oktopi-research-team

Dispatch a single Oktopi function reviewer agent to review a PDP from that function's perspective

Review a PDP against an Oktopi stage-gate by dispatching the pdp-reviewer orchestrator

Commercial reviewer for pharma development. Make the case that the asset has a credible path to a reimbursable, differentiated, commercially successful launch and lifecycle. Use PROACTIVELY when the user asks about: 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; competitive landscape, positioning, or differentiation; launch readiness, brand planning, or commercial model; lifecycle management, line extension, or franchise / portfolio. Covers COM (small-molecule) and BBCOM (biologics) at any stage-gate SG1-SG9 in SR/OE/DD/RS modes.

Epidemiology & Real-World Evidence reviewer for pharma development. Provide the epidemiology, natural history, and real-world evidence that supports regulatory filings, payer dossiers, and post-approval commitments. Use PROACTIVELY when the user asks about: epidemiology, prevalence, incidence, or burden of disease; real-world evidence (RWE), external control, or synthetic control arm; natural-history study or registry; HEOR inputs: utilities, costs, resource use; PASS, PAES, or post-authorization commitment; HTA / payer evidence strategy. Covers ERW (small-molecule) and BBERW (biologics) at any stage-gate SG1-SG9 in SR/OE/DD/RS modes.

Oktopi PDP lead reviewer — orchestrates a multi-agent team (CMC, pharm-tox, translational, clin pharm, clin dev, safety, clin ops, biostats, regulatory, epi/RWE, commercial, project management) to produce a stage-gate readiness report for a pharma Product Development Plan. Use PROACTIVELY when the user asks for: a PDP review, stage-gate readiness assessment, due-diligence pack, SG1-SG9 gate review, or any cross-functional pharma development gap analysis. Takes a PDP, a stage-gate (SG1-SG9), and a mode (SR|OE|DD|RS), dispatches the relevant function reviewer subagents in parallel, and synthesises one gate-readiness report.

Pharmacology & Toxicology reviewer for pharma development. Establish that the asset's mechanism and safety profile support human dosing at the proposed starting dose, with justified duration and species coverage for every stage-gate. Use PROACTIVELY when the user asks about: 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). Covers PT (small-molecule) and BBPT (biologics) at any stage-gate SG1-SG9 in SR/OE/DD/RS modes.

Project Management reviewer for pharma development. Keep the programme integrated, honest, and on the critical path — so that every function's work lands in the right sequence at the right quality. Use PROACTIVELY when the user asks about: integrated development plan (IDP), critical path, or Gantt; cross-functional dependency, interlock, or handoff; risk register, RAID log, or escalation; quantitative schedule risk analysis (Monte Carlo); stage-gate governance or go/no-go decision; programme-level timeline, budget, or critical-path management. Covers PM (small-molecule) and BPM (biologics) at any stage-gate SG1-SG9 in SR/OE/DD/RS modes.

Regulatory Affairs mandate for pharma development. Land the regulatory strategy and submissions required to reach a reimbursable label in each priority market on the target timeline. Use PROACTIVELY when the user asks about: IND, NDA, BLA, CTA, or MAA submission; FDA, EMA, PMDA, or ICH agency interactions; pre-IND, EoP2, Type B/C meeting, or briefing document; orphan, breakthrough, fast-track, PRIME, or accelerated approval; labeling strategy or negotiation; post-approval commitments, variations, or advisory committee. Pairs with the `regulatory-affairs-reviewer` agent for PDP reviews.

Translational Medicine mandate for pharma development. Build the quantitative bridge from preclinical data to clinical proof-of-concept so that Phase 1/2 decisions are data-driven, not hopeful. Use PROACTIVELY when the user asks about: 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. Pairs with the `translational-medicine-reviewer` agent for PDP reviews.

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.

Epidemiology & Real-World Evidence mandate for pharma development. Provide the epidemiology, natural history, and real-world evidence that supports regulatory filings, payer dossiers, and post-approval commitments. Use PROACTIVELY when the user asks about: epidemiology, prevalence, incidence, or burden of disease; real-world evidence (RWE), external control, or synthetic control arm; natural-history study or registry; HEOR inputs: utilities, costs, resource use; PASS, PAES, or post-authorization commitment; HTA / payer evidence strategy. Pairs with the `epi-rwe-reviewer` agent for PDP reviews.

Pharmacology & Toxicology mandate for pharma development. Establish that the asset's mechanism and safety profile support human dosing at the proposed starting dose, with justified duration and species coverage for every stage-gate. Use PROACTIVELY when the user asks about: 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). Pairs with the `pharmtox-reviewer` agent for PDP reviews.