PHUSE US Connect

DateMarch 16-19, 2025 LocationOrlando, FL

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PHUSE

Don’t Miss Our Presentations & Interactive Sessions:

RBQM Navigating Challenges, Maximizing Impact, and Shaping the Future

Presenters: Atorus Research, Bristol Meyers Squibb, Gilead Sciences

Monday, March 17th, 1:30 pm – 3:30 pm

R Package Risk Assessment: Balancing Programmatic and Human Inputs

Monday, March 17th, 2:00 pm – 2:30 pm

Presented by:
Arianna Cascone
Atorus Research Inc.
Data Solutions Engineer

Presented by:
Chelsea Dickens
Atorus Research Inc.
Principal Data Solutions Engineer

As pharmaceutical companies embrace open-source software like R, there are countless considerations to account for. One of the biggest factors in these considerations is risk – how do we quantify risk in using open-source software and how do we mitigate that risk? Some strategies for determining package risk involve using tools like {riskmetric}, which allow for an automated and programmatic risk assessment and the generation of a numeric risk score based on factors including package type, maintenance, community usage, and testing. However, other risk factors, including robustness of documentation and references, maintainer expertise, and even the existence of critical GitHub issues, are often overlooked in these approaches. In this paper, we will discuss our experiences with both programmatic and human inputs during risk assessment to curate and catalogue a subscription-based repository of validated R packages.

RBQM Workshop – Building Open-Source Tools Paired with Central Monitoring Best Practice

Tuesday, March 18th, 11:00 am – 12:30 pm

Presented by:
Jon Harmon
Atorus Research Inc.
Principal Data Solutions Engineer

OpenRBQM Extended: Endpoint Monitoring, Root-cause Analysis, and Workflows .OpenRBQM is a PHUSE-sponsored collaborative effort to create a toolbox of open-source R packages focused on RBQM. In the past year the OpenRBQM framework has been refactored and extended to support many new use cases, including endpoint monitoring and root-cause analysis. This presentation describes the process for creating new tools that are compatible with OpenRBQM and introduces several of these new R packages using this framework.

Submissions in a Changing World

Presenters: Atorus Research, Genentech, Johnson & Johnson

Tuesday, March 18th, 4:00 pm – 5:30 pm

{sdtm.oak} – SDTM Programming in R

Tuesday, March 18th, 5:30 pm – 7:00 pm

Presented by:
Shiyu Chen
Atorus Research Inc.
Data Solutions Engineer

An EDC (Electronic Data Capture systems) and Data Standard agnostic solution that enables the pharmaceutical programming community to develop CDISC SDTM datasets in R. The reusable algorithms concept in ‘sdtm.oak’ provides a framework for modular programming and also can potentially automate SDTM creation based on the standard SDTM spec. In this poster, we will introduce the {sdtm.oak} package, showcase its features and present a road map for future releases.

Surviving A Sunset: Being Resilient in the Face of Open-Source Disruption

Wednesday, March 19th, 9:30 am – 10:30 am

Presented by:
Frank Menius
Atorus Research Inc.
Senior Trainer, Analytics Engineering

Let’s face it, the world of data science and programming is changing. Open-source technologies like R and Python are gaining momentum across many industries where proprietary institutionalized software solutions once stood unchallenged. The problems and promises of larger decentralized data sources; real world data; machine learning; artificial intelligence; and faster outcome expectations are driving companies to seek out new, innovative solutions in pursuit of migrating market share. The pharmaceutical and life science industry is no different and is diving headlong into adopting open-source as an efficient tool to get therapies to market faster. So how do you, as a statistical programmer, survive this disruption without being left behind? This paper will focus on the key skills you need to hone today to ensure your programming future without wandering off into the sunset.

Shaping the Future: Statistical Programming

Presenters: Atorus Research, Bayer

Wednesday, March 19th, 11:00 am – 12:30 pm

Clinify: Bridging the Gap in Regulatory-Compliant TLF Generation with R

Wednesday, March 19th, 11:30 am – 12:00 pm

Presented by:
Mike Stackhouse
Atorus Research Inc.
Chief Innovation Officer

Over the past few years, the industry has made significant strides by releasing open-source R packages designed specifically for generating regulatory-compliant tables. Despite the availability of various options, organizations venturing into this territory often discover that their Tables, Listings, and Figures (TLF) requirements are not fully satisfied. To bridge this gap, we introduced clinify—a new R package that enhances and encapsulates functionalities from two robust R packages: flextable and officer.This presentation aims to shed light on several key points: our rationale behind developing a new package when numerous solutions already exist; the additional requirements and functionalities clinify meets; and our method of achieving these goals. We adopted an open-source philosophy for clinify, focusing on expanding upon an existing foundation rather than starting from scratch. Join us as we delve into why clinify represents a crucial evolution in meeting TLF needs with efficiency and flexibility.

Open Source Technology in Clinical Data Analytics (OSTCDA)

Presenters: Atorus Research, GSK

Wednesday, March 19th, 1:30 pm – 3:00 pm

Enhancing Data Sciences with Multilingual Capabilities: A Comprehensive GxP-Compliant Solution

Wednesday, March 19th, 1:30 pm – 2:00 pm

Presented by:
Casey Higgins
Atorus Research Inc.
Vice President, Analytics Engineering

Presented by:
Eli Miller
Atorus Research Inc.
Senior Manager, Analytics Engineering

Discover the future of data sciences with our multilingual platform, offering centralized data storage that is fully GxP-compliant out of the box. This innovative solution automates the addition of user and security policies, ensuring seamless and secure access to data. Our platform features OpenVal ®, a validated R package product, enhancing data integrity and compliance. Additionally, it includes open-sourced SAS macros and ready-to-use Shiny templates for efficient data review. With a robust ecosystem of partners for data storage, integrations, and cloud services, our platform provides a versatile and scalable solution for data sciences. Join us to explore how this comprehensive toolset can streamline your processes, improve data quality, and ensure regulatory compliance.

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