Institute For Pediatric Innovation

Programs: Contracted research and other activities:in addition to projects arising from the consortium innovation catalystprogram, ipi assists innovators in overcoming the barriers tocommercializing new pediatric medical devices. Ipi helped to organizethe new england pediatric device consortium ("nepdc"), which appliedfor and received a grant from the u. S. Food and drug administrationoffice of orphan product development under the latter's pediatricdevice consortium program. Nepdc provides a national portal forinnovators seeking assistance in commercializing pediatric medicaldevices. Ipi's own projects and those of its consortium hospitals areeligible for subgrants and technical assistance through nepdc, and ipiparticipates in evaluating and assisting projects presented to nepdc. Ipi assisted seattle children's hospital in determining the possibleworld health markets for a modified bubble cpap device. Ipi has also developed a website and database - pediatric medicaldevice hub - enabling clinicians to post reviews and practices forusing pediatric medical devices, and is evaluating options forexpanding and monetizing the tool. Ipi has granted a license option toone million solutions in health, a 501(c)(3) nonprofit corporation,which is now researching the opportunities and developing a businessplan. Ipi will retain rights to the pediatric medical device hub inthe pediatric market and for use in its clinical innovation catalystprogram. In 2016, ipi finalizd an agreement with pfizer, inc. Tocollaborate with the company in managing a design competition for adrug dispensing and administration device optimized for drugsformulated for pediatrics using a novel formulation technologydeveloped by the company. Drug reformulation - research activities:many fda approved drugs are provided commercially in a form that cannotreadily be dispensed to children. One-third of children seen in u. S. Children's hospitals are dispensed drugs that were reformulated in thehospital pharmacy in order to provide a liquid dose to the patients. Ipi conducted a survey of 22 u. S. Children's hospitals to identifythese reformulated drugs. Ipi worked with the university of kansas anda team from children's mercy hospital and clinics to reformulatetargeted drugs. One reformulation is completed - a liquid drug fortreating pediatric hypertension - and enalaped, llc, a for-profit llcwas established to license the reformulation. The formulation waslicensed to silvergate pharmaceuticals, llc, which undertook commercialstage development and has filed the formulation for fda approval. Silvergate has now obtained fda clearance to sell the reformulateddrug, branded epaned, and has begun sales and distribution. More than100 pediatric centers nationally have started using the drug. Ipi isseeking corporate and financial partners to develop additionalpediatric formulations of needed drugs. Ipi is now researching additional needs for new pediatric formulations,with principal focus on pediatric health needs in the developing world.

consortium activities:ipi has organized a pediatric hospital consortium to help support itsinnovation mission and development of needed devices and drugreformulations designed specifically for treating children. Theconsortium's current focus is on developing technologies needed toaddress the performance improvement mandates that healthcare payorssuch as medicaid and private insurers increasingly demand. Members ofthe consortium contribute the valued insights of clinicians andadministrators. Consortium members benefit by participating in fundedproduct development programs, receiving revenue-sharing rewards fromproducts brought to market, gaining public visibility for leadership onthis issue, playing a significant role in setting ipi priorities, andtaking the lead in shaping the design of pediatric products. Theresulting new devices and drug reformulations will improve children'shealth while benefitting the clinicians and institutions that use themand the commercial enterprises that provide them.