{
  "version": 3,
  "created_at": "2026-07-10T15:07:20.950Z",
  "task_summary": "Patient-centered pMHC / antigen-specific immunotherapy landscape report + EoE survey plan",
  "agents": [],
  "phases": [
    {
      "name": "Plan",
      "delegations": [
        {
          "steps": [
            {
              "title": "Define scope, program roster, and report architecture",
              "description": "Fix the analytical frame and the master list of programs to profile. Confirmed scope = antigen-specific immunotherapy (broad) + Tzield as approved precedent. Build a program roster spanning celiac (Nexvax2/ImmusanT, TAK-101/Cour-Takeda, KAN-101/Anokion, TIMP-GLIA), type 1 diabetes (Tzield/teplizumab, GAD-alum/Diamyd, Navacims/Parvus, pro-insulin peptides/MonoPepT1De), MS (ATX-MS-1467, tolerogenic approaches), allergy/other antigen-specific tolerance where instructive. Define the six-stage lifecycle lens to apply to each (idea generation → basic research → preclinical → trial architecture/design → trial results → post-market/coverage), plus the patient-centered overlay (PRO data, patient-org voice, PFDD timing). Deliverable: program_roster.csv and report_outline.md.",
              "title_short": "Scope & roster"
            },
            {
              "title": "Harvest trial architecture from ClinicalTrials.gov",
              "description": "Programmatically pull every registered trial for each program from ClinicalTrials.gov API v2 (search by intervention name + sponsor). Extract phase, status, enrollment, start/completion dates, design (randomization, blinding, arms, dose-escalation), primary/secondary endpoints, eligibility, and outcome-measure results where posted. Normalize into a structured table. Deliverable: trials_master.csv (one row per trial with full design fields) plus a per-program trial-timeline figure.",
              "title_short": "Trial data harvest"
            },
            {
              "title": "Reconstruct scientific origin and preclinical basis per program",
              "description": "For each program, assemble the idea-generation and basic/preclinical science from peer-reviewed literature via OpenAlex/CrossRef/PubMed and full-text retrieval: the founding mechanistic hypothesis, key discovery papers, antigen/epitope selection rationale, animal/ex-vivo proof-of-concept, and the translational bridge to first-in-human. Capture named academic founders, institutions, and company spinouts. Deliverable: origins_preclinical.md with per-program narrative and a references library (BibTeX/CSV).",
              "title_short": "Origins & preclinical"
            },
            {
              "title": "Compile trial results, outcomes, and failure/success analysis",
              "description": "For each program that reached the clinic, compile reported results: efficacy on primary/secondary endpoints, safety/immunogenicity, biomarker/mechanistic readouts, and — critically — the documented reason for success, halt, or pivot (e.g., Nexvax2 Phase 2 endpoint miss; Tzield's delay-of-onset data). Synthesize cross-program failure modes and success factors into a comparative matrix. Deliverable: outcomes_analysis.md + a cross-program results matrix figure (heatmap/table of endpoint outcomes) and a 'why programs failed/advanced' synthesis table.",
              "title_short": "Results & failure analysis"
            },
            {
              "title": "Tzield post-market adoption & coverage deep-dive",
              "description": "Build the standalone post-market case study for Tzield (teplizumab): FDA approval basis (BLA, label, indication), launch, list/net price, payer coverage policies and access barriers, real-world uptake signals, REMS/administration burden, and manufacturer access programs. Use FDA resources, openFDA, payer policy documents, and published commentary via web search. Deliverable: tzield_postmarket.md with a coverage/access summary table and adoption-timeline figure.",
              "title_short": "Tzield post-market"
            },
            {
              "title": "Patient-reported outcomes & patient-organization voice",
              "description": "Across all programs and their disease areas (celiac, T1D, MS, EoE-adjacent), synthesize published PRO/HRQoL data used in or around these trials (validated instruments, symptom/quality-of-life endpoints, published survey responses), plus positions and testimony from patient organizations (e.g., Celiac Disease Foundation, Beyond Celiac, JDRF/Breakthrough T1D, APFED for EoE). Extract patient-stated needs, concerns, and priorities. Deliverable: patient_voice.md + a PRO-instruments-by-program table.",
              "title_short": "PRO & patient voice"
            },
            {
              "title": "PFDD meetings inventory and timing analysis",
              "description": "Identify FDA Patient-Focused Drug Development (PFDD) meetings — both FDA-led and externally-led — in each relevant disease area (celiac, T1D, EoE, MS), capturing date, organizer, Voice-of-the-Patient report content, and the patient priorities recorded. Position each PFDD on the timeline relative to the corresponding pMHC program's development (before/during/after) and analyze what that timing implies for whether patient input shaped design. Deliverable: pfdd_timeline.md + a figure overlaying PFDD events on program development timelines.",
              "title_short": "PFDD timing"
            },
            {
              "title": "Cross-program synthesis, whitespace, and EoE implications",
              "description": "Integrate all streams into strategic synthesis: comparative landscape matrix (mechanism, antigen strategy, stage, outcome, patient-input maturity), lessons transferable to an EoE antigen-specific/pMHC vaccine, competitive whitespace, and risk register. Explicitly connect each lesson to an EoE design decision (antigen/allergen selection, endpoint choice, PRO strategy, trial architecture). Deliverable: synthesis figures (landscape matrix, whitespace map) and a strategic-implications section.",
              "title_short": "Synthesis & EoE"
            },
            {
              "title": "Assemble the 100+ page market report",
              "description": "Compile all sections into a single patient-centered market report (Markdown + rendered PDF/DOCX), publication-grade: executive summary, methodology, per-program dossiers structured by the six-stage lifecycle, the Tzield post-market case study, integrated patient-voice and PFDD sections, cross-program synthesis, references. Patient-centered framing threaded throughout (plain-language callouts, patient-priority boxes). Deliverable: pmhc_landscape_report.pdf (+ .md source) and all embedded figures.",
              "title_short": "Assemble report"
            },
            {
              "title": "EoE pMHC-vaccine patient survey design plan",
              "description": "As the committed follow-on, draft a plan and instrument blueprint for a survey capturing EoE patients' needs, interest, and concerns about a pMHC-based vaccine therapy. Ground it in the PRO instruments and patient priorities surfaced in the review; specify domains (efficacy expectations, route/administration tolerance, risk tolerance, prior-treatment burden, trust/consent, involvement preferences), draft candidate items, propose validated-instrument anchors, sampling/recruitment via patient orgs, and an engagement model embedding patients at each development stage. Deliverable: eoe_survey_plan.md.",
              "title_short": "EoE survey plan"
            }
          ]
        }
      ],
      "id": "phase-0"
    }
  ],
  "feasibility": {
    "rationale": "The core programs (Tzield, Nexvax2, TAK-101, KAN-101, GAD-alum, Navacims/Parvus, others) have extensive public footprints across ClinicalTrials.gov, peer-reviewed literature, FDA labels/reviews, and patient-organization/PFDD materials, all reachable through allowlisted APIs and web search. A 100+ page-equivalent report is achievable. Main uncertainty is depth of published patient-reported-outcome (PRO) and PFDD material per program — rich for celiac and T1D, thinner for early-stage platforms; I will report gaps honestly rather than fill them.",
    "confidence": "high"
  }
}