Why CMC and Manufacturing Decide CGT Success
Audio will be available soon!
About this Podcast:
A look at the intersection of cell and gene therapy manufacturing and regulatory execution, including CMC strategy and IND readiness. We unpack the operational realities of translating “beautiful biology” into patient-ready cures, guided by Emily Moran’s rare dual perspective as both a global industry expert and a clinical trial parent.
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.
Episode overview:
In this episode of The Cure Circle, host Dr. Smita Karpate is joined by Emily Moran, Founder of 3LB Consulting, a global expert at the intersection of cell and gene therapy manufacturing, CMC strategy, and regulatory execution.
While cell and gene therapies promise cures once thought impossible, most programs do not fail because of weak science — they fail because execution breaks down. Emily’s work focuses on closing that gap: translating beautiful biology into manufacturable, compliant, and patient-ready therapies.
Drawing from nearly two decades in life sciences, vaccines, and advanced therapies — and a deeply personal experience with her own children in a Phase I clinical trial — Emily brings a rare dual lens to this conversation: the precision of an operator and the urgency of a parent.
This episode goes beyond discovery and dives into the realities that determine whether a therapy ever reaches patients: IND readiness, CDMO selection, CMC strategy, GMP design, regulatory inspections, and investor confidence.
In this episode, Dr. Karpate and Emily Moran discuss:
- Why cell and gene therapy is ultimately an execution challenge, not just a scientific one
- How academic science must evolve to meet IND, CMC, and GMP expectations
- When and how scientists and clinicians should engage strategic partners and CDMOs
- What truly matters in CDMO selection — and how the wrong choice can derail years of work
- Why CMC strategy is the backbone of both regulatory success and investor confidence
- The concept of right-size process design in an uncertain, patient-driven market
- How regulators evaluate cell and gene therapy differently from traditional pharma
- Why manufacturing discipline, transparency, and focus determine patient safety
- How close we really are to patients — beyond clinical trials and hype
- What founders, scientists, and clinicians should not delay if they want to succeed in CGT
This conversation is a grounded, unsentimental look at what it actually takes to deliver cures — from lab benches to clean rooms to patients’ lives.
Episode by episode, The Cure Circle builds the missing bridge between innovation and impact.
This discussion is essential listening for anyone serious about bringing cell and gene therapies to the world.
This discussion is essential listening for anyone serious about bringing cell and gene therapies to the world.
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