--- title: Understanding Project Optimus description: Traditional oncology drug dosing, focused on finding maximum tolerated doses early on, faces growing limitations. image: https://blog.insight-rx.com/hubfs/FDA%20Oncology%20Center%20of%20Excellence.jpg --- [![InsightRX](https://blog.insight-rx.com/hubfs/insightrx_logo_white-teal.svg)](https://blog.insight-rx.com/) - For Providers - Solutions - [MIPD for Providers Explore our full solution for Bayesian model-informed dosing](https://www.insight-rx.com/mipd) - [Future of Pharmacy Learn what's next for AI in health tech, and why architecture matters](https://www.insight-rx.com/future) - Products - [InsightRX Nova Bayesian dosing (MIPD) app for bedside clinical decision support](https://www.insight-rx.com/provider/nova) - [InsightRX Apollo Real-time clinical analytics to measure outcomes](https://www.insight-rx.com/provider/apollo) - [Drug Modules Available medications for precision dosing apps](https://www.insight-rx.com/provider/drug-modules) - [For Life Sciences](https://www.insight-rx.com/life-sciences) - Overview - [InsightRX for Life Sciences Explore our solution for biopharma and clinical trial use](https://www.insight-rx.com/life-sciences) - Products - [Nova for Life Sciences Precision dosing app for clinical trial use](https://www.insight-rx.com/life-sciences/nova) - [Astra for Life Sciences AI-native environment for PK/PD modeling and simulation](https://www.insight-rx.com/life-sciences/astra) - Platform - [Continuous Learning Patented process for model retraining and improvement](https://www.insight-rx.com/platform/continuous-learning) - [Integrations Platform interoperability setup with EHRs, EDCs, and more](https://www.insight-rx.com/platform/integrations) - [Security & Regulatory Standards for product development and release](https://www.insight-rx.com/platform/security-regulatory) - [Success & Support Pharmacist-led training, onboarding, and education](https://www.insight-rx.com/platform/support) - Resources - Science - [Data Science Explore the science and learn more about our R&D](https://www.insight-rx.com/data-science) - [Scientific Publications Impactful research manuscripts with at least one InsightRX author](https://www.insight-rx.com/data-science/scientific-publications) - [How to Cite Using one of our apps? 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The current drug development paradigm is oriented toward identifying a maximum tolerated dose (MTD) in early-stage trials, and evaluating the MTD for drug activity and efficacy in Phase II and III trials. In recent years, the limitations of this approach have become clearer. In the wake of [evidence](https://www.nejm.org/doi/full/10.1056/NEJMp2109826) that many approved oncology drugs are inadequately characterized with approved doses that may be too high, the FDA’s Oncology Center of Excellence has launched an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Known as [Project Optimus](https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus), this initiative recommends a core change in how doses are selected during oncology clinical trials and post-approval studies. To accelerate speed to market and maximize their chances of a successful clinical trial, pharmaceutical and biopharma companies will need to embrace the Project Optimus paradigm of comprehensive dose characterization. They will require the ability to perform patient-specific and population-level drug response simulations in real time, within clinical trials. Companies must be able to characterize each drug’s pharmacokinetics and pharmacodynamics, and to predict dose-specific adverse events and clinical response. Implementing new dose selection and optimization strategies for each phase of a clinical trial will help pharma companies determine dosing that maximizes efficacy, safety, and tolerability—and ultimately, the usability of their products. Read the full article on Applied Clinical Trials at: [https://www.appliedclinicaltrialsonline.com/view/understanding-project-optimus](https://www.appliedclinicaltrialsonline.com/view/understanding-project-optimus) --- Image credit: FDA Oncology Center of Excellence, Project Optimus initiative. [oncology](https://blog.insight-rx.com/resources/tag/oncology) [project optimus](https://blog.insight-rx.com/resources/tag/project-optimus) [FDA](https://blog.insight-rx.com/resources/tag/fda) #### On this page… About the author [Jason Rizzo, MBA](https://blog.insight-rx.com/resources/author/jason-rizzo) Jason was Vice President of Global Biopharma Strategy at InsightRX. **Connect with us to get the latest blog updates, instantly sent to your inbox** ## Dig deeper. Explore related articles and additional posts on the InsightRX blog. [Thought Leadership Feb 27, 2024 Artificial Intelligence Drives Industry Response to Project Optimus](https://blog.insight-rx.com/resources/artificial-intelligence-drives-industry-response-project-optimus) [Thought Leadership Apr 6, 2022 Understanding FDA’s Perspective On Precision Dosing](https://blog.insight-rx.com/resources/understanding-fdas-perspective-precision-dosing) [Thought Leadership Jan 3, 2023 The 2023 PharmaVoice Crystal Ball: Peering into the future of life sciences](https://blog.insight-rx.com/resources/2023-pharmavoice-crystal-ball-peering-future-life-sciences) #### What We Do ##### For Providers - [Nova (Bayesian Dosing)](https://www.insight-rx.com/provider/nova) - [Apollo (Clinical Analytics)](https://www.insight-rx.com/provider/apollo) - [Drug Modules](https://www.insight-rx.com/provider/drug-modules) ##### For Life Sciences - [Nova (MIPD for Clinical Trials)](https://www.insight-rx.com/life-sciences/nova) - [Astra (AI-Powered Clin Pharm)](https://www.insight-rx.com/life-sciences/astra) - [Companion Applications](https://www.insight-rx.com/life-sciences/nova#companion-applications) #### How We Do It ##### Platform - [Continuous Learning](https://www.insight-rx.com/platform/continuous-learning) - [Integrations](https://www.insight-rx.com/platform/integrations) - [Security & Regulatory](https://www.insight-rx.com/platform/security-regulatory) - [Success & Support](https://www.insight-rx.com/platform/success-support) ##### Science - [Data Science](https://www.insight-rx.com/data-science) - [Scientific Publications](https://www.insight-rx.com/data-science/scientific-publications) #### Information ##### Resources - [Success Stories](https://www.insight-rx.com/success-stories) - [White Papers](https://www.insight-rx.com/white-papers) - [Publications Using InsightRX](https://www.insight-rx.com/publications-using-insightrx-software) - [How to Cite InsightRX](https://www.insight-rx.com/how-to-cite-insightrx-nova) ##### Blog - [All Posts](https://blog.insight-rx.com/resources) - [Product Innovation](https://blog.insight-rx.com/resources?section=product_innovation) - [Thought Leadership](https://blog.insight-rx.com/resources?section=thought_leadership) #### About - [Our Story](https://www.insight-rx.com/about) - [Leadership](https://www.insight-rx.com/leadership) - [Advisory Board](https://www.insight-rx.com/advisory-board) - [Our Customers](https://www.insight-rx.com/customers) - [Press Releases](https://blog.insight-rx.com/press-releases?section=press_releases) - [Media](https://blog.insight-rx.com/press-releases?section=media) - [Careers](https://www.insight-rx.com/careers) - [Contact](https://www.insight-rx.com/contact-us) --- ![CE marking](https://blog.insight-rx.com/hubfs/ce-mark-white.svg) InsightRX Nova is HITRUST CSF r2 certified, CE marked, and 21 CFR Part 11 compliant. 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