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.
Successful completion of a Phase I award justifies this renewal to commercialize a needed drug discovery software product that generates advanced insights based on specificity of drug action in different brain tissues. Critical new software features, designs and validation studies will complete the pre-commercialization phase of the development of this product. The envisioned product is expected to enhance anti-addiction drug candidate discovery and contribute to renewed confidence in small molecule drug development for opioid use disorders.
