What’s in store for this year’s Summit
All schedules in Central Standard Time (CST)
- DAY 1 | February 25
- DAY 2 | February 26
- DAY 3 | February 27
3:00pm – 4:30pm
Summit Registration
Location: Arrival Lounge
3:30pm – 4:30pm
Summit Happy Hour
Location: Foyer
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
Location: Ball Room Format: Presentation
Speaker:
- to be announced
6:00pm – 9:00pm
Summit Launch Party | Socialization & Networking
Location: Group Therapy, Hotel ZAZA 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:
- Yash Sabharwal, President & CEO, QbDVision;
- 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.
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 ZÆTHER
Location: Texas Room Format: Workshop
11:00am – 12:00pm
Fostering a Digital Culture & Effective Change Management
Location: Ball Room Format: Panel
Speakers:
- Barry Heavey, Managing Director, Accenture
- Whitney Pung, Life Sciences Strategy & Consulting, Accenture
- Vijay Raju, VP of CMC, Flagship Pioneering
- more speakers to be announced
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.
Hear from industry leaders and Digital CMC pioneers that are forging a new path towards the monetization of CMC data and formulating the new industry currency… CMC Knowledge. These sessions will showcase not just frameworks but replicable outcomes: how leading life science enterprises are putting Digital CMC principles and processes to work and doing so at scale. Technology pioneers from many of these organizations will share strategies, best practices, and organizational results to help guide the next wave of drug developers toward transformation.
2:15pm – 3:15pm
Break
3:15pm – 4:30pm
DCMC Success Stories
Location: Ball Room Format: Panel
Speakers:
- Joschka Buyel, Director of Product Management, QbDVision;
- Isabel Guerrero Montero, MSAT USP Senior Scientist, Viralgen Vector Core;
- Bill Pasutti, Associate Director of Data Science, AskBio;
- Mike Greene, Principal Engineer – TS/MS Digital Strategy, Eli Lilly and Company;
- Anthony Maguire, Director – Digital Strategy at Eli Lilly and Company.
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.
4:30pm – 5:00pm
DCMC Visioneer Awards Ceremony
Location: Ball Room
5:00pm – 6:00pm
Break
6:00pm – 9:00pm
Socialization, Dinner & Networking
Location: 307 W 5th St, Austin, TX Format: Networking
7:30am – 8:30am
Breakfast
Location: Foyer 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, ZÆTHER;
- Andy Zheng,Data Solution Architect, ZÆTHER;
- Thomas Cronin, NPI Technical Team Lead, AbbVie.
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.
10:15am – 11:00am
Workshops & Networking Break | Accelerating Digital Tech Transfer: A Collaborative Approach
Location: Texas Room Format: Workshop
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 TT 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
10:15am – 11:00am
Workshops & Networking Break | Revolutionizing Pharma with Generative AI: From Molecule to Market
To be announced
11:00pm – 12:00pm
The Future of QbDVision
Location: Ball Room Format: Panel
Speakers:
- Luke Guerrero, Chief Operating Officer, QbDVision;
- more speakers to be announced
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: 7th floor, Hotel ZAZA Format: Ideathon