A Quantitative Systems Pharmacology Software Platform for Biologics: reduce costs and accelerate development of innovative biotherapeutics

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 DESCRIPTION (provided by applicant): Drug development is a very lengthy and expensive undertaking. Failure rate for novel drugs exceeds 95%. Therefore, successful drugs must cover the costs of these failures. As such, prescription drug prices have escalated at an alarming rate and show no signs of stopping. The need for successful drugs to cover failures also means that pharmaceutical companies primarily devote resources to pursuing drug candidates that have a large enough population to allow the company to earn a return on its investment. Thus, diseases that affect only a small portion of the populace are not investigated nearly as much as, say, oncology, cardiovascular or immunology. Current practice usually involves taking modeling techniques developed for small molecule research and trying to adapt them to biologics. However, this approach, more often than not, does not provide the scientist with predictions around feasibility and optimal drug properties, resulting in wasted effort pursuing leads that have no chance of making it through clinical trials, or to be reimbursed by payors. Applied BioMath has developed tools that address high value questions in the middle of the drug development pipeline. By coupling quantitative systems pharmacology techniques with high performance computing and sophisticated mathematical algorithms, we have proven an ability to predict optimal drug properties years before entering the clinic. For the past two years we have been offering our services to pharma and biotechs alike, to rave reviews. We have also been approached with inquiries to license our software. This project will fund the development of our proprietary algorithms and toolsets into a stable, standardized software platform, that can be automatically validated for GLP, for by biologics to develop their internal systems pharmacology models. At its heart, our toolsets are built on Kronecker Bio, an open source biophysical computational engine co­developed by one of our Founders while pursuing his PhD in Biological Engineering with the Computer Science and Artificial Intelligence Lab from the Massachusetts Institute of Technology. This robust platform is currently in use, in its raw form, in the pharmaceutical industry but is limited in its adoption due to its lack of usability, quality contro and GLP validation. This project will focus on the application and presentation layer, allowing the underlying computational functionality to be easily accessed, utilized and understood, so capital requirements are less than a typical software development project. Achieving our goal of building this software platform is only the first step. What follows is a concerted push into the biologics segment, which we are currently seeding through our services offering and gaining a reputation as a firm that delivers high value on time. We have completed our second round of fundraising, raising a total of $1.8m between both rounds. This grant, plus the additional fundraising, will ensure that we are able to roll out our tools and assist drug companies in delivering best­in­class biologics, that meet unmet medical need, on an accelerated timeline to provide patients with a better quality of life. Better, faster, cheaper drugs... truly a win­win­in.