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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