Advancing the Development of Pediatric Therapeutics (ADEPT) - FDA Workshops on Pediatric Drug Developments

Each year, the FDA's Division of Pediatrics and Maternal Health in collaboration with the University of Maryland CERSI organized an annual public workshop to discuss the issue related to pediatric drug development. Starting in 2014, it has organized 7 public workshops (no event for 2020 due to Covid-19). 

           Advancing the Development of Pediatric Therapeutics (ADEPT)

ADEPT 7	2021	Complex Innovative Trial Design	"Advancing the Development of Pediatric Therapeutics Innovative Trail Design"
ADEPT 6	2019	Pediatric Patient Perspectives	Pediatric Clinical Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives NOVEMBER 12, 2019
ADEPT 5	2018	Pediatric Pharmacovigilance	Advancing Pediatric Pharmacovigilance Public Workshop AUGUST 13, 2018
ADEPT 4	2017	Big data	Application of "Big Data" to Pediatric Safety Studies
ADEPT 3	2016	Long-Term Pediatric Safety Studies	Successes and Challenges of Performing Long-Term Pediatric Safety Studies: Pediatric Drug Development Regulatory Considerations International Collaborations in Pediatrics: FDA and EMA growing together International Considerations for Pediatric Master Protocols
ADEPT 2	2015	Long-term Neurocognitive Development in Pediatrics	Evaluation of Long-term Neurocognitive Development in Pediatrics
ADEPT 1	2014	Pediatric Bone Health

For this year (2021), the 2-day public workshop was titled “Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design”. The purpose of the workshop was to discuss opportunities for leveraging complex and innovative trial designs, understand the challenges with their applications, and develop solutions on how challenges in the designs can be overcome. 

The workshop specifically focused on two topics of interest: 

• bridging biomarkers in pediatric extrapolation 
• Bayesian techniques in pediatric studies. 

In addition, the workshop allowed for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.

The presentation slides & webcast video links from the workshop are now all available.

Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop

SEPTEMBER 1 - 2, 2021