BD2K product for enhancing phenotypic screens

拟议项目解决的公共卫生问题是严重的、长期缺乏进展的 抗成瘾药物的发现和发展。GeneCentrix的“组织感受器”技术 通过在抗成瘾药物治疗过程中提供先进的见解来改变这一趋势的可能性 发现和发展。数字/计算的先进洞察力被认为是关键价值- 在制药研发中增加了一项新兴技术。我们技术背后的独特概念是 不同脑组织中抗成瘾药物作用的特异性。目前没有软件产品提供 这种能力。该计划的总体目标是将一种增强抗成瘾能力的产品商业化 通过提供以前无法获得的高级结构-活动洞察力来发现药物 以表型筛选化验为目标。第一阶段奖成功地确立了技术优势， 设想的产品的可行性和商业潜力，以及确定剩余的关键 表示有意购买产品功能的客户的担忧。这样做的总体目标是 第二阶段更新是生产商业化准备就绪的软件产品，以消除剩余的 客户对商业化的担忧。基于第一阶段构建的原型和见解 从市场分析中获得的产品商业化和可持续性的剩余障碍 已经被确认了。在这个第二阶段的项目中，我们将与该领域的一家姐妹公司建立合作伙伴关系， Molsoft LLC的产品已经解决了客户的一个关键问题。GeneCentrix技术可以 增强表型屏幕的可译性将作为功能集成到Molsoft的ICM产品线中 (目标1)。此外，客户要求和赞助商(NIDA/NCATS)期望的研发将更新产品核心 通过结合新的和不断增长的脑图谱、蛋白质组学和 药代动力学大数据(目标2)。对于本FOA，此应用程序属于领域4：工具和模型系统 并提出了一个项目，包括药物发现和开发的发展- 使技术成为可能。为产品开发过程中的活动和步骤寻求资金 包括生物信息学方法或算法的能力的开发和演示 研究数据整合和数据协调。因此，正如《外国投资协定》所要求的，广泛的验证 将对这项技术进行研究(目标3)，以证明和验证商业用途 以及提出的技术的价值主张。商业计划建立了一个明确和可行的 利用不断增长的商业机会，实现可持续的产品周期的方法 以最小的进一步第三阶段投资。总体而言，需要的商业软件产品可以从 NIH产品开发支持，这可能有助于抗成瘾药物的发现。

The public health problem addressed by the proposed project is the critical, long-term absence of progress in anti-addiction medication discovery and development. GeneCentrix’ “historeceptomics” technology has the potential to alter this trend by providing advanced insights during the process of anti-addiction medication discovery and development. Digital/computational advanced insights are recognized as the critical value- added emerging piece of technology in pharmaceutical R&D. The unique concept underlying our technology is specificity of anti-addiction drug action in different brain tissues. No software product currently provides this capability. The overall goal of this program is to commercialize a product that enhances anti-addiction medication discovery by providing previously unavailable advanced structure-activity insights specifically targeted to phenotypic screening assays. A Phase I award successfully established the technical merit, feasibility and commercial potential of the envisioned product, as well as identifying the key remaining concerns of customers who expressed intent to purchase the product capabilities. The overall objective of this Phase II renewal is to produce a commercialization ready software product that eliminates the remaining concerns of the customers for commercialization. Based on the prototype built in Phase I and the insights gained from market analysis, the remaining obstacles to commercialization and sustainability of the product have been identified. In this Phase II project, we will establish a partnership with a sister company in the space, Molsoft LLC, whose products already addresses a key customer concern. The GeneCentrix technology to enhance the translatability of phenotypic screens will be integrated as feature into Molsoft’s ICM product line (Aim 1). In addition, customer requested and sponsor (NIDA/NCATS)-desired R&D will update the product core to optimize it for anti-addiction drug discovery by incorporation of new and growing brain atlas, proteomic and pharmacokinetic big data (Aim 2). For this FOA, this application falls within Area 4: Tools and Model Systems for OUD Research and proposes a project including the development of drug discovery and development- enabling technologies. Funding is sought for activities and steps in the product development process encompassing the development and demonstration of the capability of bioinformatic methods or algorithms for research data integration and data harmonization. Accordingly, as required by the FOA, a broad validation study (Aim 3) will be performed of the technology that that will demonstrate and validate the commercial utility and value proposition of the proposed technology. The commercial plan establishes a clear and feasible approach to take advantage of a growing business opportunity that should lead to a sustainable product cycle with minimal further Phase III investment. Overall, a needed commercial software product could emerge from NIH product development support that could contribute to anti-addiction drug discovery.