Biogen

Considerations of LLM’s benefits and risks

LLMs in recent years have become immensely popular due to their ability to generate and understand text, images, audio, and video. In this talk, we will discuss the advantages of LLMs while also being mindful of their limitations and risks.

Inside an AI Project: From Idea to Value

urning an AI idea into real business value isn’t easy. This talk breaks down the key steps in an AI project, how to define its impact, and common challenges—with tips on how to overcome them.

Why Cant I Print This?: Adventures In Creating Interactive Safety Reports

For Data Monitoring Committee (DMC) reports, Biogen has moved from static, SAS-based reports to interactive R Markdown reports that allow users to immerse themselves in the data during review. While several stakeholders have welcomed this new way of …

Modelling Regulatory Intelligence with GenAI

This research introduces an innovative GenAI approach to enhance regulatory compliance in the pharmaceutical industry. Faced with evolving FDA and EMA regulations, pharmaceutical companies struggle with manual, error-prone processes for updating …

Enhancing Quality Risk Classification with Natural Language Processing

Product quality plays a vital role in the success of Biotech/Pharmaceutical organizations, and the accurate classification of quality risks is crucial to ensure the delivery of high-quality products. However, the current practice of assigning risk …

Performing a risk assessment of R packages using the Risk Assessment Shiny Application

abstract to follow

tidyCDISC an Open Source Platform in R to Analyze Clinical Trial Data

The current paradigm for analyzing clinical trial data is cumbersome it is an inefficient, slow, and expensive process. Several rounds of iterations between the main programmer and the validation programmer are usually needed to thoroughly explore …

Implementing a Risk-based Approach to R Validation

In this workshop we will walk through an implementation of the R Validation Hub's white paper A Risk-based Approach for Assessing R Package Accuracy within a Validated Infrastructure (https//www.pharmar.org/white-paper/). The workshop will explore …

Keeping things Peachy when Shiny gets Hairy

Shiny is a popular R package that lets users develop interactive web applications using just R code. The ease of use and downstream boost in productivity mean that working with Shiny can kick off a rapid request-implementation-inspiration-request …

R/Shiny Clinical Dashboards For Fun* and Profit *Note: Fun is Relative

For the Pharma Company How many times have you made a graph and gotten an email back saying "Can we change the axes?" or "Can we change the symbols?" or "I really need to look at the graph before I can tell you what I want". It would be much more …