What’s in store for this year’s Summit

All schedules in Central Standard Time (CST)

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

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.

Lewis Shipp

Digital CMC Specialist, QbDVision

Pharmaceutical scientist and expert in drug development & manufacturing across various therapeutic areas. Currently a Digital CMC Specialist at QbDVision, helping global pharma/biotech companies streamline CMC workflows to accelerate therapy delivery.

Mike Greene

Principal Engineer – TS/MS Digital Strategy, Eli Lilly and Company

Mike Greene is currently Principal Engineer – Technical Services Digital Strategy at Eli Lilly and Company where he serves as the technical subject matter expert on Product Lifecycle Management (PLM), bringing together his expertise in process control strategy across modalities and networks with his passion for transformational digital initiatives. Previously, he worked on various global cross-functional initiatives supporting Quality, Manufacturing and Technical Services including data criticality assessments for multiple modalities of API, Drug Product, Device Assembly, and Packaging processes across over 10 sites. He began his career as a frontline Technical Services engineer supporting mAb API production and SME on select unit operations and instruments. Mike graduated from Purdue University with his bachelor’s degree in Chemical Engineering and in his free time enjoys hiking and exploring the wilderness with his friends and family as well as on solo adventures.

Bill Pasutti

Associate Director of Data Science, AskBio

Bill has worked in the pharmaceutical industry for over 15 years in R&D and process development at Merck, Novartis, and AskBio. In his current role as Associate Director of Data Science, he leads a company-wide effort in creating digital road maps and connecting data sources within pre-clinical manufacturing, process development, and MSAT. His efforts are meant to improve communication and collaboration through digitalization and promote data-driven decision-making.

Victor Goetz

PhD, Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company

Victor is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. Leveraging his 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed delivery of new medicines to patients. Previous to Lilly, he held process development, manufacturing support, and laboratory automation roles at Merck and holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.

Isabel Guerrero Montero

MSAT USP Senior Scientist, Viralgen Vector Core

Isabel currently works at Viralgen Commercial Therapeutic Vector Core as an MSAT Scientist part of the Technology Transfer team. She has years of experience in molecular biology, cell culture and fermentation research with industrial experience as an Upstream Technician responsible for batch record writing and reviewing.

Vijay Raju

VP of CMC

Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.

Andy Zheng

Data Solution Architect, ZÆTHER

A Data Solution Architect working at ZÆTHER who strives to grow and develop cutting edge solutions in industrial automation and life science. Andy has 5+ years of experience within the software automation field providing innovative solutions to customers which improve process efficiency.

Tim Adkins

Director of Digital Life Sciences 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.

Ravi Medandravu

Associate Vice President, Manufacturing and Quality Tech, Eli Lilly and Company

Ravi Medandravu is a seasoned healthcare executive with over 20 years of experience in the pharmaceutical and medical device industries, specializing in global market access and health economics. He has successfully led teams to develop and implement strategies that enhance patient access to innovative therapies worldwide.

Barbara Tessier

Technical Project Lead, invoX Pharma

A great opportunity to connect with like-minded professionals in the pharma industry who are passionate about digital tools like QbDVision. Learning about advancements in Digital CMC, tech transfer, and AI in the pharma sector broadened my understanding and inspired me to explore innovative approaches in my work.

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.

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.

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.

Laurent Lefebvre - Headshot

Laurent Lefebvre

RA CMC Director, Novartis

Laurent is the Director of RA GDD CMC at Novartis. With over 10 years of experience working as a worldwide Regulatory CMC Project Lead on blockbuster brands, he is an expert in the entire CMC product lifecycle in global regulatory environments. Laurent has been a core team member of the Novartis Regulatory Strategy and Intelligence for IDMP since 2014 and a member of the EFPIA ICH M4Q support team. He is involved in regular collaborations cross-industry (IDMP roundtables, Pistoia Alliance), digital initiatives (RIM structured authoring, master data & PLM), reviewer of the ISO IDMP guidelines and a Novartis contributor to regulatory intelligence discussions.
Laurent Lefebvre - Headshot

James Maxwell

Life Sciences Innovation Lead, Accenture

James Maxwell is an Innovation Lead at Accentures Global Centre for R&D and Innovation. He leads strategic innovation programs with global Life Sciences organizations to solve challenges, rapidly prototype and prove value for future solutions across the end-to-end Life Sciences value chain. With a background in design, research and innovation strategy he has worked with multiple organizations to take an innovation approach for solving challenges across CMC.
Paul Denny-Gouldson - Headshot

Paul Denny-Gouldson

CSO, Zifo

Paul is the CSO at Zifo RnD Solutions, a global specialist scientific and process informatics service provider working across research, development, manufacturing and clinical domains. He obtained his Ph.D. in Computational Biology from Essex University in 1996 and started his career as a Post Doc, and subsequently Senior Scientist at Sanofi-Synthelabo Toulouse (now Sanofi) for five years, where he managed a multidisciplinary molecular and cell biology department. He has also founded a number of companies focused on combining science, technology and business, and authored more than 25 scientific papers and book chapters.
Chris McCurdy

Chris McCurdy

Chief Architect of Healthcare and Life Sciences at Amazon Web Services

Chris McCurdy serves as Chief Architect of Healthcare and Life Sciences (HCLS) for Amazon Web Services (AWS), where he leads teams responsible for architecting cutting-edge services, unlocking data assets, and opening novel analytics capabilities for customers. With over 20 years of industry experience, Chris plays a key role in envisioning and developing innovative solutions and services that accelerate customer value while improving patient outcomes.
Isabell Hagemann Headshot - Digital CMC Basecamp - QbDVision

Isabell Hagemann

Scientific Assistant, Biological Development, Downstream, Bayer AG

Isabell Hagemann is a biochemical engineer by training and has worked at Bayer AG in the biological development downstream department in 2017. In that time, she has worked on process development, process characterization, and the technology transfers of several biologics using high-throughput development systems, modeling approaches, and knowledge management tools.

Ganga Kalidindi

Global Head TRD Data Assets & Insights, Novartis

As the Global Head TRD Data Assets and Insights at Novartis, Ganga Kalidindi brings a unique combination of Information Technology and Product Development expertise to delivering in a regulatory landscape. Throughout his career, he has striven to make direct positive impact on business providing leadership that creates cross-functional high-performing teams. Focusing on complex business and technical challenges, leading through change, and creating success that takes programs and companies to a winning status.
Fran Leira Headshot - Digital CMC Basecamp - QbDVision

Fran Leira

Global Head of Process Engineering CoE, CSL Behring

Fran Leira is a biopharma Professional with over 20 years of experience in QC, MSAT/Tech Ops at companies like Genentech, GSK, Merck, and Lonza where he supported Product and Process Lifecycle Management at site-based and global roles. He is currently the Global Head of Process Engineering CoE at CSL Behring.

Florian Aupert Headshot - Digital CMC Basecamp - QbDVision

Florian Aupert

Lab Head, Biological Development, Bayer AG

Florian has a B. Sc. and M. Sc. in pharmaceutical biotechnology with a focus on bioprocess engineering. Since 2018, he’s worked at Bayer AG in Biological Development, concentrating on portfolio program management and tech transfer.

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.

Mark Fish

Managing Director, Scientific Informatics, Accenture

Mark Fish is Managing Director and Global Lead for Accenture’s Scientific Informatics Services Business. Mark has over 25 years of experience in leadership roles in Accenture, Brooks Life Sciences and Thermo Fisher Scientific delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and manufacturing transformation. Mark has extensive experience in agile software development, data strategy, process engineering and robotic automation for research, analytical development and quality control in Life Sciences.

Chris Puzzo

Solution Architect, Digital & Data, Zaether

Chris is a Solution Architect with Zaether, focusing on delivering next-generation digital and data solutions for GxP Life Sciences customers. Chris has previously held technical operations roles within multiple gene therapy manufacturers, including Thermo Fisher Scientific’s CDMO organization where he supported various capital projects including the design, build, and startup of new GxP manufacturing capacity.

Victor Goetz, Ph.D

Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company

Victor Goetz, Ph.D. is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. He has over 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed the delivery of new medicines to patients. Dr. Goetz holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.

Rachelle Howard

Director of Manufacturing Systems Automation and Digital Strategy, Vertex Pharmaceuticals

Rachelle is the Director of Manufacturing Systems Automation and Digital Strategy for Vertex’s Small Molecule Manufacturing Center. She oversees the site Automation Engineering function and has co-led Vertex’s global Digital Manufacturing Transformation program since 2019. She leads several initiatives related to data integrity, data management, and employee education. Rachelle is a graduate of Tufts University and the University of Connecticut where she has degrees in Chemical Engineering and a PhD in Process Control.

Vijay Raju

Vice President, CMC Management, Flagship Pioneering

Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.

Greg Troiano

Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi

Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

Pat Sacco

Senior Vice President Manufacturing, Quality, and Operations, SalioGen

Pat is a Biotechnology technical operations executive with 30+ years of experience leading and managing technical operations functions at numerous innovative companies in the biotech and life sciences industries. He has a passion for advancing and implementing best practices in pharmaceutical manufacturing.

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 a Senior Director in the Flagship Digital, IT, and Informatics team, where he leads and manages the digital evolution for Pioneering Medicines. His role is pivotal in ensuring that digital strategies align with the overall goals and objectives of the Flagship Pioneering initiative.

His robust background in digital life sciences includes expertise in applications, informatics, data management, and IT/OT management. He previously spearheaded Digital Biomanufacturing Applications at Resilience, a CDMO start-up backed by Arch, where he established a team responsible for implementing global manufacturing automation systems, Quality Assurance applications, laboratory systems, and data management applications.

Matt holds a B.S. in Biology and Biotechnology from Worcester Polytechnic Institute and an M.B.A. from the Boston University Questrom School of Business, where he focused on Strategy and Innovation.

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