2025 Digital CMC Summit
February 25 to 27, 2025 | Austin, Texas
The 2025 Digital CMC Summit brought together drug development leaders to examine how digital and AI technologies are already reshaping technical development programs across the industry.
Explore the 2025 sessions
Seven sessions from the Summit are available on demand, with speakers from Eli Lilly, Takeda, AbbVie, AskBio, Accenture, and more.
Innovation in Regulated Industries: Lessons from Space
Keynote | Doug Hurley, NASA astronaut and U.S. Marine Corps colonel
Hear how NASA and SpaceX advanced crewed spaceflight within strict regulatory requirements, and what those lessons mean for innovation in drug development.
Fostering a Digital Culture and Effective Change Management
Panel discussion | Tommy Cronin, AbbVie; Devendra Deshmukh, Thermo Fisher Scientific; Barry Heavey, Accenture; Matthew Schulze, Flagship Pioneering; Tina Beaumont, Accenture
Learn how leading organizations build data-fluent teams and manage the change that sustains digital transformation at scale.
Real-World Use Cases for CMC Digitalization and Solutions
Panel discussion | Leaders from Eli Lilly, AskBio, Viralgen, and Accenture
See how these organizations deployed Digital CMC solutions, including digitized tech transfer, and what they learned along the way.
Connecting the Digital CMC Ecosystem
Panel discussion | Bill Pasutti, AskBio; Tim Adkins, Zaether; Andy Zheng, Zaether; Lewis Shipp, QbDVision
Explore strategies and technologies that connect siloed CMC data, sharpen decisions, and raise productivity across technical development.
Project Artemis: Building a Functioning and Sustainable Digital CMC Ecosystem
Panel discussion | Michael Stapleton, QbDVision; Christoph Pistek, Takeda; Vijay Raju, Flagship Pioneering; Jack Morel, QbDVision
Learn how Project Artemis brings the industry together to drive collaboration and standardization for Digital CMC.
CMC Data: A New Frontier for the Biopharma Gold Rush
Lightning talks | Experts from ZS Associates, Thermo Fisher Scientific, and QbDVision
Get rapid insights on AI, digital tech transfer, and predictive analytics in CMC workflows.
The Future of QbDVision
Presentation | QbDVision leadership
See the QbDVision roadmap for knowledge management, AI-driven automation, and faster regulatory submissions.
Topics covered
- Digital transformation
- Digital culture and change management
- MDM to MKM
- End-to-end lifecycle management
- Knowledge management to digital twins
- Knowledge management to generative AI and AI
- Process genealogy
- Digital tech transfer
The Summit by the numbers
- 50+ hours of insights
- 100+ industry leaders
- 20+ expert-led sessions
- Speakers from the top 15 pharma and biotech companies
Who attended
Attendees came from pharma, biotech, CDMOs, industry groups, and regulatory organizations, representing roles including:
- Process development
- Analytical development
- Drug substance and drug product development
- MSAT
- CMC leadership
- Quality assurance
- Validation
- Information technology
- Facilities design
- Innovation leadership
The Digital CMC Visioneer Awards
This year's Summit recognized the leaders whose vision, innovation, and dedication are shaping the future of drug development. Read the 2025 Summit recap.
The Innovation Challenge
Cross-functional teams took on real industry bottlenecks, applying new thinking to AI-driven automation, regulatory compliance, and knowledge transfer. See the highlights and winning concepts.
Get involved in future events
Join the Digital CMC community as an attendee, speaker, or sponsor, or learn more about Project Artemis. Contact our team to get started.
This year's Summit speakers and panelists
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