x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

PODCAST

Let"s Talk Quality

Hemish Ilangaratne

“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 to share

science life sciences

All Episodes

38:22

Joe Franchetti, on his vision for the Society of...

Let"s Talk Quality ·

2024/03/13

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

en

01:02:02

Laurie Adami on how CAR-T cell therapy saved her life

Let"s Talk Quality ·

2024/02/22

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

en

31:01

Kimberly Wallbank on how to transition into the world...

Let"s Talk Quality ·

2024/02/15

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,

en

38:22

Stan Russell on how to create a value-adding quality...

Let"s Talk Quality ·

2024/02/07

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

en

27:07

Vaishali Shukla on Quality Oversight in Global...

Let"s Talk Quality ·

2024/01/30

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

en

33:38

Greg Furrow on the risks of trusting 'expert opinions'.

Let"s Talk Quality ·

2023/12/20

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

en

45:31

Jason Treese on leading the commercialisation of BMS'...

Let"s Talk Quality ·

2023/12/07

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.We discuss leading the quality function in CAR-T cell therapy,

en

30:10

Emily English on scaling for success in RNA cell...

Let"s Talk Quality ·

2023/11/29

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 forward their mission of developing safer cell therapies for patients with autoimmune diseases. We talk about the following in detail:The work Cartesian are

en

30:29

Brian Furmanski on how to achieve a culture of data...

Let"s Talk Quality ·

2023/11/09

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 Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics. Brian has a large remit, covering regulatory, quality and clinical, and is passionate about

en

37:30

Jacob Patterson on the skills you need to develop...

Let"s Talk Quality ·

2023/10/26

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 thinks quality professionals should be doing now, from both a technical skills and a leadership perspective to help grow their career, develop succession,

en

35:24

Brian Nunnally on building resilience, finding your...

Let"s Talk Quality ·

2023/10/13

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 of his struggles and frustrations that many people will be going through right now. We spoke about why lateral moves and working in different functions

en

30:39

Peggy Owens on developing her team to 'operate in the...

Let"s Talk Quality ·

2023/10/05

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 evolving. We discussed the following:The challenges of overseeing quality at a CDMO in the CGT spaceHow to develop a team that can operate in uncertain

en

35:40

John McKay on his four key pillars for achieving...

Let"s Talk Quality ·

2023/09/28

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. We discuss the following:What it takes to be a great quality assurance leaderJohn's experience of being trained by Dr W. Edwards DemingThe importance of

en

35:46

Greg Whitehead on leaving the industry in a better...

Let"s Talk Quality ·

2023/09/21

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 this is important to him and what he is doing to help bring this vision to life. We spoke about the following:How not many people set out to have a career

en

33:12

Christy Mazzarisi on her vision of building the next...

Let"s Talk Quality ·

2023/09/14

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. Christy chairs a women in quality group for ASQ where men and woman come together to break down the barriers and challenges for woman in the workplace and

en

34:29

Amnon Eylath on the origins of 'phase-appropriate'...

Let"s Talk Quality ·

2023/08/30

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 originatedHow the FDA guidance has evolved, and how it startedAmon's role in liaising with the FDA to develop a 'graded approach' to qualityHow this approach evolved into the term 'phase-appropriate' What

en

27:48

Ann Farnsworth on how to create an onboarding process...

Let"s Talk Quality ·

2023/08/23

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 details the practical measures she takes when onboarding new team members. We cover the following in detail:Ann's customizable onboarding process for new

en

27:31

Edward Armstrong on Adapting, Overcoming and...

Let"s Talk Quality ·

2023/08/16

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 quality assurance leader in today's worldHow has quality evolved in the past decade The significance of what the team at Mustang Bio are doingAutologous cell

en

31:54

Jaspreet Gill on scaling quality functions and...

Let"s Talk Quality ·

2023/08/09

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 and gene therapyThe global potential of CGT, its impact on healthcare, and why it is exciting?The hurdles we will face which could slow down progressionWhat

en

59 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter