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DIGITAL CMC SUMMIT

The future of high performance drug development is here

  • OCT 31-NOV 2
  • AUSTIN, TX
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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.

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See what you missed last year

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

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

See full schedule

Meet this year's keynote speakers

Keynote Speaker

Keynote Speaker Title

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Keynote Speaker

Keynote Speaker Title

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Keynote Speaker

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Keynote Speaker

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Featured presenters & panelists

Check back soon for upcoming speaker announcements

Yash Sabharwal

QbDVision

Luke Guerrero

QbDVision

Joschka Buyel

Bayer Pharmaceuticals

Gloria Gadea Lopez

Business Platforms

Sue Plant

Biophorum

Blake Hotz

Sanofi

Anthony DeBiase

Rockwell Automation

Andy Zheng

ZÆTHER

Tim Adkins

ZÆTHER

Chris Kopinski

Amazon

John Maguire

Sanofi

Oliver Hesse

Bayer Pharmaceuticals

Kir Henrici

The Henrici Group

Daniel Matlis

Axendia

Matthew Schulze

Flagship Pioneering

Max Peterson

Zifo

Kir Henrici

The Henrici Group

Daniel Matlis

Axendia

Yash Sabharwal

QbDVision

Luke Guerrero

QbDVision

Joschka Buyel

Bayer Pharmaceuticals

Gloria Gadea Lopez

Business Platforms

Sue Plant

Biophorum

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Presenter's Long Title, Speciality, and Business

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Presenter's Long Title, Speciality, and Business

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2023 Summit Sponsors

GOLD SPONSOR
GOLD SPONSOR
Hotel ZaZa welcomes you again.
We're back at one of Austin’s premiere destination hotels.
Explore the hotel
Hotel ZaZa welcomes you again.
We're back at one of Austin’s premiere destination hotels.
Explore the hotel
Hotel ZaZa welcomes you again.
We're back at one of Austin’s premiere destination hotels.
Explore the hotel
Hotel ZaZa welcomes you again.
We're back at one of Austin’s premiere destination hotels.
Explore the hotel
Hotel ZaZa welcomes you again.
We're back at one of Austin’s premiere destination hotels.
Explore the hotel
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Book today to get our discount Summit rate

Capped travel budget? Save 50% off standard room pricing when you reserve a room with booking code QBD103

400 Lavaca Street Austin, TX 78701 Get Directions
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Speaker’s Pretty Long Title, Specialty, and Business

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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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