Drug Development in Neonates: Big Challenges in Small Patients - an IQ Webinar

February 18, 2015

Webinar

Clinical trials in neonates are difficult, but they ARE possible, and they are certainly needed.

What the audience can learn from this webinar…

A summary of the outcome and next steps of the FDA workshop (held in Oct 2014): First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates

• Not all neonates are created equal.
• Developmental changes impacting drug disposition and response are not always predictable.
• Challenges to be overcome in neonatal study design, i.e. dose administration and blood sampling, endpoint selection

Clinical trials in neonates require attention to many details which will be discussed during the webinar. However the challenges CAN be met and overcome to provide rational, drug therapy to the most vulnerable pediatric population.

Biographies of our esteemed speakers and moderator can be viewed by clicking or copying and pasting the links below into your browser.

Speaker: Dr. Robert Ward: (https://custom.cvent.com/7BA2EE65E8B64AEBB1E77F19E7FD30BC/files/fe66ade8231d4c1f84b9e9ebfb1593ef.pdf)

• Dr Ward's Slide Presentation

Speaker: Dr. Susan McCune: (https://custom.cvent.com/7BA2EE65E8B64AEBB1E77F19E7FD30BC/files/11e22f0409484b17ab04e8f402da63dd.pdf)

• Dr. McCune's Slide Presentation

Moderator: Paulien Ravenstijn, PhD: (https://custom.cvent.com/7BA2EE65E8B64AEBB1E77F19E7FD30BC/files/f7e86a9cd31c44b7b52b2bdb5a319229.pdf)