Reports and Intelligence: Pediatric drug development

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Pediatric drug development - Regulatory
challenges and commercial opportunities

No of pages 64
Publish Date July 2014
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Description


Although pediatrics represent around two-fifths
of the global population the market for pediatric
medicines remains relatively small (accounting
for lt10 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).
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Description


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 EMAs
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.
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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

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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. 

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Table Of Content


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 Get full TOC at http//www.reportsa
ndintelligence.com/pediatric-drug-development-regu
latory-challenges-and-commercial-opportunities-mar
ket/table-of-contents
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