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 (PDCO) to cover timing and measures for all subsets of the paediatric population. The PIP is binding on the company and information on the pediatric trials is made available to the public. The paediatric data must be included in a new MAA unless a waiver or derral is agreed with PDCO. There are several incentives for companies to comply with an agreed PIP, including a six-month extension to a Supplementary Protection Certificate (SPC) or two years of additional market exclusivity for Orphan medical products.
In the US, a BPCA is voluntary for companies. In contrast, a PREA is mandatory (though Orphan drugs are exempt) and triggered by an application for a new indication, dosage form or regimen, route of administration or active ingredient. Like a PIP, the PREA requirements can be deferred or waived.
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