The future of high-performance drug development is here

February 25-27, 2025 Austin, TX

Digital Transformation
Digital Culture
Change Management
MDM to MKM
E2E Lifecycle Management
KM to Digital Twins
KM to Gen AI/AI
Digital Tech Transfer
Process Geneology
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Here’s why you should attend the Summit:

It’s the movement transforming the drug development lifecycle, powered by experts and leaders from across the pharmaceutical and technology sectors. Focused on helping organizations safely, swiftly, and effectively deliver the next generation of breakthrough therapies to patients.

It’s a can’t-miss event for:

50+

HOURS OF INSIGHTS

100+

INDUSTRY LEADERS

20+

EXPERT-LED SESSIONS

TOP15

Pharma & Biotech Speakers

Attendee raves

See what attendees are saying about our event! Discover how our sessions and community impact their work, and why they’re excited to be part of this journey.

New year, exciting new activities

Kick off the new year with exciting activities designed to spark innovation and collaboration

Innovation Challenge

An interactive session, where attendees form teams to brainstorm and develop cutting-edge solutions to real-world problems.

Keynote Panels

Attend inspiring keynote panels featuring top thought leaders and visionaries from the pharma and biotech industries.

Networking

Expand your professional network in a relaxed setting with events like the Kickoff Networking Party, Summit Soiree, and Happy Hours.

Members Only

Project Artemis

An exclusive consortium where industry experts collaborate to tackle the most pressing challenges in our field.

Meet our speakers

Stay tuned as we reveal more incredible speakers from the industry.
Exciting announcements coming soon!

Ravi Medandravu

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

Tim Adkins

Director of Digital Life Sciences Operations, ZÆTHER

Yash Sabharwal

President & CEO,
QbDVision

Mike Stapleton

Life Sciences Luminary
& Influencer

Luke Guerrero

Chief Operating Officer,
QbDVision

Joschka Buyel

Director of Product
Management, QbDVision

What’s in store for this year’s Summit

All schedules in Central Standard Time (CST)

Day 1 | Summit

Tue, Feb 25

3:00pmSummit Registration & Happy Hour
4:30pmSummit Content Session
6:00pmDinner, Networking

Day 2 | Summit

Wed, Feb 26

7:30amBreakfast
8:30amSummit Content Session
6:00pmSummit Soiree Kickoff
7:00pmSocializing, Networking

Day 3 | Summit

Thur, Feb 27

7:30amBreakfast
8:30amSummit Content Session
1:00pmInnovation Challenge
4:30pmDinner

Ready to experience the future of CMC?

Who attends the Summit?

Our diverse attendees come from key sectors such as Pharma, Industry Groups, CDMOs, Biotech, Regulatory, and more…

Attendee Roles

Company Types

How to get involved

Discover how you can actively contribute and engage with the Digital CMC community

Join the Digital CMC community
Become a future speaker
Explore Summit sponsorships
Discover Project Artemis

Join us back at Hotel ZaZa!

One of Austin’s premiere destinations will welcome attendees once again.

Secure Your Spot with the Early Bird discount!

Join top industry leaders, experts, and innovators for three days of insights, networking, and transformative discussions. Act fast – Early Bird pricing ends soon!

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.

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.

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.

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.

Joschka Buyel

Director of Product Management, QbDVision

Joschka Buyel is the Director of Product Management at QbDVision. He was previously responsible for the rollout and integration of QbDVision at Bayer and 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.

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.

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