AI Uncovered

• Oeystein Kjoersvik - Auditing AI: Quality, Compliance & the Role of GenAI in Pharma

  We’re excited to welcome Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments.In this episode, Tim and Oeystein delve into the challenges of adopting AI in regulated settings, the complexity of validating GenAI tools, and the transition from traditional processes to AI-augmented systems. They also explore Oeystein’s work with the IMPALA Consortium and the importance of cross-industry collaboration to identify and scale high-value use cases for Generative AI.Before his current role, Oeystein served as a Product Owner in Analytics at Merck IT, building analytics platforms and integrating data science across systems. He also contributed as a Machine Learning Subject Matter Expert to TransCelerate’s Intelligent Automation Group, advancing AI applications in pharmacovigilance.Oeystein brings a rare blend of technical expertise and regulatory insight. He’s passionate about helping teams adopt AI responsibly and transparently—ensuring innovation aligns with quality across the pharmaceutical landscape.Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

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• Emmanuel Walckenaer: AI’s Real-World Impact on Pharma & What’s Next in 2025

  We’re thrilled to welcome  Emmanuel Walckenaer, CEO of Yseop, back to AI Uncovered for a follow-up conversation on the rapid evolution of AI in biopharma. Since his last appearance, the industry has made significant strides in harnessing AI for regulatory submissions, clinical workflows, and medical writing—areas where Yseop is leading the charge in transforming content generation.In this episode, Tim and Emmanuel revisit the biggest AI breakthroughs of 2024 and explore how the pharmaceutical sector is shifting from skepticism to large-scale adoption. They discuss real-world success stories, the growing impact of federated data sharing, and what companies should prioritize as they plan for 2025 and beyond.With his unique perspective on SaaS growth, AI regulation, and enterprise adoption, Emmanuel provides invaluable insights for professionals navigating the intersection of AI and life sciences. If you're looking to understand the next wave of AI-driven innovation in pharma, this is an episode you won't want to miss.Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

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• Meredith Brown-Tuttle: AI’s Impact on Global Regulatory Strategy and the Future of Pharma

  We welcome Meredith Brown-Tuttle to AI Uncovered.  Meredith is the Chief Regulatory Strategist at Regulatorium, where she applies her 33 years of experience in the pharmaceutical and biologics industry. She specializes in working with small and medium-sized drug, biologic and combination product companies to navigate global regulatory strategy, intelligence and submission requirements. With a strong focus on innovation, Meredith is dedicated to revolutionizing regulatory science by integrating AI and in silico modeling into every stage of drug development. Most recently, Meredith has focused on advancing global regulatory science through the development of AI tools, aiming to streamline submission processes and improve outcomes for the industry. Her vision includes a future where entirely digital INDs, BLAs and NDAs become standard practice, supported by the widespread use of in silico modeling, digital twins and federated data sharing to enable collaboration without compromising proprietary information.In this episode, Tim  and Meredith explore the evolving landscape of global regulatory strategy and how AI can revolutionize regulatory science. Meredith shares insights from her extensive career, including her experience in crafting INDs and NDAs, her thoughts on transforming data validation standards across the industry and providing strategic guidance to companies navigating complex regulatory requirements. She also delves into the challenges and opportunities presented by AI. In addition to her work at Regulatorium, Meredith serves as a board member at the Alliance for Artificial Intelligence in Healthcare (AAIH), showcasing her commitment to leveraging innovation in regulatory affairs. Meredith is also an accomplished author of over 70 articles and two books, and she has trained thousands of professionals on writing INDs and conducting effective regulatory submissions. Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

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• Michael Penlington - Impact of AI and New Standards in Clinical Trials

  We welcome Michael Penlington to AI Uncovered. Michael has been working in Pharma for his entire career including roles in leading development of Vaccines and Clinical reporting at Novartis, as well as Senior Director roles of Science writing, Global Medical Writing and Medical Writing Center of Excellence at GSK.Most recently, Michael has taken on a new challenge as Director of Digital Clinical Development Solutions at Nurocor.In this episode, Tim and Michael discuss digital transformation in the pharmaceutical industry, with a particular focus on the role of AI in clinical development. They delve into the current trends, challenges and the driving forces behind this digital revolution in pharma. Michael shares insights from his extensive career, including his experience in medical writing and as a Director of Digital Clinical Development Solutions. He also provides insights on the impact of new standards like ICH M11 on study design, clinical trial management and data management, offering a glimpse into what the future holds for clinical processes. Michael is deeply engaged in the intersection of digital technology and life sciences, making him a leading voice in this transformative era for pharma. Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

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• Rohit Sood - Digital Transformation & AI's Role in Life Sciences

  We welcome Rohit Sood to AI Uncovered. Rohit is a seasoned executive with a strong background in commercialization and technology use in life sciences. He currently advises a variety of life science services and Private Equity firms on operations, growth and digital transformation. With over 25 years of experience in the life sciences and technology industries, Rohit has held multiple leadership roles, leveraging his expertise in AI, cloud computing and digital transformation.Rohit holds a degree in Computer Science and Applied Mathematics and an MBA from Rutgers. He is currently an adjunct lecturer at Rutgers and is pursuing his DBA in the area of scientific/technological evolution and its impact on oncology commercialization. In this episode, Tim and Rohit discuss life sciences, digital transformation and the use of generative AI in this industry. They delve into the trends, challenges and success stories of implementing AI in life sciences, exploring how digital transformation drives innovation and efficiency. Rohit provides valuable insights on how startups can differentiate themselves and shares best practices for digital transformation,  highlighting  successful strategies from his extensive consulting experience. Rohit is passionate about the intersection of technology and business and enjoys actively mentoring startups and young professionals. Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

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