[September 11, 2014]

Research and Markets: Pediatric Drug Development Report 2014 - Regulatory Challenges and Commercial Opportunities

Research and Markets (http://www.researchandmarkets.com/research/6tx7nm/pediatric_drug) has announced the addition of the "Pediatric Drug Development - Regulatory Challenges and Commercial Opportunities" report to their offering.

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 (News - Alert) 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 gree 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

Key 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.

Key Topics Covered:

1. Executive summary
2. How commercially attractive is pediatric drug development?
3. Why should pharma invest in pediatric medicines?
4. Methodology
5. Pediatric medicines: an overview
6. The pediatric population
7. Underlying/key issues for pediatric drug development
8. Unmet clinical needs
9. Current landscape
10. Regulation and legislation
11. Global harmonization
12. Strategic considerations for developing geriatric medicines
13. Clinical trial considerations
14. Pediatric formulation issues
15. Pediatric networks
16. Patient access
17. Commercial opportunities
18. Generic formulations and dosage forms
19. Rare and neglected diseases
20. Pediatric vaccines
21. Appendix

For more information visit http://www.researchandmarkets.com/research/6tx7nm/pediatric_drug

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