7.2.5. Core E. Optical systems development and corporate interaction Core Leader: Tom Baer Investigators: Christopher Contag, Gordon Kino, Pierre Khuri-Yakub, Olav Solgaard The objective of this core is to accelerate the development and acceptance of commercially viable imaging approaches through thorough market analyses, close interaction with corporate partners and potential licensees, communication with technology transfer offices at participating universities. For this purpose we have three specific aims, First, we will determine necessary performance levels for potential diagnostic applications and investigate alternative approaches for early detection of Gl cancers. In this process we will identify potential synergies with any viable alternatives and work with investigators to develop task-specific projects that incorporate these alternative approaches and support the overall objectives of this program. Second, we will conduct market analyses for applications of dual axis microscope, wide field fluorescence system and integrated hardware systems to determine the position of these new tools in the commercial landscape. And lastly, we will work with corporate partners to integrate research programs and coordinate intellectual property with these partners and technology transfer offices to accelerate commercialization of new tools and facilitate clinical implementation For the first aim we will define performance specifications for different applications of endoscopic optical/acoustic devices and the determine role of the diagnostic test in overall diagnostic process. This will involve assessing what therapeutic decisions are clarified by these diagnostic test. This will require estimating the required levels of specificity and sensitivity for given markers and ensuring that these are met by the instruments and molecular probes being developed. We will need to also estimate medical and economic consequences of false positives and false negatives to assess the value of a given procedure or test to clinical practice. What will follow is a thorough evaluation of preliminary clinical data that is obtained at Stanford and we will need to estimate the specificity and sensitivity relative to the false negatives and positives. In essence use this data to determine essential performance characteristics for instrument, and then to guide optimization of system design to meet performance objectives for the applications. The performance levels of the new designs will then be determined in preliminary trials and compared to performance 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 the approaches developed in this NTR to any alternatives, and where necessary integrate alternative technologies into the NTR program. Once a thorough study of the instrumentation is completed we will conduct market analyses for applications 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 for performing diagnostic test, determine total potential patient populations, define alternative diagnostic approaches and estimate diagnostic cost and potential pricing strategies for each new technology that is tested in this program. We can then use this data to formulate business plan based on the defined market opportunities. This will include identification of suitable corporate partners for commercializing a given technology within our current set of partners, those of other NTR funded sites, or outside of the current 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 research programs and coordinate intellectual property to accelerate commercialization of new tools and clinical implementation. Through this process we will first define intellectual property position. This will require clear invention definitions, a survey of prior art, preparation of invention disclosures, and filing of provisional applications. We will work closely with Stanford's Office of Technology Licensing (OTL) on these objectives and help this office to advertise available license, evaluate potential licensees, negotiate licensing contracts and establish performance milestones Finally, for a given technology we will work with corporate partners to coordinate technology transfer through meetings with technical and project management staff. We will organize joint oversight of preliminary clinical trials with prototype instruments. We will work with clinical sites and corporate partners to design, review and analyze clinical data, to effectively transfer technology (mechanical drawings, software, hardware to corporate partner). This Core will work closely with the Technology review board and the clinical studies review boards to ensure that the correct technologies are developed and evaluated.
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