Sessions, Tracks & Topics
Digital CMC Summit Schedule
Explore our future-focused event lineup, curated by some of the industry’s leading CMC experts and presented by an unrivaled panel of technical experts, process development gurus, and life science innovators. All times are listed in Central Standard Time (CST, PST +2).
Check back soon for more details
2:00pm – 3:00pm
Customer Breakout
QbDVision Customer Product Release (Live)
Join our team as we broadcast our newest product release webinar live from Digital CMC Summit.Â
Location: Hotel ZaZa 7th Floor – Don’t Mess With Texas Room
Format: Presentation with Q&A
3:00pm – 5:00pm
Registration
Official summit registration starts Tuesday afternoon.
Get your credentials for the summit on the 7th floor of Hotel ZaZa.
Location: 7th Floor, Hotel ZaZa
4:00pm – 5:00pm
Registration – Happy Hour
Get your badge, network and grab a drink before our opening keynote
Get your credentials for the summit on the 7th floor of Hotel ZaZa.
Location: 7th Floor, Hotel ZaZa
5:00pm – 5:15pm
Kickoff Session
Title:Â Digital CMC Summit Kickoff
Yash Sabharwal, Director, CEO, Co-Founder QbDVision
The digital transformation of pharma is underway, and it’s a strategic priority for businesses and regulators. The audience here is leading the charge.
Location: Main Stage
Format: Speaking Session
5:15pm – 6:00pm
Opening Keynote
Title: Embracing Change Together: Adapting to Price Pressures, Regulatory Shifts, and Technology Revolution for Accelerated Biopharma Time-to-Market
In today’s Biopharma landscape, pricing pressures are compelling the industry to reevaluate and revolutionize current approaches to expedite time-to-market processes.
Forward-thinking Biopharma companies are leading the way by reshaping their organizational cultures, embracing cutting-edge technologies, and aligning with modern regulatory frameworks. These strategic changes have resulted in exponential leaps in productivity across development, approval, and manufacturing phases. As a direct outcome, Bio-Pharma organizations are accelerating their time-to-market and delivering enhanced patient outcomes.
Join us in an insightful keynote by Daniel R. Matlis, President of Axendia Inc., as he delves into the transformative journey undertaken by industry leaders. Discover how they are not only adapting but thriving in the age of continuous disruption. Gain a profound understanding of why those who fail to innovate risk stagnating in this new Bio-Pharma landscape.
Location: Main Stage
Format: Keynote Speaking Session
6:00pm – 9:00pm
Socialization & Networking
Join us for networking, complimentary hors d’oeuvres and beverages.
Let’s talk it out @ Group Therapy.
Join us for an exclusive networking event at Group Therapy, Hotel ZaZa’s elite restaurant and lounge, located on the 7th floor.
- Meet and greet with life science luminaries.
- Make new connections in the Digital CMC community.
- Experience some of Austin’s premier nightlife.
7:30am – 8:30am
Breakfast & Registration
Complimentary breakfast at 7th floor atrium in Hotel ZaZa while morning arrivals check in for the summit.
8:30am – 8:45am
Welcome Session
Title: Welcome and opening remarks (safety, event details, etc.)
Ryan Shillington, CTO, Co-Founder, QbDVision
Welcome and opening remarks (safety, event details, etc.)
Location: Ball Room
8:45am – 10:00am
Content Session
Title: Trends in Digital Maturity for Biomanufacturing
Oliver Hesse, VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals
Yash Sabharwal, President & CEO, QbDVision
Relative to other industries, the biopharmaceutical industry is still well behind other industry sectors when it comes to digital maturity. Attend this session to learn more about current trends and how innovators are rapidly closing the gap.
10:00am – 10:15am
Break
Break
10:15am – 11:00am
Breakout
Title: Digital Realization for Business Value
Robert Dimitri, M.S., M.B.A., Director Digital Quality Systems, Thermo Fisher Scientific
This whitepaper has been developed for the benefit of business leaders and decision makers within the medical product and medical device regulated industries. This particularly includes those who sponsor and work with transformation leaders in their organizations.
The concepts, insights, and tools shared within this short whitepaper have been chosen to inform dialog between such leaders who are seeking to define business value, overcome perceived challenges, and adopt suitable roadmaps for specific contexts of transformation. The tension that this whitepaper seeks to provide guidance on how to balance near-term wins that justify investment, with the significant work of enabling the capabilities needed for sustainable and longer-term success.
The IAAE Life Science Advisory Board representatives are an informed and credible source of insight on matters of business and digital transformation. They have decades of experience in leading transformation initiatives, projects, and programmes, within the Life Sciences manufacturing industry. Their distilled reflections on these experiences are captured here for the benefit of their peers, and the wider community of those who lead transformation in their organizations.
The following white paper is intended to provide a consensus view on best practices and approaches for establishing the value proposition for digital transformation programs and related activities from the leaders and practitioners who have successfully navigated internal and external barriers to build programs that offer tangible benefits
Format: Whitepaper Presentation
Location: Ball Room
11:00am – 12:00pm
Content Session
Title: Mastering Data Management with a Knowledge Management Mindset
Matthew Schulze, Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering
Mike Stapleton, Life Sciences Luminary and Influencer
Devendra Deshmukh, Global Head, Digital Science Business Operations, Thermo Fisher Scientific
Yash Sabharwal, President & CEO, QbDVision
Master Data Management is a crucial next step for biotech and pharma organizations at any stage of development. It helps organizations to create and maintain a single source of truth for patient, product, and process data allowing easier decision-making, increased efficiency, and reduced costs. Join industry leaders for this panel to learn how they’ve mastered Master Data Management.
Format: Group Panel with Q&A
Location: Ball Room
12:00pm – 1:00pm
Lunch
Fuel up for the afternoon at Group Therapy, while you network with your peers and new contacts.
1:00pm – 2:00pm
Content Session
Title: Digital Regulatory Submissions: The Future is Near, Are You Ready?
Sue Plant, Phorum Director, Regulatory CMC, Biophorum
Kir Henrici, CEO, The Henrici Group
Joschka Buyel, Senior MSAT Scientist at Viralgen, Process & Knowledge Management Scientist at Bayer AG
Structured data is here to stay. Whether it’s the FDA’s KASA initiative, conversations about M4Q (R2), or discussing IDMP and PQ/CMC, you’ve probably heard rumblings in regulatory. Learn more about what’s happening in the industry and strategies you can use to align your digital initiatives to the future of CMC.
Format: Speaking Sessions & Panel
Location: Ball Room
2:00pm – 3:15pm
Content Session
Title: Driving Operational Efficiencies in CMC Operations
Todd Lybrook, Digitalization Portfolio Director, Siemens Digital Industries Software
Max Peterson, Lab Data Automation Practice Manager, Zifo
Shameek Ray, Head of Quality Manufacturing Informatics, Zifo
Ryan Nielson, Life Sciences Global Sales Director, Rockwell Automation
They’ve successfully managed digital change at their organizations, now hear how they did it. This session will cover organizational best practices that transform digital advocates into digital leaders. Learn how to build and successfully support a case for your organization by attending this session on the strategy, hurdles, and institutional impact of innovation.
Format: Speaking Sessions & Panel
Location: Ball Room
3:15pm – 3:45pm
Break
Break
3:45pm – 5:00pm
Content Session
Title: Beyond Digital CMC: Charting the Future of Digital Drug Development
Tim Adkins, Digital Life Science Operations, ZÆTHER
Andy Zheng, Data Solution Architect, ZÆTHER
Anthony DeBiase, Offering Manager, Rockwell Automation
While Digital CMC may start your digital transformation journey, additional tools and capabilities can help your team create a robust future state. Hear how Siemen’s RiffynX, Rockwell’s Digital Tech Transfer, Emerson’s Syncade, and others are shaping the future of digital drug development.
Format: Speaking Sessions & Panel
Location: Ball Room
6:00pm – 9:00pm
Summit Soiree
Join us offsite at the Summit Soiree for your fill of tacos, tequila, and tech transfer.
Plus live local music, featuring Austin’s Ruby Dice.
Venue: Malverde (La Candesa), Austin
Malverde offers skyline views of downtown Austin and looks directly into Austin City Limits. Malverde features mexican-style cuisine with a modern take.
Directions: 400-B W 2nd St, Austin, TX 78701
7:30am – 8:30am
Breakfast
Grab a complimentary breakfast at 7th floor atrium in Hotel ZaZa before diving into Day 3 activities.
8:30am – 9:45am
Content Session
Title: Real World Deployment Use-Cases for Sponsors & CDMOs
Blake Hotz, Manufacturing Sciences Data Manager, Sanofi
Grant Henderson, Sr. Dir. Manufacturing Science and Technology, VernalBio
Explore the tangible impact of Digital CMC implementation through insightful conversation with industry trailblazers. Delve into their strategies for utilization, project deployment, integration with teams and systems, and other crucial aspects. Gain exclusive access to the firsthand experiences and valuable insights shared by the pioneers of Digital CMC.
Format: Speaking Sessions & Panel
Location: Ball Room
9:45am – 10:15am
Break
Break
10:15am – 11:00am
Breakout Sessions
Title: Getting Started: Transitioning from Document-Centric to Data-Centric Development
Pharma & Biotech companies around the world are now discussing a move from document-centric to data-centric development (document-centricity of course referring to pharma’s document-dependency).Â
However, even though companies want to move away from the document, or not be ‘document-centric’, fundamentally the industry still communicates through documents, sends information via documents etc. So, the solution (as we see it) is to not rely on the document as your source of knowledge. But, to index the content of the document, building an integrated knowledge base based on structured data frameworks where key information is Findable, Accessible, Interoperable & Reusable (FAIR). Once you have done this, the document becomes what it always should have been – an after-thought, not a priority.Â
In this workshop we’re going to explore a 3-step approach to indexing content (information), as opposed to indexing documents. We’ll discuss this through an example, a QTPP, and we’ll look at how you might approach indexing the content of this typically huge, controlled document with the end result of building a digital-QTPP that is completely aligned with ICH Q8. Thereby shifting the point of scientific collaboration away from the document, and towards the data.
We hope that this workshop will provide new insight into the transition from document-centric development to data-centric development, and act as a source of inspiration to enact change at your respective organizations.Â
Format: Moderated Breakout
Location: Don’t Mess With Texas (Breakout Room)
Title: Master Data Management: The Key to a Smooth and Reliable Data PipelineÂ
A recent survey by Gartner found that 75% of pharma executives consider MDM a critical priority for their organization, yet only 15% are fully satisfied with their current MDM capabilities. This gap may be due to a number of factors, including the complexity of MDM implementation and management, a lack of awareness of best practices, and insufficient resources.
Despite the challenges, several pharma companies have successfully implemented MDM, achieving significant benefits such as improved operational efficiency, reduced costs, accelerated product development, and enhanced compliance.
In this workshop, we will discuss successful strategies from these implementations and best practices for implementing and managing MDM in pharma/biotech companies.
Format: Moderated Breakout
Location: Rainmaker (Breakout Room)
11:00am – 12:00pm
Content Session
Title: Future of QbDVision
Luke Guerrero, COO, QbDVision
Yash Sabharwal, Director, CEO, Co-Founder QbDVision
Join our team for an exclusive, behind-the-scenes look at the new and improved features coming to QbDVision.
Format: Speaking Sessions
Location: Ball Room
12:00pm – 1:00pm
Lunch
Fuel up for the afternoon at Group Therapy, while you network with your peers and new contacts.
1:00pm – 6:00pm
Pharmageek Innovation Challenge
Title: Pharmageek Innovation Challenge
Join us in redefining the traditional hackathon. This is not your typical coding challenge–it’s an immersive experience where collaboration, innovation, and ideation take center stage.
- Work shoulder to shoulder with our engineers and cross-industry experts to brainstorm innovative software features
- Have your voice heard in dynamic ideation sessions focused on practical solutions
- Eat, drink, and work with your team at a chance to win prizes
Location: To Be Announced
