University
- Robert “Skip” Nelson, Johnson & Johnson
- Aaron C. Pawlyk, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Marie Teil, UCB
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| 12:50 p.m. - 1:00 p.m. |
Closing Remarks
Tamara Johnson, FDA
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