First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates (Public Meeting at the FDA)

Date(s) - 28 Oct 2014 until 29 Oct 2014
8:00 AM - 5:00 PM

FDA, White Oak Campus

Cpath neonatal 2014


First Annual Neonatal Scientific Workshop:

Roadmap for Applying Regulatory Science to Neonates

(Public Meeting at the FDA)



This workshop will serve to map out the priorities of a new consortium devoted to applying regulatory science to the neonatal population. Academic experts, pharmaceutical companies, regulatory agencies in the US, Canada and Europe, patient foundations, NIH institutes, professional and other non-profit organizations will all have an opportunity to shape priorities and eventually join the new neonatal consortium. Co-sponsored by the U.S. Food and Drug Administration, the Critical Path Institute, and the Burroughs Wellcome Fund, the Neonatal Roadmap Workshop will also address consortium governance and operations.

Tuesday, October 28, 2014 – Wednesday, October 29, 2014
8:30 AM – 3:00 PM
Eastern Time


FDA, White Oak Campus
10903 New Hampshire Ave.
Building 31
Great Room 1503
Silver Spring, Maryland 20903


Tuesday, October 28, 2014
8:00 AM   Registration
8:30 am    Welcome
9:00 am    Session I: Innovative Trial Designs
10:30 am   Janet Woodcock
10:45 am   Coffee Break
11:00 am   Session II: Trials that allow for Extrapolation
12:30 pm   Lunch
1:30 pm     Session III: Criteria for Initiating Trials in Neonates
3:00 pm    Coffee Break
3:30 pm    Session IV: PBPK and PKPD Modeling
5:00 pm    Meeting Adjourned

Wednesday, October 29, 2014

8:00 AM   Registration

8:30 am     Session V: Clinical Outcome Assessments (COAs)
10:00 am   Coffee Break
10:30 am   Session VI: Biomarkers
12:00 pm   Lunch
1:00 pm     Session VII: Summary and Voting on Potential Projects
2:00 pm    Session VIII: Structure and Governance of a Neonatal Consortium
3:00 pm     Meeting Adjourned