P117: ReguVisionTM: Revolutionizing Drug Development by Charting FDA-Facilitated Pathways through Multidimensional Mapping
Poster Presenter
Jackson David Hanf
Student
University of Southern California United States
Objectives
The ReguVisionTM project aims to develop an interactive and publicly accessible tool that leverages drug approval data to visualize key milestones and timelines across various FDA-FRPs, equipping stakeholders with actionable insights to optimize regulatory-driven drug development strategies.
Method
After a literature review on FDA-FRPs from FDA and CIRS, a dataset was created including dates for submission, designations receipt and approval for novel drugs approved (2022-2024). A prototype visualization tool is being developed in Figma to display approval timelines and trends for FDA-FRPs.
Results
To date, this project has compiled a comprehensive database of novel drug approvals (2022-2024), mapping key regulatory milestones and FRP utilization trends. Analysis of curated source data is identifying patterns in the use of six major FDA FRPs (Accelerated approval, Priority review, Breakthrough therapy, Fast Track, Orphan drug, Expanded access) and is demonstrating that these pathways significantly reduce approval timelines compared to standard processes.
Initial findings highlight that novel drug applications utilizing FRPs generally achieve faster development and approval times, with certain pathway combinations offering the greatest time savings. The study confirms that regulatory efficiencies can be optimized by strategically selecting and combining FRPs, leading to more predictable approval timelines.
To enhance comprehension, the interactive visualization tool, currently in development, will illustrate these approval pathways using an interactive “metro-map” visualization approach. This concept enables users to select and view different regulatory pathways offering a clear representation of how FRPs influence the development and authorization processes. The tool will also incorporate bar charts, timelines, and other novel visualization techniques, driven by filtering capabilities, allowing users to explore trends based on year of approval, FRP type, and other variables. Additionally, a hybrid model employing Artificial Intelligence and Machine Learning will be used to predict the regulatory timeline for a potential product.
Preliminary design elements suggest that the metro-map format effectively conveys regulatory complexity, providing stakeholders—including pharmaceutical companies, regulators, and policymakers—with an intuitive resource for understanding the impact of FDA FRPs. Once complete, this tool will offer a novel way to visualize regulatory pathways, enhancing transparency and aiding strategic decision-making in drug development.
Conclusion
Our study underscores the critical role of FDA’s expedited regulatory pathways (FRPs) in accelerating drug development and authorizations, demonstrating that strategic selection and combination of these pathways can significantly reduce these timelines. Preliminary analyses of novel drug approvals from 2022 to 2024 confirms that FRPs, whether used individually or in tandem, contribute to regulatory efficiencies, with certain combinations yielding the most substantial time reductions. By presenting these findings through novel data visualization methods, we aim to provide meaningful insights to both industry professionals and consumers, fostering a deeper understanding of regulatory strategies.
Building on this foundation, the ReguVisionTM project is developing an interactive visualization tool designed to map FDA approval pathways using a metro-map approach. This tool will serve as an essential resource for stakeholders. By offering a dynamic, user-friendly interface, ReguVisionTM will support data-driven decision-making, allowing users to explore approval trends, optimize regulatory strategies, and identify the most efficient pathways for drug development. An innovative predictive model based off the database will allow predictions of regulatory timelines for products. This will effectively inform stakeholders during decision-making.
By transforming complex regulatory data into an accessible and interactive format, ReguVisionTM has the potential to improve transparency and streamline the impact of FRPs on drug development and authorization. As development progresses, future iterations of the tool will integrate user feedback and expand its scope to include additional global regulatory frameworks, broadening its impact and utility.
