July 15, 2020

For decades, pediatric patient populations were seen as an afterthought in drug development.

In recent years, this has begun to change as legislators have developed new approval frameworks and incentives, regional agencies have moved to harmonize their legislation and academia and nonprofit organizations have become more involved.

Even so, there remain many drug and medical device labels that lack pediatric indications, and the pipeline of therapies designed specifically for pediatric populations is relatively limited, apart from those targeting rare diseases, where the pipeline is, indeed, robust. For example, only two antidepressants have pediatric indications, yet 13.3 percent of U.S. teens between ages 12 and 17 have had at least one major depressive episode.2 Thus, there is significant opportunity based on the persisting unmet need.

Against this backdrop, pediatric health systems (PHSs) have launched innovation/entrepreneurial initiatives—within their own systems and with partners—holding the promise of medical advances designed specifically for children. It is common for them to spin off start-ups, license out technology or work across health systems to create customized solutions.

There is an opportunity for life sciences companies working in areas with potential pediatric indications to partner with PHSs to build tailored solutions for children that address the unmet need and together shape the future of pediatrics.

This paper reviews the trends favoring such partnerships, covers the benefits they deliver and offers advice to life sciences companies on how they can be used to discover, develop and validate new pediatric drugs, devices and digital therapeutics.