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From oktopi-research-team
Oktopi Research Team — 12-agent multi-agent team for pharma drug development reviews (CMC, pharm-tox, translational, clin pharm, clin dev, safety, clin ops, biostats, regulatory, epi/RWE, commercial, project management). Use PROACTIVELY when the user asks about drug development, PDP review, stage-gate readiness, due diligence of a pharma asset, or any of: drug substance or drug product development; GMP manufacturing, tech transfer, or process validation; analytical methods, specifications, or stability; CMC regulatory package, Module 3, or comparability; supply chain, API sourcing, or release testing; biologics CMC: cell line, upstream/downstream, aggregation; IND-enabling toxicology, GLP tox, or species selection; safety pharmacology, genotoxicity, or carcinogenicity; DMPK, ADME, or preclinical PK; starting dose, MABEL, HED, or first-in-human justification; juvenile, reproductive, or developmental tox; biologics-specific nonclinical concerns (immunogenicity, CRS, cytokine release); biomarker strategy, target engagement, or patient selection biomarkers; translational PK/PD modeling, human dose prediction; proof-of-mechanism or proof-of-concept design; companion diagnostic (CDx) strategy; reverse translation from clinical signals; bridging preclinical data to Phase 1/2 decisions; clinical PK, exposure-response, or dose-finding; DDI strategy or in vitro / clinical DDI studies; special populations (renal, hepatic, pediatric, pregnancy); pop-PK, PBPK, or QSP modeling; Project Optimus dose optimization; label dose justification.
How this skill is triggered — by the user, by Claude, or both
Slash command
/oktopi-research-team:oktopi-research-teamThe summary Claude sees in its skill listing — used to decide when to auto-load this skill
Claude should activate this skill whenever the user's question touches **pharmaceutical drug development**: discovery, preclinical, clinical trials, CMC/manufacturing, regulatory strategy, pharmacovigilance, clinical pharmacology, biostatistics, commercial / market access, epidemiology / RWE, or programme management.
Claude should activate this skill whenever the user's question touches pharmaceutical drug development: discovery, preclinical, clinical trials, CMC/manufacturing, regulatory strategy, pharmacovigilance, clinical pharmacology, biostatistics, commercial / market access, epidemiology / RWE, or programme management.
pdp-reviewer orchestrator agent, which will fan out to the relevant function reviewers in parallel and consolidate the report.| Code | Agent | Trigger phrases (partial) |
|---|---|---|
CMC | cmc-reviewer | drug substance or drug product development; GMP manufacturing, tech transfer, or process validation; analytical methods, specifications, or stability |
PT | pharmtox-reviewer | IND-enabling toxicology, GLP tox, or species selection; safety pharmacology, genotoxicity, or carcinogenicity; DMPK, ADME, or preclinical PK |
TM | translational-medicine-reviewer | biomarker strategy, target engagement, or patient selection biomarkers; translational PK/PD modeling, human dose prediction; proof-of-mechanism or proof-of-concept design |
CP | clinical-pharmacology-reviewer | clinical PK, exposure-response, or dose-finding; DDI strategy or in vitro / clinical DDI studies; special populations (renal, hepatic, pediatric, pregnancy) |
CDM | clinical-development-medical-reviewer | Target Product Profile (TPP) or clinical development plan (CDP); Phase 1, 2, or 3 protocol design; endpoint selection, comparator arm, or patient population |
SAF | clinical-safety-reviewer | SAE, SUSAR, or expedited safety reporting; DSUR, PBRER, or integrated safety summary; Risk Management Plan (RMP) or REMS |
COP | clinical-operations-reviewer | site activation, feasibility, or country selection; enrollment forecasting or risk-based monitoring; CRO selection, oversight, or governance |
STAT | biostatistics-reviewer | sample size, power, or estimand (ICH E9 R1); SAP, multiplicity, or alpha-spending; adaptive design, group-sequential, or external control |
REG | regulatory-affairs-reviewer | IND, NDA, BLA, CTA, or MAA submission; FDA, EMA, PMDA, or ICH agency interactions; pre-IND, EoP2, Type B/C meeting, or briefing document |
ERW | epi-rwe-reviewer | epidemiology, prevalence, incidence, or burden of disease; real-world evidence (RWE), external control, or synthetic control arm; natural-history study or registry |
COM | commercial-reviewer | market sizing (TAM/SAM/SOM), peak sales, or forecast; pricing, market access, or HTA (NICE, IQWiG, PBAC, G-BA) strategy; payer value dossier or reimbursement strategy |
PM | project-management-reviewer | integrated development plan (IDP), critical path, or Gantt; cross-functional dependency, interlock, or handoff; risk register, RAID log, or escalation |
Plus orchestrator pdp-reviewer for full PDP gap-analysis.
| User intent | Invoke |
|---|---|
| "Review my PDP at SG5 OE" or "gate readiness" or "due diligence pack" | pdp-reviewer (orchestrator) |
| Single function question ("is my SAP airtight?") | matching function reviewer |
| Stage-gate goal question ("what does SG3 require?") | the corresponding stage-gate-sg<N> skill |
| Function mandate question ("what does Translational Medicine own?") | the corresponding function-<slug> skill |
| Novel modality (bispecific, ADC, cell therapy) | flag modality to every agent so they apply modality-specific adaptive questions |
data/functions.json — all 12 functions with role, mission, mandate, triggersdata/stage-gates.json — SG1..SG9 goalsdata/stage-gate-index.json — Critical question load per (SG, mode, function)pdp-reviewer fans out in parallel, which is faster and more complete than serial calls.npx claudepluginhub oktopi-org/dev-plugin --plugin oktopi-research-teamCreates, edits, and optimizes skills for Claude Code, including drafting, evaluating with test prompts, iterating on performance, and improving skill descriptions for better triggering accuracy.