Episodios

  • #008 Machine Learning Modeling in Neuroscience Clinical Trials Design

    #008 Machine Learning Modeling in Neuroscience Clinical Trials Design
    May 22 2025
    #datascience #dataanalysis #technology #machinelearning #clinicaltrials #placebo

    In this episode, Jing Dai, Director of Biostatistics at Jazz Pharmaceuticals, shares insights from the PHUSE US Connect conference and her work on applying machine learning to neuroscience clinical trials. She discusses challenges like high placebo response and attrition, the value of interdisciplinary collaboration, and how AI/ML can shape trial design, improve regulatory readiness, and move the field toward more objective, data-driven outcomes.
    In this episode, you will learn:
    • How machine learning can help address high placebo response and attrition in neuroscience clinical trials.
    • Why traditional statistical models struggle with high-dimensional clinical data.
    • Key regulatory frameworks (GxP, GMLP) for ensuring AI/ML models meet compliance standards in drug development.
    • Practical tips for fostering interdisciplinary collaboration between biostatisticians, clinicians, and data scientists.
    Nat Chrzanowska https://www.linkedin.com/in/nat-chrzanowska/
    Jing Dai https://www.linkedin.com/in/jingdai1009/
    __________________________________________

    More about Appsilon: ► https://www.appsilon.com/

    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
    __________________________________________

    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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    34 m
  • #007 How Open Source and Community Efforts Drive R-Based FDA Submissions

    #007 How Open Source and Community Efforts Drive R-Based FDA Submissions
    May 8 2025
    #datascience #dataanalysis #technology #datascience #opensource #pharmaverse #pharma #dataanalysis #clinicaltrials

    In this episode, Ben Straub, Principal Programmer at GSK, explores the shift from proprietary software to open source tools in the pharmaceutical industry. He shares insights into regulatory challenges, the rise of R, and the impact of {admiral} and other open-source packages on clinical data analysis and submissions. From pilot programs to enterprise-wide adoption, learn why collaboration is key to reducing risk and shaping the future of regulatory workflows.

    In this episode, you will learn:
    • Lessons learned from GSK’s open source adoption journey,
    • How collaboration via pharmaverse, PHUSE, and R Consortium accelerates regulatory submissions
    • How {admiral} package for ADaM datasets was one of the triggers for widespread open source adoption in pharma
    • Why R is a dominant language in pharma
    • What are the next milestones to modernize outdated regulatory standards
    Webinar about GSK's R Journey: From Pilot Projects to Enterprise Adoption: https://www.youtube.com/watch?v=xDrt6txplek
    Admiral package: https://pharmaverse.github.io/admiral/ __________________________________________
    More about Appsilon:
    ► https://www.appsilon.com/
    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
    __________________________________________
    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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    35 m
  • #3 Pharma Brief: FDA's Animal Testing Phase-Out, AI in Clinical Development, and Open-Source News

    #3 Pharma Brief: FDA's Animal Testing Phase-Out, AI in Clinical Development, and Open-Source News
    May 7 2025
    #datascience #dataanalysis #technology #pharmabrief #clinicaltrials #technologyinpharma #pharma #pharmanewsPharma Brief is back with its third edition, packed with essential industry insights and the latest developments in pharma and biotech. This issue covers the FDA’s plan to phase out animal testing for monoclonal antibodies in favor of AI models and NAMs, insights from Stanford’s AI Index 2025 and McKinsey’s analysis of AI in clinical development, plus new tools like CDISC Dataset Generator, scMultiSim, open-source releases from Novo Nordisk and Genentech and more! You can follow Pharma Brief on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/And now it’s available in audio on all your favorite podcasting platforms. Links from the episode:FDA’s New Plan for Phasing Out Animal Testing: https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugsStanford’s AI Index Report 2025: https://hai-production.s3.amazonaws.com/files/hai_ai_index_report_2025.pdf Summary & takeaways: https://hai.stanford.edu/ai-index/2025-ai-index-reportMcKinsey & Company’s article on clinical development with AI & ML: https://www.mckinsey.com/industries/life-sciences/our-insights/unlocking-peak-operational-performance-in-clinical-development-with-artificial-intelligenceCDISC Dataset Generator for Synthetic Data: https://cdiscdataset.com/scMultiSim for Omics Data Simulation: https://www.nature.com/articles/s41592-025-02651-0Revolutionising Participant Safety Monitoring with Advanced Solutions (Risk Based Quality Management PHUSE Working Group): https://phuse.s3.eu-central-1.amazonaws.com/Archive/2025/Webinar/Worldwide/Virtual/REC_CF12.mp4 Slides: https://phuse.s3.eu-central-1.amazonaws.com/Advance/Community+Forums+/Revolutionizing+Participant+Safety+Monitoring+with+Advanced+Solutions.pdf Clinical Data Analysis: Open Source in Pharma (Free eBook): https://hubs.li/Q03kf2Pk0FDA Pilots Session (ShinyGatherings): https://youtu.be/zZMGFq57wnEOpen-Source packages:Novo Nordisk’s {connector} Package: https://novonordisk-opensource.github.io/connector/Genentech’s BRAID Foundation Models: https://github.com/Genentech/BRAIDbslib v0.9.0 is on CRAN: https://rstudio.github.io/bslib/news/index.html?_gl=1*125lu4v*_ga*NzczNzkyMTAxLjE3Mzc1NTYwMzA.*_ga_8QJS108GF1*MTc0NTkzMzIzMy4xLjAuMTc0NTkzMzIzOC4wLjAuMA..*_ga_2C0WZ1JHG0*MTc0NTkzMzIzMy45LjAuMTc0NTkzMzIzOC4wLjAuMA..#bslib-090Chores package: https://simonpcouch.github.io/chores/ Upcoming Events:Domino RevX Life Science Edition | 20 May 2025 | Philadelphia (PA), United StatesPHUSE Computational Science Symposium 2025 | 20-21 May 2025 | Utrecht, NetherlandsShinyGatherings x Pharmaverse: Presenting aNCA: From Idea to Clinical Impact | 27 May 2025 | VirtualPharmaSUG US Conference | 1-4 June 2025 | San Diego (CA), United StatesVeeva Summit | 4-5 June 2025 | Madrid, SpainPSI 2025 | 8-11 June 2025 | London, United KingdomPHUSE Single Day Event | 11 June 2025 | Boston (MA), United StatesSubscribe on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ Nat Chrzanowska https://www.linkedin.com/in/nat-chrzanowska/ __________________________________________ More about Appsilon: ► https://www.appsilon.com/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 __________________________________________ 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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    6 m
  • #006 Inside Novo Nordisk’s Path to Open Source for the Pharma and Beyond

    #006 Inside Novo Nordisk’s Path to Open Source for the Pharma and Beyond
    Apr 24 2025
    Ari Siggaard Knoph from Novo Nordisk shares how the company transitioned from SAS to R for FDA submissions. From early Shiny apps to full-scale open-source workflows, learn how this shift accelerated innovation, attracted top talent, and redefined clinical programming.

    In this episode, you will learn:
    • How Novo Nordisk transitioned from legacy systems to R for regulatory submissions
    • How Shiny applications became the catalyst for internal buy-in
    • How open-source adoption has broadened the company’s talent pool and improved productivity
    • Future directions in pharma tech
    __________________________________________
    More about Appsilon:
    ► https://www.appsilon.com/
    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
    __________________________________________
    or 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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    32 m
  • #005 Shiny’s Evolution: From Prototyping Tool to Critical Technology in Pharma

    #005 Shiny’s Evolution: From Prototyping Tool to Critical Technology in Pharma
    Apr 10 2025
    #datascience #dataanalysis #technology #clinicaltrials #rshiny #shinyforpython #pharmatech

    Shiny paved the way for R users to create interactive, production-ready applications without switching stacks. In this episode, Eric Nantz reflects on Shiny’s origins, its "lazy by design" reactivity model, and how the ecosystem matured. We dive into how Shiny for Python expands this power to new audiences, and how Shiny is becoming key to modern clinical trial workflows. Eric shares real-world examples, user reactions, and the future of interactive data science.

    In this episode, you will learn:
    • How Shiny became a game changer for people working with R
    • How the framework evolved from a simple prototyping tool to a critical asset in life sciences
    • How open source is surpassing proprietary software
    • The future of Shiny in drug development
    Links for the episode:
    • R-Podcast Episode 18 Interview with Joe Cheng https://r-podcast.org/018-interviews-with-the-rstudio-team/
    • Joe Cheng - The Past and Future of Shiny (rstudio::conf 2022 keynote) https://www.youtube.com/watch?v=HpqLXB_TnpI
    • echarts4r - Interactive visualizations for R via Apache ECharts https://echarts4r.john-coene.com
    • reactable -Interactive data tables https://glin.github.io/reactable/
    • htmlwidgets Gallery https://gallery.htmlwidgets.org/
    • renv - Project environments for R https://rstudio.github.io/renv/articles/renv.html
    • rix - Reproducible data science environments for R with Nix https://docs.ropensci.org/rix/
    • R Weekly https://rweekly.org
    • R Weekly Highlights podcast https://serve.podhome.fm/r-weekly-highlights
    • Shiny Developer Series https://shinydevseries.com
    __________________________________________
    More about Appsilon: ► https://www.appsilon.com/
    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
    _________________________________________
    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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    36 m
  • #2 Pharma Brief: AI’s Impact on Clinical Trials, Must-See Open Source Tools, and Upcoming Pharma Events

    #2 Pharma Brief: AI’s Impact on Clinical Trials, Must-See Open Source Tools, and Upcoming Pharma Events
    Apr 2 2025
    Pharma Brief is back with the latest edition, packed with valuable insights and upcoming events you don’t want to miss. This month, we’re exploring AI’s impact on clinical development (trials could be 30% faster!), along with innovative tools that streamline processes. We’ve also highlighted open-source packages to optimize your workflows.You can follow Pharma Brief on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ And now it’s available in audio on all your favorite podcasting platforms.Links from the episode:NVIDIA’s “State of AI in Healthcare and Life Sciences” Report: https://blogs.nvidia.com/blog/ai-healthcare-life-sciences-survey-2025/McKinsey & Company’s “Faster, Smarter Trials: Modernizing Biopharma’s R&D IT Applications”: https://www.mckinsey.com/industries/life-sciences/our-insights/faster-smarter-trials-modernizing-biopharmas-r-and-d-it-applicationsNovoScribe by Novo Nordisk: https://www.mongodb.com/solutions/customer-case-studies/novo-nordisk'Not a cost-cutting exercise': Novo Nordisk Chief Scientific Officer Marcus Schindler explains rationale behind pharma's R&D shake-up: https://www.fiercebiotech.com/biotech/not-cost-cutting-exercise-novo-nordisk-reshapes-rd-setupNovartis joins the Pharmaverse Council: https://pharmaverse.github.io/blog/posts/2025-03-14_welcoming__.../welcoming__novartis_to_the__pharmaverse__council!.htmlJohnson & Johnson's Open Source Journey with R in Clinical Trials | Webinar | Posit https://www.youtube.com/live/_bqeYh2kNgYWhy Clinical Trials Fail | Where Technology Meets Science Podcast | Appsilon https://youtu.be/UXfUUA1vo4IOpen-Source packages:mall: https://mlverse.github.io/mall/querychat: https://github.com/posit-dev/querychatmultideploy: https://r-pkg.thecoatlessprofessor.com/multideploy/chatlas: https://posit.co/blog/announcing-chatlas/nipals: https://github.com/johnsonandjohnson/open_nipalsEvents:Real World Data Spring Event 2025 | 9–10 April 2025 | VirtualShinyConf 2025: Life Sciences/Pharma track | 9-11 April, 2025 | VirtualPHUSE Risk Based Quality Management Working Group Webinar “Revolutionising Participant Safety Monitoring with Advanced Solutions” | 23 April, 2025 | VirtualShiny Gathering: FDA Pilots: Key Insights, Lessons Learned, and What’s Next for 2025 | 29 April, 2025 | VirtualPHUSE Single Day Event | 2 May, 2025 | Yerevan, ArmeniaPHUSE Single Day Event | 9 May, 2025 | Denver (CO), United StatesPHUSE Single Day Event | 9 May, 2025 | Beijing, ChinaOpen Call for Papers:R/Medicine 2025 https://rconsortium.github.io/RMedicine_website/Abstracts.htmlDeadline: Friday, 11 AprilPHUSE EU https://www.phuse-events.org/attend/frontend/reg/tOtherPage.csp?pageID=47086&ef_sel_menu=4278&eventID=74 Deadline: Friday, 25 AprilSubscribe on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ Nat Chrzanowskahttps://www.linkedin.com/in/nat-chrzanowska/ _________________________________________More about Appsilon: ► https://www.appsilon.comAppsilon 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 __________________________________________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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    6 m
  • #004 Technology Transformation in Clinical Trial Analysis

    #004 Technology Transformation in Clinical Trial Analysis
    Mar 27 2025
    #datascience #dataanalysis #technology #clinicaltrials #opensource #rshiny #techtransformation

    The opinions shared here do not represent the official position of Roche or Novartis.

    We explore why clinical trials lag behind in innovation—even as the research side of drug development makes massive leaps. We’ll uncover why attracting top talent is critical to driving the industry forward, particularly in adopting open-source technologies. Dive into tools like R, test automation frameworks, and data abstractions, and learn how they’re reshaping tech transformation in clinical trials. Joining us are Novartis experts Orla Doyle and James Black to unpack the challenges and opportunities ahead.

    • In this episode, you will learn:
    • Why R and open-source tools are dethroning outdated proprietary systems
    • How modern tools attract new talent and retain seasoned experts
    • The persistent inefficiency puzzle in clinical data analysis
    • Decentralized trials: balancing accessibility with data integrity
    • Building regulatory trust in open-source and agile workflows
    • AI’s future in trials, decentralized models, and global standards


    Orla Doyle
    ► https://www.linkedin.com/in/orla-doyle-53a5019a/
    James Black
    ► https://www.linkedin.com/in/epijim/
    Nat Chrzanowska
    https://www.linkedin.com/in/nat-chrzanowska/
    __________________________________________
    More about Appsilon:
    ► https://www.appsilon.com/
    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
    __________________________________________
    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/
    Más Menos
    41 m
  • #1 Pharma Brief: J&J Moves to Open Source, AI-powered Data Extraction, and Top Clinical Trials for 2025

    #1 Pharma Brief: J&J Moves to Open Source, AI-powered Data Extraction, and Top Clinical Trials for 2025
    Mar 20 2025
    Pharma Brief delivers your monthly pulse on pharma’s evolving landscape. Stay ahead with curated insights on FDA/EMA updates, AI-driven trends, and must-attend global events. We unpack breakthroughs—from novel drug approvals to open-source tools like R/Shiny—and arm you with actionable resources to in tech transformations in clinical trials. Whether it’s GxP compliance strategies or clinico-genomic advancements, we’re here to sharpen your expertise.You can follow it on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ and now it’s available in the audio on all your favorite podcasting platforms.Links from the episode:The FDA draft guidance on AI: https://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissionsAWS re:Invent Talk about Natera’s AI-Powered Data Extraction: https://www.youtube.com/watch?v=csbfwFbg8zE2024 CDER Novel Drug Approvals: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024360i Kick off CDISC recording: https://www.cdisc.org/events/webinar/360i-program-kickoff-enabling-standards-driven-automation-study-design-throughThe 360i Program is a transformative initiative designed to automate the entire clinical research data lifecycle. You can watch the recording here and the slide deck here.Top clinical trials for 2025: https://www.nature.com/articles/s41591-024-03383-y/tables/1A new study on personalized cancer treatment: https://www.nature.com/articles/s41467-024-55251-5Generative Artificial Intelligence (AI) on AWS: https://aws.amazon.com/developer/generative-ai/?ref=dc&id=b2You can now learn and build AI applications with Amazon Bedrock, SageMaker, and more.Johnson & Johnson's Open Source Journey with R in Clinical Trials”: https://www.youtube.com/watch?v=IloY1jiDD_YAbout Pharmaverse: https://pharmaverse.org/Overview of CDISC standards and their role in supporting clinical research: https://www.cdisc.org/standardsRecordings from the recent GxP Validation Summit: https://www.youtube.com/playlist?list=PLexAKolMzPcr5rd9bBF5HGoHdCznE2LcTContribute to the aNCA package GitHub: https://github.com/pharmaverse/aNCAEvents:35th Annual European Pharma Congress: 10 - 11 March, 2025 | Rome, ItalyPHUSE Single Day Event: 13 March, 2025 | Frankfurt, GermanyPHUSE US Connect 2025: 16 - 19 March, 2025 | Orlando, USPHUSE Single Day Event: 22 March, 2025 | Pune, IndiaReal World Data Spring Event 2025: 9 - 10 April, 2025 | VirtualPharma 2025: 9 - 11 April, 2025 | Barcelona, SpainPHUSE Single Day Event: 17 April, 2025 | Utrecht, NetherlandsNat Chrzanowskahttps://www.linkedin.com/in/nat-chrzanowska/ __________________________________________More about Appsilon: ► https://www.appsilon.com/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 __________________________________________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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    6 m
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