Development support for first-in- class pediatric oncology drug Project: For a listed US biotech company with marketed products, Alacrita’s pediatric oncologist consultant provided ongoing support with Phase I/II design, protocol development and medical oversight of a first-in-class oncology drug for a pediatric population. The drug mechanism has an immunotherapy modality and continues to be investigated in clinical trials. Both European (Pediatric Regulation (EC) No. 1901/2006) and US regulatory agencies (Best Pharmaceuticals for Research Act (BPCA) and Pediatric Research Equity Act (PREA)) have developed regulations to encourage the development of new medicines in pediatric populations. The EMA requires a Paediatric Investigation Plan (“PIP”) to be agreed with the Paediatric Committee (P

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