2022 DIGITAL CMC SUMMIT / ON-DEMAND SESSION
Accelerating MES Implementation
Discover how Digital CMC solutions can help streamline the transition to commercial manufacturing systems.
Session highlights & insights
Why process developers and manufacturers require fundamentally different tools to manage work and achieve their goals.
Common handoff challenges created by legacy CMC methods – and how the right solutions can mitigate them.
Why standardizing data structures and taxonomies during process development pays off in the transition to an MES.
How a digital CMC platform can help bridge new products from process development to MES implementation.
Session Speakers
Meet the group transformation experts who share their insights and expertise in this on-demand session.
Michael Cody
Director of Digital & Clinical Manufacturing, Zaether
Michael Cody
Director of Digital & Clinical Manufacturing, Zaether
As the Director of Digital & Clinical Manufacturing at Zaether, Michael focuses on biologic modalities and GMP manufacturing that inspire new approaches to integrated data solutions for informational and operational technologies. Previously, he was the Digital Operational Technology Architect for Clinical Stage ATMP clients and overall Technical Lead for OT deployments at two ISPE Facility-of-the-Year Award winning facilities.
Adam Cormack
Director of Product Management, Apprentice.io
Director of Product Management, Apprentice.io
Director, Life Sciences Strategy, Emerson Life Sciences
With 18 years at Emerson Life Sciences, Michalle was previously a Life Sciences team leader and now runs Life Sciences strategy across Emerson digital. Prior to Emerson, Michalle was with Merck for 13 years in instrumentation, automation, manufacturing, and scheduling and planning.
 Principal & Global Lead, Kalypso
SUMMARY
Creating a frictionless transition from CMC to MES implementation
All too often, the sponsor-manufacturer handoff invokes a daunting, time-consuming hurdle at the commercial finish line for new drug products. For drug developers and CDMOs alike, planning, managing, and executing a tech transfer can be a painful and protracted process with a jaw-clenching margin for error.Â
For too long, both sides have struggled with a legacy disconnect between their technological frameworks: CMC programs reliant on MS Office documents and PDFs, and manufacturers focused on highly structured MES systems designed for execution. But now, a new generation of CMC technologies has the potential to bridge this divide.
So what can these new CMC technologies do to help streamline the transition from process development workflows to the manufacturing floor?Â
At the 2022 Digital CMC Summit, a group of life science manufacturing leaders came together to discuss just that. Together they shared a range of insights on how new solutions can help connect experiment-driven, development-focused CMC workflows with robustly structured manufacturing systems optimized for one thing: consistent, on-spec production.
Stream this in-depth session to learn how the evolving interface between CMC and MES platforms can help:Â
- Reduce repetitive, error-prone data transition tasks that increase the margin for error in most tech transfers
- Provide a “transition layer” between CMC and manufacturing where process developers can organize and structure their scientific outputs for their manufacturing partnersÂ
- Create a feedback loop between process development and manufacturing that sharpens decision-making by both sponsor and CDMO
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Sign up now to watch the whole session, including a series of deep-dive presentations and an interactive live Q&A with the speakers.Â
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.
