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🤖🧬 Where Technology Meets Science
🤖🧬 Where Technology Meets Science episodes
- #010 Centralized Monitoring: Risk-based Approach to Clinical Trial Processes#datascience #centralizedmonitoring #clinicaltrials #technologyinpharma #pharmatransformation
In this episode, Jennifer Krohn, Associate Director of Risk-Based Quality Management at Gilead Sciences, shares how centralized monitoring is transforming clinical trial oversight, improving data quality, participant safety, and trial efficiency. From statistical tools and open-source innovation to CRA training and AI advancements, Jenn shares what it takes to detect critical data signals earlier, ensure trial integrity, and foster cross-functional collaboration in pharma through the open-source community.
Materials shared in the episode:
PHUSE RBQM Working GroupRBQM Education Project
PHUSE CM White Papers:- Centralized Monitoring: Exploring the Considerations and Challenges of Implementation
- Can the Value of Centralized Monitoring be Quantified
Jennifer Krohn
https://www.linkedin.com/in/jenn-krohn/
Nat 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/42 min - #009 GenAI in Clinical Reporting: Beyond the Buzz, Real Use Cases, and Future Directions#datascience #genAI #clinicaltrials #clinicalreporting #AIinpharma #GenerativeAI #Roche #AIautomation #pharmaceuticalindustry #AIchallenges #AIbot #chatbots #copilot #codingassistant
In this episode, we speak with Vincent Shen, Senior Principal Data Scientist at Roche, about the actual impact of generative AI in clinical data analysis. Vincent shares insights from his work implementing AI-powered tools, such as knowledge chatbots and coding assistants, that support clinical reporting at Roche. We discuss the evolving role of AI, the challenges of integrating it into clinical trial workflows, and the importance of rethinking the processes to ensure effective AI use.In this episode:- AI will augment rather than replace data scientists in clinical trial workflows.
- Roche has successfully deployed a GenAI-powered knowledge bot, saving an estimated 25 hours per 100 questions.
- Coding assistants help data science teams accelerate time-to-insight.
- Providing detailed specifications is essential for AI to deliver accurate and meaningful results.
- Training AI models requires extra effort to ensure they correctly interpret context and domain-specific requirements.
- The next big step is to rethink how processes are designed, not just automate existing ones.
https://www.linkedin.com/in/vincent-shen-vs/
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
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://hubs.li/Q037KddD0
► Apple Podcasts: https://hubs.li/Q037KlLl0
► YouTube: https://hubs.li/Q037Kpth0
__________________________________________
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/36 min - #4 Pharma Brief: Generative AI Advances at FDA, Pharma’s Autonomous Agents, and Open-Source Tools Spotlight#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-aiBCG
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
Subscribe 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/6 min - #008 Machine Learning Modeling in Neuroscience Clinical Trials Design#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.
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/35 min - #007 How Open Source and Community Efforts Drive R-Based FDA Submissions#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
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/36 min - #3 Pharma Brief: FDA's Animal Testing Phase-Out, AI in Clinical Development, and Open-Source News#datascience #dataanalysis #technology #pharmabrief #clinicaltrials #technologyinpharma #pharma #pharmanews
Pharma 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-drugs
- Stanford’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-report - McKinsey & 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-intelligence
- CDISC Dataset Generator for Synthetic Data: https://cdiscdataset.com/
- scMultiSim for Omics Data Simulation: https://www.nature.com/articles/s41592-025-02651-0
- Revolutionising 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/Q03kf2Pk0
- FDA Pilots Session (ShinyGatherings): https://youtu.be/zZMGFq57wnE
- Novo Nordisk’s {connector} Package: https://novonordisk-opensource.github.io/connector/
- Genentech’s BRAID Foundation Models: https://github.com/Genentech/BRAID
- bslib 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-090
- Chores package: https://simonpcouch.github.io/chores/
- Domino RevX Life Science Edition | 20 May 2025 | Philadelphia (PA), United States
- PHUSE Computational Science Symposium 2025 | 20-21 May 2025 | Utrecht, Netherlands
- ShinyGatherings x Pharmaverse: Presenting aNCA: From Idea to Clinical Impact | 27 May 2025 | Virtual
- PharmaSUG US Conference | 1-4 June 2025 | San Diego (CA), United States
- Veeva Summit | 4-5 June 2025 | Madrid, Spain
- PSI 2025 | 8-11 June 2025 | London, United Kingdom
- PHUSE Single Day Event | 11 June 2025 | Boston (MA), United States
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/7 min - #006 Inside Novo Nordisk’s Path to Open Source for the Pharma and BeyondAri 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/33 min - #005 Shiny’s Evolution: From Prototyping Tool to Critical Technology in Pharma#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
- 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/36 min - #2 Pharma Brief: AI’s Impact on Clinical Trials, Must-See Open Source Tools, and Upcoming Pharma EventsPharma 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-applications
- NovoScribe 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-setup
- Novartis joins the Pharmaverse Council: https://pharmaverse.github.io/blog/posts/2025-03-14_welcoming__.../welcoming__novartis_to_the__pharmaverse__council!.html
- Johnson & Johnson's Open Source Journey with R in Clinical Trials | Webinar | Posit https://www.youtube.com/live/_bqeYh2kNgY
- Why Clinical Trials Fail | Where Technology Meets Science Podcast | Appsilon https://youtu.be/UXfUUA1vo4I
mall: https://mlverse.github.io/mall/querychat: https://github.com/posit-dev/querychat
multideploy: https://r-pkg.thecoatlessprofessor.com/multideploy/chatlas: https://posit.co/blog/announcing-chatlas/
nipals: https://github.com/johnsonandjohnson/open_nipals
Events:
Real World Data Spring Event 2025 | 9–10 April 2025 | Virtual
ShinyConf 2025: Life Sciences/Pharma track | 9-11 April, 2025 | Virtual
PHUSE Risk Based Quality Management Working Group Webinar “Revolutionising Participant Safety Monitoring with Advanced Solutions” | 23 April, 2025 | Virtual
Shiny Gathering: FDA Pilots: Key Insights, Lessons Learned, and What’s Next for 2025 | 29 April, 2025 | Virtual
PHUSE Single Day Event | 2 May, 2025 | Yerevan, Armenia
PHUSE Single Day Event | 9 May, 2025 | Denver (CO), United States
PHUSE Single Day Event | 9 May, 2025 | Beijing, China
Open Call for Papers:- R/Medicine 2025 https://rconsortium.github.io/RMedicine_website/Abstracts.html
Deadline: Friday, 11 April - PHUSE EU https://www.phuse-events.org/attend/frontend/reg/tOtherPage.csp?pageID=47086&ef_sel_menu=4278&eventID=74 Deadline: Friday, 25 April
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/6 min - #004 Technology Transformation in Clinical Trial Analysis#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/41 min
About 🤖🧬 Where Technology Meets Science
From the publisher's feed
Where Science Meets Technology by Appsilon is a series of interviews and discussions focused on how technology can accelerate data science processes, particularly within life sciences and…
biopharmaceutical companies.
Each episode will explore various aspects of innovation and its potential to address challenges where traditional methods may fall short. We will feature internal experts from our delivery teams, along with clients and partners as guest speakers, providing valuable insights into the intersection of science and technology.
The podcast is brought to you by Appsilon.
Appsilon empowers Fortune 500 companies to leverage open-source technology for faster, data-driven decision-making in regulated environments
Each episode will explore various aspects of innovation and its potential to address challenges where traditional methods may fall short. We will feature internal experts from our delivery teams, along with clients and partners as guest speakers, providing valuable insights into the intersection of science and technology.
The podcast is brought to you by Appsilon.
Appsilon empowers Fortune 500 companies to leverage open-source technology for faster, data-driven decision-making in regulated environments