Clinical Pharmacology Corner: FDA Announces a Pediatric Ontogeny Public Workshop

FDA Announces a Pediatric Ontogeny Public Workshop for May 16, 2019

The Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a one-day public workshop entitled “Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?” on May 16, 2019, to discuss the present state of understanding of pediatric ontogeny as it pertains to pediatric drug development.

The workshop aims to address the incomplete information available on the ontogeny of several relevant physiologic systems in pediatric patients as it relates to predicting drug dosing and response in this population. These considerations are of most importance to the youngest pediatric patients, where model-informed drug development has the most potential to expedite pediatric drug development using techniques such as physiologically-based pharmacokinetics. Additional background information is available at https://go.usa.gov/xmQnb.

Workshop Objectives

The objectives of this workshop are to:

• Review the present state of knowledge of the ontogeny of systems critical to drug dosing and effect in pediatric patients.
• Discuss whether our knowledge of ontogeny of specific systems is adequate at the present time to make pediatric dosing and effect predictions through modeling and simulation.
• Identify pathways forward for acquiring the additional information needed for incorporating ontogeny into modeling and simulation predictions for pediatric new drug development.

Workshop Information

The date, time, location, and other details of the workshop are as follows:

Date: May 16, 2019

Time: 8:00 am – 4:15 pm

Location: The meeting will be held at:

• National Institutes of Health, Natcher Conference Center, Kirschstein Auditorium, 9000 Rockville Pike, Bethesda, MD 20892.
• NIH visitor information is available at https://www.nih.gov/about-nih/visitor-information.
• Natcher Conference Center information is available at https://www.genome.gov/11007522/natcher-conference-center-information/.

The agenda for the workshop is available at https://go.usa.gov/xmQNF.

Registration Information

For registration information, please visit the M-CERSI website: https://www.pharmacy.umaryland.edu/centers/cersievents/PedsOntogeny/registration/. The cost to register for this event is determined by participant type. You may register to attend in-person or remotely. Remote access is available at no cost.

This public workshop will be available to view via webcast, but pre-registration is still required. You will receive the link to access the live webinar several weeks prior to the meeting. You must log in with your username and password which you create when you register. You must pre-register at least one day before the event to ensure that you have access to the link.

Links to the recorded webcast and meeting transcript will be posted to the following website after the meeting: https://go.usa.gov/xmQnb.

If you have questions about registering for the meeting, contact Gilbert Burckart, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, phone: 301-796-2065, or email gilbert.burckart@fda.hhs.gov or Ann Anonsen at aanonsen@umd.edu.

Additional information about this workshop is available at https://www.pharmacy.umaryland.edu/centers/cersievents/PedsOntogeny/.