Archive for January, 2026

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 […]

Posted in AI Governance, Neuroplasticity Comments Off on 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
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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.

Posted in AI Governance, Pharma and Medical Device, Regulatory Medical Writing Comments Off on 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
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Intriguing Comments on Depression

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

From Thomas Tsangaras: โ€œDepression is your body saying: โ€˜I donโ€™t want to be this character anymore.โ€™โ€ โ€œI donโ€™t want to be this character anymore.โ€ So many people quietly say that line. Not just in the context of mental health but in the context of work, identity, and environments. Sometimes what we call burnout or depression […]

Posted in Neuroplasticity Comments Off on Intriguing Comments on Depression
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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 […]

Posted in AI Governance, Pharma and Medical Device, Regulatory Medical Writing Comments Off on Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy
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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 […]

Posted in AI Governance, Regulatory Medical Writing Comments Off on From Jargon to Governance: A 3-Part Blueprint for Trustworthy AI in Healthcare. The ISO AI Governance Trilogy for Pharma: Implement, Understand, and Lead.
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