7.2.5. Core E. Optical systems development and corporate interactionCore Leader: Tom BaerInvestigators: Christopher Contag, Gordon Kino, Pierre Khuri-Yakub, Olav SolgaardThe objective of this core is to accelerate the development and acceptance of commercially viableimaging approaches through thorough market analyses, close interaction with corporate partners andpotential licensees, communication with technology transfer offices at participating universities. For thispurpose we have three specific aims, First, we will determine necessary performance levels for potentialdiagnostic applications and investigate alternative approaches for early detection of Gl cancers. In thisprocess we will identify potential synergies with any viable alternatives and work with investigators todevelop task-specific projects that incorporate these alternative approaches and support the overallobjectives of this program. Second, we will conduct market analyses for applications of dual axismicroscope, wide field fluorescence system and integrated hardware systems to determine the positionof these new tools in the commercial landscape. And lastly, we will work with corporate partners tointegrate research programs and coordinate intellectual property with these partners and technologytransfer offices to accelerate commercialization of new tools and facilitate clinical implementationFor the first aim we will define performance specifications for different applications of endoscopicoptical/acoustic devices and the determine role of the diagnostic test in overall diagnostic process. Thiswill involve assessing what therapeutic decisions are clarified by these diagnostic test. This will requireestimating the required levels of specificity and sensitivity for given markers and ensuring that these aremet by the instruments and molecular probes being developed. We will need to also estimate medicaland economic consequences of false positives and false negatives to assess the value of a givenprocedure or test to clinical practice.What will follow is a thorough evaluation of preliminary clinical data that is obtained at Stanford and wewill need to estimate the specificity and sensitivity relative to the false negatives and positives. Inessence use this data to determine essential performance characteristics for instrument, and then toguide optimization of system design to meet performance objectives for the applications. Theperformance levels of the new designs will then be determined in preliminary trials and compared toperformance of competing technologies that are used in our clinical practice, reported in the literature,developed at other NTR funded sites, or in development by corporate partners. We will compare theapproaches developed in this NTR to any alternatives, and where necessary integrate alternativetechnologies into the NTR program.Once a thorough study of the instrumentation is completed we will conduct market analyses forapplications of dual-axes microscope, wide field fluorescence system and integrated hardware systems.We will determine impact on treatment of specific diagnostic protocols, estimate medical cost savings forperforming diagnostic test, determine total potential patient populations, define alternative diagnosticapproaches and estimate diagnostic cost and potential pricing strategies for each new technology that istested in this program. We can then use this data to formulate business plan based on the definedmarket opportunities. This will include identification of suitable corporate partners for commercializing agiven technology within our current set of partners, those of other NTR funded sites, or outside of thecurrent NTR. We will work with instrument manufacturers, reagent manufacturers, diagnostic companies,and clinical laboratories as appropriate for the tools developed in this program.After key potential partners are identified we will work with selected partners to integrate researchprograms and coordinate intellectual property to accelerate commercialization of new tools and clinicalimplementation. Through this process we will first define intellectual property position. This will requireclear invention definitions, a survey of prior art, preparation of invention disclosures, and filing ofprovisional applications. We will work closely with Stanford's Office of Technology Licensing (OTL) onthese objectives and help this office to advertise available license, evaluate potential licensees, negotiatelicensing contracts and establish performance milestonesFinally, for a given technology we will work with corporate partners to coordinate technology transferthrough meetings with technical and project management staff. We will organize joint oversight ofpreliminary clinical trials with prototype instruments. We will work with clinical sites and corporatepartners to design, review and analyze clinical data, to effectively transfer technology (mechanicaldrawings, software, hardware to corporate partner). This Core will work closely with the Technologyreview board and the clinical studies review boards to ensure that the correct technologies aredeveloped and evaluated.
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