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

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Connect with Steve Thompson

• LinkedIn: https://www.linkedin.com/in/stevethompsonsocal/

Connect with Emily Barker

• Linked In: https://www.linkedin.com/in/mannbark/

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• 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

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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.

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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

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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.

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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     

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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!

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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

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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.

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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

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Connect with Queens of Quality;

• Website: https://metisconsultingservices.com/
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• 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.

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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.

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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.

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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.

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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