

Cambridge-based nonprofit Institute for Pediatric Innovation Inc. (IPI) is looking to change the way pediatric devices and medicines are developed and administered by creating them specifically for children, and not just as scaled-down versions of adult products.
Historically, drugs and devices are designed to treat adults, not babies or small children. Moreover, not only are there major size discrepancies, children have a different metabolism and body chemistry than adults — meaning the devices and drugs require considerable alteration when applied to pediatric patients. “In fact, the vast majority of prescriptions given in children’s hospitals are re-compounded by the hospital pharmacist using extemporaneous formulations and mortar and pestle,” said Donald Lombardi, president and CEO of IPI.
The alteration of adult drugs requires doctors to estimate how much of a drug a child can absorb. The process runs the risk of medication error and falling out of proper compliance, said Lombardi, who began to look for a solution while chief intellectual property officer at Children’s Hospital Boston.
IPI’s long-term goal is to work with pediatric hospitals and start to find the best opportunities to create and market drugs and devices optimized to treat children. Its model includes collaborating with third parties to conduct the product research and development — the final products are licensed to companies for commercial manufacture and sale. Royalty payment terms between IPI, a hospital or a third-party commercial collaborator will be flexible, said Lombardi.
Among the current projects is one to take six off-patent drugs and redevelop them for liquid-oral delivery for children. It’s also developing child-specific medical devices for neo-natal care, including an endotracheal tube and a blood vessel visualizer. Since its launch three years ago, the nonprofit has raised $1.2 million in grants and contributions. It’s now seeking as much as $2 million this year to continue its development work.
Experts note this is an underserved market, one where most attempts at medical innovation fail. Historically, entrepreneurs and venture capitalists have avoided investing in pediatric-specific products as they are not profitable enough, said Phil Cola, vice president for research and technology at University Hospitals Case Medical Center. The Cleveland-based facility also contains the Rainbow Babies and Children’s Hospital, which is part of the IPI research consortium. “What IPI set out to do was to try and turn that unfavorable business model on its ear.”
Conceptually, what IPI is trying to provide “is absolutely needed,” said Tom Tracy, pediatric surgeon-in-chief at Hasbro Children’s Hospital in Providence, R.I. “It’s not a level playing field for children.”




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