IQ Pediatric Workshop A Success
Leaders of the IQ Consortium Pediatric Working Group (PWG) of the Drug Product Leadership Group, including Trupti Dixit, Julia Gao, Beth Galella, Karen Thompson, Rob Ju and Bob Ternik, along with Lorrene Buckley from IQ’s DruSafe Pediatric Working Group worked with representatives from the University of Maryland, the US Food and Drug Administration (FDA), the European Pediatric Formulation Initiative EuPFI, and regulatory representatives from the Pediatric Committee of the European Medicines Agency (PDCO) to organize a pediatric formulations workshop held June 8th and 9th in College Park, MD. The event was hosted by University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). The workshop was attended by 85 participants, and discussed a range of topics including age-appropriate formulations, use of excipients, understanding of the food effect for pediatric formulations co-administered with food, and biopharmaceutical considerations.
Key conclusions and outcomes were that many of the unmet needs in this space may be addressed through appropriate collaborative efforts; that FDA is interested in participating in future discussions of the DPLG Pediatric Working Group; that (1) databases capturing information on swallowability/palatability can be developed using tools similar to that used for formulation development and regulatory feedback status and (2) a framework for assessing palatability and swallowability is valuable; that (1) information about excipient use in the STEP database may be enhanced through contributions from IQ member companies and (2) a framework for assessing the risk of an excipient is valuable; and that there are opinions and approaches across companies regarding the understanding of and de-risking of the food effect for pediatric formulations co-administered with food. Each of these topics present opportunity for the IQ and EUPFI to further their collaboration on pediatric formulation topics of interest, and IQ member companies will benefit from creation of best practices.
The PWG under DPLG will incorporate the key learnings and outcomes into their forward looking scope of work. They will also identify opportunities to further their collaboration with the EuPFI, FDA and EMA. The PWG intends to collaborate with workshop stakeholders on the publication of the key discussion points of the workshop. More details on the workshop can be found at http://www.pharmacy.umaryland.edu/centers/cersievents/pedsformulation/.