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Quality

Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing

May 30, 2025

Dr. Jack Prior leads MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he spearheads global initiatives in process monitoring and AI-driven yield improvement for biologics manufacturing. Previously as Head of MSAT Digital, he led teams working to develop global process data analytics systems and to digitize laboratory operations for Industrial Affairs Specialty Care drug substance and drug product manufacturing.

His leadership spans nearly three decades at Sanofi-Genzyme, where he has led manufacturing science organizations supporting process characterization, modeling, technology transfer, and manufacturing operations for critical therapies treating rare genetic disorders. Throughout his career, he has focused on integrating process modeling and advanced analytics with manufacturing science to enhance biologics production across US and European operations. He has led manufacturing science teams supporting multiple tech transfers across the Sanofi network, including the team supporting transfer to a new continuous single-use digital facility, while advancing approaches to process modeling and scale-up.

Dr. Prior holds a Doctor of Science in Chemical Engineering from MIT, where his research in data reconciliation for bioprocess development laid the foundation for his work in process monitoring and control. His current work continues to advance manufacturing science through the integration of digital technologies, process modeling, and AI in biologics manufacturing.

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Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery
LIFE SCIENCES, MEDICAL DEVICES

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

March 3, 2025

Evaluating the effects of new regulations on the medical device sector
Providing guidance on creating and deploying efficient quality management systems
Examining the careful balance between innovation and safety mandates
Sharing approaches for conducting quality risk assessments and taking proactive measures
Charting a future course for the medical device industry with best practices and learned insights

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Proactivity – the Future of Quality
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Proactivity – the Future of Quality

December 2, 2024

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

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Promoting Quality Excellence and Cultivating a Culture of Proactive Operations
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Promoting Quality Excellence and Cultivating a Culture of Proactive Operations

December 12, 2024

Søren Thuesen Pedersen is Senior Director, External Affairs, Regulatory Policy and Intelligence at Novo Nordisk. He is a Chemical Engineer by education and has been working 30 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratory and CMC Manufacturing Development. He has been one of the founding fathers of the Novo Nordisk External Requirements’ Process; How does Novo Nordisk ensure compliance of new external requirements? Mr. Pedersen is currently responsible for the External Representation and Advocacy strategy out of Novo Nordisk’s GMP&Q area and represents Novo Nordisk in various associations ISPE, EFPIA, IFPMA and BIO. Specifically, Mr. Pedersen is a member of the EFPIA Manufacturing Quality Expert Group (MQEG) since 2019 and member of the Board of Directors in IQ Consortium.

He has furthermore been member of the Novo Nordisk Board of Directors for 12 years as an elected employee representative.

His spare time interests include Danish and EU Politics.

Martin P. Müller joined Novo Nordisk in 2014 and currently directs development projects for innovative technologies within Aseptic Manufacturing, with particular focus on formulation, filling, wash & sterilization, and environmental monitoring.

Before moving to production in Novo Nordisk, Mr. Müller has served 10 years in Device R&D, driving the digital agenda of the area, external affairs and QMS-processes and project management, among others.

Mr. Müller earned his Master of Arts from Humboldt University Berlin, Germany, and his Master of Business Administration from Copenhagen Business School, Denmark.

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Building a Leading Quality Management Framework
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Building a Leading Quality Management Framework

December 2, 2024

Karin Ann Payne is the Vice President of Corporate Quality in BMS.

In this role, Karin provides strategic quality and compliance leadership in the GxP development and implementation of an integrated QMS across the Enterprise including Research and Early development, Global Drug Development, Global Product and Supply and Medical Affairs and in support of the product lifecycle.

Prior to joining BMS she was the VP of NA Quality for Bayer where she was responsible for ensuring that Bayer remained committed to the highest standards of quality, which is paramount to the patients and customers it serves every day. She joins Bayer from Reckitt Benckiser, where she most recently held the role of Head of Global Corporate Quality Compliance. In this role, she was responsible for managing the company’s Global Quality Management System, Corporate Quality audits, and its Global metrics and Computer System Validations teams. She also managed the Europe and North America Commercial Quality teams, responsible for managing market quality. Prior to that, she held a variety of roles in Quality Assurance and Compliance including positions at Actavis and Pfizer, managing the unique challenges and opportunities of both the consumer health and pharmaceutical industries.

She holds an MLS in Pharmaceutical law (High Honors) from Seton Hall, MBA in Financial Management (High Honors) with a Certificate in International Finance from Iona University and a Bachelor’s in Biological Sciences from Rutgers University.

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Driving Transformation in Quality to Meet the Needs of Our Customers
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Driving Transformation in Quality to Meet the Needs of Our Customers

May 17, 2024

A relentless visionary, Robin Kumoluyi consistently moves people and organizations forward. Throughout her career, she has expertly crafted complex quality management strategies for multi-billion-dollar matrixed organizations. Committed to the belief that patients and customers must have access to effective medicine, Robin intentionally chose the quality function within the pharmaceutical indutry.

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals at Johnson & Johnson Corporation. Robin has responsibility for Quality & Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. Prior to her current role, Robin was VP, Global Quality Services at Johnson & Johnson, where she drove the organization’s Enterprise Quality transformation by defining, leading, and executing the strategic direction and oversight of the Quality Policies, Standards, Digital Healthcare, Innovation and Analytics, Value Chain Quality, and the overall Q&C Strategy and associated processes.

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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services

May 30, 2024

JR Humbert is currently the VP, Quality at INCOG BioPharma Services, and created and implemented the quality system at INCOG, which in three years went from company creation through successful FDA inspection in 3 years.

JR has over 20 years of pharmaceutical and biotechnology industry experience in validation, quality, technology transfer, process engineering, and program management. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica.

JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.

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Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies

July 22, 2024

As part of the 2024 edition of the Pharma Manufacturing World Summit we interviewed Peter Shearstone, Thermo Fisher Scientific’s VP Global Quality & Regulatory Affairs, about a themed lunch discussion he hosted that revolved around Compliance in the pharmaceutical space, especially as it related to companies with a worldwide footprint. How does Compliance shape the way businesses function? How is that changing over time? How did the pandemic change the way the pharmaceutical industry thinks about itself and problem-solves? What can large organizations learn from the capabilities and outlook of smaller and more nimble companies? What are the things global companies will always do well, but can still do better? What should every leader working in this space be thinking about and learning about and doing more of to improve themselves, their teams, and the industry as a whole? For all this and more, give this episode a listen!

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Fireside Chat: Advancing the Production System
MANUFACTURING, VIDEO, MANUFACTURING

Fireside Chat: Advancing the Production System

April 22, 2024

Paisley Matthews is the Vice President of Manufacturing and Safety for Boeing Defense, Space and Security and a member of the Boeing Manufacturing Operations Council. In these roles, she is responsible for ensuring the Defense, Space & Security production system consistently operates in an integrated, lean and effective manner. In this session, Paisley will discuss integrating data visualization tools for better process visibility, as well as implementing Six Sigma methodologies to reduce defects, enhance product quality, and optimize processes for consistent outputs.

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Culture of Quality Excellence Driving Competitive Advantage for Operations
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Culture of Quality Excellence Driving Competitive Advantage for Operations

November 28, 2022

Why a Culture of Quality Excellence is foundational to achieving manufacturing excellence and leads to competitive advantage for operations. Driving a culture that recognizes the Value of Quality Excellence. How to establish a Culture of Quality Excellence by focusing not only on processes and digital infrastructure but also focusing on Real-world examples of how Quality excellence is translated into manufacturing excellence, including  Vendor Management, Investigational Excellence and End to End QMS. Using Quality data in a proactive and predictive manner in order to deliver value and achieve manufacturing excellence. — RJ Doornbos VP, Global Quality Systems Bristol Myers Squibb As the Head of Global…

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The Quality Equation
LIFE SCIENCES, VIDEO, LIFE SCIENCES

The Quality Equation

November 28, 2022

Do you want to ensure that you never have a surprise regulatory inspection outcome? The equation incorporates all you need to assess the status of your site and is even better for companies with networks of sites Data integrity, quality culture, process capability, management commitment and Quality Management Systems are all assessed to produce actionable data whether you are overseeing a CMO or operate your own network of sites — Brandon Varnau Head, Industrial Affairs Specialty Care Global Business Unit Quality Operations Sanofi Brandon Varnau is Head of Industrial Affairs Specialty Care Global Business Unit Quality Operations for Sanofi. He…

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Advancing Pharmaceutical Manufacturing Quality
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Advancing Pharmaceutical Manufacturing Quality

April 8, 2022

 Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…

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Moving at the Speed of Science
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Moving at the Speed of Science

April 8, 2022

Science Will Win: Pfizer’s 5-point plan and industry pledge to finding solutions to the global health crisis Pushing the boundaries of what’s possible: Moving at Lightspeed Hope Changes Lives: The development, manufacture, and distribution of the COVID-19 vaccine and oral treatment Key takeaway: Making the Impossible Possible — John Kelly VP, Quality Operations and Environment, Health & Safety, Pfizer Global Supply Pfizer Inc. John F. Kelly is Vice President, Quality Operations and Environment, Health & Safety, responsible for leading the overall Quality function for Pfizer and for leading global EHS across the Company.  John is a member of the PGS…

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