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U.S. Department of Health and Human Services

About FDA

Animal Models of Pregnancy to Address Medical Countermeasures (MCM) for Influenza and Chemical, Biological, Radiological and Nuclear Threats in the 'At-Risk' Population of Pregnant Women

Description: The Pandemic and All Hazards Preparedness Act established in 2006 called for the implementation of national preparedness for the public health and medical needs of "at risk individuals" in the event of a public health emergency. There is a priority to advance research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to the at risk population of pregnant women. Pregnancy leads to significant physiological changes in women to accommodate the developing fetus, including cardiovascular changes and renal clearance, all of which may effect changes in which a drug is absorbed, distributed, metabolized and eliminated from the body. Because of the ethics in researching on humans and unborn babies, an animal model must be developed for testing. In order to find an animal model that will model most closely to a human, a literature review will be done, followed by this expert public workshop. The public workshop will used to gather experts in the fields of teratology, developmental toxicology, reproductive toxicology and pharmacokinetic modeling to define the experimental parameters most appropriate to include in the development of an animal model. With the information gathered from the workshop, an experimental protocol will be developed, reviewed by international experts and conducted at the National Center for Toxicological Research (NCTR). This series of experiments may also serve as a model for the evaluation of other medical countermeasures in the pregnant women and the fetus.

Public Health Benefit: Pregnant women will be given safer and more effective dosing regiments of anti-influenza drugs and related drugs based on the data gathered in pregnant animal models.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Contract location for the Public Workshop

1/31/2012

Completed 12/13/2011

2. Request for speakers and develop agenda for the workshop

1/31/2012

Completed 1/31/2012

3. Publish the Federal Register Notice announcing the workshop

1/31/2012

Completed 4/10/2012

4. Host the public workshop to involve FDA/CDER and NCTR, National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Child Health and Human Development (NICHD) on animal models of pregnancy

4/30/2012 - 5/1/2012

Completed 4/30/2012

5. Research and analyze literature regarding animal models of pregnancy

7/31/2012

Completed 7/31/2012

6. Develop Animal Model (will model absorption and distribution of an administered drug, the rate at which a drug action begins and the duration of its effect in developing nonhuman primate)

7/31/2012

Completed 7/31/2012

7. Methods Development: Develop methods to detect plasma levels of oseltamivir phosphate (prodrug) and oseltamivir carboxylate (primary metabolite of Tamiflu)

2/1/2013

Completed 2/1/2013

8. Draft white paper

1/13/2013

(3/31/2013)

(10/3/2013)

Completed 11/29/2013

9. Conduct Dose-Range finding experiments in female Rhesus monkeys

4/1/2013

(5/20/2013)

Completed 8/13/2013

10. Conduct FDA internal review of draft white paper

7/1/2013

(10/3/2013)

(12/20/2013)

Delayed

11. Obtain clearance of draft white paper

7/31/2013

(11/1/2013)

(12/20/2013)

Delayed

12. Submit white paper to journal

8/15/2013

(12/1/2013)

(12/27/2013)

Delayed

13. Conduct pharmacokinetics experiments in non-pregnant female rhesus monkeys

FY14 Q3

Not Yet Started

14. Initiate monkey breeding for pregnancy study

FY15 Q1

Not Yet Started

15. Initiate pharmacokinetics experiments in pregnant female rhesus monkeys

FY15 Q2

Not Yet Started

16. Analyze data and draft research papers

9/1/2013

(10/1/2013)

(FY15 Q3)

Not Yet Started

17. Obtain manuscript clearance and submit manuscript for publication

8/31/2015

(FY15 Q4)

Not Yet Started

Footnotes

  • The dates in italics are modified milestone due dates that have been updated due to real-time delays. The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.