
HOSTED BY
DIGITAL CMC SUMMIT
The future of high performance drug development is here
- OCT 31-NOV 2
- AUSTIN, TX
Continue the journey to tomorrow’s CMC
The Digital CMC Summit is returning this fall for another one-of-kind industry event. Join us back in Austin, TX, to see how drug development’s continuing transformation is taking shape – and discover the innovative ideas, solutions, and strategies that will change the way breakthroughs come to market.

World-class speakers
Hear from leaders who are spearheading drug development’s digital transformation.

Expert thought leaders
Share the air with some of the industry’s most renowned process, manufacturing, and innovation specialists.

Open forum
Join the kind of real, authentic conversation that can spark and sustain transformation.

Exclusive networking
See why the Summit is perfect for making new connections, starting new discussions, and discovering fresh ideas.
What to expect at the 2023 Summit
Come be part of the digital revolution in CMC: a movement that’s driving the operational, scientific, and analytical modernization of the drug development process.
Join your peers to take a fascinating, in-depth look at how CMC leaders are enhancing their risk management strategies, and creating unprecedented process intelligence.
Learn
Gather new strategies for breaking down CMC’s operational silos.
Connect
Share a unique deep-dive experience with fellow innovation experts.
Explore
Discover new approaches to enhancing productivity and mitigating risk.
Unlock
See how powerful CMC data can be with the right models and structures.
A Sneak Peak at This Year's Content Categories
THEME
Digital Tech Transfer & Control Strategy
Uncover the real world use cases for Digital CMC and how industry leaders leveraged effective knowledge management to hone and focus their product’s entire CMC lifecycle.
Digital CMC Deployment for CDMOs
Real-World Deployment Use Cases for Sponsors
Data Culture & Governance: The Path Toward Data Integrity Starts Here
THEME
Connecting the Digital CMC Ecosystem
Explore how to build a true Digital CMC ecosystem and master knowledge management by connecting process development to MES, Analytics, and Regulatory.
PD/MSAT to MES Digital Integration for Commercial Manufacturing
Connecting PD to Analytics for Enhanced Experimental Data Context
Digital Regulatory Submissions: The Future is Near, Are You Ready?
THEME
The Digital Fabric of CMC
Understand why knowledge management is critical to driving operational efficiency, dive into the latest trends, and discover how pioneers in the field are striving to swiftly bridge the digital divide.
Mastering Data Management: With a Knowledge Management Mindset
Impact of AI Throughout the Development Lifecycle
See what's in store for fall
Check back soon for session details and featured speakers
All schedules in Central Standard Time (CDT)
- DAY 1
Tuesday, October 31
3:00pm – Registration
4:30pm – Kickoff Session & Opening Keynote
6:00pm – Dinner & Socialization @ Group Therapy
- DAY 2
Wednesday, November 1
7:30am – Breakfast & Registration
8:30am – Sessions, Workshops & Breakouts
12:00pm – Lunch
1:00pm – Sessions, Workshops & Breakouts
5:00pm – Day 2 Sessions Wrap Up
6:00pm – Summit Soiree @ Malverde (La Candesa)
- DAY 3
Thursday, November 2
7:30am – Breakfast
8:30am – Sessions, Workshops & Breakouts
12:00pm – Lunch
1:00pm – Pharmageek Innovation Challenge
5:00pm – Dinner
6:00pm – Summit Afterparty
Meet this year's keynote speaker

Daniel R. Matlis
Founder & President, Axendia
Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Daniel R. Matlis
Founder & President, Axendia
Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.
Featured presenters & panelists
Check back soon for upcoming speaker announcements
Explore hotel options for Digital CMC Summit
Our discounted room rate at Hotel ZaZa is now closed.
Full price rooms are still available at Hotel ZaZa or you can browse some nearby options.