J & J Solutions, Inc. — Department of Health and Human Services SBIR Phase I: 101

Description

PROJECT ABSTRACTManual drug compounding of chemotherapy medications permits deadly dosing errors and toxic drug exposureposing unnecessary risks to patients and healthcare workersSome automated drug compounding devices have been developed in responsehoweverpoor drug containment safety capabilities and prohibitive cost and size have limited widespread adoption of existing compounding devicesCorvida Medical has developed a working prototype for a patentedautomated compounding device that will overcome the safetycostand size limitations of existing compounding equipmentAs part of a previously funded SBIR Phase I Phase II projectCorvida developed a disposable closed system drug transfer deviceCSTDto protect health care workers from toxic exposure to hazardous drugs used in cancer treatmentsThe Corvida Randamp D team has successfully validated and commercialized the Corvida CSTDdemonstrating its utility in the marketPreliminary data accumulated with our new automated compounding device prototype demonstrates feasibility of manipulation of componentsvialssyringes and CSTD disposablesand shows accuracy and repeatability to be in therangeCorvida now aims to further develop and validate a novel compounding device that integrates the advantages of automation technologyto enhance patient carewith the added containment safety capabilities of a disposable CSTDto optimize worker safetyThis innovativeautomated compounding CSTD system will ensure reliable and accurate drug compounding to prevent patient medication errors and will interface with the disposable Corvida CSTD to reduce worker exposure to hazardous drugsFurtherour novel compounding device is small enough to operate within a Class II Biological safety Cabinetso it will be available at a fraction of the cost and size of existing devicesIn this Phase I projectwe will demonstrate feasibility of our novel compounding equipment and validate the performance and usability of the device when integrated with the disposable Corvida CSTDTo achieve these goalswe will develop and engineer a beta prototype of the compounding device that meets preliminary specificationsfunctions with the Corvida CSTDand is capable of undergoing further validation testingWe will then substantiate feasibility of the automated compounding CSTD system through analytic validation testing for process reliabilityaccuracycontainmentsterilityand system throughputWe aim to show a minimumreliabilityaccuracycontainment and sterility that meet USP standardsand system throughput of at leastdoses hourSuccessful completion of these studies will result in quantitative performance validation of an innovativeautomated compounding device that works with the Corvida CSTDproviding compelling proof of concept to support continued development in Phase IIThe resulting commercialized technology will advance current clinical practice by providing accurate and reliable compounding to ensure patients are not victims of deadly errors and will also advance occupational safety by assuring health workers are not exposed to toxic drugs PROJECT NARRATIVEEvery yearerrors in chemotherapy preparation and delivery cause significant patient harmincluding deathManual drug preparation permits such dangerous errorsand further places health workers who care for cancer patients at risk of toxic exposure to hazardous drugsWe have developed an innovativeautomated drug compounding device that provides reliable and accurate dose preparation to improve patient safety and also interfaces with disposable closed system drug transfer device to protect health workers from harmful exposure