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

Operational Transformation

Learn how to eliminate operational silos that are holding back drug development.

CONNECT

Agile Control Strategy

Connect product, process, and quality attributes to ensure quality assurance across the entire drug development life cycle.

EXPLORE

Real-Time Risk Management

Explore insights to better predict, manage, and proactively control risks.

UNLOCK

Digital Tech Transfer

Unlock efficiencies through automation and consolidation of documents and data.

Speakers

Hear from industry innovators who are leading digital transformation in life sciences.

Thought Leadership

Stay ahead of the industry curve with keynotes, panels, and workshops.

Open Forum

Connect with industry leaders, influencers, and partners through breakouts sessions and Q&As.

Socialize

Join us at the welcome reception and Summit Soiree for food, drinks, and fresh air.

AGENDA

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

SUMMIT HEADLINERS

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.