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  4. > Pediatric drug development - Regulatory challenges and commercial opportunities

Although pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008).

Since the introduction of pediatric legislation there has been a substantial investment in pediatric research and the number of clinical trials performed in children has increased significantly. In the US more than 350 product labels include new pediatric information and more than 130 products have undergone a pediatric focused post-labelling safety review. In Europe there has been 221 changes regarding the safety and efficacy of medicines from the submission of old or new studies in children and 89 additions of dosing information for children as a direct consequence of Paediatric Investigation Plans (PIPs).

Despite the apparent success of the pediatric regulation, the submission of pediatric information is complex and the incentives are often insufficient to encourage industry innovation (Rose & Della Pasqua, 2011). No new drugs can be registered in the EU without a detailed PIP being approved by the EMA’s Pediatric Committee (PDCO) (Rose, 2014). Without a PIP, the registration process for a new drug can be blocked. In the US, the FDA has adopted a more pragmatic approach to pediatric drug development, providing voluntary and mandatory routes for pediatric evaluation.

Many experts agree that there is significant room to improve the EU pediatric regulations and a revision of the legislation is scheduled to take place in 2018. In the meantime, there is considerable potential for the industry to develop pediatric formulations and doses of approved and generic medicines, particularly for use in transition countries where access to high quality pediatric formulation is improving. In addition, new commercial opportunities exist to develop medicines that target pediatric specific conditions in neonates as well as rare and neglected diseases and pediatric vaccines.

Scope

- Pediatric medicines: an overview
- The pediatric population
- Underlying/key issues for pediatric drug development
- Unmet clinical needs
- Current landscape
- Regulation and legislation
- Global harmonization
- Strategic considerations for developing pediatric medicines
- Clinical trial considerations
- Pediatric formulation issues
- Pediatric networks
- Patient access
- Commercial opportunities
- Generic formulations and dosage forms
- Rare and neglected diseases
- Pediatric vaccines

ScopeKey Reasons to Purchase

- Reviews the current regulatory landscape and helps sponsors to understand the potential impact of FDA SIA regulations and the variations between EU regulation on global pediatric plans;
- Identifies the key challenges associated with pediatric drug development and the ways to overcome these hurdles;
- Assesses what issues need to be addressed in order to improve access to pediatric medicines and commercial opportunities in transition countries based on KOL insights;
- Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields in neonates, rare and neglected pediatric diseases and pediatric vaccines.

Table Of Contents

Pediatric drug development - Regulatory challenges and commercial opportunities
Executive summary
How commercially attractive is pediatric drug development?
Why should pharma invest in pediatric medicines?
Methodology
Pediatric medicines: an overview
The pediatric population
Underlying/key issues for pediatric drug development
Unmet clinical needs
Current landscape
Regulation and legislation
Global harmonization
Strategic considerations for developing geriatric medicines
Clinical trial considerations
Pediatric formulation issues
Pediatric networks
Patient access
Commercial opportunities
Generic formulations and dosage forms
Rare and neglected diseases
Pediatric vaccines
Appendix

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