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A podcast devoted to children's speech and language needs.
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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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Markus Gruell on building and overseeing the Autolus quality organisation from the very early stages!
46:09
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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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Sonia Razzetti on how to find your voice and articulate the value of quality to senior leadership.
36:18
36:18
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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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Irving Ford on leading Adaptimmune through FDA approval and commercialisation of their T cell therapy, Tecelra.
37:15
37:15
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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, on his vision for the Society of Quality Assurance (SQA)
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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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Laurie Adami on how CAR-T cell therapy saved her life
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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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Kimberly Wallbank on how to transition into the world of contracting
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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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Stan Russell on how to create a value-adding quality function.
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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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Vaishali Shukla on Quality Oversight in Global Pharmaceutical Operations
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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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Greg Furrow on the risks of trusting 'expert opinions'.
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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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Jason Treese on leading the commercialisation of BMS' first approved cell therapies
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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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Emily English on scaling for success in RNA cell therapy.
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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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Brian Furmanski on how to achieve a culture of data integrity excellence.
30:29
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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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Jacob Patterson on the skills you need to develop now, to be a quality leader of the future.
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37:30
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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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Brian Nunnally on building resilience, finding your 'north-star' and developing a world-class QC team.
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35:24
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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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Peggy Owens on developing her team to 'operate in the grey'
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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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John McKay on his four key pillars for achieving quality assurance excellence
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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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Greg Whitehead on leaving the industry in a better place.
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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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Christy Mazzarisi on her vision of building the next generation of female leaders.
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33:12
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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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Amnon Eylath on the origins of 'phase-appropriate' quality
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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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Ann Farnsworth on how to create an onboarding process through making quality relatable!
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27:48
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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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Edward Armstrong on Adapting, Overcoming and Improvising as a Quality Leader
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27:31
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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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Jaspreet Gill on scaling quality functions and leading with authenticity.
31:54
31:54
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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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[audio:http://easyspeakpodcast.com/media/EasySpeakPodcast005.mp3] Click play above or right-click here to download mp3 Easy Speak Podcast Episode 005 In this episode, the Easy Speak Podcast was recorded on-location at New Jersey City University’s Children’s Learning Center which is headed by Dr. Kerry Giordano. Dr. Taylor had an opportunity to inte…
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[audio:http://easyspeakpodcast.com/media/EasySpeakPodcast004.mp3] Click play above or right-click here to download mp3 Easy Speak Podcast Episode 004 In this episode, Dr. Taylor shares two comments that were sent in by Easy Speak Podcast listeners, then he continues his talk about some of the symptoms associated with language impairments in school …
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[audio:http://easyspeakpodcast.com/media/EasySpeakPodcast003.mp3] Click play above or right-click here to download mp3 Easy Speak Podcast Episode 003 In this episode, Dr. Taylor first shares a comment and question sent in by an Easy Speak Podcast listener and explains how the listener’s question has inspired him to plan an episode to be recorded on…
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[audio:http://easyspeakpodcast.com/media/EasySpeakPodcast002.mp3] Click play above or right-click here to download mp3 Easy Speak Podcast Episode 002 In this episode, Dr. Taylor devotes most of the program to responding to a question that was sent in by a teacher who heard Easy Speak Podcast: Episode 001. The teacher has a background in special edu…
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[audio:http://easyspeakpodcast.com/media/EasySpeakPodcast001.mp3] Click play above or right-click here to download mp3 Easy Speak Podcast Episode 001 In this episode, listeners get an introduction to a podcast devoted to the speech-language needs of children.By Dr. Charles Reid Taylor
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