The Changing Landscape of the Pharmaceutical Industry: A Preview of Cytel’s Contributions at PHUSE EU 2023


November 1, 2023

It feels like just yesterday I attended my first PHUSE conference back in 2005 in Heidelberg, Germany. Fast forward 19 years, and the pharmaceutical industry landscape has undergone significant transformations. In the world of statistical programming, data analysis, and clinical data science, the terminology and roles have evolved, allowing you to choose your preferred label. We’ve moved from a conference featuring 90 presentations, including posters, across 11 different streams to this year having more than 200 presentations spanning 18 streams. PHUSE EU will take place in Birmingham on November 5–8, 2023.

Back in 2005, the Clinical Data Interchange Standards Consortium (CDISC) was in its infancy, but it already had its dedicated stream, “CDISC and XML,” featuring 12 contributions. SAS was the predominant software at the time. Fast forward to this year and CDISC, data standards, and data submission are central themes, with dedicated streams like “Standards Implementation” and “Data Standards & Governance.” We also have multiple sessions focused on the user experience when submitting data to health authorities within the “Submission & Agencies” stream. Additionally, there is a wealth of presentations on implementations and use cases, especially within the “Script, Macros, and Automation” stream, which I will be co-leading with Elena Glathe and Willy Greenway.

The landscape is further changing with the growing influence of open-source tools, as evidenced by the adoption of new technologies and programming languages like R. The number of presentations addressing R and SAS topics is quite significant, with roughly 34 presentations discussing R use cases compared to 27 for SAS.

Cytel will make significant contributions this year again, including three presentations and one poster. The week kicks off with my biostatistics colleague, Parichay Srivastava, who will present “A Beginner’s Guide to Overcoming Attrition Bias in Clinical Research: The Method of Inverse Probability of Attrition Weighting (IPAW)” in the “Real-World Evidence” stream on Monday at 3 pm. Parichay will introduce attendees to IPAW, a potent technique to mitigate attrition bias in longitudinal studies when dealing with subjects dropping out or lost to follow-up.

 

 

  • I will follow with my presentation, “Experiencing the FDA CBER,” in the “Submission and Agencies” stream at 4:30 pm on the same day. See my recent post detailing the topic.

 

  • On Tuesday at 4 pm, Sebastià Barcelo will present in the “Application Development” stream on “Leveraging the Analysis Results (ARS): The Cytel PRISM Experience.” This builds upon the presentation from my colleague Nicolas Rouillè last year, delving into how Cytel is utilizing existing artifacts metadata, such as table shells, providing more technical insights. We’re also excited to provide a demo of our PRISM tool at our booth.

 

  • Additionally, we have a poster presentation on Tuesday at 5:30 pm, presented by Cedric Marchand, Global Head of Cytel Statistical Programming, where we’ll share our experiences in the “Migration to SAS Grid for 300 Users – From Preparation to Production.”

 

 

Cytel will have a booth at the conference, where you can engage in discussions with our Client Development Manager colleague, Jennifer Ellison, or with me, Parichay, Sebastià, Cedric, and our three other Statistical Programmer colleagues, Caroline Terril, Director of Statistical Programming, Gautham Selvaraj, Senior Manager of Statistical Programming, and Mbery Sene, Senior Statistical Programmer

We look forward to reuniting with colleagues and friends from around the world and meeting new acquaintances.

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Angelo Tinazzi

Senior Director, Statistical Programming, Clinical Data Standard & Submission

Angelo Tinazzi is Senior Director, Statistical Programming, Clinical Data Standard & Submission, at Cytel. Angelo is a well-published and recognized expert in statistical programming, with over 25 years’ experience in clinical research. In particular, his core expertise lies in the application of CDISC standards across ​different therapeutic areas, such as data submission to health authorities like the ​FDA and PMDA.

As well as being an authorized CDISC instructor, Angelo is member of the CDISC European Committee, where he also manages the Italian-speaking CDISC User Network. Angelo is also stream chair of PHUSE-EU “Scripts, Macros and Automation.”

Prior to joining Cytel, Angelo worked at Merck Serono, SENDO Foundation, Phamarcia & Upjohn, Simbologica SAS Quality Partner, the UK Medical Research Council, and the Institute for Pharmacological Research “Mario Negri.”

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