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DCMC Session
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Presentation
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Building a Digital Bridge Between R&D and Manufacturing | Digital CMC Basecamp On-Demand | Presentation

Discover how Digital CMC solutions are already driving operational and regulatory efficiency.

See how specialized platforms can help contextualize data across multiple teams, systems, and sites.

Learn how drug developers are using Digital CMC tools to bridge their development and manufacturing organizations.

Hear how operational goals and priorities can evolve across an organization’s Digital CMC journey.

It's a notoriously complex lifecycle transition. Does it have to be?

As digital transformation reshapes the drug product lifecycle, many forward thinkers are focused on one persistently challenging question: How can we streamline the shift from R&D to commercial manufacturing? At the Digital CMC Basecamp in Boston, industry luminary Mike Stapleton took charge of that important conversation.

In this deep-dive panel session, Mike leads a dynamic discussion with 5 marquee leaders from across the industry:

  • Mark Fish, Managing Director at Accenture, lays out his team's approach to developing integrated, contextualized data models that facilitate multi-site knowledge exchange.
  • Rachelle Howard, Director of Manufacturing Systems Automation and Digital Strategy at Vertex Pharmaceuticals, discuss how their digital transformation strategy helps treamline collaboration with numerous outside partners.
  • Matthew Schulze, Head of Digital Pioneering Medicines & Regulatory Systems at Flagship Pioneering, shares what he's learned from migrating legacy information systems to modern data management frameworks.
  • Greg Troiano, Head of cGMP Strategic Supply & Operations at the Sanofi mRNA Center of Excellence, shares how he and his team are building a data-centric knowledge sharing framework from the ground up.


Sign up below to get in-depth insights from every one of these industry innovators!

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QbDVision
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Michael Stapleton

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.

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Accenture
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Mark Fish

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.

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Vertex Pharmaceuticals
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Rachelle Howard

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.

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Flagship Pioneering
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Matthew Schulze

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.

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Sanofi
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Greg Troiano

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.