– Written by Michael Rimler, PHUSE Open Source Technologies Director

In November, I had the pleasure of experiencing the PHUSE EU Connect 2023 in Birmingham, UK. Rest assured, I’m not here to give you a summary of the event. For that, you can check out a personal summary by the Connect Chair, Edwin van Stein, here. Rather, I wanted to focus on a particular session, namely the panel discussion on open-source technology titled Let’s Discuss Open Source Openly: A New Path in Pharma.

I enjoyed moderating the session on Tuesday morning, which was masterfully organised by Mark Foxwell (Stream Chair) and Sumesh Kalappurakal (pharmaverse Council). The panel was comprised of many well-known experts driving the open-source movement in pharma.

From left to right: Phil Bowsher (Posit), Mehar Pratap Singh (R Consortium), Me (Moderator), Ross Farrugia (Roche), Caroline Phares (Domino Data Lab), Jesper Kjær (Danish Medicines Agency), Mark Lambrecht (SAS).

Check out that panellist list – look who was there to discuss high-impact topics on using open-source solutions for clinical drug and vaccine data analysis:

• Programming languages: R and SAS
• Platforms: SAS, Posit and Domino Data Lab
• Users: Roche
• Regulatory: Danish Medicines Agency

I don’t have an official count, but I’d bet 100 or more attendees listened to the perspectives across the panel. We had excellent engagement and discussions on topics including:

• Sustainable Business-as-Usual: Where are we seeing open source for GxP across the industry and what are the risks to sustainability? Ross Farrugia recently posted on an oncology submission from Roche using end-to-end R via pharmaverse packages, which you can read about here.
• What's Next?: As we move more confidently towards business-as-usual for our current processes, where are the next sources of value from open source? Is it AI/ML or is it interoperability? Or is it something else (or all of the above)? And how might the regulatory submission and review processes benefit from using open-source solutions? Perhaps reviewers see value in a common, shared codebase of tools that are both easily code reviewed and executed on submission data packages.
• What about me?: How will this shift towards open source impact on the people doing the work of preparing collected clinical data for submission and review? Will we need new skills? New ways of working? How might we prepare ourselves to be competitive in the marketplace as statistical programmers, data managers, statisticians and data scientists?

And what was my main takeaway? As I mentioned in this post, I observed ‘more alignment across the panellists than differences, when it comes to integrating open-source solutions into the clinical data pipeline’. Different languages, different platforms and different roles were represented on the panel, and yet there was tremendous consistency in the value of open-source solutions to enhance our ability to deliver life-saving medicines and vaccines to patients.

Keep an eye out for future PHUSE events, including the PHUSE US Connect 2024 in Bethesda, MD, where (1) you may be able to pick the brains of any of these panellists and (2) more open-source discussions will most surely occur.

In the spirit of giving, I now leave you with three additional (but related) topics:

1. OS Video Series: PHUSE recently conducted a five-part video series on Open Source Technologies in Clinical Data Analytics, which included interviews with representatives from Atorus Research, Denali Therapeutics, Pfizer, SAS and Domino Data Lab. You can connect to the series on LinkedIn here or on YouTube directly.
2. **Open Source Manuscript:**This year, we launched an initiative aimed at putting to rest many of the common questions around using open-source solutions for clinical data analytics. We are crowdsourcing the inputs in an ‘open-sourced’ way – and your input is needed! You can review the questions and contribute your thoughts through our GitHub repository. We will discuss the then-current state of the draft manuscript at the PHUSE US Connect 2024 in Bethesda.
3. OS Keynote Address: Join us on Tuesday at the PHUSE US Connect 2024. Ross Farrugia and I will be discussing Open Source: The Current State of the Industry and Projections for the Future at the morning plenary session. I hope to see you there!