Just released! Our latest podcast episode focuses on the Future of #GxP Compliance in #Pharma 🎯 @appsilon

Uploaded March 2025 | Updated September 2026, 2 weeks ago

GxP compliance is transforming pharmaceutical software, but many companies still face implementation challenges. In this episode, Paweł Przytuła, our co-founder, discusses GxP best practices, software validation, R-based submissions, and insights from top pharma companies. Paweł also covers the role of AI, open-source tools, and how pharma can build GxP-ready data science teams.

Just released! Our latest podcast episode focuses on the Future of #GxP Compliance in #Pharma 🎯

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$Pharma Brief: Generative AI Advances at FDA, Pharma’s Autonomous Agents, and Open-Source Tools #datascience #dataanalysis #technology #pharmabrief #clinicaltrials #technologyinpharma #pharma #pharmanews Pharma Brief’s fourth edition spotlights generative AI’s rapid expansion across pharma and regulatory landscapes. This issue covers the FDA’s planned rollout of generative AI tools across all centers, including the launch of Elsa to streamline reviews and inspections. We explore Anthropic’s Model Context Protocol as a new standard for context-aware AI, plus pharma’s growing use of autonomous agents in clinical operations and medical writing, with insights from BCG’s latest report. Benchling’s integration of Claude into biotech R&D workflows highlights significant time savings and smarter data management. Catch a recap of the AWS Life Sciences Symposium keynote and FDA’s public call for comments on the CDISC Dataset-JSON standard, which could reshape study data exchange. Open-source tools like {mergen}, {kuzco}, and {cheetahR} are featured to empower your R workflows with AI, computer vision, and blazing-fast data rendering. You can follow Pharma Brief on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ Now also available in audio on your favorite podcast platforms. Links from the episode: FDA’s Generative AI Rollout: https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai BCG Report on AI Agents in Pharma: https://www.linkedin.com/posts/bcg-platinion_ai-agents-and-the-model-context-protocol-activity-7330864988070309891-zhCZ Benchling + Claude Integration: https://www.anthropic.com/customers/benchling AWS Life Sciences Symposium 2025 & Keynote: https://aws.amazon.com/blogs/industries/7th-annual-aws-life-sciences-symposium/ https://www.youtube.com/watch?v=3hohXZF_3ys FDA Request for Comments on CDISC Dataset-JSON: https://www.federalregister.gov/documents/2025/04/09/2025-06051/electronic-study-data-submission-data-standards-clinical-data-interchange-standards-consortium Open Source Highlights: {muttest} https://github.com/jakubsob/muttest {mergen} https://bioinformatics.mdc-berlin.de/mergen/ gptstudio & gpttools https://github.com/MichelNivard/gptstudio {kuzco} https://github.com/frankiethull/kuzco {cheetahR} https://github.com/cynkra/cheetahR Upcoming Events: AI and SaMD in Healthcare Webinar | 18 June 2025 | Virtual PHUSE Single Day Event | 21 June 2025 | Hyderabad, India COSA Spotlight Q2 2025 | 24 June 2025 | Virtual Value-Driven Clinical Data Review Webinar | 26 June 2025 | Virtual PSI/PHUSE Change Management Event | 3 July 2025 | Cambridge, UK PSI Webinar on iRISE Consortium Results | 24 July 2025 | Virtual Open Call for Papers: R/Pharma 2025 https://sessionize.com/rpharma-2025 You can follow Pharma Brief on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ Nat Chrzanowska https://www.linkedin.com/in/nat-chrzanowska/ Appsilon empowers pharmaceutical and life sciences companies to leverage open-source technology for faster, data-driven decision-making in regulated environments. Schedule a free consultation with our expert ► https://www.appsilon.com/contact-us We design scalable and user-friendly Shiny dashboards to help you make data-driven decisions. ► https://www.appsilon.com/services/data-dashboards We design and implement Statistical Computing Environment for R and Python for efficient data analysis: ► https://www.appsilon.com/services/sce We design, implement, and optimise data analysis environments so you can focus focus on insights and innovation. ► https://www.appsilon.com/services/platform Where Technology Meets Science podcast is available on all podcasting platforms: ► Spotify: https://open.spotify.com/show/6MckhYFZCwGU4Op6P09foR ► Apple Podcasts: https://apple.co/3CJDdVy For more insights about how technology helps scientists push the boundaries of data analysis and reporting check out our blog: ► http://appsilon.com/blog LinkedIn: https://www.linkedin.com/company/appsilon/$

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