A newly formed contract research organization in California is hoping to set itself apart from competitors by focusing the bulk of its work on combating pediatric and orphan diseases.
Based in Carlsbad, CA, Agility Clinical will focus on providing customized clinical research and consulting services to small and virtual biotechnology, specialty pharma, medical device and diagnostic companies.
Its focus on pediatrics will tap into a market that may be ripe for more clinical work. According to the FDA, most drugs prescribed for children haven't been tested on them, and before the FDA initiated its pediatric program, only 20% of approved drugs were labeled for safe use in children, as the regulatory body's website details. The FDA contributes this mostly to pharma companies questioning the size and profitability of the pediatric drug market, but it also is difficult to establish trials with minors.
Still, researchers are making efforts to buck the trend. To make the clinical trial setting more inviting for kids, some CROs and R&D chiefs are advocating using things like video games as ePROs and producing pills and medications tailored to children in terms of size and taste.
- read the Agility Clinical announcement
- learn more about the pediatric drug market from the FDA