Core Offering
End-to-End
Product Development
Luminal Arc illuminates the development arc from early science to commercial execution. Click each stage to explore specific capabilities.
Core Offering
End-to-End Product Development
From company building through commercial readiness — a proven arc of strategic CMC leadership.
Stage 01: Company Building
SyenexFounder Advisory
Operations Setup
Technology Assessment
Strategic Capital Deployment
Executive Coaching
Stage 02: Pre-clinical Strategy
Arvada TherapeuticsCRO Management
CMC Roadmap to IND
RFP Process & Critical Reagent Selection
TPP Development & Program Management
INTERACT Briefing Package Preparation
Stage 03: Early Clinical
BioVex · Shire · TherionCDMO Onboarding
IND/IMPD Amendments
CMC Roadmap to BLA
Process Development & Optimization
Process & Material Risk Assessments
Stage 04: Pivotal Clinical
bluebird bio · Amgen · BioVex · Therion · ShirePC Strategy & Control Strategy Development
CDMO Management & Governance
Process Monitoring & Critical Specification Setting
Technology Transfer & Analytical Comparability
Complex Investigations
Stage 05: Commercial Readiness
bluebird bio · Amgen · BioVexPPQ Strategy & Readiness
Pre-BLA Risk Assessments & PPQ Readiness
BLA/MAA Authoring
PAI Readiness & FDA/EMA RTQs
Product Launch Strategy & Life Cycle Management
Track Record
Commercial Products Guided
Experience across several clinical and commercial programs in different modalities.
Amgen
Imlygic®
Oncolytic HSV-1
Metastatic Melanoma
bluebird bio
Lyfgenia®
LVV Gene Therapy
Sickle Cell Disease
bluebird bio / BMS
Abecma®
LVV Gene Therapy
Multiple Myeloma
bluebird bio / BMS
Skysona®
LVV Gene Therapy
CALD
bluebird bio
Zynteglo®
LVV Gene Therapy
β-Thalassemia
Ready to map your development arc?
Get in touch to explore how Luminal Arc can support your program.