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#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:
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/
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/
View all episodes
By Appsilon#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:
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/
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/