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1ST ANNUAL

DIGITAL CMC SUMMIT

ON-DEMAND

The future of high-performance drug development starts here.
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Explore Digital CMC Summit 2023

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In 2022, #DigitalCMC took off from Austin, TX.

The inaugural Summit brought together some of the industry’s leading transformation experts for a groundbreaking 3-day conference. Couldn’t make it? Eight in-depth sessions from the event are now available on-demand!

Watch on-demand

2022 SPEAKERS & PANELISTS

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Watch on-demand sessions from the 2022 Summit.

Get groundbreaking insights on drug development’s accelerating transformation, straight from the stage of last year’s very first Digital CMC Summit.

Digital Transformation of CMC: The Process is Already Underway

See why the CMC process is the ideal place to harness the digital momentum sweeping the industry.
Explore session

Transforming the CMC Lifecycle: Why the Biopharma Industry Can’t Afford to Wait​

Find out how new industry dynamics are driving transformation across the entire product lifecycle, from molecule to patient.
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Lifecycle Approaches for Robust Control Strategies

Take an in-depth look at how cutting-edge data management techniques are unlocking the potential of digital twins for CMC.
Explore session

Driving Efficiency in CMC Operations

Learn how CMC leaders are developing their innovation strategies and creating a case for change within their organizations.
Explore session

Real-World Digital CMC Use Cases

Go behind the scenes of multiple successful rollouts with the industry visionaries who planned and led them.
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The Evolving Digital CMC Ecosystem

Explore the growing range of technologies and workflows that are shaping the next generation drug development.
Explore session

Digital CMC, Validation & Quality Management

See how new process validation, data integrity, and quality management modalities are advancing CMC maturity.
Explore session

Accelerating MES Implementation

Discover how Digital CMC solutions can help streamline the transition to core commercial manufacturing platforms.
Explore session

Digital Transformation of CMC: The Processes is Already Underway

See why the CMC process is the ideal place to harness the digital momentum sweeping the industry.
Watch now

Transforming the CMC Lifecycle: Why the Biopharma Industry Can’t Afford To Wait

Find out how new industry dynamics are driving transformation across the entire product lifecycle, from molecule to patient.
Watch now

Lifecycle Approaches for Robust Control Strategies

Take an in-depth look at how cutting-edge data management techniques are unlocking the potential of digital twins for CMC.
Watch now

Driving Efficiency in CMC Operations

Learn how CMC leaders are developing their innovation strategies and creating a case for change within their organizations.
Watch now

Real-world Digital CMC use cases

Go behind the scenes of multiple successful rollouts with the industry visionaries who planned and led them.
Watch now

The evolving Digital CMC ecosystem

Explore the growing range of technologies and workflows that are shaping the next generation drug development.
Watch now

Digital CMC, Validation & Quality Management

See how new process validation, data integrity, and quality management modalities are advancing CMC maturity.
Watch now

Accelerating MES implementation

Discover how Digital CMC solutions can help streamline the transition to core commercial manufacturing platforms.
Watch now

Hear what the experts had to say about the experience.

Joschka Buyel

Joschka Buyel

Process & Knowledge Management Scientist, Bayer Pharmaceuticals

“The Digital CMC Summit is everything you want in an industry event: focused, forward-thinking, and insight-rich. It’s a fantastic opportunity for CMC professionals to explore the cutting edge of their domain.”
Michael Cody Headshot

Michael Cody

Director of Digital & Clinical Manufacturing, ZÆTHER

“If you want to see how the most innovative companies in the industry are transforming their manufacturing methods, this is the place to see it. I’m already looking forward to seeing what we explore at next year’s Summit.”
Kir Henrici Headshot

Kir Henrici

Founder and CEO, The Henrici Group

“It was an absolute pleasure to speak at the Digital CMC Summit, to connect with the incredible group of innovators who attended, and to be part of a groundbreaking movement toward our industry’s digital future.”

Brought to you by the pioneers of CMC transformation

The Digital CMC Summit is proudly sponsored by QbDVision: developers of the industry’s first and only integrated digital CMC management platform.

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Brought to you by the pioneers of CMC transformation

The Digital CMC Summit is proudly sponsored by QbDVision: developers of the industry’s first and only integrated digital CMC management platform.

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We're Back! Get ready for the 2023 Digital CMC Summit.

AUSTIN, TX | OCT 31 – NOV 2, 2023 | HOTEL ZAZA

Block your calendars and book your flights, the continuing evolution of new, integrated, digital-first drug development is back this fall. 

Explore Digital CMC Summit 2023

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Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

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Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

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Michael Stapleton

Board Advisor, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

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Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

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Daniel Matlis

Founder and 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.

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Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

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Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

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John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

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Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

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Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

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Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

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Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

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Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

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Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

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Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

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Joschka Buyel

Process & Knowledge Management Scientist, Bayer Pharmaceuticals | Ph.D., Drug Science

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

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Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

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Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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Speaker’s Pretty Long Title, Specialty, and Business

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