54 lines
3.3 KiB
Markdown
54 lines
3.3 KiB
Markdown
# Commitments
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Concrete work tasks, follow-ups, approvals, and scheduled items extracted from Gmail, Notion, Slack, direct mentions, and other work-relevant sources. Personal errands and life admin live in `/personal-logistics.md` instead.
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## Active
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### china-cde-cell-gene-therapy-rules-2026: verify CDE classification scope for Chinese pharma / CDMO conversations
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- Owner: me
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- Source: web-search — cisema.com 2026-07-24 (China CDE Defines Classification Rules for Cell & Gene Therapy Drugs)
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- Due: unscheduled
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- Status: open
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- Notes: Single credible regulatory-trade source. Pull the NMPA/CDE-direct release before the next vendor sync; check whether any active CellShot-TriArm or ClinoReactor-class deals depend on the new classification scope.
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### celvivo-clinoreactor-thewell-bioscience-xeno-free: verify TheWell Bioscience co-marketing signal on next CelVivo check
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- Owner: me
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- Source: web-search — thewellbio.com 2026-07-21 / 2026-07-23 / 2026-07-25 (Xeno-Free Cell Culture Media, Stem Cell Culture Product Guide, Apical-Out Organoids white paper — all explicitly name "CelVivo ClinoReactor™")
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- Due: unscheduled
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- Status: open
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- Notes: First vendor-anchored CelVivo ClinoReactor signal in any Tavily pull (prior pulls returned only MO:BOT / generic organoid). TheWell Bioscience is a hydrogel-media partner; their workflow pages position ClinoReactor as the scale-up vessel for apical-out organoids + hMSC expansion. Confirm with CelVivo whether this is a sanctioned co-marketing arrangement and whether it maps to any active Chinese pharma / CDMO deal.
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### china-order-no-818-clinical-translation: verify Order No. 818 (effective 2026-05-01) scope for Chinese pharma / CDMO conversations
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- Owner: me
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- Source: web-search — BetaLife LinkedIn 2026-07 (top score 0.779; explicitly cites "Order No. 818, effective May 1, 2026" with accelerated clinical-translation pathway); Tavily answer text corroborates; Roots Analysis re-mentions broader China cell-therapy regulatory pattern
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- Due: unscheduled
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- Status: open
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- Notes: Single primary source (BetaLife SG LinkedIn) but the regulation itself is a published policy text — Order No. 818 creates an accelerated clinical-translation pathway at qualified hospitals for cell therapy and 3D bioprinting after demonstrating safety and preliminary efficacy. This is **the clinical-translation counterpart** to the existing `china-cde-cell-gene-therapy-rules-2026` item (which is about classification / CMC planning). Both items matter: classification scope drives dossier content vendors need to assemble; the clinical-translation pathway drives which hospitals can host first-in-human studies. Pull the NMPA / State Council Order No. 818 direct text before the next vendor sync; check whether any active CellShot-TriArm or ClinoReactor-class deal depends on whether the buyer hospital qualifies as a "qualified hospital" under the regulation.
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<!--
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Structure for new entries:
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### <topic-key>: <short title>
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- Owner: me | team | other:<name> | unknown
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- Source: <connector> — <short ref>
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- Due: YYYY-MM-DD or unscheduled
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- Status: open | waiting | blocked | done
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- Notes: <optional context>
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## By owner
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### Mine
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- (none)
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### Team
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- (none)
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### Other
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- (none)
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-->
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## Completed recently
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Move done items here with a Completed: date so they stay auditable without cluttering Active.
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