Queens of Quality Podcast

Metis Consulting Services ML Bradley welcomed Kara Harrison to the "Queens of Quality" podcast, where Kara Harrison shared her extensive career journey in quality assurance, from the USDA and FDA to various consulting roles. Both Kara Harrison and Metis Consulting Services ML Bradley discussed the evolution of the consulting industry, emphasizing the importance of clear client scope and the challenges posed by clients who insist on incorrect approaches. A key talking point centered on the misconception among sponsors that outsourcing absolves them of responsibility, particularly concerning vendor qualification and oversight, which directly contradicts regulatory guidelines such as ICH E6R3.

Forest Flodin and Michelleanne talk about how we wish projects could go, and what some of the stumbling blocks are along the way.

This week joined by Nicole Latimer, CEO of Medrio. What do we see as we look to the future.

What do we need to ensure data integrity? How do we get there? What are some pieces we can avoid along the way?

Michelleanne and Katrina and Data Management and Quality!

Matt Bodo and Michelleanne discuss how we have yet to move the needle and why.

Queens of Quality Returns for Season 3! My first guest is Dr Lucia Mokres of Araneae Consulting. Welcome!

In this episode of Queens of Quality, co-hosts Michelleanne and Jen engage with guests Emily Barker and Steve Thompson in a conversation on AI and ethics. Major topics include AI's difficulty in dealing with negative constructs, limitations, and the role of the Algorithm Review Board (ARB). The team frames the conversation by comparing AI to different aspects of human behavior, illustrating its limitations. They delve into negative programming and its implications on pattern matching in AI.  The episode also highlights the importance of a diverse cross-section of people in ARB to minimize bias and raise various ethical considerations. Lastly, it expands on the ARB's potential in handling AI's limitations from different perspectives, confirming their readiness to tackle new challenges and inviting more diverse voices to join the conversation. 00:31 Introduction and Welcome 00:54 Discussion on AI and Ethics 01:48 Understanding Negative Programming in AI 02:12 Exploring AI's Limitations: Pattern Matching and Negation 04:27 AI's Struggle with 'No' and 'Not' 07:33 AI's Lack of Self-Awareness and Empathy 09:06 The Role of AI as a Tool, Not a Replacement 10:16 The Importance of Human Involvement in AI 11:00 AI's Struggle with Uncertainty 14:10 The Role of the Algorithm Review Board (ARB) 22:32 Conclusion and Invitation for Participation   Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Connect with Steve Thompson LinkedIn: https://www.linkedin.com/in/stevethompsonsocal/ Connect with Emily Barker Linked In: https://www.linkedin.com/in/mannbark/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: hello@metisconsultingservices.com

In this episode, the hosts, Michelleanne and Jenn, continued their conversation with Steve Thompson and special guest Emily Barker, an experienced tech professional focusing on biopharma, biotech, and AI. They discussed Emily's unique perspective, bringing tech and biopharma together, delving further into AI ethics, and creating an algorithm review board. They spoke on using AI ethically and avoiding potential catastrophes. The podcast touched on the constant evolution of AI, the careful and informed approach to its use in the life sciences field, and the importance of bringing together diverse perspectives to shape its future in a beneficial manner. They highlighted the significance of creating an AI lexicon to ensure all industry players speak the same language and invited community participation. 00:31 Introduction and Guest Introduction 01:25 Discussing AI Ethics and Algorithm Review Board 02:51 Understanding the Complexity of AI Landscape 03:56 The Importance of Language Consistency in AI 04:47 Exploring the Concept of Algorithm Review Board 06:10 The Challenges of Reproducing AI Results 07:44 Understanding the Algorithm in AI 10:47 The Role of Algorithm Review Board in AI 12:21 The Importance of Involving Diverse Perspectives in AI 13:01 The Future of AI in Life Sciences 23:02 The Need for Pre-Work in AI 26:48 Conclusion and Call to Action   Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Connect with Steve Thompson LinkedIn: https://www.linkedin.com/in/stevethompsonsocal/ Connect with Emily Barker Linked In: https://www.linkedin.com/in/mannbark/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: hello@metisconsultingservices.com

In this episode of "Queens of Quality," hosts Michelleanne, Jen, and guest Steve Thompson delve deeper into the ethical implications of AI in life sciences. They emphasize the necessity of an Algorithm Review Board (ARB) to oversee the ethical use of AI in clinical trials and beyond. Acknowledging the rapid evolution of technology and its complex application in healthcare, they stress the importance of collaboration and diverse representation to ensure ethical practices. Tune in! During this episode, you will learn about; 00:31 Introduction and Welcome Back 00:40 Discussion on AI and Clinical Trials 01:17 The Concept of Algorithm Review Board 01:44 The Evolution and Impact of Technology 02:35 The Synthetic Patient Concept 04:10 The Need for Ethical Standards in AI 05:42 The Role of Institutional Review Boards 08:49 The Importance of Diverse Representation 10:48 The Idea of Algorithm Review Board 10:59 The Need for Collaboration and Inclusion 12:15 The Risks of Misusing AI in Medicine 20:26 The Importance of Preventative Measures 21:12 Call to Action for Audience Participation 24:30 Conclusion and Invitation for Future Discussions   Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Connect with Steve Thompson LinkedIn: https://www.linkedin.com/in/stevethompsonsocal/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: hello@metisconsultingservices.com

In this engaging episode of "Queens of Quality," Michelleanne welcomes Steve Thompson to delve into the realm of ethical AI in life sciences. They explore the excitement and challenges surrounding AI's evolution, emphasizing the critical need for an ethical compass in its application. With insightful discussions on bias, data integrity, and the multidisciplinary approach necessary for success, Steve and Michelleanne highlight the intricate balance between technological advancement and ethical responsibility. Their conversation teases a promising solution, promising a deeper exploration in the next episode. Tune in! During this episode, you will learn about; 0:00:32 - Introduction and Guest Introduction (Steve Thompson) - Discussing the Importance of Ethical AI 0:01:47 - Guest's Background and Journey into AI 0:02:11 - The Current State and Future of AI 0:03:22 - The Ethical Dilemmas in AI 0:05:34 - The Importance of Continuous Improvement in AI 0:11:35 - The Challenges of Creating Synthetic Patients 0:13:32 - The Role of AI in Risk Management 0:18:48 - The Importance of Multidisciplinary Teams in AI 0:24:30 - The Ethical Considerations in AI 0:28:48 - Conclusion and Teaser for Next Episode        Love the show? Subscribe, Rate, Review, Like, and Share!   Let’s Connect!   Connect with Steve Thompson LinkedIn: https://www.linkedin.com/in/stevethompsonsocal/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email:  hello@metisconsultingservices.com

Join Michelleanne and Jenn in the Season 2 finale of Queens of Quality as they reflect on the evolution of quality and compliance in the pharmaceutical industry. Dive into insightful discussions on soft skills, inspection readiness, regulatory changes, and the importance of simplicity in this dynamic field.  Get ready for engaging conversations and a sneak peek into what's ahead in the next season!   Tune in!   During this episode, you will learn about; 0:00:32 - Introduction and Season Wrap-up 0:01:07 - Discussion on Soft Skills in Quality 0:02:45 - Insights on Inspection Readiness 0:04:03 - Changes in Regulations and Future Trends 0:06:44 - The Importance of Being a Quality Human Being 0:08:25 - The Need for Quality in Every Role 0:10:44 - Conclusion and Look Forward to Next Season   Love the show? Subscribe, Rate, Review, Like, and Share!   Let’s Connect!   Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com  

Welcome to another episode of Queens of Quality. In this episode, we explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1. These revisions bring significant changes to the pharmaceutical industry's regulatory landscape, emphasizing the importance of quality by design in clinical trials. Tune in! During this episode, you will learn about; 0:00:49 - ICH Introduction 0:02:13 - The Significance of ICH E6 and E8 0:04:41 - The Global Impact of ICH  0:08:02 - The Evolution of Technology 0:11:30 - Quality by Design  0:18:51 - Operational Feasibility 0:21:16 - Complementary Guidance              Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com

Welcome to another episode of Queens of Quality. Join us in this podcast episode as we decode compliance and quality assurance complexities in the pharmaceutical and biotech industries with Sherice Mills, founder of ADROIT Risk Management. Sherice enlightens us on the evolution of REMS programs, their importance in patient safety, and the role of the FDA. We also delve into the challenges in leadership and innovation in these industries and the need for a partnership mentality for revolutionary ideas. The episode further explores the changing expectations of the FDA from vendors, the impact on patient safety, and the need for trusted advisors. Don't miss out on this informative conversation. Tune in! During this episode, you will learn about; 0:00:32 - Guest introduction: Sherry Mills, founder of Adroit Risk Management. 0:01:39 - Discussion about the history and origins of REMS programs. 0:04:14 - Mention of the FDA's authority to require additional safety measures. 0:06:03 - Explanation of the various components of REMS programs. 0:09:12 - Discussion on the challenges of standardizing REMS programs globally. 0:16:33 - Challenges in Leadership and Innovation 0:18:58 - Addressing resistance to change within the pharmaceutical industry. 0:20:23 - Importance of in-house expertise and trusted advisors. 0:24:16 - Reference to the REMS Industry Consortium (RIC) and the need for industry collaboration. 0:27:46 - Mention of upcoming workshops and exploration of AI in the industry. 0:31:56 - Closing remarks and contact information.              Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Connect with Sherice Mills; LinkedIn: https://www.linkedin.com/in/shericerm/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com

In this episode of Queens of Quality, the hosts interview Cheryl McCarthy, a seasoned professional in the pharmaceutical and biotech industries. They discuss the complexities of quality and compliance, the new ICHU6R3 guidance, and the importance of explaining the rationale behind actions. The conversation also explores the evolution of quality control, the integration of Agile methodology, and the shift in quality culture towards collaboration. They conclude by discussing the role of auditors, the potential benefits of constructive feedback, and the learning opportunities presented by audits. Tune in! During this episode, you will learn about; 0:00:32: Introduction of the first-ever guest, Cheryl McCarthy, her background, and her consulting group, Anchor. 0:03:58: Discussion on the impact of decisions in quality assurance and risk-based approaches. 0:08:12: Conversation about the proactive and preventative approach in quality management. 0:15:33: Highlighting the importance of collaboration and communication in quality culture. 0:18:39: Emphasizing the ultimate target in quality management, which is the patient. 0:19:48: Discussion on the need for processes and controls in quality management. 0:21:07: Conversation about the value of audits and opportunities for improvement. 0:23:54: Acknowledgment of the importance of a collaborative and non-confrontational approach in quality management. 0:27:10: Closing remarks and contact information for the podcast.              Love the show? Subscribe, Rate, Review, Like, and Share!   Let’s Connect!   Connect with Cheryl McCarthy; LinkedIn: https://www.linkedin.com/in/cherylmccarthy/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com  

In this episode of the Queens of Quality podcast, we explore the importance of discussing failure alongside success in the pharmaceutical and biotech industries. With only a small percentage of drugs making it to clinical testing, failure is an integral part of the industry. We discuss the lengthy process of bringing a product to market, the challenges faced, and the significance of collaboration between academia and the industry. Join us as we delve into the complexities of drug development and the lessons learned from failures. Don't forget to subscribe, like, review, and share the podcast to help us continue the conversation. Tune in! During this episode, you will learn about; 0:00:32 The Queens of Quality discuss the topic of failure 0:02:05 From Bench to Bedside: Pharma Industry's Journey 0:05:14 The Challenge of Identifying the Right Target 0:07:57 Ensuring Support and Documentation for Clinical Phases 0:10:10 Phase One Trials: High Failure Rate and Cost Implications 0:12:05 Multiple Development Paths and the Importance of Phase Two 0:14:22 Phase Three Trials: Expanding Patient Population and Clinical Programs 0:15:52 The Final Stretch: Phase Three Programs 0:16:19 The Reality: Fast-paced and Not Funny 0:18:23 Long Timelines and Challenges in Clinical Trials 0:20:35 Study Drug Adherence: A Critical Factor in Audits 0:21:15 High Adherence Rate in Children's Oncology Study 0:23:25 The Importance of Reinvestment and Balancing Product Pipeline 0:25:31 Collaboration between academia and industry in pharmaceutical innovation 0:28:02 Progress and success in the pharma and biotech industry 0:31:16 Wrapping up the Queens of Quality Podcast              Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com

Leadership Support and Inspection Readiness: Ensuring Organizational Excellence In this enlightening episode of "Queens of Quality," hosts Michelleanne and Jenn delve into the pivotal role of leadership support in achieving operational efficiency, inspection readiness, and organizational success. They discuss the often underestimated impact of leadership in various areas, including resources, teamwork, communication, and preparedness.    Discover how leadership support can foster a culture of open communication, acknowledge imperfections, and drive excellence across departments. Join the conversation as they share valuable insights into effective leadership practices and the key to maintaining a balanced, successful organization.   Tune in! During this episode, you will learn about; [00:00:32] Introduction: Michelleanne and Jenn discuss the crucial role of leadership support in effective organizations. [00:02:28] Leadership's impact on departmental efficiency, adherence to guidelines, and overall effectiveness. [00:08:57] Emphasis on creating a safe environment for team members to share challenges, even during personal difficulties. [00:13:07] Exploring the connection between leadership actions, communication, and team members' sense of security. [00:15:27] Jenn's experience adapting leadership discussions to resonate with different perspectives. [00:19:41] Michelleanne's encounters with frequent inspections and understanding the "why" behind operations. [00:25:56] The hosts emphasize the mission-critical nature of leadership support in maintaining organizational excellence. [00:29:34]:  Call to action and closing remarks              Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com  

This podcast episode, hosted by Jen and Michelleanne, dives deep into the intricacies of pharmaceutical and biotech industries, focusing on audits, vendor qualifications, and quality compliance. The hosts unravel how health authorities are intensifying their involvement in vendor collaborations, the increasing importance of contract owners in the qualification process, and the instances where qualification audits become vital for organizations. The episode also delves into vendor qualification and audit scheduling, the role of SOPs and quality manuals, and the challenges of vendor reassessment during mergers and integrations. The conversation concludes with an exploration of respect, empathy, transparency, and open communication in vendor management and how to balance regional requirements in the qualification process. This episode is an enlightening and exciting rollercoaster ride into the world of pharmaceutical vendor management.   Tune in!   During this episode, you will learn about the following; 0:00:31 - Start of the show and Introduction of Hosts 0:02:14 - Qualification and Requalification Process Discussion 0:08:32 - Misconceptions About Vendor Qualification 0:19:04 - Document Access and Audit Scheduling Issues 0:24:16 - The Importance of Quality in Business 0:30:07 - Harmonizing Global and Local Operations 0:33:29 - Assessing Data Entry Accuracy and Guidelines 0:36:08 - Hosts' final thoughts and sign-off   Love the show? Subscribe, Rate, Review, Like, and Share!   Let’s Connect! Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com

Ever thought about the crucial role culture plays in the pharmaceutical and biotech industries? What if we told you it's not just about hiring quality people but also about cultivating an atmosphere of strong communication, compliance, and a deep understanding of roles and responsibilities? Welcome to season two of Queens of Quality. In our latest episode, we dissect this complex subject, peeling off the layers that often lead to group dynamics and group thinking pitfalls. We share some insights on creating a culture that doesn't just dwell on 'do what I say' but promotes trust and objectivity.   Did you know the importance of humor in maintaining your sanity amidst the daily grind of hard work? We couldn't agree more! Balancing the seriousness of the work with our mental well-being is an art that needs mastering. Tune in as we discuss the art of decision-making, demonstrating our work outcomes, and proactively mitigating risks using a Risk Evaluation and Mitigation Strategy (REMS). As we delve deeper into this conversation, we also touch upon the importance of evaluating potential employers and the significance of quality control in preserving your future. Join us for insights, laughter, and shared experiences on this journey toward cultivating a culture of quality. Tune in!   During this episode, you will learn about; (0:00:31) - Start of the show and Introduction of Hosts (0:01:00) - Overview of Season Two Topics (0:03:00) - Discussion on Culture of Quality (0:11:24) - The Role of Humor in the Workplace (0:16:27) - The Importance of Conservative Decision-Making and REMS (0:21:57) - The Art of Interviewing Potential Employers (0:27:03) - Maintaining Quality Control and Safeguarding Future   Love the show? Subscribe, Rate, Review, Like, and Share!   Let’s Connect! Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com

Join in another fantastic episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about Risk Evaluation and Mitigation Strategy (REMS). We talk about the history of Thalidomide and why REMS closely monitors it. Moreover, we discuss the different pieces of REMS and the difference between Single REMS & Shared REMS. Additionally, we talk about the difference between Pharmacovigilance (PV) & REMS, The REMS Industry Consortium (RIC), and how to get started with a REMS program.   Tune in!   During this episode, you will learn about; [00:30] Episode introduction [00:37] Today’s theme; Risk Evaluation and Mitigation Strategy (REMS)  [01:18] When was REMS started? [01:44] The history of Thalidomide and why REMS closely monitors it [07:03] Single REMS vs Shared REMS  [11:20] Risk piece in REMS program  [12:21] Evaluation piece in REMS program  [17:35] The difference between Pharmacovigilance (PV) and REMS [18:35] Mitigation piece in REMS program  [21:44] The REMS Industry Consortium (RIC)  [25:28] How to get started with a REMS program [26:55] What to expect in the next episode [27:41] How to connect with us    Remember to Subscribe, Rate, Review, Like, and Share! Let’s Connect! Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: info@metisconsultingservices.com