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SKILL.md

name pipeline-tracker
description Global drug development pipeline tracking by disease, target, mechanism, or company. Use for competitive intelligence, opportunity identification, and trend analysis. Keywords: pipeline, drug development, clinical trials, R&D tracking, competitive landscape
category Competitive Intelligence
tags pipeline, fda, clinical-trials, drug-development, tracking
version 1.0.0
author Drug Discovery Team
dependencies clinicaltrials-api, fda-api, pharma-projects, citeline

Pipeline Tracker Skill

Track global drug development pipeline across diseases, targets, and companies.

Quick Start

/pipeline --target "EGFR" --by-phase
/pipeline --disease "NSCLC" --phase 2,3
/pipeline --company "AstraZeneca" --oncology
/pipeline-trends --compare 2023 vs 2024

Pipeline Overview

By Development Phase

Phase Description Count (2024) Trend
Preclinical Before IND ~15,000 ↑ 5%
Phase 1 First-in-human ~2,500 ↑ 8%
Phase 2 Efficacy ~1,800 ↑ 6%
Phase 3 Confirmatory ~900 ↑ 10%
Registration Under review ~200
Approved Marketed ~1,500 ↑ 3%

By Therapeutic Area

Area Pipeline Share Growth
Oncology 38% ↑ 12%
Immunology 12% ↑ 8%
Neurology 10% ↑ 5%
Cardiovascular 8% ↓ 2%
Metabolic 8% ↑ 3%
Respiratory 6% ↑ 4%
Infectious 6% ↓ 15%
Other 12%

Output Structure

# Pipeline Analysis: EGFR Inhibitors (2024)

## Summary

| Metric | Value | vs 2023 |
|--------|-------|--------|
| Total Programs | 245 | ↑ 12% |
| Phase 3 | 18 | ↑ 20% |
| Phase 2 | 42 | ↑ 10% |
| Phase 1 | 67 | ↑ 15% |
| Preclinical | 118 | ↑ 8% |

## By Phase

### Phase 3 Programs

| Drug | Company | Indication | Status |
|------|---------|-----------|--------|
| Lazertinib | J&J | NSCLC 1L | Recruiting |
| Nazartinib | Novartis | NSCLC 2L | Active |
| Amivantamab | J&J | NSCLC | Accelerated |
| Patritumab | Daiichi Sankyo | NSCLC | Recruiting |
| Datopotamab | Merck | NSCLC | Active |
| ... | ... | ... | ... |

### Phase 2 Programs

| Drug | Company | Indication | Differentiation |
|------|---------|-----------|-----------------|
| JDQ443 | J&J | NSCLC | CNS-penetrant |
| BPI-301 | BridgeBio | CRC | Selective |
| ... | ... | ... | ... |

## By Company

### Top 10 Companies by EGFR Pipeline

| Rank | Company | Phase 3 | Phase 2 | Phase 1 | Total |
|------|---------|---------|---------|---------|-------|
| 1 | AstraZeneca | 2 | 3 | 5 | 10 |
| 2 | J&J | 3 | 4 | 3 | 10 |
| 3 | Merck | 2 | 2 | 4 | 8 |
| 4 | Roche | 1 | 3 | 3 | 7 |
| 5 | BeiGene | 1 | 2 | 4 | 7 |
| ... | ... | ... | ... | ... | ... |

## By Mechanism

| Mechanism | Count | Trend |
|-----------|-------|-------|
| 3rd-gen TKI | 45 | ↑ |
| 4th-gen TKI (C797S) | 12 | ↑↑ |
| Bi-specific | 8 | ↑↑ |
| ADC | 15 | ↑↑ |
| Allosteric | 5 | → |
| PROTAC | 3 | ↑ |

## Pipeline Trends

### 3-Year Evolution

| Year | Phase 3 | Phase 2 | Phase 1 | Total |
|------|---------|---------|---------|-------|
| 2022 | 12 | 35 | 52 | 198 |
| 2023 | 15 | 38 | 58 | 219 |
| 2024 | 18 | 42 | 67 | 245 |

**Growth Rate**: 11% CAGR

### Key Trends

1. **4th-generation expansion**: Targeting C797S resistance
2. **ADC surge**: Antibody-drug conjugates gaining
3. **CNS focus**: Brain metastasis programs
4. **Combination trials**: 40% in combinations

## Regional Distribution

| Region | Phase 3 | Phase 2 | Phase 1 |
|--------|---------|---------|---------|
| United States | 45% | 38% | 42% |
| China | 30% | 35% | 38% |
| Europe | 25% | 20% | 18% |
| Japan | 12% | 8% | 10% |
| Rest of World | 8% | 5% | 5% |

## Innovation Assessment

### Novel Mechanisms by Phase

| Mechanism | Phase 3 | Phase 2 | Phase 1 | Preclinical |
|-----------|---------|---------|---------|------------|
| 4th-gen TKI | 3 | 5 | 4 | 8 |
| ADC | 4 | 6 | 5 | 12 |
| Bispecific | 2 | 3 | 3 | 6 |
| PROTAC | 0 | 1 | 0 | 5 |
| Allosteric | 0 | 2 | 3 | 4 |

**Innovation Index**: 32% novel mechanisms

## Competitive Dynamics

### Success Rate by Phase

| Transition | Rate | Analysis |
|------------|------|----------|
| Preclinical → Phase 1 | 15% | High risk |
| Phase 1 → Phase 2 | 60% | Improved |
| Phase 2 → Phase 3 | 35% | Major hurdle |
| Phase 3 → Approval | 65% | Strong pipeline |

### Attrition Analysis

| Reason | Phase 2 | Phase 3 |
|--------|---------|---------|
| Efficacy | 45% | 40% |
| Safety | 25% | 35% |
| Commercial | 15% | 20% |
| Strategic | 10% | 5% |

## Opportunities

### White Space

| Area | Programs | Opportunity |
|------|----------|------------|
| C797S + S1278 double mutant | 0 | High |
| Brain metastasis focus | 3 | High |
| Oral 4th-gen | 2 | Medium |
| Adjuvant setting | 4 | Medium |

## Recommendations

### For New Entrants

**Avoid**: Crowded 3rd-gen space

**Consider**:
1. **CNS-penetrant 4th-gen**: 3 programs total
2. **Double mutant coverage**: Unmet need
3. **Combination-ready**: Biomarker-selected
4. **Neoadjuvant setting**: Earlier treatment

### For Investors

**Hot Areas**:
- 4th-gen TKI (resistance focus)
- ADC platforms (established targets)
- CNS programs (large unmet need)

**Rising Stars**:
- Revolution (RMC-4630)
- BridgeBio (BPI-301)
- Cullinan (PROTAC)

Running Scripts

# Target pipeline
python scripts/pipeline_tracker.py --target EGFR --by-phase

# Disease pipeline
python scripts/pipeline_tracker.py --disease "NSCLC" --phase 2,3

# Company pipeline
python scripts/pipeline_tracker.py --company "AstraZeneca" --oncology

# Trend analysis
python scripts/pipeline_tracker.py --trends 2022-2024 --target "KRAS"

# Export
python scripts/pipeline_tracker.py --export --format csv --output pipeline.csv

Requirements

pip install requests pandas numpy

# Optional for advanced features
pip install plotly seaborn

Reference

Best Practices

  1. Update regularly: Pipeline changes weekly
  2. Verify status: Check ClinicalTrials.gov
  3. **Track discontinuations: Learn from failures
  4. **Monitor conferences: ASCO, ESMO for pipeline updates
  5. **Include China: Major contributor to pipeline

Common Pitfalls

Pitfall Solution
Stale data Regular refresh from source APIs
Missing inactive trials Include suspended/terminated
Geographic bias Include global programs
Company name variants Standardize company names
Duplicate counting Use unique trial IDs