Harsha Byadarahalli Mahesh
I am a Senior Software Engineer with 10 years of experience at JuliaHub. Over the past decade, I have transitioned from developing core Julia-based desktop products (JuliaPro, Pumas) to my current role on the Operations team, I specialize in developing, deploying, and maintaining robust Julia-based software solutions. My background includes collaborating with the Pumas team to streamline the build processes for the Pumas and DeepPumas JuliaHub apps.
Currently, I am a member of the operations team, where I manage deployments and upgrades for our enterprise clients. Alongside overseeing the broader platform release process (With respect to compliance), I actively develop and maintain the RStudio and WindowsWorkstation apps. I also work closely with the compliance team to ensure the JuliaHub platform meets the strict regulatory standards required by our pharmaceutical enterprise customers.
Session
As the pharmaceutical industry shifts toward Model-Informed Drug Development (MIDD) and complex pharmacometric simulations, the Julia programming language has emerged as a frontrunner due to the availability of specialized ecosystem for Pharmacometrics (Through Pumas, SciML and JuliaDiff packages) and support for High Performance Computing, and interoperability.
However, deploying Julia in a GxP-regulated environment requires more than just efficient algorithms; it demands strict adherence to software validation, reproducibility, and data integrity standards such as FDA 21 CFR Part 11 and GAMP 5.
This talk outlines a strategic framework for making Julia code "pharma-ready." We explore the use of Julia’s native packages to maintain Reproducibility, the implementation of testing suites for the generation of validation reports and we will also explore how to use literate programming in Julia to generate documentation and reports . By leveraging Julia’s unique features, we show how developers can create high-performance workflows that satisfy both computational demands and regulatory scrutiny.