Skip to main content

Addressing the Barriers to Pediatric Drug Development Workshop Summary (2008) / Chapter Skim
Currently Skimming:

4 Models for Enhancing Pediatric Drug Development
Pages 29-35

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 29...
... Vaccine Development IN THE UNITED STATES Vaccine development in the United States can offer lessons for p ­ ediatric drug development. Both vaccines and drugs are covered by the Pediatric Research Equity Act (PREA)
Read the entire page →
From page 30...
... , a national vaccine safety surveillance program that collects information about adverse events occurring after the administration of U.S.-licensed vaccines. Reports are made by vaccine manufacturers, health care providers, state immunization programs, vaccine recipients, and other sources.
Read the entire page →
From page 31...
... Ward described an AAP collaboration with the Royal College of Pediatrics in the United Kingdom to develop a drug handbook for pediatrics that would include off-label prescribing information based on expert opinion. The key challenge, he noted, is correlating adverse events with exposure to medications.
Read the entire page →
From page 32...
... Incentives Incentives will vary according to whether a product is patentp ­ rotected, off-patent, or an orphan drug. For patent-protected ­products, submission of an application for marketing authorization or any application for a variation will incur a new obligation to provide study results in accordance with an agreed-upon PIP.
Read the entire page →
From page 33...
... The PIP will also include justification for any waivers or deferrals -- for example, if there is no significant therapeutic benefit over existing treatments for children or for a particular pediatric population, or if it is more appropriate to initiate studies in children after sufficient data for adults are available. Additional Measures All applicants will be eligible to receive free scientific advice from the EMEA on the design and conduct of pediatric studies and on pharmacovigilance measures for the postauthorization period.
Read the entire page →
From page 34...
... As with pediatric medications generally, market forces work against the development of pediatric cancer drugs. Each year 9,000 pediatric cancers are diagnosed in the United States, compared with a much larger number of adult cancers (e.g., 200,000 new breast cancer cases, 190,000 prostate cancer cases, and 160,000 lung cancer cases)
Read the entire page →
From page 35...
... The goals are to identify small molecules that are inhibitors of specific targets in pediatric cancers and could be used to explore the pathways involved in pediatric cancers, identify candidate small molecules for preclinical testing, and network with others to improve capacity and ultimately advance these agents to the level of the pediatric clinic. Finally, NCI is funding the Pediatric Cancer Drug Discovery Consortium to screen adult cancer drug candidates in animal models with pediatric tumors.
Read the entire page →

Key Terms

  • drug development
  • pediatric committee
  • pediatric populations
  • pediatric cancer
  • pediatric cancers

  • vaccine development
  • adverse events
  • marketing authorization
  • cancer drug
  • cancer drugs

  • medicinal products
  • adult cancers
  • study results
  • pediatric drugs
  • pediatric tumors

  • vaccine safety
  • national vaccine
  • drug discovery
  • adverse event
  • chemical biology

  • proposed studies
  • event reporting
  • molecularly targeted
  • surveillance program
  • european agency

  • safety surveillance
  • research hospital
  • pediatric clinic
  • pediatric population
  • pediatric medications


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.