ISPE Podcast: Shaping the Future of Pharma

In this episode, Miguelina Matthews, Head of Quality Intelligence, Advocacy and Pharmacopoeia Affairs at Sanofi, joins the podcast to share how the company is leveraging artificial intelligence to shift pharmaceutical quality management from reactive investigations to predictive, data-driven insights. Learn more about the deployment of Sanofi's "Plai" tool, emphasizing the importance of robust governance, effective change management, and human-led decision-making in scaling AI technologies across global operations.

In this episode, Miguelina Matthews, Head of Quality Intelligence, Advocacy and Pharmacopoeia Affairs at Sanofi, joins the podcast to share how the company is leveraging artificial intelligence to shift pharmaceutical quality management from reactive investigations to predictive, data-driven insights. Learn more about the deployment of Sanofi's "Plai" tool, emphasizing the importance of robust governance, effective change management, and human-led decision-making in scaling AI technologies across global operations.

On this episode, David Estapé, Technology Manager Biotechnology at CRB Group GmbH, and International Program Committee Chair of the 2026 ISPE Europe Annual Conference, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.

On this episode, David Estapé, Technology Manager Biotechnology at CRB Group GmbH, and International Program Committee Chair of the 2026 ISPE Europe Annual Conference, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.

This episode features insights from Tina Kiang, PhD, Director of the Division of Regulations and Guidance in the Office of Pharmaceutical Quality (OPQ)/Office of Policy for Pharmaceutical Quality (OPPQ) at the US Food and Drug Administration (US FDA). In a discussion facilitated by David Churchward, Head of Operations Quality Compliance and External Affairs at AstraZeneca, Kiang examines AI at the intersection of regulatory guidance and pharmaceutical innovation, sharing how AI has the potential to reshape the drug lifecycle, the US FDA’s current posture and guidance trajectory, how US FDA is currently using AI, and more.

This episode features insights from Tina Kiang, PhD, Director of the Division of Regulations and Guidance in the Office of Pharmaceutical Quality (OPQ)/Office of Policy for Pharmaceutical Quality (OPPQ) at the US Food and Drug Administration (US FDA). In a discussion facilitated by David Churchward, Head of Operations Quality Compliance and External Affairs at AstraZeneca, Kiang examines AI at the intersection of regulatory guidance and pharmaceutical innovation, sharing how AI has the potential to reshape the drug lifecycle, the US FDA’s current posture and guidance trajectory, how US FDA is currently using AI, and more.

In this episode, Susan Szathmary and Richard Jaenisch, both of Open BioPharma Research and Training Institute, join the podcast to share how to accelerate the adoption of new technologies through applied AI in pharma manufacturing and for workforce readiness.

In this episode, Susan Szathmary and Richard Jaenisch, both of Open BioPharma Research and Training Institute, join the podcast to share how to accelerate the adoption of new technologies through applied AI in pharma manufacturing and for workforce readiness.

In this recap episode recorded after the 2025 ISPE Annual Meeting, host Bob Chew shares insights on accelerating technology adoption in the pharmaceutical industry. Dive into this discussion to explore the future of pharma innovation, including transitioning from document-centric to data-driven quality systems, leveraging AI and digital twins for enhanced manufacturing processes, and reimagining risk management with statistical tools.

In this recap episode recorded after the 2025 ISPE Annual Meeting, host Bob Chew shares insights on accelerating technology adoption in the pharmaceutical industry. Dive into this discussion to explore the future of pharma innovation, including transitioning from document-centric to data-driven quality systems, leveraging AI and digital twins for enhanced manufacturing processes, and reimagining risk management with statistical tools.

This episode includes highlights from our Future of ATMPs series, featuring speakers from last year's ISPE Europe Annual Conference discussing industrialization of Advanced Therapy Medicinal Products production by replacing manual, high-cost processes with standardized and modular automation.

This episode includes highlights from our Future of ATMPs series, featuring speakers from last year's ISPE Europe Annual Conference discussing industrialization of Advanced Therapy Medicinal Products production by replacing manual, high-cost processes with standardized and modular automation.

In this episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes. Explore how to utilize the principles of Quality by Design and Quality Risk Management to create dynamic, continuous validation practices, powered by digital innovations.

In this episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes. Explore how to utilize the principles of Quality by Design and Quality Risk Management to create dynamic, continuous validation practices, powered by digital innovations.

In this episode, listen to highlights from our Artificial Intelligence-focused episodes, featuring discussions on the current state of AI in the pharmaceutical industry, key AI-related challenges and opportunities, and how AI can enable sustainable quality transformation.

In this episode, listen to highlights from our Artificial Intelligence-focused episodes, featuring discussions on the current state of AI in the pharmaceutical industry, key AI-related challenges and opportunities, and how AI can enable sustainable quality transformation.

In this episode, host Bob Chew is joined by Martin Orcoyen, President of ISPE Argentina Affiliate, Ricardo Miranda, President of the ISPE Brazil Affiliate, and Alejandro Bustamante, President of the ISPE Mexico Affiliate, to discuss the jointly hosted 2025 ISPE LATAM Symposium.

In this episode, host Bob Chew is joined by Martin Orcoyen, President of ISPE Argentina Affiliate, Ricardo Miranda, President of the ISPE Brazil Affiliate, and Alejandro Bustamante, President of the ISPE Mexico Affiliate, to discuss the jointly hosted 2025 ISPE LATAM Symposium.

In this episode, host Bob Chew shares insights on accelerating technology adoption in the pharmaceutical industry. Dive into this discussion to explore the future of pharma innovation, including transitioning from document-centric to data-driven quality systems, leveraging AI and digital twins for enhanced manufacturing processes, and reimagining risk management with statistical tools.

In this episode, host Bob Chew shares insights on accelerating technology adoption in the pharmaceutical industry. Dive into this discussion to explore the future of pharma innovation, including transitioning from document-centric to data-driven quality systems, leveraging AI and digital twins for enhanced manufacturing processes, and reimagining risk management with statistical tools.

Scott Billman, Senior Vice President, Global Engineering, Technology, and Facilities at Solventum and Immediate Past Chair of the ISPE International Board of Directors, joins the podcast to share more about the upcoming ISPE Annual Meeting and Expo. Explore the featured topics, trends, and pharmaceutical innovations, as well as opportunities for networking and career advancement that you can expect at the event.

Scott Billman, Senior Vice President, Global Engineering, Technology, and Facilities at Solventum and Immediate Past Chair of the ISPE International Board of Directors, joins the podcast to share more about the upcoming ISPE Annual Meeting and Expo. Explore the featured topics, trends, and pharmaceutical innovations, as well as opportunities for networking and career advancement that you can expect at the event.

On this episode, Gunter Baumgartner, SVP Head of Global Engineering at Takeda Pharmaceuticals International AG, and Executive Chair of 2025 ISPE Annual Meeting and Expo, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.

On this episode, Gunter Baumgartner, SVP Head of Global Engineering at Takeda Pharmaceuticals International AG, and Executive Chair of 2025 ISPE Annual Meeting and Expo, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.

In part two of our series on the future of ATMPs, Marco Flori, Global Account Manager at Staubli Robotic UK, and Dan Strange, CTO and Co-founder of Cellular Origins, join the podcast to share more about the potential and benefits of automation and robotics in the production of cellular and gene therapies.  

In part two of our series on the future of ATMPs, Marco Flori, Global Account Manager at Staubli Robotic UK, and Dan Strange, CTO and Co-founder of Cellular Origins, join the podcast to share more about the potential and benefits of automation and robotics in the production of cellular and gene therapies.  

In part one of our two-part series on the future of ATMPs, David Phasey, Business Development Director at 3P Innovation, joins the podcast to discuss the drivers of the high cost-of-goods (COGs) for ATMPs and how automation can help reduce these COGs in the future.  

In part one of our two-part series on the future of ATMPs, David Phasey, Business Development Director at 3P Innovation, joins the podcast to discuss the drivers of the high cost-of-goods (COGs) for ATMPs and how automation can help reduce these COGs in the future.  

This episode, Ben Stevens, Director of CMC Policy and Advocacy with GSK, and Eric Staib, Vice President of Corporate Quality with Syneos, join the podcast to share more about the current state of AI in the pharmaceutical industry, key AI-related challenges and opportunities facing the industry, and the work they’re doing on ISPE’s recently established Artificial Intelligence Community of Practice to help support the industry in navigating the rapid proliferation of AI.

This episode, Ben Stevens, Director of CMC Policy and Advocacy with GSK, and Eric Staib, Vice President of Corporate Quality with Syneos, join the podcast to share more about the current state of AI in the pharmaceutical industry, key AI-related challenges and opportunities facing the industry, and the work they’re doing on ISPE’s recently established Artificial Intelligence Community of Practice to help support the industry in navigating the rapid proliferation of AI. 

This episode, Takeda’s Senior Vice President, Head of Global Quality Compliance and Systems, Magaly Aham, joins the podcast to discuss how AI can enable sustainable quality transformation. She’ll touch on Takeda’s unique approach to leveraging AI, share a few key case study examples, and elaborate on how she envisions their work will help to move the industry forward.

This episode, Takeda’s Senior Vice President, Head of Global Quality Compliance and Systems, Magaly Aham, joins the podcast to discuss how AI can enable sustainable quality transformation. She’ll touch on Takeda’s unique approach to leveraging AI, share a few key case study examples, and elaborate on how she envisions their work will help to move the industry forward.

Mike Martin, President and CEO of ISPE, joins ISPE’s podcast host Robert Chew for this first episode to discuss the current pharmaceutical landscape, how the industry is responding to new challenges and opportunities, where he sees the industry going in the next five years, and more.