Episodios
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In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality, and the need for purpose-driven leadership. Lauren also highlights the importance of employee development, self-awareness, and the impact of pivotal moments in her career.
Takeaways:
Lauren fell into quality assurance rather than choosing it intentionally.Her early experiences in environmental monitoring were invaluable for her career.Quality roles allow for direct impact on patient safety and product quality.The quality assurance field is constantly evolving and challenging.Lauren values authenticity, integrity, and kindness in her leadership.She emphasizes the importance of connecting work to a greater purpose.Practical quality and team dynamics are crucial for success in quality assurance.Employee development should be tailored to individual goals and needs.Self-awareness is key to effective leadership and personal growth.Lauren believes in leaving a quiet legacy through her interactions with others.
For anyone looking to learn about how to hire great people, build a purpose driven culture, and develop their people, this is a great episode to listen to!
Thank you Lauren for joining us!
Hope everyone enjoys the show!
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Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it.
He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality leader.
Smith also discusses the need for quality to be seen as an asset and the importance of building empowered and diverse teams. He encourages aspiring quality leaders to become experts in one or two areas to differentiate themselves.
Takeaways:
Be willing to challenge the status quo and ask why things are done a certain way.Have an openness to learning and constantly strive to improve.Practice empathy and build relationships to create a positive quality culture.View quality as an asset and strive to integrate it early in the product realization process.Differentiate yourself as a quality leader by becoming an expert in one or two areas.
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In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech.
Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality and other departments within an organization. She discusses the challenges and rewards of working in a global role, including managing different time zones and cultures.
We cover:
Building strong relationships between quality and other departments.Managing different time zones and cultures.The importance of respect, authenticity, and work ethic.Using data to make informed choices.Putting yourself outside of your comfort zone.A huge thank you to Andrea for joining us on the show and for giving us her time. She's had an incredible 30-year career with Genentech/Roche, starting in 1995, and positively impacting so many lives along the way.
Hope you enjoy the show!
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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 passion for ensuring the reliability and safety of products. We talk about the benefits of gaining exposure to different areas of an organization and how that has helped Gary become the leader he is today!
We discuss the following:
The evolution of quality in the industry.The importance of a strong quality culture .The advancements in data integrity. Addressing fraud in the industry.Importance of crisis management.Learning what & how your operational partners do.Collaborating effectively.Chapters
00:00 Introduction and Podcast Inspiration02:56 Getting into Science and Transitioning into Quality07:12 The Role of Change Control in Gary's Quality Journey09:34 The Importance of Quality Culture and Data Integrity24:37 Pivotal Moments in Gary's Career Journey35:40 Important Values and Advice for Future Quality LeadersA huge thank you to Gary for joining us!
Hope you enjoy the show!
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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 learn about his journey and how he's gone developing himself - both as a quality professional and leader.
Chapters
00:00 Introduction and Background03:58 Early Interest in Science and Technology07:56 Transition from Manufacturing to Quality11:14 Transition into Leadership in Quality22:58 Impact on Product Quality and Reflections28:03 Current Focus and Future Plans34:12 Values for Success in Quality Assurance36:39 Leaving a Legacy and Advice for Future Leaders39:23 Conclusion and Contact InformationThroughout his career, Andrew has been proactive, from transitioning into quality from manufacturing to going back to school to do a Masters in Engineering Management to develop his leadership skills. He's shown self-awareness throughout his career and still to this day is always looking to improve himself as a leader.
Thank you for joining us, Andrew, and looking forward to seeing all the amazing work you and your team do for patients in the future.
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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 talk about the following:
Relocating from Miami to Michigan this year for a new VP role.Laurie's journey into science and quality. Working with different modalities, therapeutics and organizations.Laurie's love for quality and why she still has a passion for the industry.How the industry has evolved since she started.Communicating and leading cross-functionally.Moving from established organization to start-up. Laurie's hope for the futureAdvice for quality professionalsThe one person who inspired her the most.Laurie's story should give inspiration to a lot of people in the early stages of their quality career that would like to progress into a Head of Quality one day.
She is kind, generous and incredibly passionate about leadership, quality and bringing safer medicines to patients. She's shown resilience throughout her career which has allowed her to widen her remit and grow her career. Her ambition to further her career shines throughout this conversation.
Thank you Laurie for sharing your incredible journey from washing glass-wear all of those years ago to where you are now!
Excited to see you continue to impact lives in your career.
Hope everyone enjoys the show!
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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 discuss the following:
Transitioning from GCP to GMP.Industry Trends.Gaining GMP Experience.Advancing to VP from director.Building a Team and Pilot Plant.Collaboration with Stakeholders.Gaining Organizational Buy-In.Importance of Listening.Strategic Thinking.'Jim' is a great leader and most importantly a genuinely nice human being that has impacted people throughout his career in pharma and biotech. He is a credit to the industry and I'm sure his journey will inspire others to follow in his footsteps!
Thank you Jim for sharing your journey with us!
Hope everyone enjoys the show.
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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 able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders.
Takeaways
Kelly's journey into quality began unexpectedly from a background in broadcast journalism.Mentorship played a crucial role in shaping her leadership philosophy.Building confidence in decision-making is essential for quality leaders.Quality should be defined in terms of efficiency and safety.User feedback is vital for successful quality system implementation.Quality management systems should be tailored to the organization's needs.Evolving perceptions of quality have led to greater appreciation from leadership.Inspiring passion for quality involves recognizing individual interests.Legacy is defined by the success of those you mentor and support.Future quality leaders should be confident yet flexible in their decision-making.Chapters
00:00 Introduction to Quality and Career Journey02:55 Transitioning from Science to Quality Leadership06:03 Building Confidence in Quality Decisions08:52 Defining and Articulating Quality11:59 The Importance of Quality Management Systems14:58 User Feedback and Quality System Implementation17:59 Evolving Perceptions of Quality in Organizations20:55 Inspiring Passion for Quality in Teams23:50 Legacy and Mentorship in Quality Leadership27:02 Final Thoughts and Advice for Future LeadersThis is a great conversation about the significance of defining and articulating quality to your organisation and the benefits this brings.
Thank you Kelly for joining us on the show!
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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 opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Markus discusses the challenges faced by Autolus in their journey from a start-up to a commercial cell therapy company, the impact of COVID-19 and Brexit on their operations, as well a the transition from a paper-based QMS to an electronic QMS (EQMS) and the importance of having flexible systems.
Transitioning into the cell and gene therapy field requires a steep learning curveThe need for having the ability to work in a fast-paced, evolving environment.The importance of flexibility, adaptability, and collaboration The transition from a paper-based QMS to an EQMS The impact of COVID-19 and Brexit posed challenges for AutolusHow patient impact is the driving force for AutolusHow they strive to provide the best safety and efficacy dataEssential qualities for quality leadersChapters
00:00: Introduction and Overview05:04: Getting into Science and Quality Role09:06: Differences in Quality Practices Between Countries13:34: Transitioning into the Cell and Gene Therapy Field19:25: Implementing Quality Systems at Autolus23:26: Transitioning to an Electronic QMS26:38: Challenges of COVID-19 and Brexit30:43: Patient Impact in Cancer Treatment34:35: Preparing for Pivotal Trials and Commercialization37:28: Looking Ahead: Excitement for Commercialization39:14: Values to Live and Die By41:50: Leaving a Legacy44:05: Advice for Future Quality LeadersThank you Markus for sharing your incredible journey and excited to see you and your teams work come to fruition.
I hope you enjoy the show!
Markus Gruell | LinkedIn
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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 really open about the failures she has had to overcome which have helped her develop her career and others.
Takeaways
Finding your voice in leadership meetings Aligning quality objectives with business priorities are common challenges.The most rewarding aspects of working in quality.The value of listening more and speaking less for quality leaderThe importance of diverse perspectives and better decision-making.Chapters
00:00 Introduction and Background03:38 Building a Late Phase/Commercial Ready Quality Management System06:32 Transitioning from Big Pharma to Start-ups10:44 Key Challenges Faced in Career Development15:26 Finding Your Voice and Building Confidence in Leadership20:37 Aligning Quality Objectives with Business Priorities23:06 Shaping Leadership Approach and Mentoring Others24:55 Evolution of Quality as a Profession26:52 Pride in Career Achievements and Future Excitement32:36 Advice for Aspiring Quality LeadersHuge thank you to Sonia for coming on the show and being very open about the challenges she faced in her early career and how she managed to overcome these.
Hope you enjoy the show!
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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.
Irving talks about his journey from starting out his career as a Microbiologist before making his transition into the pharmaceutical industry. He started in a generics company which exposed him to a variety of product types. He worked his way up into leadership positions, across multiple different aspects of quality, to get to where he is now.
Takeaways
The benefit of working in multiple aspects of quality in your early careerDeveloping trust and building leadership capabilitiesDeveloping different generations of people Putting yourself out of your comfort zone in your careerKey ingredients for moving from clinical to commercial operations in cell therapyUnlearning everything you've learnt when working in cell therapyTraining for mindset and continuous developmentManaging stress, workload and your emotionsIrving's values, views on legacy, inspiration, and advice for future leaders!Chapters
00:00 Introduction and Overview of Irving Ford03:00 Transitioning from Clinical to Commercial Operations11:33 Building Strong Relationships and Creating a Positive Work Culture19:24 Challenges and Real-Time Decision Making in Cell Therapy25:30 Personal Values and Leaving a Legacy32:18 Advice for Future Quality LeadersHuge thank you to Irving for giving us his time!
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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 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 BenefitsIt 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!
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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 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 LifeI 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!
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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 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 ContractingThis 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!
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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 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 developThis 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.
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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 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!
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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 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!
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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 - 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, 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 TherapyLeading the Quality Function in CAR-T Cell TherapyBuilding the Team and Planning for SuccessChallenges and Setbacks in the Approval ProcessMaintaining Motivation and MissionThe Approval and ReflectionsAdvice for Quality Leaders in Cell TherapyConsiderations for the IndustryReflections on the Impact of Cell TherapyIt'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!
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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 forward their mission of developing safer cell therapies for patients with autoimmune diseases. We talk about the following in detail:
The work Cartesian are doing in RNA cell therapy and why it is exciting for patients.How early data suggests that Cartesian's lead programme can provide durable therapeutic benefit to patients with autoimmune diseases.Why Cartesian brought manufacturing in-house, the implications and the benefits of internal manufacturing.The transition in thinking and managing for risk and potential downtimes in the future versus planning for success.The challenges of bringing autologous cell therapies to patients at scale.Creating scalable processes for commercialisation, ensuring sustainability, and streamlining quality processes.At which stage in clinical development should organisations be thinking about creating scalable processes.How Cartesian are changing the way traditional cell therapies are developed and the implications of these changes.Emily’s values, her outlook on leadership, and what inspires her.It was a pleasure to speak with Emily. It’s hugely exciting to see the incredibly innovative work that her and the team at Cartesian are doing to help patients suffering from autoimmune diseases. I’m looking forward to seeing the progress that Emily and her team make in bringing these therapies closer to the patients as they scale in a commercial setting.
We will definitely have another conversation in 12 months time to see how things are progressing at Cartesian!
I hope you enjoy the show!
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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 Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics.
Brian has a large remit, covering regulatory, quality and clinical, and is passionate about all things data. He speaks about his background with the FDA, his journey to Kriya, and how he is implementing a culture of data integrity in his current role. We discuss the following:
The importance of data integrity in pharma and biotech.What does good data integrity look like? How Brian drives a culture of data integrity in his current role.Data integrity gone wrong - real life examples.The consequences of poor data integrity practises. When biotech's should be thinking about developing more robust quality systems.How to start building better data integrity practises into your business.The challenges of overseeing multiple functions in a start-up biotech.Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. For a biotech leader, especially if you're in preclinical studies, ensuring you are implementing and embedding a culture that drives data integrity excellence is paramount to your future success.
I hope you enjoy the show!
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