Drug Development’s Digital Leaders Reunite at the 2nd Annual Digital CMC Summit

DCMC On-Demand 2023 Hub
For the second year in a row, technology innovators from across the life sciences flocked to Austin, TX, for this exclusive, one-of-a-kind conference experience. Stream all 9 sessions to see how drug development’s high-performance future is taking shape.

WATCH 2023 INSIGHTS ON DEMAND

After the breakout success of last year’s inaugural Summit, we couldn’t wait to bring the Digital CMC Summit back to our hometown this year.

Over 100 attendees from 20 different organizations came together for the second annual event, bringing their passion, knowledge, and expertise to another 3 days of rich, thought-provoking insights.

Stream all the highlights and deep-dives from the 2023 summit.

The 2023 Summit featured yet another luminary lineup of experts from across the drug development industry – from top technologists and process gurus, to regulatory specialists, automation innovators, biomanufacturing leaders, and more.

Like last year, we’re once again making all their insights available on-demand. Scroll to explore all the presentations, Q&As, and expert takeaways from the 2023 Summit.

Real-World Deployment: Use Cases for Sponsors & CDMOs

Biomanufacturing leaders share how cutting-edge Digital CMC solutions are already transforming their workflows.

Beyond Digital CMC: Charting the Future of Digital Drug Development

Discover how three market-shaping organizations are unlocking new levels of performance by connecting their CMC ecosystems.

The Future of QbDVision

Two of our product leaders share what's new, what's coming, and what's next for our groundbreaking digital CMC.

Driving Operational Efficiencies in CMC Operations

Four of drug development's top digital leaders share how they've helped organizations successfully navigate transformation.

Mastering Data Management with a Knowledge Management Mindset

Life science data gurus share how drug developers can break free from information silos and unlock the power of their knowledge resources.

2023 Keynote: Embracing Change Together

Headliner Daniel R. Matlis opens the Digital CMC Summit with a look at how our industry is reevaluating and revolutionizing current approaches to expedite time-to-market.

Trends in Digital Maturity for Biomanufacturing

Learn how some of the industry's top technology experts are working to help drug manufacturers modernize their information systems.

Digital Regulatory Submissions: The Future is Near. Are You Ready?

Three experts share what's driving industry and regulators toward global harmonization and digitalization.

Digital Realization for Business Value

Take an expert-guided look at the IAAE's new white paper on developing and implementing digital transformation programs.

Get a front-row look at the 2023 Summit.

Growing momentum, continuing challenges & fresh innovation

It was another year of incisive presentations, valuable connections, and unbeatable expert content – but also a year of sober reassessment by some of drug development’s top innovation leaders. 

Digital transformation is accelerating across the industry, with more and more drug developers and biomanufacturers taking data- and technology-centric approaches to their operations. And yet, much of that progress has been uneven, uncertain, and often outpaced by new challenges and disruptions. 

Twelve months after the inaugural sSummit, Digital CMC has taken great leaps forward – but still has far to go.

This year’s speakers offered a diverse range of perspectives and opinions on how the industry can build on the advances it has already achieved, and unlock the full value of its fast-growing tech toolkit. Over 9 extraordinary sessions, they dove into: 

  • Why it’s more urgent than ever for industry, regulators, and standards bodies to collaboratively define drug development’s digital roadmap
  • How drug developers can make the critical shift from tech-driven problem-solving to tech-enabled business strategy
  • How the industry’s digital leaders are already achieving transformative alignment of their business goals, data frameworks, and company cultures
  • How and where disruptive new technologies like generative AI can fit into drug developers’ tech stack
  • And much, much more!

 

As keynote speaker Daniel R. Matlis pointed out in the summit’s opening minutes, this is the time for our whole industry to embrace change together – to move past planning for it and fully commit to harnessing it. In these 9 powerful sessions, you’ll hear 25 experts offer their view on how that can happen, what it will take, and how it’s already happening for the industry’s digital trailblazers. 

Start streaming today, and see where that unprecedented change may lead!

"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."

The next Digital CMC Summit is already taking shape.

After this year’s fresh success, our team is already looking ahead to what’s next – for the summit, for our Digital CMC community, and for our industry’s transformation trajectory. But while this year’s event raised many important questions about that future, one thing was clear to every attendee: this is a discussion that needs to continue, deepen, and expand for drug development to fully achieve the evolution it needs.

So what will that discussion look like at the next summit? We’re already hard at work envisioning how the third annual conference will build on the momentum of the last two years. Keep your calendar handy for more exciting updates!

Continue the transformation journey with us.

There’s no stopping the Digital CMC revolution, or the energy that’s already powering this community toward the next summit. You won’t want to miss where it takes us next!

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

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.

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.

Michael Stapleton

Life Sciences Luminary and Influencer

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.

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.

Daniel R. 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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

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.

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.

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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