Let's Talk Quality Hemish Ilangaratne

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 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 SQA05:09 - Vision for SQA and the Quality Assurance Industry07:27 - Promoting Quality Assurance as a Career10:09 - Challenges in Attracting Young Professionals to Quality Assurance13:39 - The Role of Technology in Quality Assurance27:26 - Advice for Future Quality Assurance Professionals29:04 - Joe's Inspiration and Motivation31:02 - Information about SQA and its Benefits

It was a privilege to be joined by Joe 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, I hope you enjoy the show!

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 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. 
I wanted to speak with Laurie, to talk about her fight against follicular non-Hodgkin lymphoma, how she learnt about a new game-changing therapy called CAR-T, and some key issues around access to patients, safety concerns raised by the FDA, bridging the gap between industry and patients, and what she is doing now to raise awareness of the benefits and potential of CAR-T. We discuss the following:
[2:40] Laurie's Diagnosis, Initial Treatment and Challenges[5:00] 12 Year Cycle of Six Lines of Therapy and Relapse [10:55] Hearing the Story of Emily Whitehead and CAR-T in 2012[14:22] Starting Sixth Line of Therapy in 2016 [14:57] Receiving a call about a CAR-T Trial in Spring, 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] Laurie's 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
I really hope people enjoy listening to Laurie's story and that it gives hope to anyone affected by Cancer, and raises awareness of the potential for CAR-T Cell Therapy to save more lives.
There are a number of challenges that Laurie is on a mission to tackle, and I would urge people to listen to this episode to learn more about how we can bridge the gap between the industry and patients, and get safter, faster and more affordable access of these therapies to more patients like Laurie.
Thank you Laurie for sharing your story with us!

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 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 WorkReasons for Getting into ContractingChanges in the Contracting WorldTypes of Projects and Team SizesShifts in Remote and On-Site WorkBuilding a Network and Finding ContractsVolunteering and ReferralsDealing with Slowdowns in the MarketSkills Needed for ConsultingMotivation and Enjoyment as a ConsultantAdvice 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 and proactively finding contracts can be a challenge without the right support systems. Kimberly shares how flexibility, problem-solving skills, and the ability to adapt to different business models are important for success as a consultant.
Hope you enjoy the show!

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 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 qualityHow to measure the strength of a quality culturePractical steps for changing perceptions Utilizing management review to enhance your value How to facilitate team developmentStan's leadership style and analogies he has used to communicateAdvice for future quality leadersThe 'one' soft-skill that Stan would advise leaders to develop
This is a fascinating 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.

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 the challenges of leading a global quality operation of 500+ people, and the key aspects which have helped her to get to where she is now. We discuss the below points:
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 you want to work in a global operation or small biotech, this is a must listen for any current or aspiring quality leader. So many great insights into the mindset of a highly successful quality leader and some key traits to help accelerate your own leadership career.
I hope you 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, Greg Furrow, Chief Quality Officer of Mustang Bio, discusses 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 ComplianceThe Risk of Mistakes and MisinformationClear Regulations in the Biotech IndustryAnswering Compliance Questions in ATMP'sThe Goal of Understanding ComplianceObligations of Leaders in Answering QuestionsAdvice for Future Quality Assurance ProfessionalsWhat 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!