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Let's Talk Quality

Hemish Ilangaratne

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“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 t ...
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Leaders in Pharma

Impetus Digital

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Together with prominent Pharmaceutical industry leaders, Impetus Digital is covering topics around what it means to be an effective leader in Pharma today. We are also exploring topics related to digital transformation, patient-centricity, industry partnerships, customer engagement, diversity in Pharma, systems thinking, current healthcare challenges, environmental and supply chain concerns, and the myriad of ways that Pharma is working to collectively and positively disrupt healthcare. At I ...
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🚀 The first-ever returning guest on the podcast! In this episode, Hemish sat down with Brian Nunnally, Enterprise Quality Control Head at CSL, to dive deep into one of the most important topics in career growth - mentorship. Brian’s career is a perfect example of how mentorship, strategic career moves, and leadership development can accelerate your…
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🎙️Would you move to a new country with no network, no guarantees - just a dream and two suitcases? That’s exactly what Katarina Bartle did. She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc. 27 years later, she…
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In today’s episode, I was joined by Biana Torres, Senior Director of Quality Assurance at Encoded Therapeutics. I really wanted to speak to Biana because she has built a strong leadership career in quality, moving through both big pharma and small biotech. She’s now leading in the dynamic world of cell and gene therapy, where quality and adaptabili…
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In today’s episode, I was joined by Shane Ernst, Vice President of Quality at Empower Pharmacy. I really wanted to speak to Shane because he has built an incredible career in quality leadership despite being an introvert - a trait many in the industry can relate to. His journey from analytical chemist to VP is full of valuable insights on leadershi…
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In this episode of Let’s Talk Quality, Hemish sat down with Rob Dallimore, Head of Quality at Wugen, to discuss his inspiring 25+ year journey in quality assurance and leadership. Rob’s experience spans small molecules, biologics, and cell therapy, giving him unique insights into what it takes to succeed across different modalities. Rob shared inva…
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In today's episode, I'm joined by Jon Voss, one of the all-time quality greats! I've been working with Jon over the past 18 months. I'd describe him as a true gent - very humble, incredibly funny with a dry sense of humour, and someone who is so passionate about this industry. Unsurprisingly he has developed some of the leaders I've interviewed on …
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On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Hanh Nguyen, Site Head of Quality at Minaris Regenerative Medicine, a global CDMO specializing in cell and gene therapies. Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced …
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On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Sang Yoon, VP of Quality Assurance at ImmunityBio, a cell and gene therapy company based in California. Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and…
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On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan, Executive Director and Head of Quality at Mural Oncology, a fast growing biotech in Waltham, Massachusetts. Here's what they discuss: How Swetha's upbringing shaped her career progression 🚀 Moving from India to the US to pursue a career in s…
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In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences. Matthew’s journey is nothing short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership.…
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In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality…
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Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it. He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality …
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In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech. Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality a…
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In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics. Gary shares that his love for reading and learning, as well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his pass…
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In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit. Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to lea…
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In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing. Laurie (as she is known as to those close to her) recently relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory! We tal…
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In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics. I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional. We discu…
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Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer. Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being abl…
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In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK. Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opp…
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Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is real…
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We are back for Season Two of Lets Talk Quality! This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics. Irving has been through the commercialisation of four cell therapy products, most recently leading Adaptimmune through the BLA and FDA approval of their engineered T cell for solid tumour, Tecelra. …
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Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of collaboration and expanding relationships with international quality colleagues and regulators. Joe highlights the need to attract and educate younger professionals about the fiel…
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This is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006. After a 12 year battle fighting follicular non-Hodgkin lymphoma, and six lines of therapy, Laurie received a call from her oncologist, informing her about a new therapy called CAR-T, that was b…
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In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She discusses the changes in the contracting market, the types of projects she takes on, and the shift towards remote and on-site work. Kimberly also provides advice on building a n…
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This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation. Stan provides practical advice for leaders to change perceptions and measure the strength of a quality culture. He also shares his leadership style and the importance of storytelling and analogies in articulating qual…
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This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma. "Act locally but think globally”. This is the mindset that Vaishali has helped instil in her role to help harmonize processes, engage the global network, and create a 'one team' quality approach. Vaishali talks us through her journey in quality and some of…
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As a biotech professional, how do you know that the questions you ask 'experts' are accurate? Is the answer based on explicit regulations? Or is it based on personal opinion, which has been formed by historical organisational practise? In this episode, Greg Furrow, Chief Quality Officer of Mustang Bio, discusses his mission to raise awareness aroun…
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This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer. Jason 'Jake' Treese, played a critical role in the development, approval and commercialization of Abecma and Breyanzi; two cell therapies which have now treated 4,700 patients in clinical and commercial settings - patient…
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This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics. Cartesian is a clinical-stage biopharmaceutical company developing RNA cell therapies designed to benefit the wide range of patients with cancer, autoimmune diseases, and respiratory diseases. We discussed RNA cell therapy and how Cartesian are bringing fo…
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The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade. Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development. In episode 11 of Let's Talk Quality, I was joined by Bri…
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This week I spoke with Jacob Patterson, VP quality for a clinical stage biotech in Rhode Island. Jacob, by his own admission, has had to continuously adapt, learn and be flexible in his approach to quality leadership. We had a great conversation about what skills the quality industry will demand in the next 10-20 years. We spoke about what Jacob th…
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This week, we spoke with Brian Nunnally, and discussed some of the challenges that Brian faced throughout his journey to where he is now, Global Head of QC at CSL. Brian is hugely passionate and is driven by being a part of and leading the best quality control function in the world. What I liked about this conversation was Brian's honest assessment…
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This week I was joined by Peggy Owens, Head of Quality at Kincell Bio, a CDMO operating in early phase cell therapy. Peggy has an extensive background in cell therapy, having worked on both the CDMO and sponsor side. We had a great discussion about the challenges of building and leading a quality function in an area of medicine which is constantly …
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On this weeks show, I speak with John McKay, a well respected, well loved and highly seasoned quality assurance leader in pharma and biotech across clinical development and commercial manufacturing. John breaks down four key pillars that he believes are critical for achieving quality assurance excellence and developing world-class quality functions…
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Welcome to episode 6 of Let's Talk Quality. I was joined by Greg Whitehead. Greg is Head of Quality at Editas Medicine and has been working in biotech for 30 years, with a particular focus on cell and gene therapy. Greg has a vision to leave the quality assurance industry in a better place than when he started in the industry. We spoke about why th…
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There are 6 female CEO's of biotech companies with a market cap of over $5bn. In this episode, I was lucky to speak with Christy, who is an incredible advocate for females in quality and the wider biotech industry. Christy has an incredible passion for helping other females leaders overcome some of the struggles that she has faced in her career. Ch…
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What exactly is 'phase-appropriate' quality? In episode 4 of Let's Talk Quality, I was joined by Amnon Eylath to discuss the origins of the well known term, 'phase-appropriate' quality. Amnon and I discuss the following: What exactly is 'phase-appropriate' quality? The history of GxP and how the term originated How the FDA guidance has evolved, and…
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Welcome to Episode 3 of Season 1, of Let's Talk Quality: The Podcast. Hemish was joined by Ann Farnsworth. Ann is the VP of Quality Assurance for C4 Therapeutics, a clinical phase biotechnology organisation, headquartered in Massachusetts. Ann explains why understanding the history of quality assurance is a key part of her leadership philosophy and…
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Welcome to Episode 2 of Let's Talk Quality! Today's guest is Edward Armstrong. Ed is the VP of Quality at Mustang Bio. What stood out about the conversation with Ed was his passion for continuous learning in quality and why all QA professionals should always be looking to adapt, overcome and improvise in quality and compliance. What makes a great q…
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Welcome to Episode 1 of Season 1, of Let's Talk Quality: The Podcast. Hemish was joined by Jaspreet Gill, Chief Quality Officer at Sangamo Therapeutics. We discussed the incredible potential of cell and gene therapies and the role that quality leaders play in helping the industry reach its full potential. Transitioning from small molecule to cell a…
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In this podcast, Jennifer Curtis and David Jackson share valuable insights on global commercial excellence. They highlight strategies to optimize product launches and maximize revenue potential based on recent research conducted by ZS on the top 25 pharma companies.Hosted by: Jennifer CurtisProduced by: Matilda Males & Sophie McManusFeaturing: Davi…
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In this episode, ZS leaders Jennifer Curtis, Pranav Srivastava and Surbhi Puri discuss customer experience in cell and gene therapy, drawing on recent ZS patient experience study outcomes.Hosted by: Jennifer CurtisProduced by: Matilda Males & Sophie McManusFeaturing: Pranav Srivastava and Surbhi Puri…
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When most global pharmaceutical launches are as likely to underperform as overperform, how can leaders ensure they prepare their organizations for success? On this episode of Inside Global Pharma, ZS leaders Jennifer Curtis and Maria Whitman share their perspectives on the next era of global launch and where leaders should be investing to set up th…
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Our latest episode on Oncology Portfolio Strategy features Josh Hattem sharing insights into the oncology therapeutic area and implications of different customer lenses on portfolio design and strategy. This episode builds on concepts addressed in a previous Inside Global Pharma episode, The Value of Focus.Hosted by: Jennifer CurtisProduced by: Mat…
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The road to commercializing cell and gene therapies was long, but during the last years we have observed strong market growth and a very crowded pipeline. In this episode, we discuss more challenges and what it takes to successfully launch and commercialize these advanced therapies.Hosted by: Jennifer CurtisProduced by: Matilda MalesFeaturing: Sank…
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In light of World AIDS Day 2021, in this episode of ‘Inside Global Pharma’ we focus on the journey to eradicating AIDS and discuss themes of inequality today and how they can be managed.Hosted by: Jennifer CurtisProduced by: Matilda Males and Sophie McManusFeaturing: Mark Saunders and Bill CoyleBy ZS
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