Three BLAs, Three Journeys, with Irving Ford, Megan Callan, and Jake Treese

Three BLAs. Three companies. One industry-defining challenge.

In this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from clinical development to commercial manufacturing for a cell or gene therapy product.

Jake Trees spent five years at Bristol Myers Squibb leading the quality function through the approval and launch of Abecma and Breyanzi, two of the first commercially approved CAR T cell therapies in the world.

Irving Ford was the first quality hire at the Celgene cell therapy facility in New Jersey, built the QC organisation from nothing, and has since led quality through four BLA approvals across multiple cell therapy companies, most recently at Adaptimmune for the approval of Aucatzyl.

Megan Callan is VP of Quality at Abeona Therapeutics, where she guided the quality team through the FDA approval of Zevaskyn, the first ever approved topical gene therapy for a rare genetic skin disorder.

These are three distinct products, three distinct companies, and three distinct leadership journeys. But across all three conversations, the same themes surface: what it takes to build a quality team from scratch, how to shift the mindset of a clinical organisation towards commercial standards, and what the moment of approval actually feels like after years of sustained effort.

In this episode, you will hear the following:

• Jake Trees on the setbacks on the road to BLA approval, including a refusal to file, cell growth failures during scale-up, and leading through a pandemic while hosting three health authority inspections
• Irving Ford on being the first quality hire at a new commercial cell therapy facility, building a team that grew to over 200 people, and why working in the gray is not a compromise but a core competency in this field
• Megan Callan on taking a quality team from five people to more than 60, coaching a clinical workforce into a commercial mindset, and what it means to empower people to make fast decisions when the patient is waiting

This episode is for anyone who is working towards a first commercial approval, scaling a quality function in cell or gene therapy, or trying to understand what it takes to lead through the most demanding regulatory and operational environment in modern pharma.

Thank you to Jake, Irving, and Megan for sharing their journeys.

Hope everyone enjoys the show.