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Where the wild things are talked about. Miles Irving, author of The Forager Handbook, discusses wild food in our domesticated world and how to tap into the wildness within us. Visit www.WorldWild.org.uk for more!
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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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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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This week Miles speaks to Dan Siegel during their journey into the Oxford countryside. Dan is an author, therapist and founder of the interdisciplinary science of Interpersonal Neurobiology. This episode, the first of 3, introduces our new format which has Miles chatting to guests as they go for a walk that includes foraging, cooking and eating a m…
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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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'We would have had to move around to follow these foods'. This week we are joined by returning guest and good friend of the podcast Monica Wilde, author of The Wilderness Cure (Simon and Schuster UK, 2022). Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldwild.org.uk…
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'We live right in the middle of tragedy. that's our daily life'. This week we are joined by Richard Trudgen, author of Why Warriors Lie Down and Die and long-time community educator working with the Yolngu people of Arnhem Land, Northern Australia. Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldw…
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‘You can’t think it, you can’t create it from your mind. It’s not like that. You see what’s next. You keep walking'. This week we are joined by Holly Bridges, a somatic therapist and author of Re-frame Your Thinking Around Autism... Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldwild.org.uk…
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‘It's the collective unconscious of a community that draws forward ancestral ways that have been lost. because they are never really lost'. This week we are joined by Rachael Knight, an attorney with expertise in community land tenure security, community natural resource governance, legal empowerment, and community-led conservation and cultural rev…
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‘How are things lost and forgotten, and when are they reclaimed?' This week we are joined by Nina Lawrin, an ethnobotanist, artist, urban forager, permaculture designer, and general world nomad... Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldwild.org.uk…
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‘Foraging is one of those essential roots to care for landscapes, care for biodiversity'. This week we are joined by Duncan Mackay, an environmental policy specialist and an elected council member of the National Trust... Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldwild.org.uk…
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‘We’re trying to create initiation that would have been developed by a community for a community, in the absence of community’. This week we are joined by Lucy O'Hagan, an ancestral skills teacher, ethnobotanist, and wild food educator... Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldwild.org.uk…
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'When you realise that you’re part of nature, it’s not just learning about it, when you realise that you actually are nature... when you link back into all of this, you’re never on your own again'... Sign up to our mailing list: https://landing.mailerlite.com/webforms/landing/c1u1n9 Visit: www.worldwild.org.uk…
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What does a new cultural story look like? How can we weave new threads to unearth old ways of being and relating? Exploring Mark Lewis' Native American heritage we begin to see the power of a story and the degree of loss which goes into the construction of one. Through exploring how the lessons he has learnt could inspire a UK wild-food cultural re…
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The fourth and final part of a series on being rooted in your body, this week's guest is Irene Lyon, somatic practitioner and nervous system expert, who joins us to explore how our nervous systems can get regulated, how to work with past trauma, and humankind's relational nature. With an eye on what is possible for our bodies, our communities, and …
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'We've lost the language of the dorsal state, which our deeper states, our otherness states'. In the third of this series on the Polyvagal theory, we are joined by Holly Bridges who explains its connection to Autism and 'otherness states'. Tune in for a deep dive into bodily states, neuroception, and what might be possible as open up spaces for oth…
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In the second of a series on the Polyvagal Theory, we are joined with respected and passionate Polyvagal clinician, consultant and lecturer, Deb Dana, to speak about what kinds of stories we tell ourselves and what this really tells us about the state we are in. She provides insight into ways to re-connect with the ventral vagal - or as she calls i…
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In the first of a series on being in your body with reference to the Polyvagal Theory, we chat with Rachel Lambert, the singing forager, who not only regales us with songs about wild plants but also shares with us her journey through somatic therapy training, her teaching philosophy, the topics of stillness and movement, and the tendency in our soc…
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Ethnobotany seeks to investigate our relationship with plants, in the wider sense it is how we relate to the earth as a living planet. How we turn to it when we are met with frightening prospectives, and how we turn away from it in our quest for control. By tapping into humanity's exceptional potential, but not turning exceptionalist, we aim to see…
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Journey with us into the biochemistry of reward, addiction’s evolutionary role, and life-supporting mechanisms, plus how they can be subverted by mechanised systems. We also discuss bee-keeping, de-organisming things, foraging as normal human behaviour, and being human when we are less than fifty-percent human cells. Joining us is Fred Gillam, medi…
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We need to know the other living things around us. The work of remembering and documenting these intricate and intimate relations is one that receives little fanfare and even less funding. What Eleonora Matarrese is doing, then, is a deep unearthing of these relations through historical documents and literature. It is this that informs her cooking …
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What happens when you become your own datum? Social scientist and forager Leanne Townsend finds herself turning into her own study subject as she looks at the lifestyles and practices that make up modern foraging. What comes to the surface time and again are the relational aspects of our ways of being; that which tells us where our beliefs, our pra…
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We've been grounded and before we take another journey around our room we should take a look at what's growing in the front garden, you might be surprised how many edible plants can go in a salad of many wild things just under your nose! In this episode we're joined with Kate Blincoe, author of The No-Nonsense Guide to Green Parenting, to discuss h…
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