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.

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.

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.

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.

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:

1. Why quality should be value-add, not a compliance hammer
2. What separates companies that get digital transformation right from those that don't
3. How to choose the right QMS without getting sold something you don't need
4. Why AI isn't delivering the ROI people expected, and what's going wrong
5. How to manage change when most people don't want it
6. What early-career quality professionals should be doing right now to accelerate

A 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:

1. How Valerie accidentally became a quality professional, and why that unplanned start shaped everything that followed
2. What it felt like to host an FDA inspection at 22, with no preparation and no safety net
3. Her philosophy of servant leadership and what it really means to lead with empathy in a regulated environment
4. The challenge of transforming a fragmented quality organisation into a connected, strategic function at Thermo Fisher
5. The difference between working on the innovator side versus the CRO side - and the unique skill set the latter demands
6. Why speed and quality are not in conflict, and how embedding quality by design from the outset actually accelerates delivery
7. Her approach to talent development - why she prefers to grow leaders from within and how she identifies that potential early
8. The growing importance of AI and digital governance in regulated environments, and why quality professionals need to engage with these tools now
9. What keeps her up at night heading into 2026 - from talent gaps to trial complexity to the pace of regulatory change
10. The advice she would give her younger self, and what she believes every aspiring quality leader needs to understand

Valerie 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 themselves

Dana 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!

In today’s episode, Hemish was joined by Anthony Mire-Sluis, Head of Global Quality at Gilead.

Tony because has lived quality from every angle - UK government and regulatory work, a stint at the FDA, and then senior global leadership roles in major pharma. That perspective is rare, and it shows in how he builds teams and drives change.

Tony’s journey is a brilliant example of how strong quality leadership is less about having all the answers, and more about building trust, listening properly, and creating systems that let people do their best work.

He talks about the following:

• How Tony’s science background (immunology, genetics, and a PhD) shaped the way he leads quality

• What 10 years in government taught him about great vs poor regulatory filings - and why he moved into industry

• The difference between leading a US-centric quality organisation vs a truly global one

• Why building a trusted leadership team is the non-negotiable for running global quality at scale

• How Tony uses his first 90 days: listening, due diligence, and getting under the skin of the culture

• Why he starts transformation from the shop floor - not from the senior leadership layer

• Digital and AI in quality: fix the process first, then digitise (otherwise you just create a clunky digital version)

• How to reduce firefighting and move quality from reactive to proactive - with better workflows and connected systems

• Managing resistance to change and bringing people along early so adoption sticks

• Advice for aspiring quality leaders: networking, knowing yourself, and broadening your experience across quality

Anthony Mire-Sluis is an authentic, people-first quality leader with a rare blend of regulatory depth and big pharma operational experience - and he’s exactly the kind of leader who makes quality a true enabler of the business.

Thank you Tony for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, Hemish was joined by Ed Armstrong and Jon Voss, two Quality leaders who’ve both worked across early-stage, clinical, and complex biotech environments.

Ed and Jon share what they’re seeing on the ground - from funding pressure and modality shifts, to how regulators are engaging, and where Quality leaders are gaining (or losing) influence.

They talk about the following:

1. The current state of pharma and biotech, and whether the market has really bottomed out
2. Which modalities and parts of the market feel resilient, and which are still struggling
3. How FDA leadership changes are (and aren’t) showing up in day-to-day work
4. The shift toward written-only FDA interactions and what that means for sponsor–agency relationships
5. Whether regulators are prioritising speed or risk, and how that tension plays out
6. Where AI and digital tools are genuinely adding value today, versus where there’s still a lot of noise
7. How Quality has evolved from “policing” to partnership over the last 20 years
8. Why pragmatic, phase-appropriate Quality systems matter more than perfection
9. Burnout in senior Quality leaders and the risk of doing too much with too few people
10. What separates Quality leaders who are listened to from those who are merely tolerated
11. What the strongest Quality teams will be doing differently by the end of 2026

Ed and Jon bring a huge amount of perspective, humility, and real-world insight to this discussion. This is a conversation for anyone leading Quality through uncertainty and trying to balance patient safety, speed, and sustainability.

Hope everyone enjoys the show!

This week on Let’s Talk Quality, we’re joined by Elisabeth Hutchins, Senior Director of Quality at Upstream Bio, for a conversation focused entirely on one theme:

How quality professionals make the transition from tactical execution to strategic leadership.

In this episode, Elisabeth shares:

• What changes as a company enters Phase 2 and Phase 3
• The moment she realised she needed to stop firefighting and start planning
• How she built the quality team around her to enable strategic thinking
• The soft skills that shape strong future QA leaders
• How to balance urgent deliverables with long-term quality strategy
• Why confidence is essential before others trust you as a strategic partner

Elisabeth brings an honest and practical perspective that will resonate with managers and directors looking to step into bigger leadership roles.

A highly insightful discussion for anyone looking to evolve into a strategic quality leader.