What’s in store for this year’s Summit
All schedules in Central Standard Time (CST)
3:00pm – 4:30pm
Summit Registration
Location: Arrival Lounge, 7th Floor
3:30pm – 4:30pm
Summit Happy Hour
4:30pm – 5:00pm
Welcome to Digital CMC Summit
Location: Ball Room    Format: Presentation
Speaker:
- Yash Sabharwal, President & CEO, QbDVision
5:00pm – 6:00pm
Keynote: Scaling Innovation in Highly Regulated Industries – Lessons from Space
Location: Ball Room    Format: Presentation
Speaker:
- Doug Hurley, Astronaut, U.S. Marine Colonel, Speaker, Trailblazer
How can industries drive innovation at speed while navigating complex regulations? NASA astronaut Doug Hurley, pilot of SpaceX’s groundbreaking Demo-2 mission, understands this challenge firsthand. As a key figure in the transition from government-led spaceflight to the private sector, Hurley played a critical role in accelerating the development of Crew Dragon—SpaceX’s first crewed spacecraft—from concept to launch in just six years, defying traditional aerospace timelines.
Hurley’s experience with multiple SpaceX missions and the Artemis program illustrates how innovation scales. If one SpaceX launch proved human spaceflight was possible, the broader mission demonstrates how these breakthroughs can be expanded across an entire industry.
In this keynote, Hurley will explore how space exploration overcame bureaucratic hurdles, embraced digital transformation, and redefined industry norms—all while maintaining the highest standards of safety and quality. His insights will highlight:
Scaling innovation under constraints – Lessons from NASA and SpaceX on accelerating progress without cutting corners.
Balancing speed, quality, and risk – How to foster rapid iteration while ensuring precision.
Breaking industry norms – What biotech and other regulated industries can learn from aerospace’s transformation.
Actionable strategies – Rethinking outdated systems, leveraging partnerships, and applying digital technologies.
Just as spaceflight evolved at an unprecedented pace, biotechnology and other regulated industries can embrace bold change to scale solutions faster than ever—without compromising safety, quality, or compliance.
Kicking off the conference, this talk will reinforce the core message: “This is possible at scale.” The At Scale theme builds on previous years—our first year focused on proving that innovation is possible, while last year highlighted that it’s already happening everywhere. This year, we shift the focus to how organizations can expand technology and new ways of working across their entire enterprise, driving transformation at scale.
6:00pm – 9:00pm
Summit Launch Party | Socialization & Networking
Location: Group Therapy, Hotel ZAZA – 7th Floor     Format: Networking
7:30am – 8:30am
Breakfast
Location: Foyer, 7th floor     Format: Buffet
8:30am – 9:00am
Welcome Session
Location: Ball Room      Format: Presentation
Speakers:
- Luke Guerrero, Chief Operating Officer, QbDVision.
9:00am – 10:00am
Project Artemis: Building a Functioning and Sustainable Digital CMC Ecosystem
Location: Ball Room      Format: Panel
Speakers:
- Mike Stapleton, Life Sciences Luminary & Influencer;
- Jack Morel, Senior Product Manager, QbDVision;
- Ravi Medandravu, Associate Vice President, Manufacturing and Quality Tech, Eli Lilly and Company;
- Christoph Pistek, VP, Head of Sustainability and Technology, R&D – Pharmaceutical Sciences, Takeda;
- Vijay Raju, VP of CMC, Flagship Pioneering.
Inspired by an ambitious NASA “moonshot”—and a historic public/industry partnership—Project Artemis is bringing together a diverse group of contributors in a pre-competitive format where they can unite their collective expertise and resources to establish industry-wide interoperability and standardization. By building a functioning and sustainable Digital CMC ecosystem, we can lay the foundation for a future where advanced therapies are developed and manufactured efficiently, effectively, and at scale. With an emphasis on tangible solutions, diverse partnerships, and long-term sustainability, Artemis will focus not just on why CMC programs need to transform, but the hands-on “how”: tools, resources, and standards that help make Digital CMC achievable industry-wide.
10:00am – 11:00am
Workshops and Networking Break
Location: Foyer, 7th floor      Format: Buffet
10:15am – 11:00am
Workshop [sponsored by ZAETHER] – Beyond the Buzzwords: Architecting a Digital Tech Stack That Actually Delivers
Location: Don’t Mess with Texas Room      Format: Workshop
Workshop Facilitator:
- Michael Cody, Director – Digital Life Science, ZAETHER
Everyone’s talking about the “Digital Tech Stack of the Future,” but what does that actually mean? Do you need a UNS or a data hub layer? Should every system share all data, or is a fit-for-purpose approach more effective? And how do you ensure your digital operations architecture is driving real business value rather than just adding complexity?
In this interactive, no-BS workshop, we’ll break down the key components of a modern digital integration strategy—separating hype from reality. Together, we’ll map out what an effective tech stack looks like, using your Digital CMC Management system as the foundation. Expect live discussions, debates, and practical takeaways on:
- The real business case for system integration—what’s essential and what’s noise
- UNS: The next big thing or just another industry buzzword?
- How to balance interoperability with fit-for-purpose efficiency
- Where companies get digital integration wrong—and how to get it right
This is not just another theoretical discussion. Join us to co-create the digital operations architecture that will actually work—today and tomorrow.
11:00am – 12:00pm
Fostering a Digital Culture & Effective Change Management
Location: Ball Room      Format: Panel
Speakers:
- Barry Heavey, Managing Director, Accenture;
- Tina Beaumont, Managing Director, Life Sciences Strategy, Accenture;
- Devendra Deshmukh, Head of Strategy, Product, & Partnerships, Thermo Fisher Scientific;
- Tommy Cronin, Digital Technical Manager, AbbVie;
- Matthew Schulze, Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering.
This panel session will address the intertwined nature of fostering a digital-first culture and implementing effective change management within the pharmaceutical organizations. As digital transformation accelerates and companies increasingly integrate new digital solutions, organizations must not only adapt technologies but also cultivate a mindset that embraces innovation and agility. Managing these transitions effectively is paramount to overcoming resistance and ensuring seamless implementations.
12:00pm – 1:00pm
Lunch
Location: Group Therapy      Format: Buffet
1:00pm – 2:15pm
CMC Data: The New Frontier for BioPharma Gold Rush
Location: Ball Room      Format: Lightning Talks
Speakers:
- Luke Guerrero, Chief Operating Officer, QbDVision;
- Yash Sabharwal, President & CEO, QbDVision;
- Nupur Sharma, Associate Partner at ZS;
- Kevin Healy, CRO, Datahow LLC.
In today’s rapidly evolving pharma landscape, the success of technology transfer depends on the seamless integration of data, digital tools, and automation. This session will explore how cutting-edge solutions—ranging from AI-driven insights and in-silico tools to advanced data strategy, governance, and workflow orchestration—are transforming tech transfer processes. We will also showcase an AI-based regulatory authoring demo, illustrating how GenAI is revolutionizing CMC documentation. Join us to explore best practices, real-world applications, and strategies to future-proof your tech transfer ecosystem.
2:15pm – 3:15pm
Break
3:15pm – 4:30pm
Real World Use-Cases for CMC Digitization and Solutions
Location: Ball Room      Format: Presentations
Speakers:
- Joschka Buyel, Director of Product Management, QbDVision;
- Isabel Guerrero Montero, MSAT USP Senior Scientist, Viralgen Vector Core;
- Mike Greene, Principal Engineer – TS/MS Digital Strategy, Eli Lilly and Company;
- Anthony Maguire, Director – Digital Strategy at Eli Lilly and Company;
- Whitney Pung, Life Sciences Strategy & Consulting, Accenture.
Biomanufacturing leaders share how cutting-edge Digital CMC solutions are already scaling their workflows. Hear from leaders in the space who will share success stories that have led to realized value for their organization.

Revolutionizing Product Lifecycle Management: The PLM QbDVision Program at Lilly
The Product Lifecycle Management (PLM) Program at Lilly aims to revolutionize how product and process information is managed throughout the Lilly Enterprise by implementing the QbDVision platform. This strategic initiative oversees the digitization of critical product lifecycle data such as product control strategies, manufacturing processes , process development history, and specifications, creating a digital backbone for the organization.
In this talk, we will take you through Lilly’s PLM journey, illustrating our holistic approach for end-to-end knowledge management, how we transitioned from concept to execution, and ultimately, how we manage at enterprise scale.
Platform Lifecycle Management Between Sponsor & CDMO with QbDVision
Technology transfer (tech transfer) is a critical procedure that facilitates the movement of innovative ideas, research findings, and technological advancements from one entity to another. However, traditional tech transfer processes often create delays, especially when development and manufacturing are in different organizations. The complicated exchange of information and continuous need for revision complicates collaboration and hinders timelines.
This presentation shares a better way to manage technology transfer, particularly intracompany transfers, using QbDVision as a central platform for shared information and collaboration. We will discuss how we are creating joint and scalable processes for managing platform transfers between AskBio and Viralgen using QbDVision. This “source of truth” allows AskBio and Viralgen to work together on the technology platform, share information in real time, improve communication (reducing the need for excessive paperwork and meetings), and identify transfer problems and process gaps early on. This approach aims to simplify technology transfer and make it more efficient, ultimately helping get the latest platform updates into GMP faster by promoting direct collaboration between development and manufacturing teams from all companies involved.
4:30pm – 5:00pm
DCMC Visioneer Awards Ceremony
Location: Ball Room
5:00pm – 6:00pm
Break
6:00pm – 9:00pm
Summit Soiree – Socialization, Dinner & Networking
7:30am – 8:30am
Breakfast
Location: Foyer, 7th Floor     Format: Buffet
8:30am – 9:45am
Connecting Digital CMC Ecosystem
Location: Ball Room      Format: Demo
Speakers:
- Lewis Shipp, Digital CMC Specialist, QbDVision;
- Bill Pasutti, Associate Director of Data Science, AskBio;
- Tim Adkins, Director of Digital Life Sciences Operations, ZAETHER;
- Andy Zheng,Data Solution Architect, ZAETHER.
Discover how market-shaping organizations are unlocking new levels of performance by connecting their CMC ecosystems. See live demonstrations of how a growing range of connected technologies are shaping the next generation of digital drug development.
Revolutionizing Digital Operations: Beyond EBR
Agile, Adaptive, and Scalable Digital Operations for the Future of Biopharma Manufacturing
Electronic Batch Records (EBRs) represent a transformative solution compared to the error-prone, inefficient paper batch records of old. However, to scale manufacturing operations, you must look beyond EBRs and into the data/information that comprises them. This session will explore how a connected, digital manufacturing ecosystem can be a)established and b) leveraged to drive operational efficiencies at scale while enhancing regulatory compliance and data integrity. At the heart of this ecosystem is an emphasis on knowledge & product lifecycle management. But, more importantly, there is an emphasis on the need to rethink conventional approaches to “managing data,” which, as you will see, necessitate a strong data culture within an organization.
The Digital Roadmap: Architecting Scalable CMC Operations with QbDVision Integration
For navigating the complexities of scaling CMC operations, a robust digital roadmap is not merely a plan but an essential tool for achieving enterprise-wide scale. This presentation argues that a well-defined digital roadmap provides the strategic architecture necessary to drive digital transformation across the entire CMC organization, enabling scalable workflows and processes. The roadmap is the central instrument of communication and vision, aligning all departments and initiatives towards a shared vision of digital maturity and enterprise-level efficiency.
Part of executing our strategic roadmap is the centralized integration of digital tools like QbDVision with core systems such as ELN and LIMS. This integration demonstrates a key roadmap component of our digital roadmap: achieving scalable data governance and automation. By standardizing data procedures within QbDVision and connecting them across the enterprise, the roadmap ensures consistent data organization, integration, and verification at scale. This enterprise-wide data harmonization unlocks more robust statistical analysis, enhancing data reliability and precision – critical for informed, scalable decision-making in CMC. This presentation will demonstrate how the digital roadmap, exemplified by QbDVision integration, is the key enabler for achieving truly scalable CMC operations.
9:45pm – 10:00pm
Break
10:00am – 10:45am
Workshops & Networking Break | Accelerating Digital Tech Transfer: A Collaborative Approach
Location: Rainmaker Room     Format: Workshop
Workshop Facilitators:
- Sana Ahmed, CSM, QbDVision;
- Isabel Guerrero Montero, MSAT USP Senior Scientist, Viralgen Vector Core.
Learn how to streamline and accelerate digital technology transfer processes within the pharmaceutical industry. This workshop will provide practical tips and techniques for efficient knowledge sharing and collaboration.
Workshop Objectives:
- Understand the challenges faced with paper/document TTÂ and opportunities in digital tech transfer
- Develop a robust digital tech transfer strategy in alignment with PDA 95
- Implement effective knowledge management practices using real world examples
- Utilize digital tools (QbDVision) and technologies to facilitate tech transfer
10:00am – 10:45am
Workshops & Networking Break | Revolutionizing Pharma with Generative AI: From Molecule to MarketÂ
Location: Don’t Mess with Texas Room      Format: Workshop
Workshop Facilitators:
- Ryan Shillington, Co-Founder & CTO, QbDVision
11:00pm – 12:00pm
The Future of QbDVision
Location: Ball Room     Format: Panel
- Luke Guerrero, Chief Operating Officer, QbDVision;
- Joschka Buyel, Director of Product Management, QbDVision
- Yash Sabharwal, President & CEO, QbDVision;
- Ryan Shillington, Co-Founder & CTO, QbDVision.
Imagine a future where CMC data is seamlessly integrated, and AI empowers your daily workflows. QbDVision, the driving force behind Digital CMC, will present a vision of this reality and outline our product roadmap for the coming years. You’ll see how to prepare for the future and master your CMC data. Discover how we are harnessing structured data and AI to accelerate the journey of therapies to patients and significantly improve the lives and efficiency of CMC professionals, making your work more rewarding and transformative.
12:00pm – 1:00pm
Lunch
Location: Group Therapy     Format: Buffet
1:00pm – 5:00pm
Innovation Challenge
Location: Foyer, 7th floor     Format: Ideathon
