SBIR/STTR Award attributes
PhaseSBIR Cloud Subscription basedCustomer Responsive Dosimetry Tool forParticle Emitters PROJECT SUMMARY Radiopharmaceutical therapyRPTthe use of targeted radionuclides to deliver radiation specifically to cancer cells and their microenvironmentis a growing area with a substantial number of large and small pharmaceuticals companies developing products in this areaThe dosimetric evaluation of therapeutic radiopharmaceuticals is a key requirementCurrently available dosimetry software was developed for diagnostic imaging applicationsIn particularit has not been validated for alpha emitter radiopharmaceutical therapy which is considerably more involvedIn this Phase I application we propose to develop the key software elements that will demonstrate feasibility towards a broader cloud based Medical Internal Radiation DoseMIRDCommittee S value compatible dose calculation toolThis tool willbe applicable to pre clinical studiesbe well validatedproperly account for the yield and emission spectrum of daughtersand appropriately consider the different pharmacokinetics of long livedemitting daughters relative to the parentIn phase Iwe focus on alpha particle emitting RPTsBased on client requeststhis area has been identified as the area of greatest needThe specific aims for phase I areDevelop a module to calculate the time integrated activity ofRPTs that properly accounts for the yield and differential pharmacokinetics ofemitting daughtersUsing our already existingD RD platformdevelop automated procedures to calculate S values for allemitters being considered foremitter therapyDevelop a module to calculate absorbed doses for radionuclides that also includeparticle emissionsIntegrate the modules of aimsandinto a cloud based dosimetry tool that can be accessed by subscriptionValidate the tool using data by comparison with previously calculated data setsThere is increasing interest inemitter RPTRPTThe development of commercial software that is consistent with the S value based MIRD methodology will be valuable in helping develop safeRPTFor exampleRadiopharmaceutical Imaging and DosimetryLLCRAPIDalready hasin a little more than one year of operationobtainedcontracts withdifferent companies related to dosimetry of new therapeutic agentsFive of these contracts are related to alpha particle emittersIn this Phase I proposal we are focusing on the most immediate market needand a product that could be developed with a relatively modest investmentCompletion of Phase I will demonstrate the feasibility of this concept and open the way toward a full commercial product in Phase IIThe work proposed in phase I will be performed in conformity with requirements for an FDA device approval application that we project for a Phase II application PhaseSBIR Cloud Subscription basedCustomer Responsive Dosimetry Tool forParticle Emitters PROJECT NARRATIVE The dosimetric evaluation of therapeutic radiopharmaceuticals is a key requirementCurrently available dosimetry software was developed for diagnostic imaging applicationsIt has not been validated for alpha emitter radiopharmaceutical therapy which is considerably more involvedWe propose to develop the key software elements that will demonstrate feasibility towards a broader cloud based Medical Internal Radiation DoseMIRDCommittee S value compatible dose calculation tool that is designed for radiopharmaceutical therapyincluding with alpha emitters
