OpenWiki Bot
68 lines
6.4 KiB
Markdown
68 lines
6.4 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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### cellink-bio-x-gen3-customer-evidence: verify Cellink BIO X Gen 3 / BIO X6 customer pipeline on next Cellink check
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- Owner: me
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- Source: web-search — Nuclear Mechano-Oncology LinkedIn 2026-07 (score 0.601; "our new BIO X Gen 3 bioprinter has now been installed … first hands-on training session"); CELLINK official LinkedIn 2026-07-28 (score 0.287; BIO X6 at University of Miami 3D Bioprinting Facility); third-party market report LinkedIn 2026-07-28 (score 0.659; Cellink revenue uptick following strategic acquisitions); appellaser.ro practical selection guide 2026-07-24 (score 0.303; BIO X Gen 3 general-purpose positioning)
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- Due: unscheduled
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- Status: open
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- Notes: First vendor-anchored Cellink signal in any Tavily pull after 5 prior pulls of zero Cellink product mentions. Four distinct sources: customer install LinkedIn (Eastern Europe), vendor LinkedIn (CELLINK U. Miami), market report, independent selection guide. Verify with Cellink whether the BIO X Gen 3 / BIO X6 nomenclature is current product naming or if one is being deprecated; whether any of the named customer accounts (Nuclear Mechano-Oncology; U. Miami 3D Bioprinting Facility) maps to active Chinese pharma R&D / CDMO opportunities. Companion to the existing `celvivo-clinoreactor-thewell-bioscience-xeno-free` item.
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### china-cgt-2026-july-developments: monitor gene-editing trial death fallout + Merck–Bio-Techne / CARsgen satri-cel context for Chinese pharma / CDMO positioning
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- Owner: me
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- Source: web-search — Straits Times 2026-07-24 (score 0.313; patient death in China gene-editing trial draws fire); LiveScience 2026-07-24 (score 0.145; 6-year-old girl, investigation into gene-therapy regulations); SCMP 2026-07-29 (score 0.203; "Fear of policy backlash" — same-day coverage with this Tavily pull); Roots Analysis 2026-07-24 (score 0.669; Merck–Bio-Techne $11.3B acquisition June 2026 + CARsgen satri-cel CAR-T approval for stomach cancer June 2026); BioSpace 2026-07-27 (score 0.535; Summit/Merck China-first regulatory navigation)
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- Due: unscheduled
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- Status: open
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- Notes: Material new development in the China regulatory lane — sits **on top of** the existing `china-cde-cell-gene-therapy-rules-2026` and `china-order-no-818-clinical-translation` items, not replacing them. Two positive signals (Merck–Bio-Techne acquisition; CARsgen satri-cel solid-tumor CAR-T approval) show the China CGT manufacturing environment is consolidating around advanced therapeutics. One negative signal (gene-editing trial death + published regulatory backlash) could foreshadow stricter CDE / NMPA / hospital-level oversight and tighter qualification criteria for "qualified hospitals" under Order No. 818. Together these affect: (a) qualification timelines for the CellShot-TriArm and ClinoReactor-class deals Robin has in flight, (b) which "qualified hospitals" remain eligible to host first-in-human studies, (c) whether CelVivo / 3Brain / Cellink vendor positioning for Chinese pharma R&D / CDMO accounts needs to change tone (e.g. emphasize safety documentation, IRB-grade workflows). Pull NMPA / hospital-IRB statements on the gene-editing trial case before next Chinese customer conversation.
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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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## Completed recently
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