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Let's Talk Quality

Hemish Ilangaratne

“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.

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  • 24 episodes
  • weekly
  • Avg 30 min
  • English

Episodes 24

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  • S4 · E9
    April 14 · 38 min· Video

    Laurie Adami on Life After CAR-T, and the Reality Patients Still Face

    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 it This 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. Timestamps: (00:00) A Journey of Survival and Remission (02:28) Life After CAR-T: Misconceptions and Realities (05:35) The Ongoing Battle: Side Effects and Daily Life (08:30) Patient Advocacy: Bridging the Gap with Pharma (11:00) The Disconnect: Patient Needs vs. Industry Understanding (13:48) Access and Awareness: The Challenges of CAR-T Therapy (16:36) The Future of CAR-T: Innovations and Progress (19:30) Writing a Memoir: Sharing the Patient Experience

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  • S4 · E8
    March 31 · 29 min· Video

    How to Drive KPI's the Right Way in Global Quality, with Burak Begen

    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 leaders Leading global teams across time zones and cultures Building a partnership mindset in quality instead of a “policing” approach Creating the right KPI culture and avoiding “watermelon metrics” Empowering teams to make decisions and building psychological safety If 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. Timestamps: (00:00) Introduction to Burak Begen (06:00) The Importance of Quality in Leadership (10:39) Cultural Influences on Leadership (16:11) Navigating Time Zones and Cultural Differences (21:03) The Role of KPIs in Quality Management (27:51) Looking Ahead: Future Aspirations

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  • S4 · E7
    March 24 · 25 min· Video

    Developing Future A-Player Quality Leaders, with Melodie Bryce

    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 leader What 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 success Melodie 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. Timestamp: (00:00) Introduction to Quality Leadership (04:01) Challenges in Quality Leadership (06:15) Developing Future Leaders (08:33) Hiring for Success (11:01) Assessing New Hires (13:57) Leadership Evolution (16:04) Cultural Insights in Quality (18:56) Advice for Aspiring Leaders

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  • S4 · E6
    March 17 · 31 min· Video

    Lessons from Building Quality in Start-Up Cell Therapy, with Rex Ready

    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 risk In 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. Timestamps: (00:00) Introduction (02:30) From Funeral Director to Biotech: A Unique Path (05:47) Early Experiences in Quality Control (07:26) Leadership in Quality: Building Relationships (09:57) Vision for the Future: Drug Development and Quality (15:04) Building Effective Relationships in Quality (17:59) Prioritizing Quality in a Lean Team (22:58) Planning for Future Growth in Quality (28:01) Reflections on Cell and Gene Therapy

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Showing 21–24 of 24 episodes