Advancing the Development of Pediatric Therapeutics (ADEPT 7)
Wednesday, September 1, 2021
Advancing the Development of Pediatric Therapeutics (Adept 7) Complex Innovative Trial Design
Wednesday, September 1, 2021 (10:00 a.m. - 1:15 p.m. EST)
Thursday, September 2, 2021 (10:00 a.m. - 3:00 p.m. EST)
Collaborative, virtual workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)
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About the Event:
The main objective of the “Advancing the Development of Pediatric Therapeutics (Adept 7) Complex Innovative Trial Design” workshop is 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 will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies. In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.
The workshop will be open to the public. More information will be coming soon.
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $25,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.