Archive for the ‘AI Governance’ Category

๐–๐ก๐ฒ “๐•๐ข๐ซ๐ญ๐ฎ๐š๐ฅ ๐’๐œ๐ซ๐ž๐ž๐ง๐ข๐ง๐ ” ๐ข๐ฌ ๐๐จ ๐‹๐จ๐ง๐ ๐ž๐ซ ๐„๐ง๐จ๐ฎ๐ ๐ก ๐Ÿ๐จ๐ซ ๐Ž๐ซ๐ฉ๐ก๐š๐ง ๐†๐๐‚๐‘๐ฌ

Posted by Michael A. S. Guth on January 5th, 2026

๐…๐จ๐ซ ๐ฒ๐ž๐š๐ซ๐ฌ, ๐ญ๐ก๐ž ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ฒ ๐ซ๐ž๐ฅ๐ข๐ž๐ ๐จ๐ง ๐ญ๐ซ๐š๐๐ข๐ญ๐ข๐จ๐ง๐š๐ฅ ๐ฏ๐ข๐ซ๐ญ๐ฎ๐š๐ฅ ๐ฌ๐œ๐ซ๐ž๐ž๐ง๐ข๐ง๐  ๐ญ๐จ ๐Ÿ๐ข๐ง๐ ๐ง๐ž๐ž๐๐ฅ๐ž๐ฌ ๐ข๐ง ๐ญ๐ก๐ž “๐ƒ๐š๐ซ๐ค ๐†๐ž๐ง๐จ๐ฆ๐ž” ๐ก๐š๐ฒ๐ฌ๐ญ๐š๐œ๐ค. ๐๐ฎ๐ญ ๐Ÿ๐จ๐ซ ๐จ๐ซ๐ฉ๐ก๐š๐ง ๐ญ๐š๐ซ๐ ๐ž๐ญ๐ฌ ๐ฅ๐ข๐ค๐ž ๐†๐๐‘๐Ÿ๐Ÿ’๐Ÿ—, ๐ฐ๐ก๐ž๐ซ๐ž ๐ฅ๐ข๐ ๐š๐ง๐ ๐œ๐ก๐ž๐ฆ๐ข๐ฌ๐ญ๐ซ๐ฒ ๐ข๐ฌ ๐ฎ๐ง๐๐ž๐Ÿ๐ข๐ง๐ž๐, ๐ฐ๐ž ๐ง๐ž๐ž๐ ๐ฆ๐จ๐ซ๐ž ๐ญ๐ก๐š๐ง ๐š ๐›๐ž๐ญ๐ญ๐ž๐ซ ๐ฌ๐ž๐š๐ซ๐œ๐ก ๐ž๐ง๐ ๐ข๐ง๐ž. ๐–๐ž ๐ง๐ž๐ž๐ ๐š ๐†๐ž๐ง๐ž๐ซ๐š๐ญ๐ข๐ฏ๐ž ๐„๐ง๐ ๐ข๐ง๐ž. ๐€๐ฌ ๐ฉ๐š๐ซ๐ญ ๐จ๐Ÿ ๐ฆ๐ฒ ๐ฅ๐š๐ญ๐ž๐ฌ๐ญ “๐ˆ๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ข๐š๐ฅ ๐๐ฅ๐ฎ๐ž๐ฉ๐ซ๐ข๐ง๐ญ” ๐Ÿ๐จ๐ซ ๐ƒ๐ซ๐ฎ๐  ๐ƒ๐ข๐ฌ๐œ๐จ๐ฏ๐ž๐ซ๐ฒ ๐“๐จ๐๐š๐ฒ, ๐ˆโ€™๐ฏ๐ž ๐จ๐ฎ๐ญ๐ฅ๐ข๐ง๐ž๐ ๐ฐ๐ก๐ฒ […]

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๐Œ๐จ๐ฏ๐ข๐ง๐  ๐๐ž๐ฒ๐จ๐ง๐ ๐ญ๐ก๐ž “๐‡๐ข๐ ๐ก-๐€๐ญ๐ญ๐ซ๐ข๐ญ๐ข๐จ๐ง” ๐„๐ซ๐š ๐จ๐Ÿ ๐‚๐๐’ ๐ƒ๐ซ๐ฎ๐  ๐ƒ๐ข๐ฌ๐œ๐จ๐ฏ๐ž๐ซ๐ฒ

Posted by Michael A. S. Guth on January 5th, 2026

J๐ฎ๐ฌ๐ญ ๐ฌ๐ฎ๐›๐ฆ๐ข๐ญ๐ญ๐ž๐ ๐š ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ข๐œ ๐ฉ๐ž๐ซ๐ฌ๐ฉ๐ž๐œ๐ญ๐ข๐ฏ๐ž ๐ญ๐จ ๐š ๐ฅ๐ž๐š๐๐ข๐ง๐  ๐๐ซ๐ฎ๐  ๐๐ข๐ฌ๐œ๐จ๐ฏ๐ž๐ซ๐ฒ ๐ฃ๐จ๐ฎ๐ซ๐ง๐š๐ฅ. ๐“๐ก๐ž ๐Ÿ๐จ๐œ๐ฎ๐ฌ? ๐€ ๐ง๐ž๐ฐ ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ข๐š๐ฅ ๐›๐ฅ๐ฎ๐ž๐ฉ๐ซ๐ข๐ง๐ญ ๐Ÿ๐จ๐ซ ๐๐ž-๐ซ๐ข๐ฌ๐ค๐ข๐ง๐  ๐ญ๐ก๐ž ‘๐ƒ๐š๐ซ๐ค ๐†๐ž๐ง๐จ๐ฆ๐ž.’ ๐“๐ก๐ž ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ฒ ๐ข๐ฌ ๐ฆ๐จ๐ฏ๐ข๐ง๐  ๐ฉ๐š๐ฌ๐ญ ๐ญ๐ก๐ž ๐ž๐ซ๐š ๐จ๐Ÿ ๐ฌ๐ž๐ซ๐ž๐ง๐๐ข๐ฉ๐ข๐ญ๐ฒ-๐๐ž๐ฉ๐ž๐ง๐๐ž๐ง๐ญ ๐๐ž๐จ๐ซ๐ฉ๐ก๐š๐ง๐ข๐ณ๐š๐ญ๐ข๐จ๐ง. ๐Œ๐ฒ ๐ฉ๐ซ๐จ๐ฉ๐จ๐ฌ๐ž๐ ๐Ÿ๐จ๐ฎ๐ซ-๐ฉ๐ข๐ฅ๐ฅ๐š๐ซ ๐œ๐š๐ฆ๐ฉ๐š๐ข๐ ๐ง ๐ข๐ง๐ญ๐ž๐ ๐ซ๐š๐ญ๐ž๐ฌ: ๐€๐ ๐ง๐จ๐ฌ๐ญ๐ข๐œ ๐…๐ฎ๐ง๐œ๐ญ๐ข๐จ๐ง๐š๐ฅ ๐’๐œ๐ซ๐ž๐ž๐ง๐ข๐ง๐  (๐†๐ข/๐จ ๐ฏ๐ฌ. ฮฒ-๐š๐ซ๐ซ๐ž๐ฌ๐ญ๐ข๐ง ๐›๐ข๐š๐ฌ). ๐‚๐ซ๐ฒ๐จ-๐„๐Œ ๐†๐ฎ๐ข๐๐ž๐ ๐‘๐š๐ญ๐ข๐จ๐ง๐š๐ฅ ๐ƒ๐ž๐ฌ๐ข๐ ๐ง. ๐€๐ˆ-๐„๐ง๐š๐›๐ฅ๐ž๐ ๐†๐ž๐ง๐ž๐ซ๐š๐ญ๐ข๐ฏ๐ž ๐‚๐ก๐ž๐ฆ๐ข๐ฌ๐ญ๐ซ๐ฒ (๐ฆ๐จ๐ฏ๐ข๐ง๐  ๐ฅ๐ž๐š๐ ๐จ๐ฉ๐ญ๐ข๐ฆ๐ข๐ณ๐š๐ญ๐ข๐จ๐ง ๐ข๐ง๐ญ๐จ […]

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๐…๐ซ๐จ๐ฆ ๐€๐ฌ๐ฌ๐ข๐ฌ๐ญ๐š๐ง๐œ๐ž ๐ญ๐จ ๐€๐ ๐ž๐ง๐œ๐ฒ: ๐–๐ก๐ฒ ๐๐ซ๐ž๐œ๐ข๐ฌ๐ข๐จ๐ง ๐‚๐š๐ซ๐ž ๐†๐ข๐š๐ง๐ญ๐ฌ ๐๐ž๐ž๐ ๐‚๐จ๐ฆ๐›๐ข๐ง๐ž๐ ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ/๐“๐ก๐ž๐ซ๐š๐ฉ๐ž๐ฎ๐ญ๐ข๐œ ๐€๐ซ๐ž๐š/๐€๐ˆ ๐’๐ค๐ข๐ฅ๐ฅ๐ž๐ ๐“๐š๐ฅ๐ž๐ง๐ญ

Posted by Michael A. S. Guth on January 3rd, 2026

๐“๐ก๐ž “๐๐ฎ๐ซ๐ฉ๐ฅ๐ž ๐’๐ช๐ฎ๐ข๐ซ๐ซ๐ž๐ฅ” ๐“๐š๐ฅ๐ž๐ง๐ญ ๐†๐š๐ฉ Recruiters often call this the โ€œpurple squirrelโ€ profile: a “unicorn” blending deep regulatory strategy, therapeutic area such as neurology research expertise, with a fundamental understanding of AI application.

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Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy

Posted by Michael A. S. Guth on January 3rd, 2026

Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy In my independent review of the CARES-310 trial (Camrelizumab-Rivoceranib), I analyzed a common pitfall in modern drug development: the reliance on 16-week primary endpoints to justify long-term therapeutic narratives. While a 16-week data cut can deliver a clean p-value for a regulatory […]

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From Jargon to Governance: A 3-Part Blueprint for Trustworthy AI in Healthcare. The ISO AI Governance Trilogy for Pharma: Implement, Understand, and Lead.

Posted by Michael A. S. Guth on January 2nd, 2026

Implement AI. Understand AI. Govern AI. Your ISO Framework for Clinical Innovation. Beyond the Black Box: The ISO Framework for Ethical AI in Life Sciences. AI in Pharma? Master the ISO Playbook. (Implement. Understand. Govern.) ๐‡๐ž๐š๐๐ฅ๐ข๐ง๐ž: ๐๐ฎ๐ข๐ฅ๐๐ข๐ง๐  ๐“๐ซ๐ฎ๐ฌ๐ญ ๐ข๐ง ๐€๐ˆ-๐ƒ๐ซ๐ข๐ฏ๐ž๐ง ๐‚๐ฅ๐ข๐ง๐ข๐œ๐š๐ฅ ๐“๐ซ๐ข๐š๐ฅ๐ฌ: ๐–๐ก๐ฒ ๐˜๐จ๐ฎ๐ซ ๐Ž๐ซ๐ ๐š๐ง๐ข๐ณ๐š๐ญ๐ข๐จ๐ง ๐๐ž๐ž๐๐ฌ ๐š๐ง ๐€๐ˆ๐Œ๐’ (๐€๐ˆ ๐Œ๐š๐ง๐š๐ ๐ž๐ฆ๐ž๐ง๐ญ ๐’๐ฒ๐ฌ๐ญ๐ž๐ฆ) ๐“๐ก๐ž ๐ฉ๐ซ๐จ๐ฆ๐ข๐ฌ๐ž ๐จ๐Ÿ ๐€๐ˆ […]

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