SCHEDULE

Sessions, Tracks & Topics

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).

3:00pm – 5:00pm

Registration

Official summit registration starts Wednesday afternoon.

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: 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: Transforming the CMC Lifecycle: Why the Bio-Pharma Industry Can’t Afford To Wait

Daniel R. Matlis, Founder & President, Axendia

This special session will take an in-depth look at:

  • FDA’s KASA and emerging approaches to maximizing review agility
  • Digital transformation across the entire product lifecycle – from molecule to patient
  • How technology accelerates time to market by optimizing operations and breaking down silos

 

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.)

Yash Sabharwal, Director, CEO, Co-Founder QbDVision

Welcome and opening remarks (safety, event details, etc.)

Location: Ball Room

8:45am – 9:30am

Content Session

Title: The Digital Transformation of CMC Processes is Underway

Yash Sabharwal, Director, CEO, Co-Founder QbDVision

This session will explore the increased prioritization of digital transformation within pharma and biotech and why Digital CMC is the ideal starting point. We’ll discuss how Digital CMC strategically unlocks knowledge, increases process understanding, and reduces quality risks to harness your science’s power.

Format: Speaking Session

Location: Ball Room

9:30am – 10:30am

Content Session

Title: Building Operational Efficiency with Digital CMC

Yash Sabharwal, Director, CEO, Co-Founder QbDVision
Oliver Hesse, VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals
Chris Kopinski, Business Development Executive at AWS | Life Sciences & Healthcare

This session will discuss organizational best practices for leaders to build and successfully support a case for change. In this panel, you’ll hear from top pharma leaders discussing the strategy, hurdles, and institutional impact of innovation. 

Format: Panel & Moderator

Location: Ball Room

10:30am – 10:45am

Break

Break

10:45am – 11:15am

Breakout Sessions & Workshops

Title: Integrated Risk Management

Brainstorming session on what can be done to improve risk management activities in the industry.

Format: Moderated Breakout

Location: Don’t Mess With Texas (Breakout Room)

Title: Tech Transfer Deep Dive

Brainstorming session on what can be done to improve tech transfer in the industry.

Format: Moderated Breakout

Location: The Rainmaker (Breakout Room)

11:15am – 12:15pm

Content Session

Title: Digital CMC Deployment – Real World Use Cases – Part 1 of 2

Gloria Gadea-Lopez, Head of Global Consultancy, Business Platforms
Joschka Buyel, Process & Knowledge Management Scientist, Bayer Pharmaceuticals
John Maguire, Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

SMEs discuss digital CMC implementation and usage strategies, including taxonomy, project rollout, group meetings, and more. Get behind the scenes stories of successful rollouts from the pioneers of digital CMC, along with all of the tips and tricks they learned on the way.

Format: Speaking Sessions

Location: Ball Room

12:15pm – 1:15pm

Lunch

Fuel up for the afternoon at Group Therapy, while you network with your peers and new contacts.

1:15pm – 2:15pm

Content Session

Title: Digital CMC Deployment – Real World Use Cases – Part 2 of 2

Steve Keizer, Senior Quality Assurance Director, Artisan Bio
Amol Thote, Senior Director, Bayer Pharmaceuticals
Justin Grahek, Associate Development Scientist, Bayer Pharmaceuticals

SMEs discuss digital CMC implementation and usage strategies, including taxonomy, project rollout, group meetings, and more. Get behind the scenes stories of successful rollouts from the pioneers of digital CMC, along with all of the tips and tricks they learned on the way.

Format: Speaking Sessions

Location: Ball Room

2:15pm – 3:45pm

Content Session

Title: The Digital CMC Ecosystem

Rob Brooksbank, Principal Consultant, Zifo R&D Solutions
Guy Verrastro, Director of Strategic Account Management, Scitara
Sam Gardner, Senior Product Manager for Health and Life Sciences, JMP Statistical Discovery

Digital CMC may be the start of your digital transformation journey, but there are many other tools and capabilities for consideration as part of a more robust future state. Learn how QbDVision interacts with other technologies and workflows and what next-generation drug development could look like.

Format: Speaking Sessions

Location: Ball Room

3:45pm – 4:00pm

Break

Break

4:00pm – 5:00pm

Content Session

Title: Accelerating MES Implementations with Digital CMC

Michael Cody, Director of Digital & Clinical Manufacturing, Zaether
Adam Cormack, Director of Product Management, Apprentice.io
Michalle Adkins, Life Science Consulting Director, Emerson Automation Solutions
Sachin Misra, Principal & Global Lead, Kalypso

Digital CMC may start your digital transformation journey, but the MES is often the centerpiece of the transition to commercial production.  During this panel section, you’ll hear from some of the leaders in our space discussing the evolving role of MES solutions for the current and new therapeutic modalities.

Format: Panel with Moderator

Location: Ball Room

6:00pm – 9:00pm

Summit Soiree

Join us offsite at the Summit Soiree for complementary food, drinks and socializing in a relaxed environment.

Venue: The Well, Austin

The Well blends top-tier nutrition, local and sustainable farming, and authentic flavors for a breakthrough culinary experience that redefines healthy food in Downtown Austin.

Directions: 440 W 2nd Street, 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 – 8:45am

Welcome Session

Title: Kickoff Final Day of Digital CMC Summit

Yash Sabharwal, Director, CEO, Co-Founder QbDVision

Welcome and opening remarks to kickoff final day of Digital CMC Summit

Location: Ball Room

8:45am – 9:30am

Keynote

Title: Lifecycle Approaches for Robust Control Strategies

Dr. Christoph Herwig, Professor, Vienna University of Technology

This special session will take an in-depth look at:

  • Data management to CMC understanding
  • The deployment of digital twins and its link to MES

 

Format: Keynote Speaking Session

Location: Ball Room

 

9:30am – 10:45am

Content Session

Title: Digital CMC, Validation, and Quality Management

Rebecca Waterbury, Founder, Exemplar Compliance
Kir Henrici, CEO, The Henrici Group
Jack Garvey, Managing Partner, Compliance Architects LLC

As the move to the digitization of information continues in pharma and biotech, the new paradigms of data management are challenging the existing paradigms for data integrity, validation, and overall quality management. In this session, we will explore how digital transformation can drive new modalities of process validation, data integrity, and overall quality management to dramatically improve CMC maturity.

Format: Speaking Sessions

Location: Ball Room

10:45am – 11:00am

Break

Break

11:00am – 11:30am

Breakout Sessions & Workshops

Title: Collaborating with CDMO’s

Discuss best practices for partnering with CDMOs (Contract Development and Manufacturing Organizations) to ensure a smooth and efficient drug development process and how robust CMC and quality assurance strategies are key for success.

Format: Moderated Breakout

Location: Don’t Mess with Texas (Breakout Room)

Title: Q&A with QbDVision Engineering

Open discussion with QbDVision engineers to  explore what’s possible using our API.

Format: Moderated Breakout

Location: The Rainmaker (Breakout Room)

11:30am – 12:30pm

Content Session

Title: Future of QbDVision

Ryan Shillington, CTO, Co-Founder, QbDVision
Luke Guerrero, COO, QbDVision
Yash Sabharwal, Director, CEO, Co-Founder QbDVision

During this session, get an exclusive behind-the-scenes sneak peek into what features are coming down the pipeline for QbDVision, plus a never before seen demonstration on a brand new capability.

Format: Speaking Sessions

Location: Ball Room

12:30pm – 1:30pm

Lunch

Grab a complimentary lunch at Group Therapy, and get out and explore Austin for the afternoon.