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. ON TRACK ON TRACK 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) 1/13/2013 Completed 2/1/2013 8. Draft white paper 1/13/2013 (6/1/2013) Not Yet Started 9. Conduct Dose-Range finding experiments in female Rhesus monkeys 5/20/2013 Not Yet Started 10. Conduct pharmacokinetics experiments in pregnant female rhesus monkeys 9/1/2013 Not Yet Started 11. Conduct FDA internal review of draft white paper 7/1/2013 Not Yet Started 12. Obtain clearance of draft white paper 7/31/2013 Not Yet Started 13. Submit draft manuscript to journal 8/15/2013 Not Yet Started 14. Analyze data and draft research papers TBD Not Yet Started 15. Provide response to journal review TBD Not Yet Started 16. Submit revised manuscript for publication TBD Not Yet Started http://www.fda.gov/AboutFDA/Transparency/track/ucm237964.htm FDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboard http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm Medical Countermeasures Initiative (MCMi) ਍††਍਍਍਍਍਍਍