#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

Open-Source packages:

• 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/ 

Upcoming Events:

• 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

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/

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/

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-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

Open-Source packages:
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

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/

#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/ 

#datascience #dataanalysis #GxP #PharmaTech #SoftwareValidation #FDARegulations #ClinicalTrials #LifeSciences #R #PharmaInnovation #TechInPharma
GxP compliance is shaping the future of pharmaceutical software engineering, yet many companies still struggle with implementation. In this episode, Appsilon’s co-founder, Paweł Przytuła, unpacks GxP best practices, software validation, and how R-based submissions are gaining traction with regulatory bodies like the FDA. He also shares industry insights from Roche, Novo Nordisk, and GSK, explores emerging trends like AI in validation, and discusses how pharma companies can leverage open-source tools while ensuring compliance. Don’t miss this deep dive into the intersection of software and life sciences!
In this episode, you will learn:
What is GxP in software engineering and why it’s critical for regulatory approval in life sciences
What GxP compliance means for pharma software
How leading pharma companies approach R-based submissions
What are the risks of ignoring GxP in software development
How AI, statistical computing environments (SCEs), and open-source innovations are transforming software validation in pharma
How to build a strong GxP-ready data science team  

Guest: Paweł Przytuła https://www.linkedin.com/in/pawelprzytula
Your host: Nat Chrzanowska https://www.linkedin.com/in/nat-chrzanowska/ 
__________________________________________
Mentioned resources:
Paper on R-based Submissions to the FDA: https://pharmasug.org/proceedings/2024/SS/PharmaSUG-2024-SS-344.pdf
Presentation on Novo Nordisk's Journey towards open source: https://phuse.s3.eu-central-1.amazonaws.com/Archive/2023/Connect/EU/Birmingham/PRE_TT12.pdf
GSK's R Journey to Open Source: https://www.youtube.com/watch?v=xDrt6txplek&ab_channel=PositPBC
Roche's End-to-End R Journey to Submission: https://www.youtube.com/watch?v=BlJNILSoZlM&ab_channel=PositPBC 
__________________________________________
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/ 

In this episode of Technology Meets Science, we welcome David Meza, Head of Analytics at NASA’s Human Capital Office. David shares how data science and AI are transforming talent management at NASA, ensuring the right individuals are matched with critical missions. From knowledge graphs to generative AI, he explains how NASA is leveraging technology to optimize workforce planning, upskilling, and recruitment. Tune in for insights on AI-driven talent analytics, the challenges of data accessibility, and what it takes to land a career at NASA.

In this episode, you will learn:

• How NASA uses data science, analytics, knowledge graphs, and AI to align employees' skills and competencies with space mission roles
• How NASA tackles cleaning and structuring workforce data
• How AI models help to assess employee skills, identify gaps, and recommend training programs to upskill the workforce.
• How open-source tech stack, including Python, R, SQL, Databricks, and knowledge graphs enable smarter decision-making
• What it takes to work at NASA, from passion-driven careers to the importance of continuous learning

__________________________________________

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/ 

Together with Eric Genevois-Marlin, former Head of Data Sciences in R&D and Biostatistics at Sanofi, we uncover the reasons behind clinical trial failures. Drawing from his 20+ years of experience leading science and technology teams in bringing new drugs to market, we'll examine real-world examples and extract lessons from both successes and failures.In this episode, you will learn:

• What the risks are in clinical trials
• The main causes of clinical trial failures
• Examples of success stories
• Lessons learned from clinical trials that go wrong
• How to minimize the risks of failure

__________________________________________
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/

"Where Technology Meets Science" is a podcast series diving into the intersection of technology and life sciences. We bring together industry experts, innovators, and thought leaders to explore how advanced technologies are reshaping data science processes in biotechnology, biopharma, environmental sciences, genetics, and similar fields. Together with experts from companies like Roche, Novartis, NASA, and J&J, we uncover solutions that address complex challenges, accelerate research, and push beyond traditional scientific methods, offering listeners insights into the evolving landscape of scientific discovery.