Welcome back, Dr. Sarah Chen

Your workspace has 9 runs this month across 12 packs.

Total Runs

84%

Avg Confidence

Packs Used

This Month

Recent Executions

Pack	Output	Date	Status	Confidence
ONC Oncology Trial Design Pack ONC-001	Phase 3 NSCLC Trial Design Rationale	Mar 30, 2026	Completed	91%(High)
REG FDA IND Strategy Pack REG-001	IND Strategy for CBX-4192	Mar 29, 2026	Completed	87%(High)
BIO Biomarker Validation Pack BIO-001	PD-L1 CPS Validation Review	Mar 28, 2026	Completed	78%(Moderate)
ONC Dose Optimization Pack (Project Optimus) ONC-002	Dose-Finding Analysis — Timeout	Mar 27, 2026	Failed	--
CMC Excipient Justification Pack CMC-001	Excipient Safety Review for Oral Formulation	Mar 26, 2026	Running	--

Saved Outputs

View all

Phase 3 NSCLC Trial Design Rationale v2

Oncology Trial Design Pack · Mar 30, 2026

NSCLCPhase 3Endpoint Selection

IND Filing Strategy — CBX-4192

FDA IND Strategy Pack · Mar 29, 2026

INDPre-clinicalFirst-in-Human

PD-L1 CPS Biomarker Validation Summary

Biomarker Validation Pack · Mar 28, 2026

PD-L1Companion DiagnosticAssay Validation

Favorite Packs

ONC

Oncology Trial Design Pack

Oncology

REG

FDA IND Strategy Pack

Regulatory Strategy

BIO

Biomarker Validation Pack

Biomarker & Translational

CMC

Excipient Justification Pack

CMC & Quality

Saved Selector Paths

Open Selector

NSCLC 2L+ IO Combination Design

4 packs

Oncology > Solid Tumor > NSCLC > Second Line > Combination IO/Chemo

Saved Mar 25, 2026

First-in-Human IND Preparation

3 packs

Regulatory > IND > First-in-Human > Oncology > Small Molecule

Saved Mar 20, 2026

Recommended for You

Browse all

Based on your recent work in oncology trial design and regulatory strategy.

ONC

Oncology

Accelerated Approval Evidence Pack

Compiles FDA accelerated approval precedents, surrogate endpoint acceptance history, and confirmatory trial requirements to support accelerated approval strategies.

View pack

REG

Regulatory Strategy

Breakthrough/Fast Track Evidence Pack

Compiles FDA expedited program precedents, designation request strategies, and acceptance criteria analysis to support Breakthrough Therapy and Fast Track applications.

View pack

Competitive Intelligence

Competitive Landscape Pack

Maps the competitive landscape for your therapeutic area including pipeline assets, clinical trial activity, regulatory milestones, and strategic positioning analysis.

View pack