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).

CHECK BACK SOON FOR FULL DETAILS!

11:00am – 4:00pm

Arrivals & Hotel Check-In

Check into your hotel room and get settled. 

4:00pm – 5:00pm

Registration

Official summit registration starts Wednesday afternoon.

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: Group Therapy at 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: Group Therapy at Hotel ZaZa

5:15pm – 6:00pm

Opening Keynote

Title: TBD

Details to be announced soon.

Location: Group Therapy at Hotel ZaZa

6:00pm – 9:00pm

Socialization & Networking

Join us for networking, complimentary hors d’oeuvres and beverages.

Details to be announced soon.

Location: Group Therapy at Hotel ZaZa

7:00am-9:00am

Breakfast & Registration

Complimentary breakfast at Group Therapy in Hotel ZaZa while morning arrivals check in for the summit.

9:00am – 9:15am

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

9:15am – 10:00am

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

10:00am – 11:00am

Content Session

Title: Building Operational Efficiency with Digital CMC

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

11:00am – 11:15am

Break

Break

11:15am – 12:00pm

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: Collaborating with CDMOs

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: The Rainmaker (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: Ball Room

12:00pm – 1:00pm

Lunch

Fuel up for the afternoon while you network with your peers and new contacts.

1:00pm – 2:30pm

Content Session

Title: Digital CMC Deployment – Real World Use Cases

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: Panel & Moderator

Location: Ball Room

2:30pm – 2:45pm

Break

Break

2:45am – 3:30pm

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: 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)

Title: Tech Transfer Deep Dive

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

Format: Moderated Breakout

Location: Ball Room

3:30pm – 5:00pm

Content Session

Title: Digital CMC, Validation, and Quality Management

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

6:00pm – 9:00pm

Summit Soiree

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

Location: TBD

7:00am – 9:00am

Breakfast

Grab a complimentary breakfast at Group Therapy in Hotel ZaZa before diving into Day 3 activities.

9:00am – 10:00am

Content Session

Title: The Digital CMC Ecosystem

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: Panel with Moderator

Location: Ball Room

10:00am – 11:00am

Content Session

Title: Future of 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: Speakers

Location: Ball Room

11:00am – 11:15am

Break

Break

11:15am – 12:00pm

Breakout Sessions & Workshops

Title: Collaborating With CDMOs

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)

Title: TBA

TBA

Location: Main Stage

12:00pm – 1:00pm

Closing Keynote

Title: TBA

Details to be announced soon.

Location: Ball Room

1:00pm – 1:30pm

Lunch

Grab a complimentary lunch and get out and explore Austin for the afternoon.