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Luminal Arc

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Biotech Advisory & Strategic CMC Leadership

Illuminating the Development
Arc from Early Science to

Commercial Execution

Luminal Arc partners with scientific founders, emerging biotech teams, and global organizations to build the operational foundations required for long-term success.

 
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Imlygic® (Amgen)

Lyfgenia® (bluebird)

Abecma® (bluebird/BMS)

Zynteglo® (bluebird)

Skysona® (bluebird)

Replagal® (Shire)

Elaprase® (Shire)

Core Offering

End-to-End Product Development

From company building through commercial readiness — a proven arc of strategic CMC leadership.

 

Stage 01: Company Building

Syenex
Founder Advisory
Operations Setup
Technology Assessment
Strategic Capital Deployment
Executive Coaching

Stage 02: Pre-clinical Strategy

Arvada Therapeutics
CRO Management
CMC Roadmap to IND
RFP Process & Critical Reagent Selection
TPP Development & Program Management
INTERACT Briefing Package Preparation

Stage 03: Early Clinical

BioVex · Shire · Therion
CDMO Onboarding
IND/IMPD Amendments
CMC Roadmap to BLA
Process Development & Optimization
Process & Material Risk Assessments

Stage 04: Pivotal Clinical

bluebird bio · Amgen · BioVex · Therion · Shire
PC 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 · BioVex
PPQ Strategy & Readiness
Pre-BLA Risk Assessments & PPQ Readiness
BLA/MAA Authoring
PAI Readiness & FDA/EMA RTQs
Product Launch Strategy & Life Cycle Management
View Full Development Arc
Our Approach

Why Luminal Arc

An integrative, founder-forward approach to navigating biotech’s most complex operational decisions.

  • Founder Advisory​

Seeing the whole ecosystem and applying an integrative approach founders don’t get anywhere else.

  • Narrative Architecture

Translating complex science into a legible narrative investors and partners value.

  • Operational Sequencing

Understanding the operational reality to identify what to do now, what to defer, and what is required to progress to the next milestone.

Learn About Our Approach
Engagement Models

How We Work &
Who We Work With

  • How I Work
  • Advisory & Board Alignment
Strategic counsel on capital sequencing, technology selection, and board readiness.
  • Fractional Leadership
Embedded executive presence guiding CMC, PD, and MSAT teams.
  • Interim CMC Leadership
Hands-on technical direction during CDMO onboarding, tech transfers, and filings.
  • Project-Based Strategy Support
Focused engagements for BLA authoring, PAI readiness, and due diligence.
  • Who I Work With
  • Scientific Founders
Academic leaders transitioning breakthrough biology into commercial ventures.
  • Emerging Biotech Teams
Companies advancing from preclinical candidate selection to Phase 1 trials.
  • Venture-Backed Startups
Teams under capital runway constraints hitting key inflection points.
  • CGT & Complex Modality Companies
Cell and gene therapy programs requiring specialized CMC expertise.
See Engagement Models

About The Founder

Led by Michael Burns — Biotech Executive & CMC Leader

Michael Burns is a biotech executive and CMC/Process Development leader with more than 20 years of experience helping advanced therapies move from early development through commercial launch. His experience spans both traditional and cell & gene therapy programs, including work at Amgen, where he supported the commercialization of Imlygic®, and bluebird bio, where he helped lead late stage development and commercialization of Lyfgenia®, Abecma®, Skysona®, and Zynteglo®.

Read Full Bio & Career

“Breakthrough science doesn’t become a fundable company by accident. It requires a sequence of decisions that connect biology to operations, capital, narrative, and strategy.”

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