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. 

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: 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

Daniel R. Matlis, Founder & President, Axendia

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

Gloria Gadea Lopez, Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering
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

Chris Kopinski, Business Development Executive, Life Sciences & Healthcare at AWS
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

Todd Lybrook, Digitalization Portfolio Director, Siemens Digital Industries Software
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

Joschka Buyel, Senior MSAT Scientist at Viralgen, Process & Knowledge Management Scientist at Bayer AG
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). 

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. 

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. 

Format: Moderated Breakout

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

Title: Master Data Management: The Key to a Smooth and Reliable Data Pipeline 

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

Ryan Shillington, CTO, Co-Founder, 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

Luke Guerrero, COO, QbDVision

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

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. 

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: 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

Daniel R. Matlis, Founder & President, Axendia

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

Gloria Gadea Lopez, Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering
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

Chris Kopinski, Business Development Executive, Life Sciences & Healthcare at AWS
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

Todd Lybrook, Digitalization Portfolio Director, Siemens Digital Industries Software
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

Joschka Buyel, Senior MSAT Scientist at Viralgen, Process & Knowledge Management Scientist at Bayer AG
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). 

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. 

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. 

Format: Moderated Breakout

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

Title: Master Data Management: The Key to a Smooth and Reliable Data Pipeline 

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

Ryan Shillington, CTO, Co-Founder, 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

Luke Guerrero, COO, QbDVision

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

Diana Bowley

Associate Director, Data & Digital Strategy, AbbVie

Diana is the Associate Director, Data & Digital Strategy in S&T-Biologics Development and Launch leading the organization’s Digital Transformation since October 2021. She joined AbbVie in 2012 in the R&D-Discovery Biologics group focused on antibody and multi-specific protein screening and engineering, leading multiple programs to the cell line development stage. In 2017 she joined Information Research and led a team of IT professionals who supported AbbVie’s Discovery Scientists in Biotherapeutics, Chemistry, Immunology and Neuroscience. She has a PhD in Molecular Biology from The Scripps Research Institute and Bachelor of Science in Chemistry from The University of Northern Iowa.

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Board Director, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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