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DIGITAL CMC BASECAMP

Your journey towards high-performance drug development starts here

  • TUESDAY, MAY 14TH 2024
  • BOSTON, MA
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Start the journey to tomorrow’s CMC

Every digital transformation story has a beginning. Coming to Digital CMC Basecamp is the first step for life science leaders interested in starting their journey. These exclusive events capture the energy and authenticity of the Digital CMC Summit, but in a smaller, more intimate setting where the life science community can speak freely and discover the innovative ideas, solutions, and strategies that will change drug development for the better.

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World-class speakers

Hear from leaders who are spearheading drug development’s digital transformation.

Panel

Expert thought leaders

Share the air with some of the industry’s most renowned process, manufacturing, and innovation specialists.

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Open forum

Join the kind of real, authentic conversation that can spark and sustain transformation.

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Exclusive networking

See why Basecamp is perfect for making new connections, starting new discussions, and discovering fresh ideas.

What to expect at Digital CMC Basecamp

Come be part of the digital revolution in CMC: a movement that’s driving the operational, scientific, and analytical modernization of the drug development process.

Join your peers to take a fascinating, in-depth look at how CMC leaders are enhancing their risk management strategies, and creating unprecedented process intelligence.

Learn

Gather new strategies for breaking down CMC’s operational silos.

Connect

Share a unique deep-dive experience with fellow innovation experts.

Explore

Discover new approaches to enhancing productivity and mitigating risk.

Unlock

See how powerful CMC data can be with the right models and structures.

See what's in store

  • Basecamp Schedule
12:00pm to 1:00pm | Registration
Official Digital CMC Basecamp registration starts Thursday afternoon.
1:00pm to 1:15pm | Welcome to Digital CMC Basecamp

The digital transformation of pharma is underway, and it’s a strategic priority for businesses and regulators. The audience here is leading the charge.


Speaker: Luke Guerrero, COO, QbDVision

Format: Speaking Session

1:15pm to 2:00pm | How Structured Data Frameworks Provide the Foundation for CMC Digitization and Digitalization
Overview: The future of CMC will be shaped by digitization and digitalization supported by structured data frameworks. This presentation will focus on how structuring your CMC data is foundational to the development of a vertically integrated knowledge base for lifecycle management. Specifically, key topics will be explored such as bridging the chasm between development and manufacturing and how a structured CMC framework can provide rich contextualization to data in data lakes and data warehouses. The advent of AI has created many opportunities to leverage the vast amounts of data generated by pharma and biotech companies. Explore how structured data can make the application of AI tools more robust.

Join us for discussions on:
  • Structured Data Frameworks Fit for Pharma/Biotech Development
  • Hierarchy of Taxonomies and Ontologies Supporting Structured Frameworks
  • Building A Vertically Integrated Knowledge Base Using a Digital CMC Approach
  • How Structured Data Will Support the Future of Regulatory Submissions

Presentation: How Structured Data Frameworks Provide the Foundation for CMC Digitization and Digitalization.
Speaker: Yash Sabharwal, Director, CEO, Co-Founder QbDVision

Format: Speaking Session
2:00pm to 3:00pm | Building a Digital Bridge Between R&D and Manufacturing
Overview: Explore the transformative role of Digital CMC solutions and how they address the challenges faced by life science companies throughout pre-commercial development stages. Modern PLM and end-to-end lifecycle management technologies are revolutionizing how pharma and biotech deliver new therapies to patients. These tools have been shown to enhance operational efficiencies, streamline regulatory initiatives, and accelerate key workflows from R&D through commercial phases. Learn how these platforms contextualize data across multiple teams, systems and sites to provide a holistic view of development activities for commercial translation and regulatory compliance.

Join us for discussions on:
  • How organizations are thinking about Digital CMC to drive operational and regulatory efficiency
  • How organizations are addressing the challenges of bridging their development and manufacturing organizations
  • Perspectives from organizations operating at different scales on their Digital CMC journeys

Moderator: Mike Stapleton, Board Director at QbDVision
Panelists:
Greg Troiano, Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi
Pat Sacco, Senior Vice President Manufacturing, Quality, and Operations, SalioGen
Rachelle Howard, Director of Manufacturing Systems Automation and Digital Strategy at Vertex Pharmaceuticals
Matthew Schulze, Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Format: Panel Session
3:00pm to 3:15pm | Break & Networking

Break time! Beverages and Snacks will be provided. Socialize and network with speakers and attendees.

3:15pm to 4:00pm | Standardizing CMC Development Practices Across a Portfolio of Products

Overview:
The advent of newer technologies and advanced modalities has reinstated CMC as a critical enabler of life changing therapies. This incredible superpower to touch lives also comes with greater responsibility towards our scientists. How can CMC scientists be even more focused on science? How can we make their everyday work more meaningful? This talk will apply the lens of how standardization and digitalization across the value chain can make work more efficient and impactful for the scientists.

Join us for discussions on:

  • Big trends defining the future CMC paradigm.
  • Key opportunities for standardization and digitalization across the value chain from a biotech and big pharma perspective
  • Making the workplace more exciting for the scientists of today and the future


Speaker: Vijay Raju, Vice President, CMC at Pioneering Medicines/Flagship Pioneering

Format: Keynote Speaking Session

4:00pm to 5:00pm | Real-World Use-Cases for CMC Digitalization
Overview: Explore the tangible impact of Digital CMC implementation through insightful conversations 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.

Join us for discussions on:
  • Opportunities for making the transition from legacy knowledge management to a modern digital CMC ecosystem
  • Leveraging a Digital CMC approach to bring structure and context to primary data systems (e.g. ELNs, LIMS, Historians)
  • Linking control strategy discussions with automation and control systems design
  • Integration of Digital CMC technologies with downstream solutions (e.g. MES, ERP) to streamline the transfer into commercial operations.

Presentation: Data Strategies for CMC to Support Lifecycle Management
Moderator: Luke Guerrero, COO, QbDVision
Speakers:
Diana Bowley, Associate Director, Data & Digital Strategy, AbbVie
Victor Goetz, Ph.D, Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company

Format: Presentations followed by live Q&A with Panel
5:30pm to 8:00pm | Basecamp Afterparty
Join us at Glass House for the Basecamp Afterparty and enjoy complementary dinner, drinks and networking.

Location: Glass House [Get Directions]

Featured speakers & moderators

KEYNOTE SPEAKER

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.

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KEYNOTE SPEAKER

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.

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Diana Bowley

AbbVie

Greg Troiano

Sanofi

Pat Sacco

SalioGen

Vijay Raju

Flagship Pioneering

Matthew Schulze

Flagship Pioneering

Victor Goetz, Ph.D

Eli Lilly and Company

Rachelle Howard

Vertex Pharmaceuticals

Yash Sabharwal

QbDVision

Mike Stapleton

QbDVision

Luke Guerrero

QbDVision

Yash Sabharwal

QbDVision

Luke Guerrero

QbDVision

Joschka Buyel

Bayer Pharmaceuticals

Gloria Gadea Lopez

Business Platforms

Sue Plant

Biophorum

BasecampSponsors

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CIC Innovation Center Welcomes You To Digital CMC Basecamp.
Our basecamp event kicks off at CIC Innovation Center, 245 Main St., Cambridge, MA at 12pm.
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Basecamp Afterparty at Glass House | 5:30pm
Glass House is a restaurant, bar, and modern day “meeting house” inspired by the history and present day identity of Kendall Square.
Explore Glasshouse
World-Class Speakers & Expert Thought Leaders
Hear from leaders who are spearheading drug development’s digital transformation.
Explore Our Speakers
Exclusive Networking
See why the Basecamp is perfect for making new connections, starting new discussions, and discovering fresh ideas.
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Basecamp

CIC Cambridge @ 245 Main – 3rd Floor, Mosaic Room

245 Main St, Cambridge, MA 02142

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Afterparty

Glass House

450 Kendall Street, Cambridge, MA 02142

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Request an invite to Digital CMC Basecamp

Welcome to Digital CMC Basecamp! Our events are currently exclusive and invite only.

If you’re interested in attending and believe you’d be a valuable addition to our community, please fill out the form on the right and tell us why you’d like to join us.

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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.

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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.

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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.

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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.

Linkedin

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.

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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.

Linkedin

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.

Linkedin

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.

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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.
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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.

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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.

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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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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.

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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.

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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.

Linkedin

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.

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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.

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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.

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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.

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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.

Linkedin

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

Linkedin

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.

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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.

Linkedin

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.

Linkedin

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.

Linkedin

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.

Linkedin

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.

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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.

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