The Future of High-Performance Drug Development is Here
Join Us In-Person for the 1st Annual Digital CMC Summit
Digital CMC Summit is transforming the way drug development teams work together by breaking down the operational and knowledge silos that are holding back the modernization of drug development. Hear from global thought leaders and industry experts who are reshaping the way product and process teams develop and deliver life-changing therapies.
What to Expect
We’ll explore opportunities to simplify and modernize the CMC process—breaking down barriers that hold back the future of high-performance drug development. Join the Digital CMC movement and learn how to unlock knowledge, increase process understanding, and reduce quality risks to truly harness the power of your science.
Learn how to eliminate operational silos that are holding back drug development.
Agile Control Strategy
Connect product, process, and quality attributes to ensure quality assurance across the entire drug development life cycle.
Real-Time Risk Management
Explore insights to better predict, manage, and proactively control risks.
Digital Tech Transfer
Unlock efficiencies through automation and consolidation of documents and data.
Hear from industry innovators who are leading digital transformation in life sciences.
Stay ahead of the industry curve with keynotes, panels, and workshops.
Connect with industry leaders, influencers, and partners through breakouts sessions and Q&As.
Join us at the welcome reception and Summit Soiree for food, drinks, and fresh air.
The Foundation for Next-Gen Drug Development
All times in Central Standard Time (CST)
Wednesday | Nov. 2
3:00pm – Registration
5:00pm – Kickoff Session & Opening Keynote
6:00pm – Dinner & Socialization @ Group Therapy
Thursday | Nov. 3
7:30am – Breakfast & Registration
8:30am – Sessions, Workshops & Breakouts
12:15pm – Lunch
1:15pm – Sessions, Workshops & Breakouts
5:00pm – Day 2 Sessions Wrap Up
6:00pm – Summit Soiree @ The Well
Friday | Nov. 4
7:30am – Breakfast
8:45am – Keynote Session
9:30am – Sessions, Workshops & Breakouts
12:30pm – Lunch
Introducing our keynote speakers
Meet the industry luminaries who’ll make downtown Austin the epicenter of drug development innovation next month.
Keynote | 5:15PM - 6:00PM | WEDS 11/2
Transforming the CMC Lifecycle:
Why the Bio-Pharma Industry Can’t Afford To Wait
Daniel Matlis, Founder & President, Axendia, Inc
Daniel R. Matlis is the Founder and President of Axendia with over three decades of industry experience. He is an active contributor to the FDA’s Case for Quality Initiative and member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials.
Keynote | 9:00aM - 10:00aM | FRI 11/4
Lifecycle Approaches for Robust Control Strategies
Christoph Herwig, Ph.D, Prof of Bioprocess Engineering, Vienna University of Technology
An accomplished professor and research scientist who works closely with ISPE, Pharma 4.0, and digital transformation initiatives, Dr. Herwig’s focus will take us on a deep-dive into the connection between science-based development methods and scalable bioprocess manufacturing.
PRESENTERS & PANELISTS
Our marquee keeps getting brighter!
Check out the global thought leaders, industry veterans, and transformation experts who’ll deliver this year’s can’t-miss presentations and guide our hands-on breakouts.
Group Therapy Luncheon Sponsored By
HOTEL ZAZA | AUSTIN, TX
Drop your bags just steps away from all the Summit activities
Enjoy your stay at the luxurious Hotel Zaza, located in the vibrant heart of downtown Austin, Texas.