A research tool for drug development and clinical trial planning that transforms a disease indication into a publication-quality dossier — covering mechanistic landscape, competitive intelligence, endpoint framework, and study design patterns — sourced from current regulatory guidance, trial registries, and medical literature. Pairs naturally with vera-clinical-trial-designing and vera-master-trial-designing.

What it does

Given an indication, the skill systematically researches and assembles:

MoA landscape — all mechanistic targets and pathways under investigation
Compound landscape — approved and pipeline drugs with sponsor, mechanism, phase, primary readout, and headline efficacy / safety
Endpoint framework — primary and key secondary endpoints classified by authority tier (HA-Guided, Community Consensus, Literature Emerging) with explicit citations
Study design patterns — arm structure, control choice, sample size, duration, region — extracted from existing trials
Synthesis — first-pass dossier with executive summary, narrative sections, and cross-referenced tables

Output is a structured Word or PDF dossier (Markdown fallback if the docx / pdf skills aren’t available). Optional external-reviewer pass via a reviewer-LLM MCP, with structured self-review as the default fallback.

Who it’s for

Biotech / pharma R&D scientists building a competitive landscape before committing to a development plan.
Clinical scientists and regulatory affairs preparing Type B / Type C briefing books that need an endpoint-authority and competitor-design table.
Postdocs and career-switchers entering biotech who want a reproducible workflow for landscape due diligence.

What to watch for

The skill classifies endpoints into authority tiers but does not decide whether a “Community Consensus” endpoint is strong enough for your registration strategy. That’s regulatory judgment.
SoC benchmark selection stays with the user — the skill catalogs published efficacy data, but choosing which trial’s control arm rate is the right H0 for your design depends on patient population, line of therapy, and treatment era.
Competitive positioning — the skill maps the landscape; deciding where a new compound differentiates is strategic judgment.

Tested

Yes — built by a working biostatistician for internal use, then released as an open-source skill. Step 06b external review is optional and falls back to structured self-review when no reviewer-LLM MCP is configured.

Verdict

The skill structures the research and synthesis. Translating a landscape into specific design parameters — and making the development go/no-go call — remain the user’s responsibility.