Life Sciences AI Exchange - Sparked by ArisGlobal

The episode of the Life Sciences, AI Exchange features Hans Van Leeuwen (a regulatory consultant at ArisGlobal) and Ian Crone (Head of Regulatory Strategy and Growth at ArisGlobal) discussing how regulatory affairs (RA) is changing as pharma moves from document-based submissions to structured data.   They note that companies still lack a true "single source of truth," relying on fragmented systems, manual handoffs, Excel trackers, and costly reconciliation that can create duplication, inconsistencies, and errors—pressures intensified by faster development and accelerated reviews post-COVID.   They argue structured regulatory data (including IDMP) improves standardization, data quality, and internal communication, while enabling earlier detection of discrepancies as agencies increasingly use AI/ML to analyze submissions. They propose RA evolve from a submission-focused function to a product-data steward leading master data governance, API-enabled integrations, and unified RIM approaches, with structured master data hubs helping speed time to market and reduce delays.   00:00 Podcast Overview 00:38 Meet the Hosts 01:10 Data Everywhere in Pharma 02:37 No Single Source of Truth 04:51 Shift to Structured Submissions 07:06 IDMP as a Data Standard 09:08 RA as Data Steward 10:51 Culture Shift and AI Fears 12:30 Future RA in Development 15:16 Master Data Strategy and RIM 17:15 Wrap Up and Thanks

Moderator: Ian Crone, ArisGlobal Panellists: Remco Munnik (Arcana Life Sciences) Peter Brandstetter (Accenture) Frits Stulp (Implement Consulting Group)   In this episode, the focus is on IDMP and its role in transitioning from document-based to data-driven regulatory affairs. Key points include the status of IDMP adoption within the EU, the readiness and challenges of current systems, and the potential of structured data to empower AI applications. The conversation highlights how structured, high-quality product data can enhance regulatory processes, from signal detection to submission automation. Participants stress the importance of robust data foundations, referencing examples from other industries and emphasizing the transformative potential of data governance. The discussion concludes with actionable steps for companies to make meaningful progress, emphasizing the alignment of leadership, structure, tooling, and mindset in embracing data and AI for improved healthcare delivery.   00:42 Episode Overview: IDMP in Motion 01:04 Guest Introductions 01:35 Current State of EU IDMP Adoption 03:01 EMA's Role and Data Management 08:04 AI Applications in Regulatory Affairs 12:22 The Importance of Data Quality 13:07 Future of AI and IDMP in Regulatory Affairs 17:35 Challenges and Solutions for Implementation 23:39 Predictions for the Future 28:45 Actionable Steps for Companies 32:12 Conclusion and Final Thoughts  

In this episode of the Life Sciences Gen AI Exchange Podcast, host Lucinda Smith, Chief Safety Product Officer at ArisGlobal, talks with Claudia Lehmann Head of Global PSPV Operations at Boehringer Ingelheim. They discuss the journey and practical application of AI in pharmacovigilance, the benefits of AI and automation over the past five years, and the current use of Gen AI to further improve processes. The conversation covers the decision-making process behind adopting AI, overcoming technical hurdles, change management, and the impact on roles and processes within the organization. Claudia highlights the importance of starting small, understanding and assessing risks, continuous learning, and evolving with technology in a highly regulated industry. 00:00 Introduction to the Life Sciences Gen AI Exchange Podcast 00:42 Guest Introduction and Episode Focus 01:02 Journey into AI in Pharmacovigilance 03:06 Challenges and Successes in AI Implementation 05:56 Decision-Making and Project Structure 15:18 Technical Hurdles and Model Validation 18:37 Change Management and Building Trust in AI 29:31 Lessons Learned and Recommendations 33:11 Conclusion and Future Outlook

In this episode of the Life Sciences Gen I Exchange podcast, host Agnes Cwienczek from ArisGlobal discusses the impact of AI on regulatory affairs with Preeya Beczek, a regulatory affairs and compliance expert. They explore the use of AI in regulatory impact assessments, emphasizing the importance of speeding up the process, ensuring compliance, and managing complex data flows. The conversation covers the need for governance, accurate data, and prioritizing use cases to derive maximum value. They also highlight the importance of starting small, involving human elements, and the need for the industry to embrace AI technology actively. 00:00 Introduction to Regulatory AI 00:20 Meet the Experts: Agnes and Priya 01:49 The Growing Importance of AI in Regulatory Affairs 04:23 Challenges in Regulatory Impact Assessment 07:27 AI Solutions for Regulatory Challenges 11:07 End-to-End Regulatory Processes 19:22 The Future of AI in Regulatory Affairs 25:44 Final Thoughts and Advice 28:32 Closing Remarks and Next Steps

Host: ·       Emmanuel "Manny" Belabe Global Head, Operational Excellence at ArisGlobal Guest: Michelle Bridenbaker, RN, BSN, MS, MBA COO of Unbiased Science, VP of MILE (Medical Information Leaders in Europe) Episode Overview: AI is revolutionizing healthcare by enhancing patient safety, streamlining medical communications, and driving improved health outcomes. However, as technology takes center stage, the human element must remain a cornerstone of healthcare delivery.   In this episode, we'll hear from Michelle Bridenbaker, a patient-focused leader with deep expertise in healthcare operations, communication, and technology integration. Michelle will explore how AI is shaping the future of healthcare, discuss the importance of maintaining empathy and expertise alongside innovation, and share real-world examples of AI's transformative impact on patient safety and communication.

In this episode of The Life Sciences Gen AI Exchange podcast, host Jason Bryant is joined by Daniel Berglund from Nordic Capital and Aman Wasan of Aris Global to explore the growing impact of generative AI and automation on life sciences research and development.   The discussion covers economic pressures facing the industry, the importance of leveraging the latest technologies, and strategies for effectively driving innovation while managing costs. The experts share insights on practical steps companies can take to implement these technologies to ensure business success amidst competitive and regulatory challenges.     00:00 Introduction to the Life Sciences Gen AI Exchange 00:51 Meet the Experts: Daniel Berglund and Aman Wasson 02:48 Economic Challenges in Life Sciences 05:42 The Role of Automation and Gen AI 07:59 Navigating the Hype and Realities of Gen AI 12:35 Balancing Cost Efficiency and Innovation 17:55 Small Biotech Companies and Automation 18:57 Leveraging Technology for Problem Solving 20:43 Understanding and Addressing Customer Concerns 22:30 Collaborative Problem Solving in Pharma 24:12 Success Stories and Business Cases 26:29 Practical Steps for Leveraging Automation and Gen AI 30:53 Managing Change in Digital Transformations 32:51 Modularity in Modern Technology 33:33 Conclusion and Future Discussions