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Emily Moran

3LB Consulting (Three Little Birds Consulting)
Cell & Gene Therapy Manufacturing
CMC & Regulatory Strategy

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About the guest:

Emily Moran is the Founder of 3LB Consulting, a life sciences advisory firm focused on cell and gene therapy execution, spanning manufacturing strategy, CMC development, CDMO selection, and regulatory readiness.

With nearly two decades of experience across vaccines, biologics, and advanced therapies, Moran specializes in translating innovative science into manufacturable, compliant, and patient-ready products. Her work supports early-stage startups, academic spinouts, and late-stage biotechs navigating the complex path from discovery through IND, clinical trials, and commercialization.

Professional
Background & Training:

At LIT, Schelker’s team focuses on improving T-cell fitness, developing and validating genetically enhanced T cells that persist longer, resist exhaustion, and have improved antitumour efficacy, with programs moving toward early-phase clinical trials such as ESOSTEM155 (a NY-ESO-1 TCR-modified stem-like T-cell therapy).

Over the past seven years, she has worked extensively in cell and gene therapy, advising programs across autologous and allogeneic modalities, viral vector production, and advanced manufacturing platforms. Her experience spans process development, analytical strategy, raw material control, facility design, equipment selection, and GMP readiness.

Research, Manufacturing
& Advisory Focus:

Through 3LB Consulting, Moran helps organizations resolve the most common causes of failure in advanced therapies — not science, but execution.
Her areas of focus include:
  • IND and CMC strategy development for cell and gene therapies
  • CDMO selection, auditing, and fitness-for-purpose assessments
  • GMP facility design, scale-up planning, and right-size process design
  • Regulatory inspection readiness and agency engagement strategies
  • Manufacturing risk mitigation across early clinical to commercial stages

She is particularly known for helping teams anticipate execution gaps early, reducing costly rework, regulatory delays, and loss of investor confidence.

Personal Motivation &
Patient-Centered Perspective:

Moran’s commitment to advanced therapies is shaped not only by professional expertise, but by personal experience. In 2012, her children participated in a Phase I clinical trial for a life-saving treatment, exposing her firsthand to the urgency, complexity, and emotional stakes involved in early-stage therapies.
This experience deeply informs her approach to consulting — combining operational discipline with patient urgency, and reinforcing her belief that safe, compliant manufacturing is the fastest path to access, affordability, and impact.

Industry Presence &
Thought Leadership:

Moran is an active participant in global life sciences forums, frequently engaging in discussions on:
  • The evolution of cell and gene therapy manufacturing models
  • Regulatory expectations for novel modalities
  • Investor perspectives on execution risk in advanced therapies
She regularly advises teams preparing for regulatory submissions, inspections, and strategic partnerships, and is known for bridging communication gaps between scientists, clinicians, quality teams, regulators, and investors.

Professional
Philosophy:

At her core, Moran is a manufacturing operator who believes that:
Cures are not delivered by discovery alone — they are delivered by systems that work.
Her work emphasizes focus, transparency, and disciplined execution as the foundation for translating innovation into real-world patient benefit.

Episodes:

Episode 2

Why CMC and Manufacturing Decide CGT Success

with Emily Moran

A look at the intersection of cell and gene therapy manufacturing and regulatory execution, including...
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