2022 DIGITAL CMC SUMMIT / ON-DEMAND SESSION
Real-World Digital CMC Deployment Use Cases
Go behind the scenes with CMC visionaries to see how they plan and implement their transformation initiatives.
Session highlights & insights
How digital CMC sets up a foundation for organizational agility, workflow visibility, and robust process control.
Session Speakers
Meet the group transformation experts who share their insights and expertise in this on-demand session.
Gloria Gadea-Lopez
Head of Global Consultancy, Business Platforms
Gloria Gadea-Lopez
Advisor | Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering
Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.).
Joschka Buyel
Process & Knowledge Management Scientist, Bayer Pharmaceuticals
Joschka Buyel
Process Knowledge Management Scientist, Bayer
Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.
John Maguire
Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence
John Maguire
Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence
Steve Keizer
Senior Quality Assurance Director, Artisan Biotechnologies
Steve Keizer
Senior Quality Assurance Director, Artisan Bio
Amol Thote
Senior Director, Bayer Pharmaceuticals
Amol Thote
Justin Grahek
Process Development & Digitalization Scientist, Bayer Pharmaceuticals
Justin has over 20 years of biopharmaceutical lab experience in process development, scale-up, technology transfer, process characterization, and digital implementation. In his current role he is responsible for driving the rollout and integration of QbDVision for biologic projects at Bayer Pharmaceuticals.
SUMMARY
Discover how industry leaders are implementing digital CMC
In this series of expert presentations, transformation veterans from across the industry share their real-world experience with implementing, managing, and sustaining digital transformation in the CMC process.Â
As each of these six specialists explains, digitizing CMC operations is key to unlocking greater efficiency and productivity – both for established organizations and up-and-coming innovators. Each presenter offers a unique view of how digital CMC principles are already helping their team and organization achieve a new level of scientific and operational performance.Â
In this presentation series from the 2022 Digital CMC Summit:
- Gloria Gadea-Lopez explains why implementing digital CMC solutions is a critical first step in helping her customers prepare for a successful transition to Manufacturing 4.0. She explains how the right digital CMC platform can help drug developers lay a foundation of trackable, reusable, collaboration-friendly infrastructure for their product programs.Â
- Dr. Joschka Buyel offers an in-depth look at how his Bayer team manages the deployment of new digital CMC solutions, creates data taxonomies to maximize the value of those technologies, and leverages them to accelerate development of key assets like process descriptions.Â
- John Maguire shares how digital CMC principles have helped the Sanofi mRNA Center of Excellence shift from a legacy project-focused approach to a strategic platform approach – one that is already enabling them to significantly increase their throughput of valuable mRNA products.
- Steve Keizer delves into how his team at the Artisan Bio “Cell Foundry” discovered that a digital CMC platform can be the perfect development bridge between early-stage R&D workflows and commercial-scale GMP activities.Â
- Dr. Amol Thote and Justin Grahek share how Bayer Pharmaceutical uses a digital CMC platform to both streamline development of well-established substance classes and create scalable development platforms for cutting-edge cell and gene therapies.Â
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Don’t miss the group discussion at the end, where these six experts field some insightful questions about how they’re managing the interdisciplinary collaboration at the heart of any digital transformation process.
Stream these exclusive insights from the 2022 Digital CMC Summit.
Sign up to watch eight full sessions captured live at the 2022 Digital CMC Summit — including in-depth presentations, Q&A, and moderated deep-dives into our industry’s digital future.
