Three BLAs. Three companies. One industry-defining challenge.Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene TherapyIn 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 inspectionsIrving 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 fieldMegan 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 waitingThis 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.

The non-linear path is often the most powerful one.Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma.I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and consulting, and built her executive presence not through a linear climb but through curiosity, flexibility, and a willingness to take opportunities as they came.Cinta's journey began with a biophysics degree, a near-completed master's in mechanical engineering, and early laboratory work on human growth factors and the varicella zoster vaccine. Life changed direction more than once - moving across the country, starting a family, building a consulting practice that spanned 17 years - and through each transition, she added a new dimension to her expertise. Today she leads quality assurance, quality control, quality systems, and CMC regulatory at a company she describes as scientifically driven, ethically led, and genuinely exciting.What stands out about Cinta is her philosophy of leadership. She talks about moving from task-oriented thinking to big-picture ownership, about not micromanaging the talented people around you, and about the importance of keeping a personal board of directors - mentors you check in with at different stages of your career. She is also candid about the moments where she did not immediately see an opportunity for what it was, and honest about what that taught her.We talk about the following:- How a biophysics background and an unfinished master's became an asset in a 30-year career- Why Cinta moved from R&D to validation to quality and what each transition taught her- The value of 17 years in consulting and the leadership jump it created- How quality professionals can move from task-oriented contributors to big-picture leaders- The role of AI in quality and manufacturing, and why human oversight is non-negotiable- Why quality voices are still largely absent from board-level conversations- What it means to treat everyone in your company as a quality professionalCinta Burgos is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Cinta for sharing your incredible journey.Hope everyone enjoys the show.

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear.In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb.I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has lived through multiple acquisitions, spin-offs and complete pivots in therapeutic modality - each time emerging in a stronger, more interesting role than before.Mike began his career at APP Pharmaceuticals on a midnight QC shift, testing in-process samples on a graveyard schedule. From there, he followed the Abraxane asset into aBraxis Bioscience, built out supplier quality relationships across Central and South America, and eventually relocated from Chicago to New Jersey when Celgene consolidated its operations.That move opened the door to something entirely new - a CAR-T therapy program called BB2121 - a field Mike had never worked in and knew little about. Eight years later, he is now heading quality for in vivo CAR-T, one of the most cutting-edge modalities in all of biopharma.What makes Mike Ruane such a compelling guest is not just the breadth of his experience but his philosophy. He is a first-principles thinker who has thrived precisely because he never assumed the existing process was the right one. He asks the uncomfortable questions, encourages his team to do the same, and believes deeply that curiosity is the most underrated skill in quality.We talk about the following:How working in a lean generic drug environment early in his career shaped his mindset foreverNavigating multiple acquisitions and spin-offs within a single career arcWhat it takes to step into an entirely new therapeutic modality with no prior experienceWhy curiosity and asking the right questions is the real engine of career growth in qualityHow he interviews candidates and what most people get wrong when they are being interviewedMike Ruane is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Mike Ruane for sharing your incredible journey.Hope everyone enjoys the show.

CAR-T Saved Her Life. Why Can’t Most Patients Access It?In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast.I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we’ve had.Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her life and finally for the first time in 12 years put her in a complete remission.Now, two years on, she’s back.Still in a complete remission and requiring no further treatment nearly 8 years post CAR T infusion, Laurie is now considered cured even though her cancer is still labeled incurable.But what stood out to me in this conversation is that while the science has progressed… many of the systemic challenges patients face haven’t.We talk about the following:· What life actually looks like after being “cured” of cancer· The long-term side effects of 12 years of treatment· Why most biotech and pharma professionals have never spoken to a patient· The reality behind “patient centricity” in the industry· Why 80% of eligible patients still can’t access CAR-T therapy· The biggest bottlenecks in access - awareness and insurance· The financial burden of cancer treatment in the US· Where real progress is being made in cell and gene therapy· The future of CAR-T in autoimmune diseases and beyond· Laurie’s memoir and why every biotech employee should read itThis is an honest conversation about the gap between scientific progress and real-world patient impact.A huge thank you to Laurie for returning to the show and tell her story again! The work she is doing to help raise awareness is inspiring, and I’d urge anyone to connect with Laurie and follow her journey.If you work in biotech, pharma, healthcare, or you’d like to learn more about the challenges this industry still faces… this is one you need to hear.

Perseverance, perspective and people-first leadership in a global quality role.In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers.I really wanted to speak to Burak because he’s built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of what it actually takes to operate at that level.Burak’s career hasn’t been linear or easy. From starting his career in Turkey, moving to the US for his PhD, rebuilding his career from scratch, and navigating setbacks like job losses and site closures - his story is defined by perseverance and resilience.What stood out is how those experiences shaped the way he leads today. He leads from the front, sets high standards, but always stays close to his teams. Whether it’s staying late to close records or travelling globally to connect with people on site, his leadership is grounded in accountability and support.We talk about the following:Why perseverance is a defining trait for quality leadersLeading global teams across time zones and culturesBuilding a partnership mindset in quality instead of a “policing” approachCreating the right KPI culture and avoiding “watermelon metrics”Empowering teams to make decisions and building psychological safetyIf you are a quality professional managing multiple sites a leader struggling with KPIs, culture or engagement across sites, or someone who wants to step into a larger global role, then this episode is for you.Thank you Burak for sharing your incredible journey.Hope everyone enjoys the show.

Great quality leaders don’t just build systems - they build people, culture and confidence.In today's episode I was joined by Melodie Bryce, Chief Quality Officer at Kincell Bio.Melodie’s journey is a brilliant example of how diverse experience across manufacturing, supply chain, training and quality can shape a well-rounded quality leaderWhat stood out most is her approach to leadership. Melodie focuses heavily on building strong teams, developing future leaders and creating an environment where people are supported but also expected to take ownership. She combines high standards with a genuine commitment to coaching and mentorship.We talk about the following:· How to assess a quality organisation when you first join· Why hiring “stronger than you” is critical to building high-performing teams· What makes a great quality leader in fast-growing biotech environments· The importance of being a self-starter in quality roles· How to develop future leaders through coaching and mentorship· What to look for in the first two weeks of hiring someone· Leading through remediation and why it accelerates growth· Building a quality culture where everyone takes ownership· Balancing compliance with real-world decision making in cell therapy· Why “digging deep” is the foundation of leadership successMelodie is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality leader looking to develop stronger teams and future leaders, then this episode is for you.Thank you Melodie for sharing your incredible journey.Hope everyone enjoys the show.

If you are the first quality hire in a startup, your job is not to build everything at once.Your job is to build the right things first.That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality.A few practical points he shared stood out:· Follow the path of the product· Understand the patient experience· Focus first on what directly affects patient safety· Build procedures around processes that already work· Prioritise quality investment based on stage, modality, and riskIn early-phase environments, it is easy to create a long list of things you would like to have.An EQMS. A fuller audit programme. More formal vendor oversight. A bigger team.All of that matters.But not all of it matters equally on day one.Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it.That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate.A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment.

Quality is changing. The systems are getting smarter, the data is getting bigger, and the people side is still the hardest part.This week, I sit down with Dennis Rodman, Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics.Dennis brings a rare perspective to quality. With 13 years at BMS across operations, technical services, and quality, he now helps a gene editing company prepare for its first commercial product.In this episode, we explore:Why quality should be value-add, not a compliance hammerWhat separates companies that get digital transformation right from those that don'tHow to choose the right QMS without getting sold something you don't needWhy AI isn't delivering the ROI people expected, and what's going wrongHow to manage change when most people don't want itWhat early-career quality professionals should be doing right now to accelerateA practical, honest conversation for anyone working at the intersection of quality, systems, and people.

From accidental quality professional to global quality leader - Valerie Brown's story is one of courage, curiosity, and conviction.In today's episode I was joined by Valerie Brown, Head of Global Quality Assurance and Compliance at Thermo Fisher Scientific's Clinical Research Group.I really wanted to speak to Valerie because she brings something different to the quality leadership conversation. Yes, she has held senior quality roles across innovator companies, CDMOs, and now one of the largest CROs in the world. But what makes her story compelling is how she got there - and what she learned along the way.Valerie didn't plan to work in quality. At 22, she was asked to be a scribe for an FDA inspection. The host fell ill on the day. She stepped in - no preparation, no safety net - and handled it.Someone told her she had a knack for it. She wasn't sure she agreed. She still wanted to be in the lab, in manufacturing, doing what she knew. But that moment planted a seed.What followed was a career that took her across CDMOs, innovator companies including Gilead Sciences, and now Thermo Fisher - where she leads global quality assurance and compliance for the clinical research group. She has sat on both sides of the table, as sponsor and as service provider, and that experience shapes everything about how she leads.We talk about the following:How Valerie accidentally became a quality professional, and why that unplanned start shaped everything that followedWhat it felt like to host an FDA inspection at 22, with no preparation and no safety netHer philosophy of servant leadership and what it really means to lead with empathy in a regulated environmentThe challenge of transforming a fragmented quality organisation into a connected, strategic function at Thermo FisherThe difference between working on the innovator side versus the CRO side - and the unique skill set the latter demandsWhy speed and quality are not in conflict, and how embedding quality by design from the outset actually accelerates deliveryHer approach to talent development - why she prefers to grow leaders from within and how she identifies that potential earlyThe growing importance of AI and digital governance in regulated environments, and why quality professionals need to engage with these tools nowWhat keeps her up at night heading into 2026 - from talent gaps to trial complexity to the pace of regulatory changeThe advice she would give her younger self, and what she believes every aspiring quality leader needs to understandValerie Brown is a highly accomplished global quality leader whose career is a masterclass in adaptability, influence, and patient-centric thinking. She leads with purpose, develops people with intention, and approaches every challenge with the mindset of a problem solver - exactly the kind of leader our industry needs more of.Thank you Valerie for sharing your incredible journey. Hope everyone enjoys the show!

What if the leader you become is shaped less by your title, and more by the life you’ve lived?In today's episode I was joined by Dana Adcock, Quality Consultant and former Senior Director of Quality Systems.I really wanted to speak to Dana because she brings something different to the quality leadership conversation. Yes, she has decades of experience leading global audit and quality systems teams. But what makes her story powerful is how openly she connects her personal journey to the leader she has become.Dana shares how growing up as an adult child of alcoholics shaped her early career. Avoiding conflict. Playing small. Hiring people who thought like her. Shying away from leadership roles despite being promoted into them.Over time, through personal hardship, therapy, motherhood, and reflection, she stepped into leadership differently. More intentional. More courageous. More authentic.We talk about the following:· How early life patterns show up in leadership behaviour· Why many capable professionals avoid management roles· Moving from conflict avoidance to confident, purpose-led leadership· Building diverse teams instead of hiring people “just like you”· The mindset shift that happened during her “midlife awakening”· How adopting her daughter Abby changed how she leads and advocates· The link between personal resilience and professional courage· Showing up authentically on LinkedIn and why it felt terrifying· What “living the fourth quarter intentionally” really means· Advice for quality professionals who feel pressure to hide parts of themselvesDana is a thoughtful, courageous and deeply reflective leader who demonstrates that strength in quality leadership isn’t about technical authority alone – it’s about self-awareness, integrity and the willingness to grow.Thank you Dana for sharing your incredible journey.Hope everyone enjoys the show!