Let's Talk Quality: The Podcast🎙️

In this week's episode we were joined by Joseph Franchetti, the recently appointed President of the Society of Quality Assurance (SQA). Joe 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 field of quality assurance. He discusses the role of technology, including AI and blockchain, the challenges and opportunities they present, as well as offering advice for future quality assurance professionals. 🎤01:25 - Election as President of SQA 🎤 05:09 - Vision for SQA and the Quality Assurance Industry 🎤 07:27 - Promoting Quality Assurance as a Career 🎤 10:09 - Challenges in Attracting Young Professionals to Quality 🎤 13:39 - The Role of Technology in Quality Assurance 🎤 27:26 - Advice for Future Quality Assurance Professionals 🎤 29:04 - Joe's Inspiration and Motivation 🎤 31:02 - Information about SQA and its Benefits It was a privilege to be joined by Joseph and hear him discuss his vision for the SQA, the wider industry, the role that technology will play, and what benefits the SQA can offer to future and existing members. Thanks for listening, enjoy the show!

🎙This is very special episode! Hemish 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 being developed by Kite Pharma. They were opening a clinical trial at UCLA with five patients. Laurie was to be patient number one. One month after her CAR-T treatment, Laurie was in complete remission. Laurie is now focused on patient advocacy, volunteering and fundraising for cancer research, especially CAR-T immunotherapy. [02:40] Laurie’s Diagnosis, Initial Treatment and Challenges [05:00] 12 Year Cycle of Six Lines of Therapy and Relapse [10:55] Hearing the Story of Emily Whitehead and CAR-T [14:22] Starting Sixth Line of Therapy in 2016 [14:57] Receiving a call about a CAR-T Trial in 2018 [18:55] Going Through CAR-T Cell Therapy [21:32] Complete Remission [24:18] Becoming a Patient Advocate Volunteer [26:41] Patient Access and Challenges [35:41] Response to the FDA Safety Advisory on CAR-T [41:30] Bridging the Gap Between Industry and Patients [46:16] The Potential and Future of CAR-T Therapy [51:34] Living Life to the Full [58:41] Meeting the People that Saved Her Life We hope you enjoy listening to Laurie’s story and that it gives hope to anyone affected by cancer. Laurie's mission is to raise awareness of the potential for CAR-T, and highlight issues around access to therapies, safety, and how we can bridge the gap between industry and patients. Thank you Laurie for sharing your story with us! Enjoy the show!

🎙 Episode 17 of Let's Talk Quality: The Podcast🎙️ In this conversation, Kimberly Wallbank, an experienced Quality Systems consultant 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 network and finding contracts, including the importance of volunteering and referrals. She emphasizes the need for flexibility, problem-solving skills, and a strong support system when starting out in contracting. 🎤 Kimberly's Background and Consulting Work 🎤 Reasons for Getting into Contracting 🎤 Changes in the Contracting World 🎤 Types of Projects and Team Sizes 🎤 Shifts in Remote and On-Site Work 🎤 Building a Network and Finding Contracts 🎤 Volunteering and Referrals 🎤 Dealing with Slowdowns in the Market 🎤 Skills Needed for Consulting 🎤 Motivation and Enjoyment as a Consultant 🎤 Advice for Starting Out in Contracting This is a conversation which is worth listening for anyone considering become a contractor. The contracting market has seen changes, with more consultants entering the market and building a network. Kimberly shares how flexibility, problem-solving skills, and the ability to adapt to different business models are important for success as a consultant. Thank you to Kimberly for joining us and sharing her journey. Hope you enjoy the episode!

Welcome to episode 16 of Let's Talk Quality: The Podcast🎙️featuring Stan Russell.   How do you add real value as a quality function?   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 quality to the organisation, which can result in a function that is seen as truly valuable. We discuss the following:   🎤 What is a 'Quality Culture' and why is it important?  🎤 Evolution of the perception of quality  🎤 How to measure the strength of a quality culture  🎤 Practical steps for changing perceptions  🎤 Utilizing management review meetings to enhance value  🎤How to facilitate team development  🎤 Stan's leadership style and analogies he has used to communicate  🎤 Advice for future quality leaders  🎤 The 'one' soft-skill that Stan would advise leaders to develop   This is a true insight into how quality leaders can ensure they are creating a function that puts people and the patient first, whilst enhancing the value and perception of the quality function within their organisation.   Stan is a true leader with an exceptional track record of quality leadership in enterprise and start-up organisations. A huge thank you for coming on the show!

📢 We're back for episode 15 of Let's Talk Quality: The Podcast🎙️ This week Hemish was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma to discuss the challenges of leading a global quality operation. "Act locally but think globally” 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 the challenges of leading a global quality operation of 500+ people, and the key traits that have helped shape her career path. Here are the key points discussed: 🎤The challenges of managing a global quality operation. 🎤Navigating the pandemic and transitioning into a remote world. 🎤Managing people in time-zones across the US, Europe, and Asia. 🎤Staying relevant with guidelines across different jurisdictions. 🎤Balancing compliance and innovation in the cell therapy industry. 🎤How to manage M&A and the complex transition that takes place. 🎤The evolution of guidelines and technology over the past two decades. 🎤How to stay relevant in a constantly evolving landscape. 🎤The skills Vaishali has developed to progress to where she is now. 🎤Vaishali's outlook on leadership, and within the ATMP space. Whether your objective is to work in a global operation or small biotech, this is a must listen for any current or aspiring quality leader. A huge thank you to Vaishali for giving us her time and for sharing such valuable insights into the mindset of a highly successful quality leader. Enjoy the show!

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, Hemish Ilangaratne was joined by Greg Furrow, Chief Quality Officer of Mustang Bio, to discuss his mission to raise awareness around the importance of industry 'experts' providing accurate and evidence-based information, rather than relying solely on personal experience or company practice. As a recognised 'expert' himself, Greg talks about organisations and individuals giving disclaimers about their opinions. He encourages both experts and learners to prioritize understanding compliance and to seek the facts rather than blindly trusting opinions. We discuss the following: 🎤The Importance of Understanding Compliance 🎤The Risk of Mistakes and Misinformation 🎤Clear Regulations in the Biotech Industry 🎤Answering Compliance Questions in ATMP's 🎤The Goal of Understanding Compliance 🎤Obligations of Leaders in Answering Questions 🎤Advice for Future Quality Assurance Professionals 🎤What Inspires Greg in his Career. Huge thanks to Greg for sharing his views and raising awareness around this important matter. Greg is on a mission to move away from giving subjective personal opinions based on organisational practises - towards a compliance framework anchored in explicit regulations and guidance documents. Enjoy the show! Link in the comments⬇

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 - patients that are often on their last line of treatment, and last hope of a successful treatment.   Hemish and Jason discuss leading the quality function in CAR-T cell therapy, the challenges faced in gaining approval for these therapies, the background of CAR-T cell therapy, the importance of building a strong team, the setbacks encountered during the approval process, and the motivation and inspiration behind the work.    🎤Understanding CAR-T Cell Therapy 🎤Leading the Quality Function in CAR-T Cell Therapy 🎤Building the Team and Planning for Success 🎤Challenges and Setbacks in the Approval Process 🎤Maintaining Motivation and Mission 🎤The Approval and Reflections 🎤Advice for Quality Leaders in Cell Therapy 🎤Considerations for the Industry 🎤Reflections on the Impact of Cell Therapy   It's an incredible, emotional, and highly insightful story. For anyone that is leading an organisation through clinical development, particularly within cell therapy, this is a must listen! A huge thank you to Jason Treese for joining us on Let's Talk Quality: The Podcast🎙️

🎤 Here's a clip from Episode 12 of Let's Talk Quality: The Podcast🎙️featuring Emily English, VP of Quality at Cartesian Therapeutics. Hemish and Emily discussed how Cartesian are advancing their mission of developing RNA cell therapies for patients with autoimmune diseases and how they are preparing for commercial readiness. ➡Available on all major podcast platforms! Link in the comments⬇

🎙In episode 11 of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne was joined by Brian Furmanski, Chief Regulatory Officer at Kriya Therapeutics, Inc. Brian spoke about the critical significance of excellent data integrity practises within the pharma and biotech industry. Drawing from his experience at the FDA, Brian talks us through his journey to Kriya, and how he is implementing a culture of data integrity in his current role. 🎤The importance of great data integrity in pharma and biotech. 🎤What does good data integrity look like? 🎤How Brian drives a culture of data integrity at Kriya. 🎤Data integrity gone wrong - real life examples. 🎤The consequences of poor data integrity practises. 🎤When biotech's should be developing more robust quality systems. 🎤How to start building better data integrity practises into your business. There are unfortunately, increasing volumes of data integrity violations cited in FDA warning letters and several examples of poor data integrity practises, resulting in serious consequences for the organisation. Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. We hope you enjoy the show! Available on Apple, Spotify and all other major podcast platforms.

Here's a list of all ten episodes so far and our guests⬇ Jaspreet Gill on scaling quality functions and leading with authenticity. Edward Armstrong on Adapting, Overcoming and Improvising. Ann Farnsworth on how to create an onboarding process through making quality relatable! Amnon Eylath on the origins of ‘phase-appropriate’ quality. Christy Mazzarisi, MSRAQA on her vision of building the next generation of female leaders. Greg Whitehead on leaving the industry in a better place. John McKay on four key pillars for achieving quality assurance excellence. Peggy Owens on developing her team to ‘operate in the grey’. Brian Nunnally on building resilience, finding your ‘north-star’ and developing a world-class QC team. Jacob Patterson on the skills you need to develop now, to be a quality leader of the future. Thank you to all of our incredible guests on the show so far! If you'd like to learn more about the show or would like to be a guest, please click on the link in the comments ⬇ We have some exciting guests coming up. Stay tuned! Rx Group