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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Pediatric Investigation Plans (PIPs)

Historically, drug development in children has been commercially unattractive and few pediatric studies were performed. Prescribing in children was often off-label with little knowledge of dose, pharmacokinetics, efficacy or safety in children. Paediatric studies are ethically and practically difficult. However, since 1997 the US introduced laws making it a requirement to investigate medicines in children, along with incentives for doing so. In the EU paediatric regulation exists as Regulation (EC) No 1901/2006. BioVentures Consulting Limited works with its clients to ensure the Pediatric Investigation Plans (PIPs) are agreed with the European Medicines Agency (EMA) and that regulatory requirements are being followed. We can provide the pediatric section to the RMP and the PSUR during the 2 years for which it is on a 6-monthly cycle. BioVentures Consulting Limited is able to advice on whether or not it is mandatory to submit a PIP, and ensure that it covers all existing indications, pharmaceutical forms and routes of administration as well as new ones; or advise on whether exemptions may apply, for example in generics or biosimilar products.

Consulting Limited advises clients on the importance of planning the PIP process, and not to underestimate the timelines or size of the task

In compiling the PIP, BioVentures Consulting Limited can advise on whether alternative age subsets can be justified, by what means and when (e.g. pre-term, newborns, infants, children and adolescents) and ensure that the necessary data can be obtained from the development programme to treat the appropriate paediatric population. For example, we can advise on whether a waiver, age-appropriate formulation, juvenile animal studies, PK or PK/PD studies, efficacy and safety studies or a deferral, are appropriate for each of these age categories.

BioVentures Consulting Limited can provide strategic advice such as making appropriate use of waivers and deferrals, the incorporation of population PK sub-sets in the Phase III clinical

programme, when PK/PD studies remain the best option or whether efficacy and safety studies may in fact apply.

Importantly, BioVentures Consulting Limited can also advise clients on the PIP timing. For example, whether it should be submitted before Phase II, or whether it should be deferred until relevant adult data have been collected. We can advise on the differences in interpretation in what is mean by ‘defer’ between the US and the EU. BioVentures Consulting Limited can also advise clients on whether waivers may be applicable if paediatric studies are considered inappropriate, and to seek approval from the Paediatric Committee.

In essence, 'no PIP, no MA

BioVentures Consulting Limited can oversee the submission process on behalf of its clients. This can include the letter of intent, cover letter, Part A of the administrative form, Parts B to E providing the detailed science and regulatory justification and the annexes such as the bibliography and Investigator’s Brochure. BioVentures Consulting Limited can project manage the process and timing of the submission, from the letter of intent, to submission, validation, consideration by the Pediatric Committee (PDCO) and approval. We can also manage the timetable and process in cases where the PDCO reject the application and request modification and resubmission. BioVentures Consulting Limited advises clients on the importance of planning the PIP process, and not to underestimate the timelines or size of the task in order not to become on the critical path for the CTA or MAA. An MAA will not be valid unless the PIP has been agreed (or a full set of waivers) and the agreed commitments have been completed. In essence, ‘’no PIP, no MA’’. BioVentures Consulting Limited can provide valuable support to its client throughout the PIP process.

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