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.

Key concepts for successful implementation of digital CMC solutions, and how they apply to core CMC workflows.
Where digital CMC solutions can be applied to mature substance classes and cutting-edge cell and gene therapies.
How applying digital CMC principles can help organizations move from a project approach to a platform approach.

Session Speakers

Meet the group transformation experts who share their insights and expertise in this on-demand session.

Gloria Gadea-Lopez

Gloria Gadea-Lopez

Head of Global Consultancy, Business Platforms

More about Gloria
Joschka Buyel

Joschka Buyel

Process & Knowledge Management Scientist, Bayer Pharmaceuticals

More about Joschka
John Maguire Headshot

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

More about John
Steve Keizer Headshot

Steve Keizer

Senior Quality Assurance Director, Artisan Biotechnologies

More about Steve
Amol Thote Headshot

Amol Thote

Senior Director, Bayer Pharmaceuticals

More about Amol
Justin Grahek Headshot

Justin Grahek

Process Development & Digitalization Scientist, Bayer Pharmaceuticals

More about Justin

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. 

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. 

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. 
  • 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. 
  • 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. 
  • 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. 

 

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.