Dora Vallejo – Ardila, Senior Medical Monitor/ Clinical Research Physician at Avance Clinical, shared a post on LinkedIn:
“Unlocking Precision Oncology Opportunities in Australia: A Strategic Asset for Biotechs and CROs
If you’re developing biomarker-driven therapies—or running trials in precision oncology—TOPOGRAPH is a clinical intelligence tool you should know. Developed by Frank Lin.
TOPOGRAPH (Therapy-Oriented Precision Oncology Guidelines for Recommending Anti-cancer Pharmaceuticals) is a curated, Australian-specific database linking biomarkers, tumor types, and therapies, tiered by:
- Level of clinical evidence (from regulatory approval to early-phase trials)
- TGA/PBS status (Australia’s regulatory and reimbursement systems)
- Biomarker resistance data (R1/R2 tiers)
- Trial readiness (via POTTR integration with genomic outputs)
Why it matters for biotech and CRO strategy:
1. Target Identification and Trial Justification
- Use TOPOGRAPH to identify biomarkers with strong preclinical/phase I-II evidence (T3/T4) but no TGA-approved therapies (T1).
- Align early-stage assets with clinically relevant molecular targets underserved in Australia.
2. Site Feasibility and Patient Stratification
- Cross-reference unmet biomarker–cancer pairs with trial saturation levels.
- Focus on cancer types underrepresented in trials despite high biomarker prevalence.
- Design basket or umbrella trials where local infrastructure (MoST, Garvan, ICON, etc.) can support recruitment.
3. Regulatory Planning
- TOPOGRAPH explicitly flags therapies that are:
- Approved internationally (e.g., FDA, EMA) but not registered in Australia (T2)
- Associated with reimbursement barriers (PBS gaps)
- Enables early market access modeling and regulatory engagement strategy in AU/NZ markets.
4. Biomarker-Driven Trial Matching
- Integrate TOPOGRAPH’s companion tool, POTTR, into:
- Molecular tumor boards
- Patient screening workflows
- Adaptive enrichment protocols
5. De-risking Development with Resistance Data
R1/R2 tiers highlight predictive biomarkers of resistance—essential for:
Exclusion criteria
Stratification or sequencing
Designing combination trials to overcome resistance
Example Use Cases:
- KRAS G12C in colorectal or pancreatic cancer: T2 agent with variable access in Australia → opportunity for Phase II local expansion cohort
- FGFR alterations in rare tumors: T3/T4 evidence, no TGA approval → justify a biomarker-led, tumor-agnostic basket trial
- MSI-high or TMB-high in rare sarcomas or CNS tumors: checkpoint inhibitors supported internationally, limited local trials
For biotechs, it’s a roadmap.
Start exploring the database and incorporating TOPOGRAPH insights into your next trial design.”
More posts featuring Dora Vallejo – Ardila.