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Artwork for ISPE Podcast: Shaping the Future of Pharma

ISPE Podcast: Shaping the Future of Pharma

ISPE
Artificial Intelligence
Pharma 4.0
Atmps
ISPE
Quality Risk Management
Automation
Sanofi
Validation 4.0
Data-Driven Quality System
Digital Transformation
FDA
Quality By Design
Sustainability
Process Digital Twin
ISPE Annual Meeting and Expo
Advanced Therapeutic Medicinal Products
Automation and Robotics
Open Biopharma Research and Training Institute
Regulatory
Cell Therapy

The International Society for Pharmaceutical Engineering’s ISPE Podcast: Shaping the Future of Pharma is ISPE’s newest platform for sharing the latest insights and thought leadership on pharmaceutical manufacturing, technology, and regulatory trends impacting the pharmaceutical industry. Join ISPE’s podcast host Robert Chew and our featured guests each episode to hear directly from the innovators,... more

PublishesTwice monthlyEpisodes37Foundeda year ago
Number of ListenersCategory
Business

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Artwork for ISPE Podcast: Shaping the Future of Pharma

Latest Episodes

n this episode, listen to highlights from our most recent Artificial Intelligence-focused episodes, featuring discussions with speakers from the FDA, Sanofi, and the Open BioPharma Research and Training Institute on the potential for AI to reshape th... more

In this recap 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 Elec... more

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... more

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... more

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Recent Guests

Michelle Vuolo
Head of Quality at Tulip Interfaces, co-lead of the Validation 4.0 Guide Team
Tulip Interfaces
Episode: Ep 18 Recap: Embracing Validation 4.0 for a Digital Pharma Future
Victor de Oliveira Silva Ferreira
Project Manager for PEQMS, Implementation of Electronic Systems for the Quality Management System at Instituto de Tecnologia em Imunoviobiológico, Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Episode: Ep 18 Recap: Embracing Validation 4.0 for a Digital Pharma Future
Miguelina Matthews
Head of Quality Intelligence, Advocacy, and Pharmacopeia Affairs at Sanofi
Sanofi
Episode: Ep 17 AI in Quality Transformation
David Estapé
Chair of the Conference International Program Committee
CRB Group GmbH
Episode: Ep 16 Insights from the 2026 ISPE Europe Annual Conference Committee Chair
David Churchward
Head of Operations, Quality, Compliance, and External Affairs at AstraZeneca
AstraZeneca
Episode: Ep 15 Integration of Artificial Intelligence in the Pharmaceutical Industry: A US FDA Perspective
Dr. Tina Kiang
Director, Division of Regulation and Guidance within the Office of Pharmaceutical Quality, CDER, FDA
FDA
Episode: Ep 15 Integration of Artificial Intelligence in the Pharmaceutical Industry: A US FDA Perspective
Susan Szathmary
Co-presenter from Open BioPharma Research and Training Institute
Open BioPharma Research and Training Institute
Episode: Ep 14 AI in Workforce Readiness
Richard Jaenisch
Co-presenter from Open BioPharma Research and Training Institute
Open BioPharma Research and Training Institute
Episode: Ep 14 AI in Workforce Readiness
Michelle Volo
Head of Quality at Tulip Interfaces and co-lead of the Validation 4.0 Guide Team
Tulip Interfaces
Episode: Unlocking Innovation: Embracing Validation 4.0 for a Digital Pharma Future

Host

Bob Chew
Host of ISPE Podcast: Shaping the Future of Pharma (with ISPE affiliation).

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#145
Indonesia/Business
Apple Podcasts
#235
Mexico/Business

Talking Points

Recent interactions between the hosts and their guests.

Ep. 5 The Future of ATMPs Pt. 2
Q: Is the technology being discussed proven, or is it still theoretical?
The approach leverages proven components (robots, sterile welding, existing third-party tools) and demonstrates automation concepts in practice; while some performance projections are theoretical, the underlying technologies are established and being integrated in new ways to scale ATMP production.
Ep. 5 The Future of ATMPs Pt. 2
Q: What are the biggest manufacturing challenges inhibiting production and cost of cell and gene therapies?
The main challenges are labor- and capital-intensive processes, expensive clean-room environments, and the need to standardize consumables and unit operations to enable scalable, cost-effective manufacturing.
Exploring AI with the Newest ISPE Community of Practice
Q: So with respect to this specific artificial intelligence COP, what are your goals, what's your intentions, and what specific challenges and opportunities is the COP looking to address?
The COP aims to establish focused topic areas, form active subcommittees, and create a bridge between ISPE activities and external groups like GAMP and Pharma 4.0, while addressing education, regulatory readiness, and practical use cases in AI and ML.
Ep 4 The Future of ATMPs
Q: What does “low-hanging fruit” look like for automation in ATMP manufacturing?
Low-hanging fruit includes process optimization, better quality control via instrumentation, and simple automation like barcode scanning to streamline workflows, which can deliver meaningful cost reductions without heavy upfront investments.
Ep 4 The Future of ATMPs
Q: What are the biggest drivers of the high cost of ATMPs?
The guests explains that ATMPs are a broad mix with varied manufacturing chains, but the most impactful cost reductions will come from improvements in the manufacturing process itself—through lean practices, better instrumentation, digitization, and ultimately standardization of consumables and components to enable mechanization.

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Frequently Asked Questions About This Podcast

What is This Podcast about and what kind of topics does it cover?

The series centers on pharmaceutical manufacturing, technology, and regulatory trends, with a strong emphasis on Pharma 4.0, digitalization, AI in quality and manufacturing, and data-driven approaches to validation and compliance. Episodes explore how digital tools, continuous risk management, and real-time data transform traditional quality systems, often through practical case studies from industry leaders, regulatory perspectives, and conference insights. Notable themes include Validation 4.0, Quality by Design, digital twins, AI-driven quality improvements, workforce development in pharma, and regional/regulatory contexts shaping adoption across markets. The show often features practitioners and leaders from major pharma and tech-enable... more

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1. Think Fast Talk Smart: Communication Techniques
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this podcast launched a year ago and published 37 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on this podcast?

Recent guests on this podcast include:

1. Michelle Vuolo
2. Victor de Oliveira Silva Ferreira
3. Miguelina Matthews
4. David Estapé
5. David Churchward
6. Dr. Tina Kiang
7. Susan Szathmary
8. Richard Jaenisch

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