case_id stringlengths 8 8 | modality stringclasses 6
values | indication stringlengths 5 20 | mechanism stringlengths 13 31 | target stringlengths 3 13 | model_system stringclasses 10
values | study_design stringlengths 17 45 | efficacy_summary stringlengths 28 65 | safety_summary stringlengths 30 50 | pk_pd_summary stringlengths 17 63 | biomarker_summary stringlengths 11 47 | confounders stringlengths 25 56 | data_gaps stringlengths 33 59 | decision_options stringclasses 1
value | expected_best_decision stringclasses 3
values | expected_rationale_bullets stringlengths 71 139 | red_flags_expected stringlengths 31 71 | risk_level stringclasses 3
values |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PDC-0001 | Small molecule | NAFLD | PPAR modulation | PPAR-delta | Mouse DIO | 8w; n=12/arm; 3 doses; vehicle control | Liver fat -18% at top dose; no dose-response; ALT unchanged | No deaths; mild weight loss at top dose; AST +22% | Exposure high variance; Tmax delayed; trough below EC50 in 2/12 | FGF21 +5% (ns); inflammatory panel mixed | Food intake not controlled; weight loss may drive effect | No histology scoring; no blinded readout | GO|HOLD|KILL | HOLD | Effect lacks dose-response|Possible confound from weight loss|AST rise needs clarification|PK variability undermines interpretation | No dose-response|Confounded efficacy|Liver enzyme signal|PK variability | Medium |
PDC-0002 | mAb | Oncology solid tumor | Receptor blockade | EGFR | PDX model | 21d; n=8; weekly dosing; comparator anti-EGFR | Tumor growth inhibition 48% vs control; consistent across animals | No clinical signs; cytokines stable | Exposure consistent; target occupancy 85% | pERK down 60% post-dose; rebounds by day 7 | PD sampling timing may bias rebound | No immunogenicity assessment; no combo data | GO|HOLD|KILL | GO | Efficacy consistent|Clean safety|Strong target engagement|PD matches MoA|PK stable | PD rebound risk|Missing immunogenicity | Low |
PDC-0003 | Small molecule | Alzheimer's | Kinase inhibition | GSK3beta | Rat | 4w; n=10; oral daily; two doses | Cognitive score improved 9% (p=0.08); no clear dose separation | Sedation reported in 4/10 high dose; falls in 2/10 | Brain exposure adequate; peripheral exposure high | pTau down 12% (ns); neuroinflammation unchanged | Sedation may inflate cognitive test artifacts | No chronic tox; no female animals | GO|HOLD|KILL | KILL | Efficacy weak and not significant|Dose separation absent|CNS side effects prominent|Biomarker shift minimal|Risk of symptomatic masking | Weak efficacy|CNS adverse effects|No dose separation | High |
PDC-0004 | siRNA | Hypercholesterolemia | RNA silencing | PCSK9 | Non-human primate | Single dose; n=4; follow 8w | LDL -52% sustained to week 6 | Platelets stable; mild injection reactions | Exposure consistent; durable effect | PCSK9 protein down 80% at week 2 | Small n limits confidence | No repeat-dose tox; no off-target transcriptome | GO|HOLD|KILL | GO | Large durable LDL reduction|Safety acceptable|Mechanism confirmed|Clear translational precedent | Small n|Missing repeat-dose tox | Low |
PDC-0005 | Small molecule | Asthma | Inflammation modulation | CRTH2 | Guinea pig | 2w; allergen challenge; n=9 | Airway resistance improved 25% at mid dose only; high dose worse | No deaths; mild diarrhea at high dose | Exposure increases with dose; high dose peak high | Eosinophils down 10% (ns) | High dose paradox suggests off-target | No receptor occupancy assay; no metabolite ID | GO|HOLD|KILL | HOLD | Non-monotonic efficacy suggests off-target|High dose worsening is concerning|Need occupancy and off-target profiling|GI tolerability issues | Non-monotonic response|Worsening at high dose|Missing occupancy | Medium |
PDC-0006 | Cell therapy | Oncology hematologic | Engineered T cells | BCMA | Mouse xenograft | n=10; single infusion; 30d follow | Complete response in 6/10; partial in 2/10 | Cytokine spike day 2; 1 death likely CRS | Cells expand 50x then contract | IL6 high in responders and non-responders | Supportive care inconsistent | No dose-ranging; no mitigation strategy tested | GO|HOLD|KILL | HOLD | Strong efficacy but safety event|Need CRS mitigation plan|Dose-ranging required|Supportive care variability confounds safety read | Treatment-related death|CRS risk|No dose-ranging | High |
PDC-0007 | Small molecule | Type 2 diabetes | GLP1 agonism (oral) | GLP1R | Dog | 4w; n=6; fed vs fasted arms | HbA1c trend -0.3; glucose AUC improved 12% only fasted | Nausea in 3/6; vomiting in 1/6 | Huge food effect; exposure drops 70% fed | Insulin secretion markers mixed | Fed/fasted imbalance across groups | No formulation optimization; no exposure-response model | GO|HOLD|KILL | HOLD | Efficacy depends on fasting|Food effect undermines real-world use|Need formulation work|GI AEs present|Exposure-response unclear | Severe food effect|Real-world feasibility risk|GI AEs | Medium |
PDC-0008 | mAb | Autoimmune | Pathway inhibition | IL-23 | NHP | Repeat dose q4w x3; n=5 | Inflammation score down 40% sustained | No serious AEs; mild infections in 2/5 | Exposure stable; ADA detected low titer | IL-17A down 55% | Mild infections may signal immunosuppression depth | No opportunistic infection panel; small n | GO|HOLD|KILL | GO | Clear efficacy|Manageable safety|PK stable|ADA low|Mechanism consistent | Infection signal|Limited infection workup | Low |
PDC-0009 | Small molecule | Oncology | DDR inhibition | ATR | Cell line + mouse | In vitro IC50 strong; in vivo 14d; n=10 | Tumor reduction 15% only in one line; others none | Weight loss 12% in treated; neutropenia noted | Exposure exceeds IC90; narrow margin | pCHK1 down 70% | In vivo model may not match biomarker-defined population | No patient stratification hypothesis; limited combo testing | GO|HOLD|KILL | KILL | In vivo efficacy poor despite target engagement|Toxicity significant|Therapeutic window weak|No clear responder hypothesis | Poor efficacy|Toxicity|Narrow window | High |
PDC-0010 | Protein | Rare disease | Enzyme replacement | IDUA | NHP | Single dose; n=3; 6w follow | Substrate down 35% in plasma; tissue unknown | Hypersensitivity reaction in 1/3 | Exposure adequate; half-life short | Biomarker response transient | Premedication not standardized | No tissue biodistribution; no repeat dosing | GO|HOLD|KILL | HOLD | Some biomarker effect but transient|Hypersensitivity risk needs plan|Need tissue readouts|Need repeat-dose data | Hypersensitivity|No tissue efficacy data | Medium |
PDC-0011 | Small molecule | Depression | NMDA modulation | NR2B | Rat | 2w; n=12; behavioral assays | Behavioral improvement 20% across tests | No deaths; locomotor hyperactivity at high dose | Exposure OK; brain penetration high | BDNF up 30% | Hyperactivity may inflate behavioral outcomes | No chronic tox; abuse liability not explored | GO|HOLD|KILL | HOLD | Signal present but confounded by hyperactivity|Need assay controls|Need longer tox|Need liability assessment | Behavior confound|CNS activation risk | Medium |
PDC-0012 | Vaccine | Infectious disease | Neutralizing antibody induction | Spike antigen | Mouse | Prime-boost; n=15 | Neutralization titers high; challenge protection 80% | Local reactogenicity moderate; no severe AEs | PK not applicable | Th1 skew; cytokines acceptable | Challenge model variability | No durability beyond 8w; no variant panel | GO|HOLD|KILL | GO | Strong protection|Safety acceptable|Immune profile supports protection|Clear next experiments identified | Durability unknown|Variant coverage unknown | Low |
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